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U.S. Department of Health and Human Services

Safety

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Orencia (abatacept) Lyophilized Powder for Intravenous Infusion


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Hypersensitivity
  • Infections
  • Immunizations

ADVERSE REACTIONS

  • Clinical Studies Experience in Juvenile Idiopathic Arthritis
    • Immunogenicity
  • Postmarketing Experience

DRUG INTERACTIONS

  • Other Biologic RA Therapy

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • Pregnancy Registry
  • Pediatric Use

NONCLINICAL TOXICITY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility

PATIENT COUNSELING INFORMATION

  • Concomitant Use With Biologic Medications for RA
    • Hypersensitivity
    • Infections
    • Immunizations
    • Pregnancy and Nursing Mothers
    • Blood Glucose Testing

PATIENT PACKAGE INSERT

  • What is Orencia?
  • What should I tell my doctor before treatment with Orencia?
    • Tell your doctor about all the medicines you take...
  • What are the possible side effects of Orencia?
  • Common side effects of Orencia in both adults and children...
  • In children, other side effects may include...
  • General information about Orencia
  • What are the ingredients in Orencia?

WARNINGS AND PRECAUTIONS

Hypersensitivity

...Of the 190 patients with juvenile idiopathic arthritis treated with Orencia in clinical trials, there was one case of a hypersensitivity reaction (0.5%)...

Infections

...Anti-rheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with Orencia. In clinical studies with Orencia, patients who screened positive for hepatitis were excluded from study.

Immunizations

...It is recommended that patients with juvenile idiopathic arthritis be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Orencia therapy.