Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor-alpha (TNF-α), neutralizing its biological function. It is a Disease-Modifying Anti-Rheumatic Drug (DMARD) and a cornerstone of biologic therapy for various autoimmune and inflammatory conditions in India. The 40mg/0.8ml formulation is a high-concentration, citrate-free, single-dose prefilled syringe or pen, designed to reduce injection site pain and improve patient convenience.
Adult: Typically 40 mg administered subcutaneously every other week. For some conditions (e.g., Crohn's disease, Hidradenitis Suppurativa), an initial loading dose of 160 mg (four 40 mg injections on Day 1 or split over two days) followed by 80 mg two weeks later, then 40 mg every other week.
Note: For subcutaneous use only. Administer in the thigh or abdomen (avoid 2-inch area around navel). Rotate injection sites. Allow prefilled syringe/pen to reach room temperature (15-30 minutes) before injection. Do not shake. Inject the full 0.8ml. Dispose of needle in a sharps container. A healthcare professional should train the patient on self-injection technique.
Adalimumab is a fully human monoclonal antibody that binds with high affinity and specificity to soluble and transmembrane forms of human TNF-α, a key pro-inflammatory cytokine. This binding prevents TNF-α from interacting with its p55 and p75 cell surface TNF receptors (TNFR1 and TNFR2), thereby inhibiting TNF-mediated cellular responses.
Pregnancy: Pregnancy Category B (US FDA). Limited human data. IgG antibodies cross the placenta, especially in the third trimester, potentially affecting infant immune response. Use only if clearly needed. Indian registry data suggests generally favorable outcomes. Live vaccines should not be given to infants exposed in utero for up to 6 months.
Driving: No known effects on driving ability. However, dizziness or visual disturbances (rare side effects) could impair skills.
| Abatacept | Increased risk of serious infections, no added benefit shown. Concurrent use is not recommended. | Major |
| Anakinra | Increased risk of serious infections and neutropenia. Concurrent use is not recommended. | Major |
| Live Vaccines (MMR, Varicella, Yellow Fever, Oral Polio, Rotavirus) | Risk of disseminated infection. Avoid administration during therapy. | Major |
| Methotrexate | Concomitant use reduces the formation of anti-adalimumab antibodies by ~50%, potentially improving efficacy and pharmacokinetics. | Moderate |
| Other Immunosuppressants (Azathioprine, 6-Mercaptopurine) | May increase risk of infections, particularly opportunistic ones. Benefit-risk must be assessed. | Moderate |
| Warfarin | Case reports of increased INR and bleeding; monitor INR closely if co-administered. | Moderate |
Same composition (Adalimumab (40mg/0.8ml)), different brands: