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What is amgevita used for? A guide to indications and treatment

3 min read

According to the European Medicines Agency, Amgevita is a biosimilar medicine highly similar to Humira, used to treat various inflammatory conditions by targeting the immune system. This guide will detail what is amgevita used for, covering its specific indications for adults and children, its mechanism of action, and important safety considerations.

Quick Summary

Amgevita (adalimumab-atto) is a biosimilar medication prescribed for a range of autoimmune diseases, including rheumatoid arthritis, Crohn's disease, psoriasis, and uveitis. It works by blocking a key inflammatory protein to reduce symptoms and inflammation.

Key Points

  • Adalimumab-atto: Amgevita contains the active ingredient adalimumab-atto, a biosimilar of the original biologic Humira.

  • TNF-alpha Blocker: It works by blocking the inflammatory protein tumor necrosis factor-alpha (TNF-α).

  • Wide Range of Uses: Indications include various forms of arthritis, inflammatory bowel diseases, and skin and eye conditions.

  • Immune System Suppression: Amgevita has boxed warnings for increased risk of serious infections and certain cancers.

  • Adult and Pediatric Use: It is approved for adults and certain pediatric patients.

  • Administration: It is given via subcutaneous injection.

  • Requires Medical Supervision: Treatment requires specialist supervision and monitoring for side effects.

In This Article

What is Amgevita (adalimumab-atto)?

Amgevita (adalimumab-atto) is a prescription biological medicine used to treat a range of inflammatory conditions caused by an overactive immune system. It is a biosimilar version of Humira (adalimumab) and is considered to be highly similar with no clinically meaningful differences in safety or effectiveness for its approved uses. Amgevita works by blocking the action of tumor necrosis factor (TNF), a protein involved in causing inflammation.

Approved uses of Amgevita

Amgevita is approved to treat several chronic inflammatory conditions in adults and children. It is administered via subcutaneous injection. Specific uses include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. For a detailed list of indications, consult the resources provided.

How Amgevita works

Amgevita's mechanism of action involves its active ingredient, adalimumab-atto, a monoclonal antibody. It specifically targets and blocks tumor necrosis factor (TNF), a protein that plays a key role in the inflammation associated with many autoimmune diseases. By neutralizing TNF, Amgevita helps reduce inflammation and symptoms.

Comparison: Amgevita vs. Humira

Amgevita is a biosimilar of Humira, sharing the same active ingredient (adalimumab-atto vs. adalimumab) and mechanism of action (TNF-alpha blocker). While they treat many of the same adult inflammatory conditions, there are some differences, particularly in pediatric indications and available forms.

Feature Amgevita (adalimumab-atto) Humira (adalimumab)
Drug Type Biosimilar of Humira Reference biological drug
Active Ingredient Adalimumab-atto Adalimumab
Mechanism of Action Same (TNF-alpha blocker) Same (TNF-alpha blocker)
Approved Adult Indications Many of the same inflammatory conditions Many of the same inflammatory conditions
Approved Pediatric Indications Approved for certain pediatric conditions (JIA, CD), but some differ from Humira Broader pediatric approvals for some conditions, such as UC and HS
Available Forms Prefilled syringe and prefilled autoinjector Prefilled syringe, prefilled pen, and vial

Important safety information and risks

Before starting Amgevita, discuss all health conditions and medications with your doctor. Amgevita carries boxed warnings due to potential serious risks, including:

Boxed warnings

  • Serious Infections: Increased risk of serious infections, including TB and other opportunistic infections. Screening for latent TB is required before treatment.
  • Malignancy (Cancer): Increased risk of certain cancers, including lymphoma. A rare, fatal lymphoma has been reported, particularly in young males with IBD also on other immunosuppressants.

Other serious risks

  • Hepatitis B reactivation in chronic carriers.
  • New or worsening congestive heart failure.
  • Nervous system problems like multiple sclerosis and Guillain-Barré syndrome.
  • Lupus-like syndrome.

Common side effects

Common side effects may include injection site reactions, headache, upper respiratory infections, rash, nausea, and abdominal pain.

Who should avoid Amgevita?

Amgevita is not suitable for everyone. It is contraindicated in patients with an active severe infection (including active TB), a known allergy to adalimumab or other ingredients (some pens contain latex), or moderate to severe heart failure (NYHA class III/IV). It should not be used with other TNF blockers or specific immunomodulators like anakinra.

Conclusion

Amgevita, a biosimilar of Humira, treats inflammatory conditions by blocking TNF-alpha. Risks include serious infections and certain cancers due to its immunosuppressant action. Consultation with a healthcare provider is vital to determine if Amgevita is appropriate. For further details, consult resources like {Link: NHS https://www.nhs.uk/medicines/adalimumab/about-adalimumab/} or {Link: RxList https://www.rxlist.com/amjevita-drug.htm}.

Frequently Asked Questions

Amgevita is a biosimilar medicine containing the active substance adalimumab-atto. It is considered highly similar to Humira (adalimumab), the original reference biologic medicine, with no clinically meaningful differences in safety or effectiveness for approved uses.

Amgevita works by blocking a protein called tumor necrosis factor (TNF), which is overproduced in certain autoimmune diseases and causes inflammation. By binding to TNF, adalimumab-atto reduces inflammation and helps alleviate symptoms.

Common side effects include injection site reactions (redness, pain, itching), upper respiratory infections, headaches, and rash.

Yes, Amgevita can increase the risk of serious infections because it suppresses the immune system. This includes TB and opportunistic infections. Patients are screened for TB before starting treatment and monitored closely afterward.

Amgevita has a boxed warning about an increased risk of certain cancers, including lymphoma and skin cancer. In some cases, rare and aggressive lymphomas have been reported, particularly in certain young patients with inflammatory bowel disease.

Amgevita is given as a subcutaneous injection, which can be done using a prefilled syringe or autoinjector. The dose is injected under the skin in the thigh or abdomen, and injection sites should be rotated.

It may take a few weeks to see an improvement in symptoms after starting Amgevita, although the exact timeframe can vary depending on the specific condition being treated.

Amgevita is approved for certain pediatric uses, such as juvenile idiopathic arthritis (JIA) in children aged 2 and older and Crohn's disease in children aged 6 and older. However, specific pediatric approvals and safety considerations, such as the risk of malignancies, can vary compared to the reference drug, Humira.

Contraindications for Amgevita include an active severe infection (including TB), moderate to severe heart failure, known hypersensitivity to adalimumab or other ingredients (some pens contain latex), and use with certain other biologic drugs.

No, Amgevita is not a cure for rheumatoid arthritis or other autoimmune conditions. It is a long-term treatment designed to manage symptoms, reduce inflammation, and slow the progression of joint damage.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.