Generic name: MEPOLIZUMAB 100mg in 1mL
Dosage form: injection, powder, for solution
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NUCALA is for subcutaneous (SC) use only.
The recommended dosage of NUCALA is 100 mg administered once every 4 weeks by SC injection into the upper arm, thigh, or abdomen.
2.2 Eosinophilic Granulomatosis with Polyangiitis
The recommended dosage of NUCALA is 300 mg administered once every 4 weeks by SC injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen. It is recommended that the individual 100-mg injections be administered at least 5 cm (approximately 2 inches) apart if more than 1 injection is administered at the same site.
Preparation of the 300-mg dose for treatment of EGPA requires the reconstitution of 3 separate 100-mg vials as described below [see Dosage and Administration (2.3)].
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)].
- Reconstitute NUCALA in the vial with 1.2 mL of 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.
- 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.
- 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.
- 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.
- If the reconstituted solution is not used immediately:
- store below 30°C (86°F),
- do not freeze, and
- discard if not used within 8 hours of reconstitution.
- For SC administration, preferably using a 1-mL polypropylene syringe fitted with a disposable 21- to 27-gauge x 0.5-inch (13-mm) needle.
- 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.
- Administer the 1-mL injection (equivalent to 100 mg of mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.
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