Severe Asthma

Adults and Adolescents Aged 12 Years and Older

The recommended dosage of NUCALA in adults and adolescents aged 12 years and older is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen [see Dosage and Administration (2.5, 2.6)].

Pediatric Patients Aged 6 to 11 Years

The recommended dosage of NUCALA for injection in pediatric patients aged 6 to 11 years is 40 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen [see Dosage and Administration (2.5, 2.6)].

Chronic Rhinosinusitis with Nasal Polyps

The recommended dosage of NUCALA is 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen [see Dosage and Administration (2.5, 2.6)].

Eosinophilic Granulomatosis with Polyangiitis

The recommended dosage of NUCALA is 300 mg administered once every 4 weeks by subcutaneous injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen [see Dosage and Administration (2.5, 2.6)]. Administer individual 100-mg injections at least 5 cm (approximately 2 inches) apart.

Hypereosinophilic Syndrome

The recommended dosage of NUCALA is 300 mg administered once every 4 weeks by subcutaneous injection as 3 separate 100-mg injections into the upper arm, thigh, or abdomen [see Dosage and Administration (2.5, 2.6)]. Administer individual 100-mg injections at least 5 cm (approximately 2 inches) apart.

Preparation and Administration of NUCALA for Injection Vial

NUCALA for injection 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 for injection 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.

2.

Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized powder, which may have a cake-like appearance. 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 for injection, 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:

1.

store below 30°C (86°F),

2.

do not freeze, and

3.

discard if not used within 8 hours of reconstitution.

Administration of 100-mg Dose

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 for injection. 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 of mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

Administration of 40-mg Dose

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 0.4 mL of reconstituted NUCALA for injection. Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation.

3.

Administer the 0.4-mL injection (equivalent to 40 mg of mepolizumab) subcutaneously into the upper arm, thigh, or abdomen.

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

Preparation and Administration of NUCALA Injection Prefilled Autoinjector and Prefilled Syringes

NUCALA injection is intended for use under the guidance of a healthcare provider.

The 100-mg/mL prefilled autoinjector and 100-mg/mL prefilled syringe are only for use in adults and adolescents aged 12 years and older. A patient may self-inject or the patient caregiver may administer NUCALA injection 100 mg/mL subcutaneously after the healthcare provider determines it is appropriate.

The 40-mg/0.4-mL prefilled syringe is only for use in children aged 6 to 11 years and must be administered by the healthcare provider or the patient caregiver. The patient caregiver may administer NUCALA injection 40 mg/0.4 mL subcutaneously after the healthcare provider determines it is appropriate.

Provide proper training in subcutaneous injection technique and on the preparation and administration of NUCALA injection prior to use [see Instructions for Use].

1.

Remove the prefilled autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to injection. Do not warm NUCALA injection in any other way.

2.

Prior to administration, visually inspect the window of the prefilled autoinjector or the prefilled syringe for particulate matter or discoloration. NUCALA injection should be clear to opalescent, colorless to pale yellow to pale brown in color. Do not use NUCALA injection if the product exhibits discoloration, cloudiness, or particulate matter. Do not use the NUCALA prefilled autoinjector or prefilled syringe if dropped on a hard surface.

3.

Administer the subcutaneous injection into the thigh or abdomen, avoiding the 5 cm (approximately 2 inches) around the navel. The upper arm can also be used if a caregiver administers the subcutaneous injection.

4.

For use in EGPA and HES, ensure injection sites for each subcutaneous injection are separated by at least 5 cm (approximately 2 inches).

5.

Never give injections into areas where the skin is tender, bruised, red, or hard.

6.

If a dose is missed, administer a dose as soon as possible. Thereafter, the patient can resume dosing on the usual day of administration. If the next dose is already due, then administer as planned.