SACT (Systemic anticancer therapy) (Formulary)

Important: Formulation and dosage details

Formulation:

Tablets 50mg, 100mg, 150mg (hospital use only)

Dosage:

As per SMC:

• 2179: For the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or in women who have received prior endocrine therapy.
  SMC restriction: for use in women who have progressed on or after (neo) adjuvant endocrine therapy, or progressed during first-line endocrine-based therapy for advanced breast cancer 
• 2135: for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
• 2494: in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

Important: Formulation and dosage details

Formulation:

Tabets 100mg (hospital use only)

Dosage:

As per SMC:

• 2346: as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  SMC restriction: as monotherapy for the treatment of adult patients with previously untreated CLL who have a 17p deletion or TP53 mutation and in whom chemo-immunotherapy is unsuitable.
• 2347: as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
  SMC restriction: as monotherapy for the treatment of adult patients with previously untreated CLL without a del(17p) or TP53 mutation and who are ineligible for fludarabine, cyclophosphamide and rituximab (FCR) therapy.
• 2348: As monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
  SMC restriction: For adults with relapsed/refractory CLL who have had at least one previous therapy, in whom chemo-immunotherapy is unsuitable.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Tablets 20mg, 30mg, 40mg, 50mg (hospital use only)

Dosage:

As per SMC 920/13: As monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 25mg/mL (hospital use only)

Dosage:

As per SMC 878/13: in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.

Important: Formulation and dosage details

Formulation:

Capsules 150mg (hospital use only)

Dosage:

As per SMC 2012: as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Important: Formulation and dosage details

Formulation:

Injection 50mg/mL unlicensed (hospital use only)

Important: Formulation and dosage details

Formulation:

Film-coated tablets 60mg (hospital use only)

Dosage:

As per SMC:

• 2472: treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
• 2579: in adults for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 1mg/ml (hospital use only)

Dosage:

As per SMC 2181: in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adult patients with newly diagnosed, low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count ≤10 x 103/µl), characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene. 

Important: Formulation and dosage details

Formulation:

Tablets film-coated 20mg, 40mg (hospital use only)

Dosage:

As per SMC 2482: for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), and without a known T315I mutation. 

Important: Formulation and dosage details

Formulation:

Tablets 1mg, 5mg (hospital use only)

Dosage:

As per SMC 855/13: for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.

For use after failure of prior treatment with sunitinib or pazopanib off-label or a cytokine.

Important: Formulation and dosage details

Formulation:

Powder for suspension for injection 100mg (hospital use only)

Dosage:

As per SMC 589/09: for treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML).

Important: Formulation and dosage details

Formulation:

Tablets 200mg, 300mg (hospital use only)

Dosage:

As per SMC 2533: maintenance therapy in adult patients with acute myeloid leukaemia who achieved complete remission or complete remission with incomplete blood count recovery following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, haematopoietic stem cell transplantation.

Important: Formulation and dosage details

Formulation:

Film-coated tablets 40mg (hospital use only)

Dosage:

As per SMC 2587: treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable or undesirable.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 25mg, 100mg (hospital use only)

Dosage:

As per SMC 694/11: first-line treatment of chronic lymphocytic leukaemia (CLL) (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. 

Important: Formulation and dosage details

Formulation:

Solution for infusion 25mg/mL (hospital use only)

Dosage:

As per SMC:

• 806/12: In combination with carboplatin and paclitaxel, for the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  SMC restriction: In patients with FIGO stage IV disease.
• 1135/16: in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
  SMC restriction: for use in combination with cisplatin and paclitaxel. 

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 15,000 units (hospital use only) unlicensed

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 3·5mg (hospital use only)

Dosage:

As per SMC:

• 126/04: d for the treatment of patients with multiple myeloma who have received at least two prior therapies, have demonstrated disease progression on the last therapy and who are refractory to alternative licensed treatments for this stage of the disease. 
• 302/06: as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. 
• 822/12: in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.
• 927/13: In combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
  SMC restriction: use as triple therapy in combination with dexamethasone and thalidomide. 
• 1075/15: in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Important: Formulation and dosage details

Formulation:

Tablets 100mg, 500mg (hospital use only)

Dosage:

As per SMC 910/13: Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 50mg (hospital use only)

Dosage:

As per SMC:

• 845/12: treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
  • following autologous stem cell transplant (ASCT) or
  • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).

