For: Asthma, Churg-Strauss Allergic Angiitis
Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients with severe eosinophilic asthma, and for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome). NUCALA- mepolizumab injection, powder, for solution
GlaxoSmithKline LLC
1 INDICATIONS AND USAGE
NUCALA� is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. [See Clinical Studies (14).]
Limitations of Use
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NUCALA is not indicated for treatment of other eosinophilic conditions.
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NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
NUCALA is for subcutaneous use only.
The recommended dose of NUCALA is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen.
2.2 Preparation and Administration
NUCALA should be reconstituted and administered by a healthcare professional. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended [see Warnings and Precautions (5.1)].
Reconstitution Instructions
1.
Reconstitute NUCALA in the vial with 1.2 mL Sterile Water for Injection, USP, preferably using a 2- or 3-mL syringe and a 21-gauge needle. The reconstituted solution will contain a concentration of 100 mg/mL mepolizumab. Do not mix with other medications.
2.
Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake. Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.
Note: Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation. Reconstitution is typically complete within 5 minutes after the Sterile Water for Injection has been added, but it may take additional time.
3.
If a mechanical reconstitution device (swirler) is used to reconstitute NUCALA, swirl at 450 rpm for no longer than 10 minutes. Alternatively, swirling at 1,000 rpm for no longer than 5 minutes is acceptable.
4.
Visually inspect the reconstituted solution for particulate matter and clarity before use. The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle free. 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 administered.
5.
If the reconstituted solution is not used immediately:
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store below 30�C (86�F),
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do not freeze, and
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discard if not used within 8 hours of reconstitution.
Administration
1.
For subcutaneous administration, preferably using a 1-mL polypropylene syringe fitted with a disposable 21- to 27-gauge x 0.5-inch (13-mm) needle.
2.
Just before 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.
3 DOSAGE FORMS AND STRENGTHS
For injection: 100 mg of lyophilized powder in a single-dose vial for reconstitution.
