Adalimumab

Active infection including localised infections, active TB, and severe infections (e.g. sepsis, opportunistic infections); moderate to severe heart failure (NYHA class III/IV). Concurrent administration of live vaccines.

Patient with history of opportunistic infections, chronic or recurrent infection, underlying conditions predisposing to infection (e.g. advanced or poorly controlled diabetes); pre-existing or recent-onset central or peripheral nervous system demyelinating disorders, COPD, mild heart failure (NYHA class I/II) or decreased left ventricular function; history or known malignancy (other than successfully treated non-melanoma skin cancer), history of significant haematologic abnormalities. HIV-positive patients and HBV carriers. Patients exposed to TB and those who resided in or travelled to areas with endemic TB or mycoses. Patients undergoing surgery and heavy smokers. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause vertigo and visual impairment, if affected, do not drive or operate machinery. Monitoring Parameters Perform active and latent TB screening prior to initiation and during therapy. Evaluate for HBV infection prior to initiation of therapy. Examine for the presence of non-melanoma skin cancer, particularly for patients with history of extensive immunosuppressant treatment or psoriasis patients with history of psoralen and ultraviolet A (PUVA) radiation therapy. Obtain CBC with differential and complete metabolic panel at baseline. Closely monitor for signs and symptoms of infection, TB (including patients who tested negative for latent TB before therapy initiation), HBV infection (in HBV carriers), blood dyscrasias, hypersensitivity reactions, lupus-like syndrome, or malignancies during and after treatment.

Significant: New-onset or worsening of heart failure; antibody formation. Rarely, anaphylaxis or other serious hypersensitivity reactions, autoimmune disorders (e.g. lupus-like syndrome), new-onset or exacerbation of demyelinating disease (e.g. optic neuritis, multiple sclerosis, peripheral demyelinating disease, including Guillain-Barre syndrome); haematologic disorders (e.g. pancytopenia, aplastic anaemia). Blood and lymphatic system disorders: Leucopenia, thrombocytopenia, leucocytosis, neutropenia, agranulocytosis, coagulation and bleeding disorders. Cardiac disorders: Tachycardia, chest pain. Ear and labyrinth disorders: Vertigo. Eye disorders: Conjunctivitis, blepharitis, eye inflammation, visual impairment. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, dyspepsia, GERD. General disorders and administration site conditions: Inj site reactions (e.g. pain, pruritus, swelling, bleeding), flu-like symptoms, oedema, pyrexia, impaired healing. Infections and infestations: Herpes simplex or zoster infection. Investigations: Positive ANA titre; increased creatine phosphokinase, uric acid, blood lactate dehydrogenase, and liver enzymes. Metabolism and nutrition disorders: Hypercholesterolaemia, hyperlipidaemia, dehydration, hypokalaemia, hypocalcaemia, hyperglycaemia, hypophosphataemia. Musculoskeletal and connective tissue disorders: Back or musculoskeletal pain, muscle spasm. Neoplasms benign, malignant and unspecified: Benign neoplasm. Nervous system disorders: Headache, paraesthesia, migraine. Psychiatric disorders: Insomnia, anxiety, mood alteration, depression. Renal and urinary disorders: Haematuria, renal impairment, UTI. Respiratory, thoracic and mediastinal disorders: Sinusitis, upper and lower respiratory tract infection, pharyngitis, nasopharyngitis, asthma, dyspnoea, cough. Skin and subcutaneous tissue disorders: Skin rash, alopecia, pruritus, onychoclasis, hyperhidrosis, urticaria, new-onset or worsening of psoriasis. Vascular disorders: Hypertension, flushing, haematoma.
Potentially Fatal: Serious infections such as active TB (including reactivation of latent TB), invasive fungal infections (e.g. aspergillosis, blastomycosis, histoplasmosis, candidiasis, coccidioidomycosis, pneumocystosis), and bacterial, viral or other opportunistic infections (including listeriosis and legionellosis); leukaemia, lymphomas (e.g. hepatosplenic T-cell lymphoma) and other malignancies. Rarely, hepatitis B virus (HBV) reactivation.

May reduce the serum concentrations of warfarin, theophylline and ciclosporin.

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-a) inhibitors. Used as immunosuppressants.