Product Information
Humimab-HC (Adalimumab Injection) is a targeted biologic therapy designed to modulate the immune system by specifically binding to TNF-α, a pro-inflammatory cytokine involved in systemic inflammation. By neutralizing TNF-α, Humimab-HC effectively diminishes inflammatory responses, providing relief from symptoms and preventing further joint and tissue damage associated with autoimmune disorders.
This medication is available in a 40 mg/0.4 mL pre-filled syringe, intended for subcutaneous administration. The convenience of a pre-filled syringe facilitates self-administration, empowering patients to manage their treatment regimen effectively.
Indications
Humimab-HC is indicated for the treatment of:
- Rheumatoid Arthritis: To reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active disease.
- Psoriatic Arthritis: To reduce signs and symptoms of active arthritis, inhibit the progression of structural damage, and improve physical function.
- Ankylosing Spondylitis: To reduce signs and symptoms in patients with active disease.
- Crohn’s Disease: To reduce signs and symptoms and induce and maintain clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Ulcerative Colitis: For inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants.
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 0.4 mL of Humimab-HC contains:
- Active Ingredient: 40 mg of Adalimumab.
- Inactive Ingredients: Mannitol, polysorbate 80, and water for injection.
Dosage and Administration
- Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: 40 mg administered every other week via subcutaneous injection.
- Crohn’s Disease and Ulcerative Colitis: Initial dose of 160 mg (administered as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2), followed by 80 mg two weeks later (Day 15). Maintenance dose of 40 mg every other week starting on Day 29.
- Plaque Psoriasis: Initial dose of 80 mg, followed by 40 mg every other week starting one week after the initial dose.
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. Humimab-HC 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 Humimab-HC.
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, Humimab-HC 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 Humimab-HC, patients should be screened for latent tuberculosis infection.
- Patients should be informed about the potential risks and benefits of Humimab-HC.
- 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.
