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Active Pharma Ingredients / 06 Aug 2026

ADALIMUMAB

Generic Name: ADALIMUMAB

ABSTRACT -

Adalimumab is a recombinant human IgG1 monoclonal antibody that binds tumor necrosis factor alpha (TNF-alpha) and inhibits its interaction with TNF receptors. It is used as an immunomodulating biologic for inflammatory autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis according to local approvals. It reduces inflammatory activity but can increase susceptibility to serious infection.

DOSAGE - 

Adalimumab should be administered only under medical supervision, with regimen selected for the approved indication and patient factors.

  • For several adult inflammatory conditions, a common maintenance regimen is 40 mg by subcutaneous injection every other week.
  • Some indications require induction dosing, higher maintenance dosing, weekly dosing, or weight-based pediatric dosing.
  • Patients should receive injection training and should not change dose or schedule without the prescriber.
  • Screening for tuberculosis, hepatitis B, and relevant infections is generally required before starting therapy.

SIDE EFFECTS - 

Reported or potential side effects may include:

  • Injection-site pain, redness, itching, or swelling
  • Upper respiratory tract infection
  • Sinusitis
  • Headache
  • Rash
  • Nausea
  • Abdominal pain
  • Back pain
  • Elevated liver enzymes
  • Hypertension
  • Serious infection including tuberculosis, fungal, bacterial, or viral infection
  • Reactivation of hepatitis B
  • Demyelinating disease or neurologic symptoms
  • Heart failure worsening
  • Blood count abnormalities
  • Lupus-like syndrome
  • Malignancy risk signal including lymphoma and skin cancer
  • Allergic or anaphylactic reactions

ALLRGIC REACTIONS–

(These symptoms may indicate an allergic reaction to the drug.)

  • Skin rash
  • Itching
  • Hives
  • Swelling of face, lips, tongue, or throat
  • Difficulty breathing
  • Wheezing
  • Severe dizziness
  • Rapid heartbeat
  • Chest tightness
  • Anaphylaxis
  • Severe hypersensitivity reactions

 

DRUG INTERACTIONS–

Adalimumab affects immune function and should be used cautiously with:

  • Live vaccines, which are generally avoided during treatment
  • Other biologic immunosuppressants or TNF inhibitors
  • Abatacept, anakinra, rituximab, or similar immunomodulators unless specifically directed
  • Corticosteroids, methotrexate, azathioprine, mercaptopurine, or other immunosuppressants that may increase infection risk
  • Warfarin, cyclosporine, or theophylline when inflammation changes may affect drug metabolism
  • Patients should inform healthcare providers about all prescription medicines, non-prescription medicines, herbal products, and supplements being used.

PREAUTIONS–

  • Evaluate for active infection before each dose and withhold treatment for serious infection as directed.
  • Screen for latent tuberculosis and hepatitis B before initiation and monitor as clinically indicated.
  • Use caution in patients with recurrent infection, chronic lung disease, diabetes, heart failure, demyelinating disease, malignancy history, or significant immunosuppression.
  • Vaccinations should be updated before therapy when possible; avoid live vaccines during treatment.
  • Pregnancy and breastfeeding decisions should be individualized with specialist guidance.
  • Use only as prescribed and maintain regular follow-up visits.

WARNINGS –

  • Serious and sometimes fatal infections can occur, including tuberculosis, invasive fungal infections, bacterial sepsis, and opportunistic infections.
  • Malignancies, including lymphoma and other cancers, have been reported with TNF blockers.
  • Anaphylaxis, demyelinating disease, cytopenias, heart failure worsening, lupus-like syndrome, and liver injury may occur.
  • Fever, persistent cough, weight loss, night sweats, shortness of breath, jaundice, unusual bruising, or neurologic symptoms require prompt medical evaluation.
  • Keep out of reach of children.
  • In case of overdose or severe adverse reaction, seek immediate emergency medical attention.

Have any questions? or Need help Contact us – 022 6163 6163 | support@medicus.com

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