SMC restriction: treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):

• • following autologous stem cell transplant (ASCT) or
  • following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
• 2229: The treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
  SMC restriction: for the treatment of patients with advanced CTCL, defined as mycosis fungoides stage IIB and above, primary cutaneous anaplastic large cell lymphoma or Sézary
  Syndrome.
• 2310: in combination with cyclophosphamide, doxorubicin and prednisone (CHP) for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).

Important: Formulation and dosage details

Formulation:

Tablets 30mg, 90mg, 180mg (hospital use only)

Dosage:

As per SMC:

• 2147: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
• 2314: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. 

Important: Formulation and dosage details

Formulation:

Tablets 2mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 40mg/mL (hospital use only)

Dosage:

As per SMC 735/11: cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of adult patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
SMC restriction: for use in patients who have received at least 225mg/m2 (three cycles) of docetaxel and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Important: Formulation and dosage details

Formulation:

Tablets 20mg, 40mg, 60mg (hospital use only)

Dosage:

As per SMC:

• 1234/17: For the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. 
• 2386: in combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults. 

Important: Formulation and dosage details

Formulation:

Tablets 15mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 150mg, 500mg (hospital use only)

Dosage:

As per SMC:

• 34/03: treating locally advanced/metastatic breast cancer. 
• 193/05: the adjuvant treatment of patients following surgery for Stage III (Dukes’ C stage) colon cancer. Oral capecitabine appears to be as least as effective as standard IV 5FU/FA chemotherapy with the convenience of oral administration.
• 401/07: first line treatment of patients with advanced gastric cancer in combination with a platinum-based chemotherapy regimen. 
• 507/08: treatment of metastatic colorectal cancer.  

and NICE guidance:

• TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer.
• CG81: Advanced breast cancer: diagnosis and treatment.
• TA100: Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer.

Important: Formulation and dosage details

Formulation:

Powder and solvent for solution for injection 10mg (hospital use only)

Dosage:

As per SMC 2266: Treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 10mg/mL (hospital use only)

Dosage:

See NICE guidance CG121.

Important: Formulation and dosage details

Formulation:

Powder for solution for infusion 10mg, 30mg, 60mg (hospital use only)

Dosage:

As per SMC:

• 1242/17: In combination with dexamethasone alone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
• 2290: in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  SMC restriction: for patients who have received only one prior therapy.

Important: Formulation and dosage details

Formulation:

Capsules 150mg (hospital use only)

Dosage:

As per SMC 1097/15: Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Important: Formulation and dosage details

Formulation:

Solution for infusion 5mg/mL (hospital use only)

Dosage:

As per SMC:

• 279/06: in combination with radiation therapy for the treatment of patients with locally advanced squamous cell cancer of the head and neck.
• 543/09: treatment of patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy. 
• 1012/14: Treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:
  • in combination with irinotecan-based chemotherapy
  • in first-line in combination with FOLFOX;
  • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

SMC restriction: for use in patients with RAS wild-type metastatic colorectal cancer, in
combination with irinotecan or oxaliplatin-based chemotherapy, in patients who have not
previously received chemotherapy for their metastatic disease (first-line treatment).

and NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer.

Important: Formulation and dosage details

Formulation:

Tablets 2mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 1mg/mL (hospital use only)

Dosage:

See NICE guidance NG122: Lung cancer: diagnosis and management.

Important: Formulation and dosage details

Formulation:

Solution for subcutaneous injection 2mg/mL (hospital use only)

Dosage:

As per SMC 537/09: treatment of hairy cell leukaemia.

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 10,000 units (hospital use only)

Important: Formulation and dosage details

Formulation:

Capsules 200mg, 250mg (hospital use only)

Dosage:

As per SMC:

• 865/13: treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
• 1329/18: treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).
• 1152/16: First-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). 

Important: Formulation and dosage details

Formulation:

Tablets 50mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 1 gram (hospital use only)

Important: Formulation and dosage details

Formulation:

Intrathecal injection 20mg/mL (hospital use only) 

Important: Formulation and dosage details

Formulation:

Injection 100mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Capsules 50mg, 75mg (hospital use only)

Dosage:

As per SMC:

• 1023/15: monotherapy treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  SMC restriction: for use in patients with unresectable or metastatic BRAFV600 mutation-positive metastatic melanoma who have received no prior therapy.
• 2131: In combination with trametinib for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

Important: Formulation and dosage details

Formulation:

Injection 200mg, 500mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 15mg, 30mg and 45mg (hospital use only)

Dosage:

45mg once daily until disease progression or toxicity.

As per SMC 2184: As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 500 micrograms (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 20mg/mL (hospital use only)

Dosage:

As per SMC:

• 1205/17: As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
  SMC restriction: for use as a fourth line treatment option.
• 2180: In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  SMC restriction: in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only.

and as per local advice, approved for use in NHS Highland, in place of SMC 2302: Daratumumab in combination with bortezomib, lenalidomide and dexamethasone (Dara-VRD), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Important: Formulation and dosage details

Formulation:

Solution for injection 120mg/mL (15mL) (hospital use only)

Dosage:

As per SMC 2447: In combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.

Important: Formulation and dosage details

Formulation:

Solution for injection 1800mg/15ml (hospital use only)

Dosage:

As per SMC 2536: in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 100mg/5ml and 400mg/20ml (hospital use only)

Dosage:

As per SMC 2536: in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Important: Formulation and dosage details

Formulation:

Tablets 300mg (hospital use only)

Dosage:

As per SMC:

• 2297: Darolutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. 
• 2604: treatment of adults with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

Important: Formulation and dosage details

Formulation:

Tablets 20mg, 50mg, 80mg, 100mg, 140mg (hospital use only)

Dosage:

As per SMC 370/07: for the treatment of adult patients with chronic, accelerated or blast phase chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.

Important: Formulation and dosage details

Formulation:

Powder for solution for infusion 20mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Injection 50mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 20mg/mL (hospital use only)

Dosage:

See NICE guidance:

• CG81: Advanced breast cancer: diagnosis and treatment.
• TA101: Docetaxel for the treatment of hormone-refractory metastatic prostate cancer.
• NG101: Early and locally advanced breast cancer: diagnosis and management.
• NG122: Lung cancer: diagnosis and management.

Important: Formulation and dosage details

Formulation:

Solution for injection 2mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 2mg/mL (Caelyx pegylated-liposomal^®) (hospital use only)

Dosage:

As per SMC: 84/03: treatment of metastatic breast cancer where there is an increased cardiac risk.

and NICE guidance TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer.

Important: Formulation and dosage details

Formulation:

Solution for injection 40mg/ml (Restricted: hospital use only)

Dosage:

As per SMC 2669: as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Important: Formulation and dosage details

Formulation:

Capsules 50mg, 75mg (hospital use only)

Dosage:

450mg once daily plus binimetanib 45mg twice daily.

As per SMC:

• 2238: In combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 
• 2312: In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.

Important: Formulation and dosage details

Formulation:

Capsules 100mg, 200mg (hospital use only)

Dosage:

As per SMC:

• 2294: as monotherapy for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
• 2295: as monotherapy for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,
  • who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
  • who have not received a prior NTRK inhibitor
  • who have no satisfactory treatment options 

Important: Formulation and dosage details

Formulation:

Solution for injection 48mg (Restricted: Hospital use only)

Dosage:

As per SMC 2632: monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for injection 4mg/0.8ml (Restricted: Hospital use only)

Dosage:

As per SMC 2632: monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Important: Formulation and dosage details

Formulation:

Solution for infusion 2mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Solution for injection 0·44mg/mL (hospital use only)

Dosage:

As per SMC 1065/15: for the treatment of adult patients with locally advanced or metastatic breast
cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.  Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.
SMC restriction: for use in patients with locally-advanced or metastatic breast cancer who have progressive disease after at least two prior chemotherapeutic regimens for advanced disease which includes capecitabine if indicated.

Important: Formulation and dosage details

Formulation:

Tablets 100mg, 150mg (hospital use only)

Dosage:

As per SMC 220/05: treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. 

Important: Formulation and dosage details

Formulation:

Capsules 50mg, 100mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 20mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 2·5mg, 5mg, 10mg (hospital use only)

Dosage:

As per SMC:

• 595/10: the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy. 
• 872/13: For the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
• 1215/17: for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. 

Important: Formulation and dosage details

Formulation:

Capsules 100mg (hospital use only)

Dosage:

As per SMC 2462: for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Important: Formulation and dosage details

Formulation:

Tablets 10mg (hospital use only)

Dosage:

As per SMC 176/05: the treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves. First line treatment should only be initiated in patients with advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.

and NICE guidance TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia.

