Product Information
Intacept 50 mg Injection is a biologic medication designed to modulate the immune system by targeting TNF-α, a cytokine involved in systemic inflammation. By inhibiting TNF-α, Intacept effectively reduces inflammatory responses, alleviating symptoms and preventing joint and tissue damage associated with autoimmune disorders.
This medication is available in a 50 mg/1.0 mL pre-filled syringe intended for subcutaneous administration. The pre-filled syringe format facilitates ease of use, allowing for self-administration under appropriate guidance.
Indications
Intacept 50 mg Injection is indicated for the treatment of:
- Rheumatoid Arthritis: To reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active disease.
- Ankylosing Spondylitis: To reduce signs and symptoms in patients with active disease.
- Psoriatic Arthritis: To reduce signs and symptoms of active arthritis and inhibit the progression of structural damage.
- Plaque Psoriasis: For the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Composition
Each 1.0 mL of Intacept 50 mg Injection contains:
- Active Ingredient: 50 mg of Etanercept.
- Inactive Ingredients: Sucrose, L-Lysine Monohydrate, and Water for Injection.
Dosage and Administration
- Rheumatoid Arthritis and Psoriatic Arthritis: 50 mg administered once weekly via subcutaneous injection.
- Ankylosing Spondylitis: 50 mg administered once weekly via subcutaneous injection.
- Plaque Psoriasis: Initial dose of 50 mg twice weekly (administered 3 or 4 days apart) for 3 months, followed by a maintenance dose of 50 mg once weekly.
Note: Dosage may vary based on individual patient factors and specific indications. Always follow the prescribing physician’s recommendations.
Precautions
- Infections: Patients should be evaluated for active infections, including tuberculosis, before initiating treatment. Intacept may increase the risk of serious infections.
- Allergic Reactions: Severe allergic reactions, including anaphylaxis, have been reported. Discontinue use if a serious allergic reaction occurs.
- Malignancies: There is an increased risk of malignancies in patients receiving TNF blockers.
- Vaccinations: Live vaccines should be avoided during treatment with Intacept.
- Monitoring: Regular monitoring for signs and symptoms of infection during and after treatment is recommended.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Do not freeze.
- Protect from light by storing in the original carton until time of administration.
- If needed, for convenience, Intacept may be stored at room temperature up to 25°C (77°F) for a period up to 14 days. After removal from the refrigerator, it must be used within 14 days or discarded, even if it is returned to the refrigerator.
Note
- Prior to initiating therapy with Intacept, patients should be screened for latent tuberculosis infection.
- Patients should be informed about the potential risks and benefits of Intacept.
- Regular follow-ups and laboratory tests are essential to monitor patient response and detect any adverse effects early.
- This medication should only be used under the supervision of a healthcare professional experienced in the diagnosis and treatment of the indicated conditions.
