Safety

Ziagen (abacavir sulfate) Tablets and Oral Solution

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

September 2015

Summary View

BOXED WARNING - updated

WARNING: HYPERSENSITIVITY REACTIONS, and LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY

Hypersensitivity Reactions
  • Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with Ziagen (abacavir). Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele. Ziagen is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with Ziagen or reinitiation of therapy with Ziagen, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue Ziagen immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible. Following a hypersensitivity reaction to Ziagen, NEVER restart Ziagen or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.
Lactic Acidosis and Severe Hepatomegaly with Steatosis
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue Ziagen if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

CONTRAINDICATIONS

  • *updated with new information regarding the HLA-B*5701 allele

WARNINGS AND PRECAUTIONS

  • *Updated with hypersensitivity reactions information

ADVERSE REACTIONS

  • *Updated with hypersensitivity reactions information

USE IN SPECIFIC POPULATIONS

  • *information added for patients with impaired hepatic function

PATIENT COUNSELING INFORMATION

  • *added subsection on Immune Reconstitution Syndrome

 

March 2015

Summary View

WARNINGS AND PRECAUTIONS

Use with Other Abacavir-containing Products section added
  • ZIAGEN is one of multiple abacavir-containing products. Concomitant administration of ZIAGEN with other products containing abacavir is not recommended. 

 

March 2012

Summary View

MEDICATION GUIDE

The most common side effects of  Ziagen in children include:
 

  • fever and chills
  • nausea
  • vomiting
  • rash
  • ear, nose, or throat infections
     

 

Page Last Updated: 10/09/2015
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