adalimumab

Adalimumab

API- Adalimumab

Packaging- Single-dose Pre-filled Syringe

Strength- 40mg/0.8mL

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Description

Adalimumab is a tumor necrosis factor (TNF) blocker used for Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Ulcerative Colitis (UC), Crohn’s Disease (CD), Plaque Psoriasis (Ps), Hidradenitis Suppurativa (HS), and Uveitis (UV).

Dosage and Side Effects

Dosage of Adalimumab should be administered by subcutaneous injection.

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

  • Recommended Dosage for adults is 40 mg every other week. Some patients with Rheumatoid Arthritis not taking methotrexate may benefit from enhancing the dosage to 40mg every week or 80mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Uveitis: 

  • Recommended Dosage for Pediatric Weight (2 Years of Age and Older) 10 kg (22 lbs) to less than 15 kg (33 lbs), 15 kg (33 lbs) to less than 30 kg (66 lbs), 30 kg (66 lbs) and greater is 10 mg, 20 mg, 30 mg every other week respectively.

Crohn’s Disease:

  • Recommended Dosage for Adults is 160 mg on Day 1 (given in 1-day or split over 2-consecutive days); 80 mg on Day 15; and 40mg every other week starting on Day 29.
  • Recommended Dosage for Pediatric Patients Weight (6 Years of Age and Older) 17 kg (37 lbs) to less than 40 kg (88 lbs): 80 mg on Day 1; 40 mg on Day 15; and 20mg every other week starting on Day 29.
  • Recommended Dosage for Pediatric Patients Weight 40 kg (88 lbs) and greater; 160 mg on Day 1 (single dose or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.

Ulcerative Colitis:

  • Recommended Dosage for Adults: 160 mg on Day 1 (given in 1-day or split over 2-consecutive days), 80 mg on Day 15, and 40 mg every other week starting on Day 29. Discontinue in patients without outcomes of clinical remission by 8 weeks (Day 57).
  • Recommended Dosage for Pediatric Patients (5 Years of Age and Older) Weight 20 kg (44 lbs) to less than 40 kg (88 lbs): 80 mg on Day 1; 40 mg on Day 8; 40 mg on Day 15; 40 mg every other week or 20 mg every week starting on Day 29.
  • Recommended Dosage for Pediatric Patients (5 Years of Age and Older) Weight 40 kg (88 lbs) and greater: 160 mg on Day 1 (single dose or split over two consecutive days); 80 mg on Day 8; 80 mg on Day 15; and 80 mg every other week or 40 mg every week starting on Day 29.

Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their Adalimumab regimen.

Plaque Psoriasis or Adult Uveitis:

  • Recommended Dosage for Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after the initial dose.

Hidradenitis Suppurativa:

  • Recommended Dosage for Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; 80 mg on Day 29 and subsequent doses: 40 mg every week or 80 mg every other week.
  • Recommended Dosage for Adolescents (12 years of age and older) Weight 30 kg (66 lbs) to less than 60 kg (132 lbs): 80 mg on Day 1; For Day 8 and subsequent doses: 40 mg every other week.
  • Recommended Dosage for Adolescents (12 years of age and older) Weight 60 kg (132 lbs) and greater: 160 mg on Day 1 (given in 1 day or split over 2-consecutive days); 80 mg on Day 15; For Day 29 and subsequent doses: 40mg every week or 80mg every other week.

The most commonly reported side effects due to adalimumab injection include infections (e.g. upper respiratory, sinusitis), headache, injection site reactions, and rash.

Warning and Precautions

  • Do not start adalimumab during an active infection. In case an infection develops, monitor carefully, and stop adalimumab treatment if the infection becomes serious.
  • For patients who develop a systemic illness on adalimumab, consider empiric antifungal therapy for those who reside or travel to such regions where mycoses are endemic.
  • The safety of using live or live-attenuated vaccines in infants exposed to exemptia in utero is unspecified. Risks and benefits should be considered before vaccinating (live or live-attenuated) exposed infants.
  • Therapy with adalimumab may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops signs/symptoms suggestive of a lupus-like syndrome following therapy with adalimumab, discontinue treatment.
  • Cases of worsening congestive heart failure (CHF) and new-onset congestive heart failure have been reported with TNF blockers. Caution needs to be exercised when using exemptia 40 mg injection in patients who have heart failure and monitor them carefully.
  • Concurrent use of interleukin-1 antagonist and another TNF-blocker was related to a greater proportion of severe infections and neutropenia and no added benefit in comparison to TNF-blocker alone in patients with RA. Therefore, the combination of adalimumab and interleukin-1 antagonist is not recommended.
  • Patients should seek immediate medical help if they develop signs/symptoms suggestive of blood dyscrasias or infection (e.g., bruising, bleeding, persistent fever, pallor) while on Adalimumab. Consider discontinuation of Adalimumab therapy in patients with confirmed significant hematologic abnormalities.
  • Exercise caution in considering the administration of Adalimumab in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Adalimumab should be considered in case any of these disorders develop.

FAQ's

What type of drug is Adalimumab?

Adalimumab (Exemptia) specifically is a type of drug known as tumor necrosis factor (TNF) inhibitors.

Is Exemptia 40 mg a bio-similar medicinal product?

Yes, exemptia 40 mg is the first ADA biosimilar medicinal product. 

Is Adalimumab a biologic?

Yes, Adalimumab is a kind of medication known as biological therapy. 

Who should not take Exemptia?

You should not start taking Exemptia in case you have any kind of infection unless your health specialist says it is okay.

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