Mepolizumab

Commercial name

Nucala®

Manufacturer

GlaxoSmithKline AG

Mechanism of action

Humanised monoclonal IgG1κ antibody that inhibits IL-5

Authorization in dermatology

Severe eosinophilic asthma

Eosinophilic granulomatosis with polyangiitis (EGPA)

Chronic rhinosinusitis with nasal polyps (CRSwNP)

Hypereosinophilia syndrome

SVK coverage

No

Limitation for reimbursement

Eosinophilic asthma: adjunctive treatment: at least.

2. Exacerbations within 12 months whilst on standard therapy; need for treatment with systemic corticosteroids. Blood eosinophil count of ≥0.15 G/L; EGPA: recurrent or treatment-resistant, with prior stabilisation of the disease using systemic corticosteroids.

Dosage form

Pre-filled syringe/pre-filled pen

Before starting therapy

No preliminary investigations required except for a complete blood count; where necessary, a pregnancy test (optional: liver function tests/screening for HBV and HCV).

Monitoring laboratory parameters

Not necessary, clinical monitoring only.

Monitoring intervals

Clinical check-ups every 3 months

Administration

s.c.

Dosage

Severe eosinophilic asthma: 100 mg every 4 weeks;

EGPA and hypereosinophilia syndrome: 300 mg every 4 weeks

Onset of effect

If no therapeutic success has been achieved after 16 weeks, the treatment should be discontinued.

Caution

Parasitic diseases (particularly helminth infections), pregnancy and breastfeeding (insufficient data)

Annual cost in CHF (first year including induction phase)

14,616 (14,616)

Interruption

Helminth infection during treatment and lack of response to treatment, hypersensitivity reaction.

Clinical evaluation

Week 32: 84 per cent reduction in blood eosinophils

Development of anti-drug antibodies

Approximately 6% develop anti-drug antibodies.

Contraindications

Hypersensitivity to the active substance or to any of the other ingredients. No data are currently available regarding pregnancy, breast-feeding or fertility

Adverse drug reactions

Upper abdominal pain, reactions at the injection site, headaches, lower respiratory tract infection, urinary tract infection, pharyngitis

Use in HBV infection

Insufficient data

Use in HCV infection

Insufficient data

Use in HIV infection

Insufficient data

Interactions

Insufficient data

Use in latent TB infection

Treatment with isoniazid and vitamin B6 for 9 months; biologics may be started 1 month after TB treatment

Cancer risk

Insufficient data