Avsola injection for autoimmune and inflammatory diseases

Avsola is an intravenous injectable biosimilar to Remicade (infliximab) used to treat various autoimmune conditions. It works by blocking tumor necrosis factor (TNF), a protein involved in causing inflammation in diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and severe plaque psoriasis.

It is approved for use in adults and pediatric patients (age 6 and older for some indications) with moderate to severe disease activity who have not responded adequately to conventional therapies.

• Crohn's disease (adults): To reduce symptoms, induce and maintain remission, and reduce fistulas in patients with moderately to severely active disease unresponsive to conventional treatment.
• Crohn's disease (pediatric, age ≥6): To reduce symptoms and maintain remission in moderately to severely active disease.
• Ulcerative colitis (adults): To reduce symptoms, induce and maintain remission, promote mucosal healing, and eliminate corticosteroid use in moderately to severely active disease with inadequate response to conventional therapy.
• Ulcerative colitis (pediatric, age ≥6): To reduce symptoms and maintain remission in moderately to severely active disease.
• Rheumatoid arthritis (adults): In combination with methotrexate, to reduce symptoms, inhibit structural joint damage progression, and improve physical function in moderately to severely active disease.
• Ankylosing spondylitis (adults): To reduce symptoms in active disease.
• Psoriatic arthritis (adults): To reduce symptoms, inhibit structural damage progression, and improve physical function.
• Plaque psoriasis (adults): For treatment of chronic severe plaque psoriasis in patients who are candidates for systemic therapy and when other systemic therapies are less appropriate; requires close monitoring.

infliximab-axxq, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate, polysorbate 80, sucrose

Avsola is a tumor necrosis factor (TNF) blocker. TNF is an inflammatory protein that plays a key role in the immune system and contributes to inflammation in autoimmune diseases. By binding to and neutralizing TNF, Avsola reduces inflammation and the immune response that causes symptoms and tissue damage in these conditions.

General Administration

• Avsola is given by intravenous infusion over at least 2 hours using an in-line sterile filter.
• Premedication with antihistamines, acetaminophen, and/or corticosteroids may be used to reduce infusion reactions.
• The solution must be reconstituted and diluted to a concentration between 0.4 mg/mL and 4 mg/mL in 0.9% sodium chloride and administered within 3 hours of preparation.

Adult dosing

• Crohn's disease and fistulizing Crohn's disease: 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks. Dose may be increased to 10 mg/kg every 8 weeks if response is lost.
• Ulcerative colitis: 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks.
• Rheumatoid arthritis (with methotrexate): 3 mg/kg at weeks 0, 2, and 6, then every 8 weeks; dosing may be increased up to 10 mg/kg every 8 weeks or every 4 weeks for incomplete response.
• Ankylosing spondylitis: 5 mg/kg at weeks 0, 2, and 6, then every 6 weeks.
• Psoriatic arthritis and plaque psoriasis: 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks.

Pediatric dosing (age 6 and older)

• Crohn's disease and ulcerative colitis: 5 mg/kg at weeks 0, 2, and 6, then every 8 weeks.

Additional notes

• Patients not responding by week 14 are unlikely to benefit from continued treatment and should be evaluated for discontinuation.
• Close monitoring for infusion reactions is essential.

None explicitly stated in the provided label text.

Serious infections

Avsola increases the risk of serious infections including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections from opportunistic pathogens such as Legionella and Listeria. These infections can lead to hospitalization or death.

• Test for latent TB prior to starting therapy; if positive, treat before Avsola initiation.
• Monitor all patients for signs of active TB during treatment, even if the initial TB test was negative.
• Discontinue Avsola if a serious infection or sepsis develops.

Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers including Avsola.

Rare cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported, mostly in adolescent and young adult male patients with Crohn's disease or ulcerative colitis treated concomitantly with azathioprine or 6-mercaptopurine.

Infusion Reactions

Hypersensitivity and infusion reactions may occur during or shortly after infusion.

• Premedication can reduce risk.
• Mild to moderate reactions may be managed by slowing or stopping infusion temporarily and then resuming at a slower rate.
• Discontinue infusion if severe hypersensitivity reactions occur.

Common side effects

• Infections (including respiratory and urinary tract infections)
• Infusion-related reactions such as fever, chills, rash, pruritus
• Headache
• Abdominal pain

Serious side effects

• Serious infections including tuberculosis and invasive fungal infections
• Malignancies including lymphoma and hepatosplenic T-cell lymphoma
• Severe infusion reactions
• Heart failure exacerbation

Concomitant use with immunosuppressants such as methotrexate, corticosteroids, azathioprine, or 6-mercaptopurine increases the risk of serious infections and malignancies. AVSOLA should be used cautiously and patients closely monitored when given with these agents.

No specific pregnancy or lactation information provided in the supplied label text.

No specific overdose information provided in the supplied label text.

Store lyophilized powder as per package instructions. Reconstituted and diluted solutions should be used within 3 hours and not stored. Discard any unused portion.