ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

Screen for the HLA-B*5701 allele prior to initiating therapy with ZIAGEN.

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:

• who have the HLA-B*5701 allele
• with moderate or severe hepatic impairment

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.

The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, ZIAGEN is contraindicated in these patients.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including ZIAGEN.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including ZIAGEN. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

Several prospective, observational, epidemiological studies have reported an association with the use of abacavir and the risk of myocardial infarction (MI).

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively.

In a trial of 11 HIV-1–infected subjects receiving methadone-maintenance therapy with 600 mg of ZIAGEN twice daily (twice the currently recommended dose), oral methadone clearance increased.

The background risk for major birth defects and miscarriage for the indicated population is unknown. Animal studies: fetal malformations, developmental toxicity, and increased incidence of stillbirth and lower body weights.

The Centers for Disease Control and Prevention recommends that HIV-1–infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Abacavir is present in human milk. Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ZIAGEN.

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• Use in patients under 3 months of age. GoToSource

⚠️  Patients with the HLA-B*5701 allele gene have a higher risk of abacavir hypersensitivity reactions.

Increased risk of myocardial infarction, hypersensitivity reaction (excessive or abnormal immune system reaction) and anaphylaxis (potentially life-threatening allergic reaction). GoToSource

Hepatic steatosis (fatty liver disease), myopathy (skeletal muscle  disease), neuropathy (nerve damage),  myelotoxicity (bone marrow suppression) and lactic acidosis (too much acid in the body). GoToSource

Immune reconstitution syndrome (worsening of an existing infection or disease process or appearance of a new infection/disease process soon after initiation of therapy). GoToSource

Stevens–johnson syndrome and toxic epidermal necrolysis (severe skin disorder). GoToSource

Liver injury. GoToSource

No major injury lawsuits reported.