Source: FDA, National Drug Code (US) Revision Year: 2020
Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa.
EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe.
Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.
| Dosage Forms and Strengths |
|---|
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Injection: 105 mg/1.17 mL clear to opalescent, colorless to light yellow solution in a single-use prefilled syringe. A full dose of EVENITY requires two single-use prefilled syringes. |
| How Supplied |
|---|
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EVENITY (romosozumab-aqqg) injection is a clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-use prefilled syringe. Each single-use prefilled syringe contains 105 mg of EVENITY in a deliverable volume of 1.17 mL. To deliver a full dose, inject two 105 mg/1.17 mL EVENITY prefilled syringes, one after the other for a total dose of 210 mg.
The prefilled syringe is not made with natural rubber latex. |
| Drug | Countries | |
|---|---|---|
| EVENITY | Austria, Australia, Brazil, Canada, Estonia, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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