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AMJEVITA

ADALIMUMAB-ATTO

Manufacturer: Optum Health Solutions (Ireland) Limited

Score: 144.0

Quick Summary

AMJEVITA (ADALIMUMAB-ATTO) is a tumor necrosis factor blocker used to treat various conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. The drug has a boxed warning for serious infections and malignancy. It is administered via subcutaneous injection, and dosing varies by condition and patient population. Special considerations are needed for use in pregnancy, pediatric, and geriatric populations.

Key Clinical Findings and Indications

  • Rheumatoid arthritis
  • Juvenile idiopathic arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Crohn's disease
  • Ulcerative colitis
  • Plaque psoriasis
  • Hidradenitis suppurativa

Important Safety Information

Warning

SERIOUS INFECTIONS and MALIGNANCY: Increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens. Discontinue AMJEVITA if a patient develops a serious infection or sepsis.

Contraindications

Adverse Reactions

  • Infections
  • Injection site reactions
  • Headache
  • Rash
  • Hypersensitivity reactions
  • Hepatitis B virus reactivation
  • Neurologic reactions
  • Hematological reactions
  • Heart failure
  • Autoimmunity

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal or hepatic impairment.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis

Adult Dose

40 mg every other week

Pediatric Dose

20 mg every other week for patients 15 kg to less than 30 kg, 40 mg every other week for patients 30 kg and greater

Crohn's disease

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29

Pediatric Dose

80 mg on Day 1, 40 mg on Day 15, and 20 mg every other week starting on Day 29 for patients 17 kg to less than 40 kg, 160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29 for patients 40 kg and greater

Ulcerative colitis

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg every other week starting on Day 29

Pediatric Dose

Not established

Plaque psoriasis

Adult Dose

80 mg initial dose, followed by 40 mg every other week starting one week after initial dose

Pediatric Dose

Not established

Hidradenitis suppurativa

Adult Dose

160 mg on Day 1, 80 mg on Day 15, and 40 mg every week or 80 mg every other week starting on Day 29

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects.

Nursing Mothers

  • The safety of adalimumab in nursing mothers has not been established.

Pediatric Use

  • The safety and effectiveness of adalimumab have been established in pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis and 6 years of age and older with Crohn's disease.

Geriatric Use

  • A total of 519 RA patients 65 years of age and older, including 107 patients 75 years of age and older, received adalimumab in clinical studies. No overall difference in effectiveness was observed between these patients and younger patients.