NUCALA POWDER FOR SOLUTION FOR INJECTION 100mg

Indications

NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 12 years and older (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

Hypersensitivity to mepolizumab or to any of the excipients.

Dosage and Administration

Pharmaceutical form: Powder for solution for infusion.

NUCALA should be administered by a health care professional.

NUCALA should be prescribed by physicians experienced in the diagnosis and treatment of severe eosinophilic asthma.

Following reconstitution, NUCALA should only be administered as a subcutaneous injection (e.g. upper arm, thigh, or abdomen) (see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Populations

Adults and Adolescents (12 years and older)

The recommended dose is 100 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children (up to 12 years of age)

The safety and efficacy of NUCALA have not been established in children less than 12 years of age.

Elderly (65 years or older)

No dosage adjustment is recommended in patients 65 years or older (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment

Dose adjustments in patients with renal impairment are unlikely to be required (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment

Dose adjustments in patients with hepatic impairment are unlikely to be required (see Pharmacokinetics – Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).