Nucala Caution For Usage

Incompatibilities: Do not mix the reconstituted solution for injection with other medicinal products.
Instructions for Use/Handling: NUCALA is provided as a lyophilized powder in a single-use vial for subcutaneous injection only. NUCALA does not contain a preservative therefore reconstitution by a healthcare professional should be carried out under aseptic conditions.
Once reconstituted, NUCALA will contain a concentration of 100 mg/mL mepolizumab. The reconstituted solution of mepolizumab, if not used immediately, should be stored below 30°C, and should not be frozen. Any unused concentrate or solution remaining after 8 hours must be discarded.
Instructions for reconstitution of each 100 mg vial: 1. Reconstitute the contents of the vial with 1.2 mL of sterile Water for Injection preferably using a 2 to 3 mL syringe and a 21 gauge needle. The reconstituted solution will contain a concentration of 100 mg/mL mepolizumab.
2. The stream of sterile Water for Injection should be directed vertically onto the center of the lyophilized 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: 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 has been added, but it may take additional time.
3. 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.
4. Visually inspect the reconstituted solution for particulate matter and clarity prior to use. The solution should be clear to opalescent, and colorless 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.
5. The reconstituted solution of NUCALA, if not used immediately: Store below 30°C.
Discard if not used within 8 hours of reconstitution.
Do not mix with other medications.
Do not freeze.
Instructions for administration: 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.
If more than one vial is required for administration of the prescribed dosage, repeat steps 1 to 3. It is recommended that individual injection sites are separated by at least 5 cm.