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HomeAboutAboutBiologics & BiosimilarsAbout ABRILADADosingTotality of EvidenceTotality of EvidenceStructural & Functional SimilarityEfficacySafety & ImmunogenicityExtrapolationMultiple-Switching StudyProduct InformationReimbursement & SupportReimbursement
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PP-ABD-USA-0264
Indications
  • Rheumatoid Arthritis: ABRILADA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
  • Juvenile Idiopathic Arthritis: ABRILADA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
  • Psoriatic Arthritis: ABRILADA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
  • Ankylosing Spondylitis: ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Crohn’s Disease: ABRILADA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis: ABRILADA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
         
    Limitations of Use:
 
    The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
  • Plaque Psoriasis: ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Uveitis: ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Please see Full Prescribing Information, including BOXED WARNINGMedication Guide, and Instructions for Use, for ABRILADA.