Important: Formulation and dosage details

Formulation:

Powder for solution for injection or infusion 50mg (hospital use only)

Dosage:

See SMC advice 176/05 and NICE guidance TA29.

Important: Formulation and dosage details

Formulation:

Solution for infusion 25mg/mL, 50mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Cream 5% (Efudix)

Important: Formulation and dosage details

Formulation:

Tablets, film coated 100mg, 150mg (hospital use only)

Dosage:

As per SMC 2300: treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
SMC restriction: for the treatment of patients with severe symptomatic ITP or with a high risk of bleeding who have not had a suitable response to other therapies, including a thrombopoietin receptor‐agonist (TPO-RA), or where use of a TPO-RA is not appropriate.

Important: Formulation and dosage details

Formulation:

Solution for injection 250mg (specialist recommendation or initiation only)

Dosage:

For use as monotherapy - as per SMC 114/04: for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

For use with palbociclib - as per SMC 2149: for the treatment of hormone receptor (HR)-positive, humanepidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast
cancer:

• in combination with an aromatase inhibitor;
• in combination with fulvestrant in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Also see fulvestrant shared care protocol.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 200mg, 1 gram (hospital use only)

Dosage:

As per SMC 154/05: in combination with paclitaxel for the treatment of patients with metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. 

See NICE guidance:

• NG85: Pancreatic cancer in adults: diagnosis and management.
• NG122: Lung cancer: diagnosis and management
• TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 5mg (hospital use only)

Dosage:

As per SMC 2089: For combination therapy with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
SMC restriction: use in patients with a favourable, intermediate or unknown cytogenetic profile.

Important: Formulation and dosage details

Formulation:

Tablets film-coated 40mg (hospital use only)

Dosage:

As per SMC 2252: as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 2.5mg, 10mg (Restricted: Hospital use only)

Dosage:

As per SMC 2614: As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.

Important: Formulation and dosage details

Formulation:

Capsules 500mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Oral solution 100mg/mL (hospital use only)

Dosage:

As per SMC 2271: for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.
SMC restriction: children who are too young to be able to swallow capsules/tablets and adults and adolescents who have difficulty in swallowing solid oral dosage forms.

Important: Formulation and dosage details

Formulation:

Capsules 140mg (hospital use only)

Dosage:

As per SMC:

• 1150/16: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
• 1151/16: the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
  SMC restriction: patients with relapsed/refractory CLL and for whom fludarabine-based regimens are inappropriate. 

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Film-coated tablets 140mg (hospital use only)

Dosage:

As per SMC:

• 2259: in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.
  SMC restriction: for use in patients who have received at least one prior therapy.
• 2387: as a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy.
  SMC restriction: for use in patients who have received at least one prior therapy.
• 2543: in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Important: Formulation and dosage details

Formulation:

Capsules 5mg, 10mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 10mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 100mg, 150mg (hospital use only)

Dosage:

As per SMC:

• 1026/15: In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
  • who have received at least one prior therapy, or
  • as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.

• 1039/15: Monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. 

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for injection 1 gram, 2 grams (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 100mg, 400mg (hospital use only)

Dosage:

As per SMC:

• 01/02: treatment of chronic myeloid leukaemia.
• 08/02: for patients with Kit-positive gastrointestinal stromal tumours (GIST).
• 26/02: licence extension has been granted on the basis of interim analyses which show superiority of imatinib over interferon combination therapy in terms of cytogenetic and haematological response.
• 584/09: adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
  SMC restriction: Imatinib is restricted to use in patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria).

and NICE guidance:

• TA70: Guidance on the use of imatinib for chronic myeloid leukaemia.
• TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 20mg/mL (hospital use only)

Dosage:

See NICE guidance NG151: Colorectal cancer.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 20mg/ml (hospital use only)

Dosage:

As per SMC 2303: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.
SMC restriction: patients receiving fourth-line therapy.

Important: Formulation and dosage details

Formulation:

Tablets 250mg (Restricted: Hospital use only)

Dosage:

As per SMC 2615: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.

Important: Formulation and dosage details

Formulation:

Capsules 4mg, 10mg (hospital use only)

Dosage:

As per SMC:

• 1179/16: treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
• 2138: As monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.
• 2199: in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
• 2476: treatment of adults with advanced renal cell carcinoma (RCC), in combination with pembrolizumab, as first-line treatment.
  SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 44mg/100mg (hospital use only)

Dosage:

As per SMC 2130: The treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes. In a randomised phase III study, in adults (aged 60 to 75 years) with high risk AML, liposomal daunorubicin/cytarabine improved overall survival when compared with a standard of care regimen. 

