Generic Name

Infliximab

Brand Names
Avsola, Inflectra, Remicade, Renflexis, Zymfentra
FDA approval date: August 24, 1998
Classification: Tumor Necrosis Factor Blocker
Form: Injection, Kit

What is Avsola (Infliximab)?

AVSOLA is a tumor necrosis factor blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Approved To Treat

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Brand Information

    AVSOLA (infliximab-axxq)
    1DOSAGE FORMS AND STRENGTHS
    For injection: 100 mg of infliximab-axxq as a white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and dilution.
    2CONTRAINDICATIONS
    The use of AVSOLA at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure
    AVSOLA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab products or any of the inactive ingredients of AVSOLA or any murine proteins [severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness]
    3OVERDOSAGE
    Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects
    4DESCRIPTION
    Infliximab-axxq, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line.
    AVSOLA (infliximab-axxq) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder for intravenous infusion after reconstitution and dilution. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the final concentration is 10 mg/mL and 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).
    5REFERENCES
    1. Turner D, Otley AR, Mack D, et al. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: A prospective multicenter study.
    6PATIENT COUNSELING INFORMATION
    Advise the patient or their caregiver to read the FDA-approved patient labeling (Medication Guide).
    Patients or their caregivers should be advised of the potential benefits and risks of AVSOLA. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting AVSOLA therapy and to reread it each time they receive an infusion.
    7PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton Label
    100
    AMGEN
    NDC 55513-670-01
    AVSOLA
    100 mg/vial
    For Intravenous infusion only
    Single-Dose Vial. Discard unused portion.
    Contents: Each carton contains one 100 mg AVSOLA Single-Dose Vial.
    Rx Only
    PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton Label