NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML [SIN16811P]

Product Info

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML

[SIN16811P]

Indications

Severe Eosinophilic Asthma

NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 6 to 11 years old (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage and Administration

Pharmaceutical form: Solution for injection in 40 mg/0.4 mL pre-filled syringe (safety syringe)

NUCALA should only be administered as a subcutaneous injection (see Use and Handling and Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

NUCALA must be administered by a healthcare professional or a caregiver. It may be administered by a caregiver if a healthcare professional determines that it is appropriate, and the caregiver is trained in injection techniques.

Populations

Severe Eosinophilic asthma

Children aged 6 to 11 years old:

The recommended dose is 40 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

The safety and efficacy of NUCALA have not been established in children less than 6 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).

Contraindications

Hypersensitivity to mepolizumab or to any of the excipients.