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U.S. Department of Health and Human Services

Safety

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Ziagen (abacavir sulfate) Tablets and Oral Solution July 2008


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Hypersensitivity Reaction
    • Clinical Management of Hypersensitivity
    • Risk Factor: HLA-B*5701 Allele
    • Myocardial Infarction

ADVERSE REACTIONS

  • Postmarketing Experience
    • Cardiovascular
      • Myocardial infarction

PATIENT COUNSELING INFORMATION

  • Information About Therapy With Ziagen
    • Hypersensitivity Reaction - Inform patients: that if they develop symptoms consistent with a hypersensitivity reaction they should call their doctor right away to determine if they should stop taking Ziagen...
  • The following three section headers were added:
    • Lactic Acidosis/Hepatomegaly
    • Redistribution/Accumulation of Body Fat
    • Information About HIV Infection

MEDICATION GUIDE

  • What is the most important information I should know about Ziagen?
    • Serious Allergic Reaction to Abacavir: ...Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not...
  • Before starting Ziagen, tell your doctor about all of your medical conditions, including if you:
    • have been tested and know whether or not you have a particular gene variation called HLA-B*5701.
    • have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.
  • What are the possible side effects of Ziagen?
    • Some HIV medicines including Ziagen may increase your risk of heart attack...
    • ...Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BOXED WARNING

WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY

Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. HLA-B*5701-negative patients may develop a suspected hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients.

Regardless of HLA-B*5701 status, permanently discontinue Ziagen if hypersensitivity cannot be ruled out, even when other diagnoses are possible.

CONTRAINDICATIONS

...NEVER restart Ziagen or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status [see Warnings and Precautions (5.1), Adverse Reactions (6)]...

WARNINGS AND PRECAUTIONS

Hypersensitivity Reaction

...Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of a hypersensitivity reaction. Screening is also recommended prior to
reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended and should be considered only with close medical supervision and under exceptional circumstances when the potential benefit outweighs the risk.

HLA-B*5701-negative patients may develop a hypersensitivity reaction to abacavir; however, this occurs significantly less frequently than in HLA-B*5701-positive patients. Regardless of HLA-B*5701 status, permanently discontinue Ziagen if hypersensitivity cannot be ruled out, even when other diagnoses are possible...

Clinical Management of Hypersensitivity

...If the patient is of unknown HLA-B*5701 status, screening for the allele is recommended prior to reinitiation of Ziagen...

...Even in the absence of the HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction...

Risk Factor: HLA-B*5701 Allele (new section)

Studies have shown that carriage of the HLA-B*5701 allele is associated with a significantly increased risk of a hypersensitivity reaction to abacavir...

...Screening for carriage of the HLA-B*5701 allele is recommended prior to initiating treatment with abacavir. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir...

Myocardial Infarction (new section)

In a published prospective, observational, epidemiological study designed to investigate the rate of myocardial infarction in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of myocardial infarction (MI)...