Important: Formulation and dosage details

Formulation:

Capsules 40mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 10mg (Restricted: hospital use only)

Dosage:

As per SMC 2609: as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
SMC restriction: where chimeric antigen receptor (CAR) T-cell therapy is unsuitable, not tolerated or ineffective.

Important: Formulation and dosage details

Formulation:

Tablets 25mg, 100mg (hospital use only)

Dosage:

As per SMC:

• 2239: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease
  has progressed after:
  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or
  • crizotinib and at least one other ALK TKI.
• 2415: as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Important: Formulation and dosage details

Formulation:

Tablets 2mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 50mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Oral suspension 100mg/mL (hospital use only)

Dosage:

As per SMC 798/12: for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. 

Important: Formulation and dosage details

Formulation:

Tablets 10mg unlicensed (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 400mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Solution for injection 100mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Oral solution 10mg/5mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Solution for injection 25mg/mL, 100mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Intrathecal injection 50mg/2mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets 50mg (hospital use only)

Dosage:

As per SMC 1330/18: In combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FMS-like tyrosine kinase 3 (FLT3) mutation-positive.

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 10mg, 20mg, 40mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 2mg/mL (hospital use only)

Important: Formulation and dosage details

Formulation:

Film coated tablets 100mg, 150mg, 200mg (Restricted: Hospital use only)

Dosage:

As per SMC 2636: The treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Important: Formulation and dosage details

Formulation:

Film-coated tablets 40mg (hospital use only)

Dosage:

As per SMC 2251: for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago. 

Important: Formulation and dosage details

Formulation:

Capsules 150mg, 200mg (hospital use only)

Dosage:

As per SMC:

• 440/08: treatment of chronic phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib.
  SMC restriction: use in patients who are in the chronic phase of the disease. 
• 709/11: for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.

Important: Formulation and dosage details

Formulation:

Capsules (Vargetef^®) 100mg, 150mg (hospital use only)

Dosage:

As per SMC 1027/15: in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

Important: Formulation and dosage details

Formulation:

Capsules 100mg (hospital use only)

Dosage:

As per SMC:

• 1341/81: As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal
  cancer who are in response (complete or partial) to platinum-based chemotherapy.
  SMC restriction: to patients who do not have a germline BRCA mutation.
• 2338: as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III or IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 25mg/mL (hospital use only)

Dosage:

See SMC advice 1008/14.

Important: Formulation and dosage details

Formulation:

Capsules 50mg (hospital use only)

Dosage:

As per SMC 1047/15: monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. 

Important: Formulation and dosage details

Formulation:

Film-coated tablets 100mg, 150mg (hospital use only)

Dosage:

As per SMC:

• 2209: : for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
• 2366: as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
• 2367: as monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
  SMC restriction: patients with BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• 2368: in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. 
• 2518: as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have human epidermal growth factor receptor 2 (HER2)-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
• 2617: in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Important: Formulation and dosage details

Formulation:

Tablets 40mg, 80mg (hospital use only)

Dosage:

As per SMC:

• 1214/17: the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).
  SMC Restriction: in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor.
• 2382: As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
• 2383: as monotherapy for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
  SMC restriction: treatment with osimertinib is subject to a three-year clinical stopping rule.

Important: Formulation and dosage details

Formulation:

Film-coated tablets 40mg, 80mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 5mg/mL (hospital use only)

Dosage:

As per SMC 211/05: in combination with fluorouracil and folinic acid, for the adjuvant treatment of stage III (Dukes’ C) colon cancer after complete resection of the primary tumour.

and NICE guidance:

• CG131: Colorectal cancer: diagnosis and management.
• TA100: Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 6mg/mL (hospital use only)

Dosage:

See NICE guidance:

• CG81: Advanced breast cancer: diagnosis and treatment.
• TA55: Guidance on the use of paclitaxel in the treatment of ovarian cancer.
• TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer.
• NG101: Early and locally advanced breast cancer: diagnosis and management.
• NG122: Lung cancer: diagnosis and management.

Important: Formulation and dosage details

Formulation:

Capsules 75mg, 100mg, 125mg (hospital use only)

Dosage:

As per SMC:

• 1276/17: treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
  • in combination with an aromatase inhibitor;
  • in combination with fulvestrant in women who have received prior endocrine therapy.  In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

SMC restriction: in combination with an aromatase inhibitor for first-line treatment of HR-positive HER2-negative locally advanced or metastatic breast cancer.

• 2144: for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
  • in combination with an aromatase inhibitor;
  • in combination with fulvestrant in women who have received prior endocrine therapy.  In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
  • This submission relates to use in combination with fulvestrant in women who have received prior endocrine therapy.
• 2149: for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:
  • in combination with an aromatase inhibitor;
  • in combination with fulvestrant in women who have received prior endocrine therapy.
    In pre- or perimenopausal women, the endocrine therapy should be combined with a
    luteinizing hormone-releasing hormone (LHRH) agonist. 
  • This submission relates to use in combination with fulvestrant in women who have received prior endocrine therapy.

Important: Formulation and dosage details

Formulation:

Concentrate for intravenous infusion 20mg/mL (hospital use only)

Dosage:

See NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer.

Important: Formulation and dosage details

Formulation:

Capsules 10mg, 15mg, 20mg (hospital use only)

Dosage:

As per SMC 1122/16: In combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. 

Important: Formulation and dosage details

Formulation:

Tablets 200mg, 400mg (hospital use only)

Dosage:

See SMC advice 676/11.

Important: Formulation and dosage details

Formulation:

Tablets 4·5mg, 9mg, and 13·5mg (hospital use only)

Dosage:

As per SMC 2399: for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Important: Formulation and dosage details

Formulation:

Injection, powder for concentrate for solution for infusion 100mg, 500mg (hospital use only)

Dosage:

As per SMC:

• 192/05: in combination with cisplatin for the treatment of chemotherapy-naïve patients with stage III/IV unresectable malignant pleural mesothelioma. 
• 342/07: monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology. SMC restriction: use in patients with good performance status who would otherwise be eligible for treatment with docetaxel. 
• 531/09: in combination with cisplatin for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
  SMC restriction: patients in whom histology has been confirmed as adenocarcinoma or large
  cell carcinoma. 
• 770/12: monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 25mg/ml [generic pemetrexed] and concentrate for solution for infusion 1mg/ml [generic cisplatin] (hospital use only) off-label

Dosage:

As per NCMAG109: in combination with cisplatin as adjuvant treatment for patients with completely resected stage IIA to IIIA non-squamous, non-small-cell lung cancer.

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 10mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Solution for infusion 420mg (hospital use only)

Dosage:

As per SMC:

• 2119: for use in combination with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
• 2120: In combination with trastuzumab and docetaxel, in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
• 2284: for use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.
  SMC restriction: for use in patients with lymph node-positive disease.

Important: Formulation and dosage details

Formulation:

Solution for injection (Phesgo) 600mg/600mg, 1200mg/600mg (hospital use only)

Dosage:

As per SMC 2364: 

Early breast cancer (EBC)

In combination with chemotherapy in:

• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.

Metastatic breast cancer (MBC)

In combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

SMC restriction: Restricted to use in line with previous SMC advice for pertuzumab and trastuzumab (see SMC 2284; 2120; 2119; 928/13 and 278/06).

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 140mg (hospital use only)

Dosage:

As per SMC:

• 2282: in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for haematopoietic stem cell transplant.
• 2524: in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant (HSCT).
• 2525: in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
  SMC restriction: patients with an International Prognostic Index (IPI) score of 2 to 5.

Important: Formulation and dosage details

Formulation:

Tablets 15mg, 45mg (hospital use only)

Dosage:

As per SMC 1032/15: Adult patients with:

• Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are resistant
  to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib
  is not clinically appropriate; or who have the T315I mutation.

Important: Formulation and dosage details

Formulation:

Capsules 50mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Film-coated tablets (Restricted: hospital use only)

Dosage:

As per SMC 2699: in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

Important: Formulation and dosage details

Formulation:

Solution for injection 1,000kBq/mL (hospital use only)

Dosage:

As per SMC 1077/15: for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. 

Important: Formulation and dosage details

Formulation:

Powder for solution for infusion 2mg (hospital use only)

Dosage:

See NICE CG131: Colorectal cancer: diagnosis and management.

Important: Formulation and dosage details

Formulation:

Tablets 40mg (hospital use only)

Dosage:

As per SMC:

• 1031/15: Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
• 1316/18: as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib.
• 2562: as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy.

