Monoclonal antibodies (Formulary)

BENRALIZUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled syringe 30mg/mL (hospital use only)

Dosage:

As per SMC2155: as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
SMC restriction: patients with blood eosinophils ≥150 cells/microlitre, and either ≥4 prior asthma exacerbations needing systemic corticosteroids in the previous 12 months or treatment with continuous oral corticosteroids over the previous 6 months.

Notes:

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

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled pens 30mg/mL (hospital use only)

Dosage:

As per SMC2155: as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
SMC restriction: patients with blood eosinophils ≥150 cells/microlitre, and either ≥4 prior asthma exacerbations needing systemic corticosteroids in the previous 12 months or treatment with continuous oral corticosteroids over the previous 6 months.

Notes:

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

DUPILUMAB

Important: Therapy notes

MHRA advice: Dupilumab (Dupixent): risk of ocular adverse reactions and need for prompt management (November 2022) (www.gov.uk).

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe 200mg, 300mg (specialist use only)

Dosage:

As per SMC2317: in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
SMC restriction: for the treatment of patients with blood eosinophils ≥150 cells/microlitre and FeNO ≥25 parts per billion, and ≥4 exacerbations in the preceding year, who have previously received biologic treatment with anti-IgE or anti-IL-5 therapies.

Notes:

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

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled pen 200mg, 300mg (specialist use only)

Dosage:

As per SMC2317: in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
SMC restriction: for the treatment of patients with blood eosinophils ≥150 cells/microlitre and FeNO ≥25 parts per billion, and ≥4 exacerbations in the preceding year, who have previously received biologic treatment with anti-IgE or anti-IL-5 therapies.

Notes:

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

MEPOLIZUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled syringes 100mg/mL (hospital use only)

Dosage:

As per SMC1149/16: as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
SMC restriction: patients who have eosinophils of at least 150 cells per microlitre (0.15 x 109/L) at initiation of treatment and have had at least four asthma exacerbations in the preceding year or are receiving maintenance treatment with oral corticosteroids.

Notes:

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

Important: Formulation and dosage details

Formulation:

Solution for injection pre-filled pens 100mg/mL (hospital use only)

Dosage:

As per SMC1149/16: as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
SMC restriction: patients who have eosinophils of at least 150 cells per microlitre (0.15 x 109/L) at initiation of treatment and have had at least four asthma exacerbations in the preceding year or are receiving maintenance treatment with oral corticosteroids.

Notes:

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

OMALIZUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe 75mg/0·5mL, 150mg/mL (hospital use only)

Dosage:

By subcutaneous injection, adults and children over 6 years, according to immunoglobin E concentration and body-weight, refer to SPC.

As per SMC708/11: omalizumab is indicated in adults, adolescents (12 years of age and older) and children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma.
SMC restriction: Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

TEZEPELUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe 210mg/1.91mL (110mg/mL) (specialist initiation only)

Dosage:

As per SMC2541: as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
SMC restriction: in adults and adolescents 12 years and older who either (i) experienced at least three exacerbations in the previous year and are not receiving maintenance treatment with oral corticosteroids or (ii) have blood eosinophils ≥150 cells/microlitre and are receiving maintenance treatment with oral corticosteroids.

Notes:

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

Important: Formulation and dosage details

Formulation:

Solution for pre-filled pen 210mg/1.91ml (110mg/mL) (specialist initiation only)

Dosage:

As per SMC2541: as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
SMC restriction: in adults and adolescents 12 years and older who either (i) experienced at least three exacerbations in the previous year and are not receiving maintenance treatment with oral corticosteroids or (ii) have blood eosinophils ≥150 cells/microlitre and are receiving maintenance treatment with oral corticosteroids.

Notes:

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

Editorial Information

Document Id: F359