NUCALA Powder for solution for injection Ref.[8924] Active ingredients: Mepolizumab

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

Posology

Adults and adolescents aged 12 years and older

The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks.

Children aged 6 to 11 years old

The recommended dose of mepolizumab is 40 mg administered subcutaneously once every 4 weeks.

Nucala is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s disease severity and level of control of exacerbations.

Special populations

Paediatric population

The posology of Nucala in children and adolescents aged between 6 to 17 years old with severe refractory eosinophilic asthma has been determined by limited efficacy, pharmacokinetic and pharmacodynamic studies and supported by modelling and simulation data (see sections 5.1 and 5.2).

Elderly patients

No dose adjustment is required for elderly patients (see section 5.2).

Renal and hepatic impairment

No dose adjustment is required in patients with renal or hepatic impairment (see section 5.2).

Method of administration

Nucala is for subcutaneous injection only and should be administered by a healthcare professional. It may be injected into the upper arm, thigh, or abdomen.

The powder should be reconstituted prior to administration and the reconstituted solution should be used immediately. For instructions on the reconstitution of the medicinal product before administration, see section 6.6.

Each vial of Nucala should be used for a single patient, and any remainder of the vial should be discarded.

Single doses of up to 1,500 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.

Shelf life: 4 years.

After reconstitution: Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.

Store below 25°C.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Clear, colourless 10 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a plastic flip-cap containing 100 mg powder for solution for injection.

Pack sizes:

• 1 vial
• Multipack comprising 3 (3 packs of 1) vials

Not all pack-sizes may be marketed.

Reconstitution should be carried out under aseptic conditions.

Instructions for reconstitution for each vial:

1. Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably using a 2 to 3 mL syringe and a 21 gauge needle. The stream of sterile water should be directed vertically, onto the centre of the lyophilised cake. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved. Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation. Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time.
2. If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450 rpm for no longer than 10 minutes. Alternatively, swirling at 1000 rpm for no longer than 5 minutes is acceptable.
3. Following reconstitution, Nucala should be visually inspected for particulate matter and clarity prior to use. The solution should be clear to opalescent, and colourless to pale yellow or pale brown, free of visible particles. Small air bubbles, however, are expected and acceptable. If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be used.
4. The reconstituted solution, if not used immediately must be:

• Protected from sunlight
• Stored below 30°C, not frozen
• Discarded if not used within 8 hours of reconstitution

Instructions for administration of 100 mg dose:

1. For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
2. Just prior to administration, remove 1 mL of reconstituted Nucala. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation.
3. Administer the 1 mL injection (equivalent to 100 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

Instructions for administration of 40 mg dose:

1. For subcutaneous administration, a 1 mL polypropylene syringe fitted with a disposable needle 21 gauge to 27 gauge x 0.5 inch (13 mm) should preferably be used.
2. Just prior to administration, remove 0.4mL of reconstituted Nucala. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation. Dispose of the remaining solution.
3. Administer the 0.4mL injection (equivalent to 40 mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.