Generic Name

Infliximab

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

What is Avsola (Infliximab)?

ZYMFENTRA is a tumor necrosis factor blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following treatment with an infliximab products administered intraneously. ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.
Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms
Tired of the same old research?
Check Latest Advances

Related Clinical Trials

Treatment of Immune Checkpoint Inhibitor-Related Colitis With Infliximab or Vedolizumab: A Randomized Trial

Summary: This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrh...

Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis

Summary: This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of IMDC CTCAE v5.0 grade ≥ 2 due to ICI therapy alone (α-PD-(L)1 monotherapy or combined with another ICI, such as α-CTLA-4 or α-LAG-3) or ICI plus an oral tyrosine kinase inhibitor that in the opinion of the treating physician requir...

Zymfentra (Infliximab-dyyb) REal World Cohort STudy

Summary: The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their ...

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
    Avsola has been selected.