Source: FDA, National Drug Code (US) Revision Year: 2019
Infliximab-axxq, the active ingredient in AVSOLA, 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-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
AVSOLA is supplied as a sterile, white to slightly yellow, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2. Each single-dose vial contains 100 mg infliximab-axxq, dibasic sodium phosphate, anhydrous (4.9 mg), monobasic sodium phosphate, monohydrate (2.2 mg), polysorbate 80 (0.5 mg), and sucrose (500 mg).
No preservatives are present.
| Dosage Forms and Strengths |
|---|
|
For injection: 100 mg of infliximab-axxq as a white to slightly yellow lyophilized powder in a single-dose vial, for intravenous use. |
| How Supplied | ||
|---|---|---|
|
Each AVSOLA (infliximab-axxq) for Injection 20 mL vial is individually packaged in a carton. AVSOLA is supplied as a single carton containing 1 vial.
Each single-dose vial contains 100 mg of infliximab-axxq for final reconstitution volume of 10 mL. Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 |
| Drug | Countries | |
|---|---|---|
| AVSOLA | Brazil, Canada, Turkey, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
