Nucala

/ GSK

Severe eosinophilic asthma
The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
CRSwNP
The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Nucala is intended for long-term treatment. Consideration can be given to alternative treatments in patients who have shown no response after 24 weeks of treatment for CRSwNP. Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks.
COPD
The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.
Limitations:
For the indication of COPD, mepolizumab may not be used in patients with an eosinophil level less than 150 cells/μL.
EGPA
The recommended dosage of Nucala is 300 mg administered once every 4 weeks by subcutaneous injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen. Administer individual 100-mg injections at least 5 cm (approximately 2 inches) apart.
HES
The recommended dose of mepolizumab is 300 mg administered subcutaneously once every 4 weeks.
See prescribing information for full details.

Severe eosinophilic asthma
Add-on treatment for severe refractory eosinophilic asthma in adult patients.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.
Chronic obstructive pulmonary disease (COPD)
Add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease with an eosinophilic phenotype.
Eosinophilic granulomatosis with polyangiitis (EGPA)
Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Hypereosinophilic syndrome (HES)
Add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Hypersensitivity to the active substance or to any of the excipients.

Mepolizumab must not be used to treat acute asthma exacerbations. Asthma-related adverse events or exacerbations may occur during treatment. Patients must be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. Abrupt discontinuation of corticosteroids after initiation of Mepolizumab therapy is not recommended. Reduction in corticosteroid doses, if required, must be gradual and performed under the supervision of a physician.
Hypersensitivity and administration-related reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash,  bronchospasm, hypotension), have occurred following administration of Mepolizumab. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
Parasitic infections: Eosinophils may be involved in the immunological response to some helminth infections. Patients with preexisting helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with Mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
COPD patients with low blood eosinophil counts
Data do not support the use of Nucala in patients with COPD with blood eosinophil count <150 cells/mcL and no evidence of blood eosinophil count ≥300 cells/mcL in the previous 12 months.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
See prescribing information for full details.

Severe eosinophilic asthma
In placebo-controlled studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache (20%), injection site reactions (8%) and back pain (6%).
CRSwNP
In a placebo-controlled study in patients with CRSwNP, the most commonly reported adverse reactions during treatment were headache (18%) and back pain (7%).
COPD
In three placebo-controlled studies in patients with COPD, the most commonly reported adverse reactions during treatment were headache (10%), back pain (7%) and arthralgia (5%).
EGPA
In a placebo-controlled study in patients with EGPA, the most commonly reported adverse reactions during treatment were headache (32%), injection site reactions (15%) and back pain (13%). Systemic allergic/hypersensitivity reactions were reported by 4% of EGPA patients.
HES
In a placebo-controlled study in patients with HES, the most commonly reported adverse reactions during treatment were headache (13%), urinary tract infection (9%), injection site reactions and pyrexia (7% each).
See prescribing information for full details.

No interaction studies have been performed. Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab. Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes. The potential for drug-drug interactions with mepolizumab is therefore considered low.

Pregnancy: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Lactation: There are no data regarding the excretion of mepolizumab in human milk.
See prescribing information for full details.

There is no clinical experience with overdose of mepolizumab. Single doses of up to 1500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities. There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

Storage: Store below 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
Compatibility: This medicinal product must not be mixed with other medicinal products.