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.
ABACAVIR (a ba KA vir) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 months old for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
alcohol or alcohol containing products
This medicine may also interact with the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.
HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.
A small number of people may have a severe allergy to this medicine. Some symptoms are a skin rash, fever, nausea, vomiting, stomach pain, severe tiredness, aches, or generally feeling sick. A list of these symptoms is on the Warning Card given to you by your pharmacist. You should carry this Warning Card with you. If you have these symptoms while taking this medicine, stop the medicine and call your doctor right away.
If you stop this medicine because you ran out of medicine or because you may have had an allergic reaction, talk to your doctor. Do not restart this medicine without your doctor's advice. Severe hypersensitivity reactions can occur within hours and may include life-threatening hypotension and death.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
breathing problems, cough
diarrhea
fever or chills, sore throat
nausea, vomiting, unusual stomach upset or pain
redness, blistering, peeling or loosening of the skin, including inside the mouth
unexplained weight loss
unusually weak or tired
weight gain around waist, back, or thinning of face, arms, legs
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. May be refrigerated. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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