What is Avsola and how does it work?
Avsola (infliximab-axxq) is a TNF-alpha blocker, a biosimilar of Remicade (infliximab). In autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and others, the immune system attacks healthy tissues, leading to excessive production of TNF-alpha, a protein central to inflammation. This excess TNF-alpha causes chronic inflammation and tissue damage.
Avsola neutralizes TNF-alpha by binding to its soluble and transmembrane forms. By blocking TNF-alpha from binding to its receptors, Avsola disrupts the inflammatory process, reducing swelling and symptoms. Because it affects the immune system, monitoring for side effects, particularly infections, is important.
Medical conditions treated by Avsola
Avsola treats a variety of conditions in adults and children who haven't responded well to standard treatments, including Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis.
How Avsola is administered
Avsola is given as an intravenous (IV) infusion in a clinical setting under medical supervision. The process includes:
- Preparation: The medication is reconstituted and diluted with sterile saline.
- Infusion: The solution is infused into a vein over at least two hours.
- Monitoring: Patients are observed during and after the infusion for adverse reactions.
- Schedule: An initial phase involves infusions at weeks 0, 2, and 6, followed by maintenance infusions every 6 to 8 weeks, depending on the condition.
Avsola vs. Remicade: A comparison
As a biosimilar of Remicade, Avsola is considered highly similar with no clinically meaningful differences in safety and efficacy. Differences primarily relate to cost and market specifics.
| Feature | Avsola (infliximab-axxq) | Remicade (infliximab) |
|---|---|---|
| Drug Class | TNF-alpha blocker (biosimilar) | TNF-alpha blocker (reference biologic) |
| FDA Approval | Approved in 2019 for all Remicade indications | Approved in 1998 |
| Mechanism | Works the same way by binding to and neutralizing TNF-alpha | Works the same way by binding to and neutralizing TNF-alpha |
| Administration | Intravenous (IV) infusion | Intravenous (IV) infusion |
| Cost | Often more cost-effective due to biosimilar pricing | Can be more expensive; original patent holder |
| Interchangeability | Not designated as an interchangeable biosimilar, requiring a specific prescription | Reference product for multiple biosimilars |
Risks, side effects, and important safety information
Avsola can affect the immune system and carries risks of serious side effects, necessitating patient awareness and communication with their doctor.
Common side effects include:
- Upper respiratory tract infections
- Headache
- Coughing
- Stomach pain and nausea
- Fatigue
- Infusion-related reactions
Serious warnings and potential side effects include:
- Serious Infections: Increased risk of serious and fatal infections like TB, bacterial sepsis, and fungal infections. TB testing is required before treatment.
- Malignancy (Cancer): Increased risk of certain cancers, including lymphoma. Rare, fatal cases of hepatosplenic T-cell lymphoma have occurred, mainly in young males with CD or UC on other immunosuppressants.
- Heart Failure: Can worsen heart failure and is contraindicated at doses over 5 mg/kg in moderate to severe cases.
- Hepatitis B Virus Reactivation: Can reactivate the virus in carriers, potentially fatally. Testing is required before treatment.
- Other Serious Effects: Includes liver problems, blood disorders, nervous system disorders, and severe allergic reactions.
Conclusion
Avsola is a biosimilar medication effectively treating various chronic autoimmune diseases by blocking the inflammatory protein TNF-alpha. It relieves symptoms and helps manage disease progression in conditions like rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Understanding its mechanism, administration, and potential side effects is crucial. Patients should maintain open communication with their healthcare provider for safe and effective use. {Link: DailyMed https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de34bcb7-b524-45c8-9181-61c6f48d540e&audience=consumer} provides further information.
