Avsola (Infliximab)

Description

Avsola (infliximab-axxq) is a biosimilar to Remicade (infliximab), a chimeric monoclonal antibody that binds with high affinity to tumor necrosis factor-alpha (TNF-a), a pro-inflammatory cytokine involved in the pathogenesis of several autoimmune diseases. By neutralizing TNF-a, Avsola reduces inflammation and modulates immune response. It is indicated for the treatment of moderate to severe Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, typically in patients who have had an inadequate response to conventional therapies.

Directions

Avsola is administered by intravenous infusion, typically over at least 2 hours. The dosing schedule varies by indication:

• Rheumatoid arthritis: 3 mg/kg at weeks 0, 2, and 6, then every 8 weeks (in combination with methotrexate)

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

• Ankylosing spondylitis and psoriatic arthritis: 5 mg/kg at the same interval

• Plaque psoriasis: Initial 5 mg/kg dose followed by repeat infusions at 2 and 6 weeks, then every 8 weeks

Premedication with antihistamines, antipyretics, or corticosteroids may be considered to minimize infusion reactions. Patients should be closely monitored during and after infusions.

Ingredients

Each vial of Avsola contains:

• Infliximab-axxq 100 mg

• Sucrose

• Polysorbate 80

• Monobasic sodium phosphate monohydrate

• Dibasic sodium phosphate dihydrate

The lyophilized powder must be reconstituted and diluted prior to infusion. The formulation is preservative-free.

Contraindications

Avsola is contraindicated in patients with:

• Known hypersensitivity to infliximab, murine proteins, or any component of the formulation

• Moderate to severe heart failure (NYHA class III/IV)

• Active infections, including tuberculosis, sepsis, or opportunistic infections

Cautions

Serious infections, including tuberculosis, invasive fungal infections, and opportunistic infections, have occurred. Evaluate patients for latent TB prior to starting treatment, and monitor closely during therapy. Avsola may increase the risk of malignancies, particularly lymphoma and skin cancer. Hepatitis B reactivation can occur; screening and monitoring are necessary. Use with other biologics or immunosuppressants may increase the risk of adverse events. Infusion-related reactions (acute or delayed) may occur; patients should be monitored and treated appropriately.

Side Effects

Common side effects of Avsola include:

• Upper respiratory tract infections

• Headache

• Nausea

• Abdominal pain

• Rash

• Sinusitis

• Cough

• Infusion-related reactions (fever, chills, chest discomfort)

Serious side effects may include:

• Serious infections (TB, fungal, bacterial)

• Heart failure exacerbation

• Hepatitis B reactivation

• Lymphoma and other malignancies

• Demyelinating disease

• Lupus-like syndrome

• Severe infusion reactions

Product Code : 14896