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)?

For people with chronic inflammatory diseases like rheumatoid arthritis, Crohn’s disease, or ulcerative colitis, daily life can feel unpredictable and exhausting. Pain, swelling, fatigue, and digestive distress can interfere with even simple routines. Avsola (infliximab-axxq) offers hope and relief for those battling these long-term immune-driven conditions. 

Avsola is a biologic medication that helps reduce inflammation by targeting specific immune system activity. It belongs to a class of drugs known as tumor necrosis factor (TNF) inhibitors, which are designed to block a protein involved in inflammation. Approved by the U.S. Food and Drug Administration (FDA), Avsola is a biosimilar to Remicade (infliximab), meaning it works in the same way and has been proven to be just as safe and effective. 

This medication is prescribed for several autoimmune diseases where the body’s immune system mistakenly attacks its own tissues. For many patients, Avsola can significantly improve symptoms, prevent long-term damage, and restore quality of life. 

What does Avsola do? 

Avsola is used to treat a range of autoimmune and inflammatory diseases, including: 

  • Rheumatoid arthritis (in adults): to reduce joint pain, swelling, and stiffness when used with methotrexate. 
     
  • Ankylosing spondylitis: to relieve back pain and stiffness caused by spinal inflammation. 
     
  • Psoriatic arthritis: to improve joint and skin symptoms in people with psoriasis-related arthritis. 
     
  • Plaque psoriasis: to reduce redness, scaling, and thickened skin patches. 
     
  • Crohn’s disease and ulcerative colitis (in adults and children): to control inflammation in the digestive tract and reduce flare-ups. 

By reducing inflammation, Avsola helps patients experience fewer symptoms and longer periods of disease control. Many report feeling less pain, improved mobility, and better overall energy. Clinical studies and FDA reviews confirm that Avsola provides equivalent safety and effectiveness to Remicade, the original infliximab product (FDA, 2023). 

How does Avsola work? 

Avsola contains infliximab-axxq, a monoclonal antibody that targets a specific protein in the body called tumor necrosis factor-alpha (TNF-α). TNF-α plays a major role in the body’s immune response and is responsible for triggering inflammation. 

In autoimmune diseases, TNF-α levels are often abnormally high, leading the immune system to attack healthy tissues. This causes chronic inflammation, pain, and tissue damage. Avsola binds to TNF-α, blocking its activity and preventing it from triggering inflammation. 

By doing this, Avsola helps reduce swelling, pain, and tissue damage in affected joints, skin, or intestines depending on the disease being treated. 

Clinically, this mechanism matters because persistent inflammation can lead to irreversible joint damage, intestinal scarring, or organ complications. By controlling inflammation early and effectively, Avsola helps preserve long-term function and quality of life. 

Avsola side effects 

Like all biologic medicines, Avsola can cause side effects. Most are mild to moderate, but serious reactions can occur in some patients. Understanding what to watch for helps ensure safe and effective treatment. 

Common side effects include: 

  • Upper respiratory infections (such as sinus or sore throat infections) 
     
  • Headache or fatigue 
     
  • Cough or mild fever 
     
  • Stomach pain or nausea 
     
  • Skin rash or itching at the injection site 

Serious side effects (less common): 

  • Infusion reactions: Fever, chills, or shortness of breath can occur during or after infusion; patients are monitored. 
  • Infections: Avsola increases the risk of serious infections (e.g., tuberculosis, hepatitis B, fungal infections); screening is recommended pre-treatment. 
  • Heart and liver issues: Rarely, Avsola may worsen heart failure or cause liver inflammation. 
  • Cancer risk: A low risk of certain cancers (e.g., lymphoma) exists for patients on TNF blockers; discuss with a healthcare provider. 

Avoid Avsola with active infections, moderate to severe heart failure, or infliximab allergies. Report persistent fever, weight loss, night sweats, or unexplained bruising immediately. Most tolerate Avsola well, and benefits often outweigh risks. 

Avsola dosage 

Avsola is administered as an IV infusion by a healthcare professional, typically in a clinic or hospital, over several hours. Infusion frequency varies by condition, with initial doses a few weeks apart, followed by maintenance infusions every few weeks for symptom control. 

Avsola affects the immune system, so doctors may order regular blood tests for liver function, blood cell counts, and infection risk. They may also test for tuberculosis or hepatitis B before treatment.  

Older adults, or those with chronic infections or weakened immune systems, require special care, potentially with adjusted treatment or more frequent monitoring. Patients should attend all infusions and report any side effects between visits. 

Does Avsola have a generic version? 

Avsola is itself a biosimilar to the biologic medication Remicade (infliximab). Biosimilars are not identical to generics, they are highly similar versions of complex biologic drugs that have been rigorously tested to ensure they are just as safe, effective, and pure as the original product. 

Avsola, an FDA-approved infliximab biosimilar from 2019, joins Inflectra and Renflexis. While no generic infliximab exists due to its biologic nature, biosimilars offer affordable, quality treatment. Providers can guide patients on formulation choices, insurance, and medical needs. 

Conclusion 

Avsola (infliximab-axxq) is a trusted, effective treatment option for several chronic inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. By blocking the inflammation-causing TNF-α protein, it helps reduce pain, swelling, and tissue damage allowing patients to regain control over their health and daily lives. 

Though requiring regular infusions and medical supervision, Avsola offers significant long-term benefits for many. With consistent monitoring and doctor communication, most patients can safely manage their conditions. If you have a chronic autoimmune disease, discuss Avsola with your doctor; it can help control inflammation and improve your quality of life. 

References 

  1. U.S. Food and Drug Administration (FDA). (2023). Avsola (infliximab-axxq) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Infliximab (intravenous route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Infliximab injection: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Tumor necrosis factor inhibitors in autoimmune disease management. Retrieved from https://www.nih.gov 
     

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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