Hefiya (Adalimumab)

Hefiya is indicated for the management of several immune‑mediated inflammatory disorders where inhibition of tumor necrosis factor‑α (TNF‑α) is beneficial.

• Moderate to severe rheumatoid arthritis in adults who have had an inadequate response to conventional disease‑modifying antirheumatic drugs (DMARDs).
• Active psoriatic arthritis, including peripheral joint disease and axial involvement.
• Moderate to severe plaque psoriasis that is unsuitable for topical therapy alone.
• Ankylosing spondylitis and non‑radiographic axial spondyloarthritis.
• Crohn’s disease in adults with moderate to severe activity.
• Ulcerative colitis in adults with moderate to severe disease.

The safety profile of Hefiya reflects the pharmacology of adalimumab, a TNF‑α inhibitor, and includes both common and less frequent serious reactions.

Common

• Injection site reactions such as redness, swelling, itching, or mild pain that usually resolve within a few days.
• Upper respiratory tract infections, including sinusitis, nasopharyngitis, or mild bronchitis.
• Headache, often described as mild to moderate intensity.
• Nausea or transient gastrointestinal discomfort.

Serious

• Serious infections, for example tuberculosis, bacterial sepsis, opportunistic fungal infections, or viral infections such as herpes zoster.
• Reactivation of hepatitis B virus in patients with prior exposure.
• Malignancies, including lymphoma, solid tumors, or non‑melanoma skin cancers.
• New onset or worsening congestive heart failure.
• Demyelinating disorders such as multiple sclerosis‑like events.

When prescribing Hefiya, clinicians should evaluate patient history and monitor for conditions that could increase risk during therapy.

• Screen for active or latent tuberculosis before initiating treatment and repeat monitoring as clinically indicated.
• Assess for chronic or recurrent infections, including hepatitis B and C status.
• Evaluate for a history of malignancy, particularly lymphoproliferative disorders.
• Review cardiac function; avoid use in patients with moderate to severe heart failure.
• Consider vaccination status; administer necessary vaccines prior to starting therapy.
• Use caution in pregnant or breastfeeding women; discuss potential risks and benefits.

Adalimumab may interact with other medicines that affect the immune system or increase infection risk.

Avoid

• Live vaccines administered during treatment, as the immunosuppressive effect can reduce vaccine efficacy and increase adverse events.
• Concurrent use of other biologic disease‑modifying agents (e.g., abatacept, rituximab) due to heightened immunosuppression.
• Combination with JAK inhibitors (e.g., tofacitinib) should be avoided due to overlapping immunosuppressive mechanisms.

Use with caution

• Systemic corticosteroids, which may augment infection risk.
• Immunosuppressive agents such as methotrexate or azathioprine, requiring close monitoring.
• Antiviral therapies for hepatitis B, as reactivation can occur.
• Concomitant use of interferon‑beta in multiple sclerosis patients.
• Concurrent use of NSAIDs may increase risk of infection and should be monitored.