Important: Formulation and dosage details

Formulation:

Tablets 200mg (hospital use only)

Dosage:

600mg once daily for 3 weeks, repeat every 28 days.

As per SMC:

• 1295/18: In combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial endocrine-based
  therapy.
• 2198: for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
  SMC restriction: women who have relapsed on or within 12 months of completing (neo) adjuvant endocrine therapy, or those who have progressed on first-line endocrine-based therapy for advanced breast cancer. 

Important: Formulation and dosage details

Formulation:

Tablets 200mg, 250mg, 300mg (hospital use only)

Dosage:

As per SMC 2224: As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. 
SMC restriction: to patients who do not have a BRCA mutation.

Important: Formulation and dosage details

Formulation:

Tablets 5mg, 10mg, 15mg, 20mg (hospital use only)

Dosage:

As per SMC:

• 867/13: the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
• 2213: The treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea (hydroxycarbamide).

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 180mg (hospital use only)

Dosage:

As per SMC 2446: Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease. 

Important: Formulation and dosage details

Formulation:

Tablets 20mg (Restricted: hospital use only)

Dosage:

As per SMC:

• 2673: In combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
• 2674: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Important: Formulation and dosage details

Formulation:

Capsules 40mg and 80mg (hospital use only)

Dosage:

As per SMC:

• 2370:
  • Selpercatinib as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib.
  • Selpercatinib as monotherapy is indicated for the treatment of adults and adolescents 12
    years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require
    systemic therapy following prior treatment with cabozantinib and/or vandetanib.
• 2573: monotherapy for the treatment of adults with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
  SMC restriction: for use in treatment-naïve patients who have not previously received a RET-inhibitor or any other systemic treatments for their advanced stage of disease.

Important: Formulation and dosage details

Formulation:

Tablets 200mg (hospital use only)

Dosage:

As per SMC:

• 482/08: the treatment of hepatocellular carcinoma.
  SMC restriction: in patients with advanced hepatocellular carcinoma who have failed or are
  unsuitable for surgical or loco-regional therapies. 
• 1055/15: treatment of patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma, refractory to radioactive iodine. 

Important: Formulation and dosage details

Formulation:

Film-coated tablets 120mg (hospital use only)

Dosage:

As per SMC 2443: as monotherapy for the treatment of adult patients with KRAS G12C-mutated, locally advanced or metastatic, non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.

Important: Formulation and dosage details

Formulation:

Capsules 12·5mg, 25mg, 50mg (hospital use only)

Dosage:

As per SMC 275/06: treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. 

and NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma.

Important: Formulation and dosage details

Formulation:

Capsules 0.25mg, 1mg (Restricted: hospital use only)

Dosage:

As per SMC 2607: as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer.  Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments.  Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. 

Important: Formulation and dosage details

Formulation:

Solution for injection 10mg/ml (Restricted: hospital use only)

Dosage:

See SMC advice 2668: as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Important: Formulation and dosage details

Formulation:

Capsules (Teysuno^®) 15mg/4·35mg/11·8mg, 20mg/5·8mg/15·8mg (hospital use only)

Dosage:

As per SMC 802/12: tegafur/gimeracil/oteracil is indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.
SMC restriction: tegafur/gimeracil/oteracil is restricted to use in patients with advanced gastric cancer who are unsuitable for an anthracycline, fluorouracil and platinum triplet first-line regimen.

Important: Formulation and dosage details

Formulation:

Capsules 5mg, 20mg, 100mg, 250mg (hospital use only)

Dosage:

See NICE TA23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer).

Important: Formulation and dosage details

Formulation:

Film-coated tablets 225mg (hospital use only)

Dosage:

As per SMC 2535: For the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. 

Important: Formulation and dosage details

Formulation:

Hard capsules 890 micrograms and 1,340 micrograms (hospital use only)

Dosage:

As per SMC 1335/18: the first-line treatment of adult patients with advanced renal cell carcinoma and for adult patients who are vascular endothelial growth factor receptor and mammalian target of rapamycin pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced renal cell carcinoma (RCC).
SMC restriction: to first-line treatment of advanced RCC.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 1mg (hospital use only)

Dosage:

See NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 0·25mg, 1mg (hospital use only)

Dosage:

As per SMC 2283: Treatment of adult patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents.

