NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML [SIN16171P]

Product Info

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML

[SIN16171P]

Indications

Severe Eosinophilic Asthma

NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 12 years and older.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
NUCALA is indicated as add-on maintenance treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Eosinophilic Granulomatosis with Polyangiitis (EGPA)

NUCALA is indicated as add-on treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients.

Hypereosinophilic Syndrome (HES)
NUCALA is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Dosage and Administration

Pharmaceutical form:

Solution for injection in a pre-filled pen (auto-injector)

Solution for injection in a 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 may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate and the patient or caregiver are trained in injection techniques.

Populations

Severe Eosinophilic asthma

Adults and Adolescents (12 years and older)

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

CRSwNP

Adults

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

Children

Use in patients less than 18 years of age is not relevant for CRSwNP.

EGPA

Injection sites should be at least 5 cm apart (see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults

The recommended dose is 300 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

EGPA: NUCALA is not indicated in patients under 18 years of age.

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.

HES

Injection sites should be at least 5 cm apart (see Use and Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults

The recommended dose is 300 mg of NUCALA administered by subcutaneous (SC) injection once every 4 weeks.

Children

The safety and efficacy of NUCALA have not been established in children.

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.