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Drug Notebook

Generic Name: abacavir

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Ziagen
An NRTI - used for Nonoccupational Exposure and treats HIV Infection
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FDA Alerts

  • Serious and sometimes fatal hypersensitivity reactions reported. These hypersensitivity reactions are a multiorgan syndrome usually characterized by a sign or symptom in ≥2 of the following groups: fever, rash, GI (including nausea, vomiting, diarrhea, abdominal pain), constitutional (including generalized malaise, fatigue, aching), and respiratory (including dyspnea, cough, pharyngitis). (See Hypersensitivity Reactions under Cautions.)
  • Individuals who carry the human leukocyte antigen (HLA)-B*5701 allele are at high risk for a hypersensitivity reaction. Prior to initiation of abacavir therapy, screening for the HLA-B*5701 allele is recommended. Screening also is recommended prior to reinitiation of abacavir therapy in patients who previously tolerated the drug whose HLA-B*5701 status is unknown. (See Hypersensitivity Reactions under Cautions.)
  • Discontinue abacavir as soon as a hypersensitivity reaction is suspected. Permanently discontinue if hypersensitivity cannot be ruled out regardless of the patient's HLA-B*5701 status, even when other diagnoses are possible.
  • Do not restart abacavir or any abacavir-containing preparation following a hypersensitivity reaction because more severe symptoms can recur within hours and have included potentially life-threatening hypotension and death. Severe or fatal hypersensitivity reactions can occur within hours after reintroduction of abacavir in patients with no identified history or unrecognized symptoms of abacavir hypersensitivity.
  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
  • The fixed-combination preparation Epzicom® contains 2 NRTIs (abacavir and lamivudine) and the fixed-combination preparation Trizivir® contains 3 NRTIs (abacavir, lamivudine, zidovudine); these are intended only for patients whose regimen would otherwise include abacavir and the other components.
  • If using Epzicom® or Trizivir®, consider that severe, acute exacerbations of hepatitis B virus (HBV) infection have been reported when lamivudine was discontinued in patients coinfected with HBV and HIV. Closely monitor hepatic function for at least several months following discontinuance of Epzicom® or Trizivir® in patients coinfected with HBV and HIV. If appropriate, initiation of therapy for HBV infection may be warranted.
  • If using Trizivir®, consider that zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in those with advanced HIV infection, and that prolonged zidovudine use has been associated with symptomatic myopathy.

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(a BAK a veer)

What is the most important information I should know about abacavir?

Stop using abacavir and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again.

You may need a blood test before you start taking abacavir for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

Read the Warning Card that comes with this medication, and carry it with you at all times so you will know the symptoms of allergic reaction to watch for.

Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses in a row, you could have a dangerous or even fatal allergic reaction when you start taking abacavir again. If you stop taking abacavir for any reason, talk to your doctor before you start taking the medication again.

Abacavir may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

Abacavir can also cause severe or life-threatening effects on the liver . Call your doctor at once if you have any of these liver symptoms while taking abacavir: nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What is abacavir?

Abacavir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Abacavir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Abacavir is not a cure for HIV or AIDS.

Abacavir may also be used for other purposes not listed in this medication guide.

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