Important: Formulation and dosage details

Formulation:

Tablets 500 micrograms, 2mg (hospital use only)

Dosage:

As per SMC:

• 1161/16: in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  SMC restriction: to first-line treatment.
• 2328: in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
  SMC restriction: after first line treatment.

Important: Formulation and dosage details

Formulation:

Solution for subcutaneous injection 600mg (hospital use only)

Dosage:

As per SMC:

• 278/06: treatment of patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
• 623/10: in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.  It is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
  SMC restriction: for use in patients whose tumours have HER2 overexpression defined by immunohistochemistry (IHC) 3+ (“HER2 high expresser”). 
• 928/13: treatment of adult patients with HER2 positive metastatic breast cancer (MBC) and early breast cancer (EBC) in a range of settings (full details of licensed indication presented later in advice document).  Trastuzumab should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
  SMC restriction: Subcutaneous trastuzumab injection is accepted for use in line with previous SMC advice for intravenous trastuzumab (this excludes its use in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab).

and NICE:

• TA34: Guidance on the use of trastuzumab for the treatment of advanced breast cancer.
• NG101: Early and locally advanced breast cancer: diagnosis and management.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 100mg (hospital use only)

Dosage:

As per SMC:

• 2388: As monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received two or more prior anti-HER2-based regimens.
• 2545: as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
  SMC restriction: in patients who have received one prior anti-HER2-based regimen. 
• 2608: as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 100mg, 160mg (hospital use only)

Dosage:

As per SMC:

• 990/14: as a single agent, for the treatment of adult patients with human epidermal growth factor type 2 (HER2)-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.  Patients should have either:
  • Received prior therapy for locally advanced or metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.
• 2298: As a single agent, for the adjuvant treatment of adult patients with human epidermal growth factor-2 (HER2) positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2 targeted therapy.

and NICE TA458: Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane.

Important: Formulation and dosage details

Formulation:

Capsules 10mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Tablets (Lonsurf^®) 15mg/6·14mg, 20mg/8·19mg (Restricted: hospital use only)

Dosage:

As per SMC:

• 1221/17: The treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents. 
• 2329: As monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
  SMC restriction: for use as third line treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction.
• 2654: In combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.

Important: Formulation and dosage details

Formulation:

Tablets 50mg, 150mg (hospital use only)

Dosage:

As per SMC 2398: in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens

Important: Formulation and dosage details

Formulation:

Tablets 240mg (hospital use only)

Dosage:

As per SMC 792/12: as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
SMC restriction: for use in the first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

Important: Formulation and dosage details

Formulation:

Film-coated tablets 10mg, 50mg, 100mg (hospital use only)

Dosage:

As per SMC:

• 1249/17: as monotherapy for the treatment of chronic lymphocytic leukaemia (CLL):
  • in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for
    or have failed a B-cell receptor pathway inhibitor.
  • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both
    chemoimmunotherapy and a B-cell receptor pathway inhibitor. 
• 2166: in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
• 2293: In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).  Venetoclax-obinutuzumab, compared with chlorambucil-obinutuzumab, significantly improved progression-free survival in adults with CLL and co-morbidities.
  SMC restriction: for use in (1) patients without del (17p)/TP53 mutation who are not fit to
  receive FCR (fludarabine, cyclophosphamide and rituximab) chemo-immunotherapy and (2)
  patients with del (17p)/TP53 mutation. 
• 2412: in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. 

Important: Formulation and dosage details

Formulation:

Solution for injection 10mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Solution for injection 1mg/ml (hospital use only)

Important: Formulation and dosage details

Formulation:

Powder for solution for injection 5mg (hospital use only)

Important: Formulation and dosage details

Formulation:

Capsules 20mg, 30mg (hospital use only)

Dosage:

As per SMC:

• 179/05: first line treatment of stage lll or lV non-small-cell lung cancer.
• 324/06: treatment of advanced breast cancer stage III and IV relapsing after, or refractory to, an anthracycline-containing regimen.

and NICE CG81: Advanced breast cancer: diagnosis and treatment.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 10mg/mL (hospital use only)

Dosage:

See NICE CG81: Advanced breast cancer: diagnosis and treatment.

Important: Formulation and dosage details

Formulation:

Capsules 80mg (hospital use only)

Dosage:

As per SMC:

• 2528: as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
• 2600: as monotherapy for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
  SMC restriction: For adults with CLL in whom chemo-immunotherapy is unsuitable.
• 2684: as monotherapy for the treatment of adult patients with marginal
  zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.