ZIAGEN® (abacavir sulfate)
See the full Prescribing Information for ZIAGEN
Indication and Usage
ZIAGEN Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection.
ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir.
In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions than patients taking ZIAGEN 300 mg twice daily.
Important Safety Information
Hypersensitivity Reaction (HSR)
- ZIAGEN contains abacavir sulfate, which has been associated with serious and sometimes fatal hypersensitivity reactions. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (including dyspnea, cough, or pharyngitis). Discontinue ZIAGEN as soon as a hypersensitivity reaction is suspected. Permanently discontinue ZIAGEN if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
- Following a hypersensitivity reaction to abacavir, NEVER restart ZIAGEN or any other abacavir-containing product because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
- Reintroduction of ZIAGEN, or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result in serious or fatal hypersensitivity reactions. Such reactions can occur within hours.
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir and other antiretrovirals.
- Hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon with or without ribavirin. Patients receiving interferon with or without ribavirin and ZIAGEN should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of ZIAGEN should be considered as medically appropriate.
- 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 system responds 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.
- Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown.
- In clinical trials with ZIAGEN, the most common adverse events of at least moderate intensity (≥5% frequency) Grades 2-4 were nausea (19%), headache (13%), malaise and fatigue (12%), nausea and vomiting (10%), drug hypersensitivity (9%), diarrhea (7%), gastritis (6%), depressive disorders (6%), fever and/or chills (6%), musculoskeletal pain (6%), rashes (6%), and anxiety (5%).