Product Information

Description

NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: 1 Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. (1.1), 2 Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2), 3 The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.3), 4 The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for =6 months without an identifiable non-hematologic secondary cause. (1.4).

Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa. NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL [see Dosage and Administration (2.5)]. Each vial delivers 100 mg of mepolizumab, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0. The vial stopper is not made with natural rubber latex. NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use. NUCALA injection is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29-gauge, half-inch needle and in a single-dose, 1-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3. NUCALA injection is supplied in a single-dose, 0.4-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 0.4 mL delivers 40 mg mepolizumab, citric acid monohydrate (0.38 mg), EDTA disodium dihydrate (0.0074 mg), polysorbate 80 (0.08 mg), sodium phosphate dibasic heptahydrate (1.66 mg), and sucrose (48 mg), with a pH of 6.3. The prefilled autoinjector and prefilled syringe are not made with natural rubber latex.