Immunomodulating drugs used in the treatment of multiple sclerosis (Formulary)

ALEMTUZUMAB

Important: Therapy notes

MHRA advice: Alemtuzumab (Lemtrada) - updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions (February 2020) (www.gov.uk).
MHRA advice: Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements (May 2019) (www.gov.uk). 


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

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

Dosage:

See SMC advice 959/14.

CLADRIBINE

Important: Therapy notes

MHRA advice: Cladribine (Mavenclad): new advice to minimise risk of serious liver injury (March 2022) (www.gov.uk).

Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Tablets 10mg (specialist use only)

Dosage:

As per SMC 1300/18: treatment of adult patients with highly active relapsing multiple sclerosis
(MS) as defined by clinical or imaging features.

SMC restriction:

  • Patients with rapidly evolving severe relapsing-remitting MS: patients with two or more relapses in the prior year whether on treatment or not, and at least one T1 gadolinium-enhancing lesion.
  • Patients with sub-optimal therapy relapsing-remitting MS: patients with one or more relapses in the previous year while on disease modifying therapy, and at least one T1 gadolinium-enhancing lesion or nine T2 lesions. 

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

DIMETHYL FUMARATE

Important: Therapy notes

MHRA advice: Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia (January 2021) (www.gov.uk).


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Enteric coated capsules 120mg, 240mg (specialist use only)

Dosage:

See SMC advice 886/13. For advice on monitoring during and following treatment refer to SPC.

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

FAMPRIDINE

Important: Therapy notes

For improvement of walking disability in multiple sclerosis.  
Assessment is carried out by physiotherapy.

Important: Formulation and dosage details

Formulation:

Tablets 10mg (specialist use only)

Dosage:

As per SMC 2253: For the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS [expanded disability status scale] 4-7).

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

FINGOLIMOD

Important: Therapy notes


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Capsules 500 micrograms (specialist use only)

Dosage:

See SMC advice 763/12.

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

GLATIRAMER

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection 20mg/mL (specialist use only)

Dosage:

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

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe 20mg/mL, 40mg/mL (specialist use only)

Dosage:

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

INTERFERON BETA

Important: Therapy notes

MHRA advice: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome (December 2014) (www.gov.uk).

Important: Formulation and dosage details

Formulation:

Solution for injection beta-1a 22 micrograms (Rebif®), 44 micrograms (Rebif®), 30 micrograms (Avonex®) (specialist use only)

Dosage:

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

Important: Formulation and dosage details

Formulation:

Solution for injection, beta-1b 300 micrograms (Betaferon®), 300 micrograms (Extavia®) (specialist use only)

Dosage:

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

NATALIZUMAB

Important: Therapy notes

MHRA advice: Natalizumab (Tysabri): progressive multifocal leukoencephalopathy - updated advice to support early detection (April 2016) (www.gov.uk).

Shared care protocol for the administration of natalizumab.

Important: Formulation and dosage details

Formulation:

Solution for intravenous infusion 20mg/mL (specialist use only)

Dosage:

See SMC advice 329/06.

OCRELIZUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion 300mg (s)

Dosage:

As per SMC 2121: The treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
SMC restriction: Treatment of relapsing remitting multiple sclerosis (RRMS) in adults with active disease defined by clinical or imaging features who are contra-indicated or otherwise unsuitable for alemtuzumab.

OFATUMUMAB

Important: Therapy notes

MHRA advice: Ofatumumab: reminder of risk of serious and fatal infusion reactions (December 2014) (www.gov.uk).

  • Ofatumumab is intended for patient self-administration by subcutaneous injection. The first injection should be performed under the guidance of a healthcare professional. Treatment should be initiated by a physician experienced in the management of neurological conditions.
  • See Summary of Product Characteristics (SPC) for more information.




Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe/pen 20mg/0·4mL (hospital use only)

Dosage:

The recommended dose is 20mg ofatumumab administered by subcutaneous injection with initial dosing at weeks 0, 1 and 2, followed by subsequent monthly dosing, starting at week 4.

See SMC advice 2357: treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
SMC restriction: treatment of relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

OZANIMOD

Important: Therapy notes


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Capsules 0·23mg and 0·46mg (starter packs) and 0.92mg (specialist use only)

Dosage:

See SMC advice 2309: treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
SMC restriction: suitable for or requesting an oral treatment.

PEGINTERFERON BETA

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringes (beta-1a; Plegridy®) 63 micrograms, 94 micrograms, 125 micrograms (specialist use only)

Dosage:

See SMC advice 1018/14

PONESIMOD

Important: Therapy notes

Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Titration pack and film-coated tablets 20mg (under specialist direction only)

Dosage:

See SMC advice 2384: the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
SMC restriction: Adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features, suitable for or requesting an oral treatment. 

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

SIPONIMOD

Important: Therapy notes


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Tablet 0.25mg titration pack (specialist use only)

Dosage:

See SMC advice 2265.

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

Important: Formulation and dosage details

Formulation:

Tablet 2mg (specialist use only)

Dosage:

As per SMC 2265: treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.

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

TERIFLUNOMIDE

Important: Therapy notes


Risk minimisation materials

Important: Formulation and dosage details

Formulation:

Tablets 14mg (specialist use only)

Dosage:

See SMC advice 940/14.

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

Editorial Information

Last reviewed: 03/07/2020

Document Id: F292