Source: FDA, National Drug Code (US) Revision Year: 2021
Infliximab-abda, the active ingredient in RENFLEXIS, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-abda is produced in a recombinant cell line and is purified by a series of steps that includes measures to inactivate and remove viruses.
RENFLEXIS (infliximab-abda) for Injection is supplied as a sterile, white, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 6. Each mL contains 10 mg infliximab-abda, dibasic sodium phosphate heptahydrate (0.12 mg), monobasic sodium phosphate monohydrate (0.63 mg), polysorbate 80 (0.05 mg), and sucrose (50 mg). No preservatives are present.
| Dosage Forms and Strengths |
|---|
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For injection: 100 mg vial: 100 mg lyophilized infliximab-abda in a 20 mL vial for injection, for intravenous use. |
| How Supplied |
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Each RENFLEXIS (infliximab-abda) for Injection 100 mg vial is individually packaged in a carton. NDC 0006-4305-02 – 100 mg vial Each single dose vial contains 100 mg of lyophilized infliximab-abda for final reconstitution volume of 10 mL. Manufactured by: Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889 USA |
| Drug | Countries | |
|---|---|---|
| RENFLEXIS | Australia, Brazil, Canada, United States |
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