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Nucleoside reverse transcriptase inhibitors (NRTIs)
Abacavir solution has caused severe and sometimes fatal allergic reactions. Contact your doctor right away if you develop fever; rash; nausea, vomiting, diarrhea, or stomach pain; cough, sore throat, or trouble breathing; unusual tiredness or achiness; or general feeling of being unwell. Do NOT take abacavir solution again or take any other medicine that contains abacavir if you have had an allergic reaction to abacavir solution. You may be at risk for an even more severe allergic reaction.
Patients who have a certain gene type called HLA-B*5701 have an increased risk of allergic reaction. A lab test may be performed before you start abacavir solution to see if you have this gene type. Discuss any questions or concerns with your doctor.
Abacavir solution may cause severe and sometimes fatal high blood acid levels (lactic acidosis) and liver problems. The risk of these problems may be greater if you are a woman, are very overweight, or have a history of liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Contact your doctor right away if you develop yellowing of the skin or eyes; dark urine; pale stools; stomach pain; nausea; vomiting; diarrhea; persistent loss of appetite; fast or difficult breathing; fast or irregular heartbeat; unusual weakness or tiredness; unusual muscle pain or tenderness; unusual feeling of cold (eg, in arms or legs); shortness of breath; sluggishness; or severe or unusual drowsiness, dizziness, or light-headedness.
Treating HIV infection with other medications.
Abacavir solution is a nucleoside analog reverse transcriptase inhibitor (NRTI). It works by slowing down the growth of HIV, the virus that causes AIDS.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with abacavir solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with abacavir solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if abacavir solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use abacavir solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use abacavir solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; headache; lack of energy; loss of appetite; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or arm pain; ear pain; eye pain, redness, or swelling; fainting; fever or chills; mental or mood changes (eg, depression); mouth sores; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; shortness of breath, cough, or sore throat; stomach pain; swollen lymph nodes; symptoms of lactic acidosis (eg, fast breathing; fast or irregular heartbeat; unusual muscle pain or tenderness; unusual cold feeling in the arms or legs; sluggishness; severe or unusual drowsiness, dizziness, or light-headedness); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite); unusual achiness, sweating, or swelling; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of abacavir solution:
Store abacavir solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep abacavir solution out of the reach of children and away from pets.
This information should not be used to decide whether or not to take abacavir solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about abacavir solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using abacavir solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
Not all side effects for abacavir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
Applies to abacavir: oral solution, oral tablet
In addition to its needed effects, some unwanted effects may be caused by abacavir. In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking abacavir:Less common
Some of the side effects that can occur with abacavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
Applies to abacavir: oral solution, oral tablet
Patients receiving once-daily abacavir had a significantly higher incidence of severe hypersensitivity reactions and severe diarrhea than patients on the twice-daily regimen.[Ref]
Common (1% to 10%): Drug hypersensitivity (Grades 2 to 4; 9%), hypersensitivity reaction (Grades 2 to 4; 8%)
Rare (less than 0.1%): Abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia (at least 1 case)
Frequency not reported: Serious and sometimes fatal hypersensitivity reactions (including fever, skin rash [maculopapular, urticarial, or variable appearance], malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, lethargy, myolysis, edema, abnormal chest X-ray [infiltrates], paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions [conjunctivitis and stomatitis], elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, lymphopenia)[Ref]
Serious and sometimes fatal hypersensitivity reactions have been reported. Frequently observed signs and symptoms have included, but were not limited to, fever, skin rash (maculopapular, urticarial, or variable appearance), malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, and cough. Other symptoms of abacavir hypersensitivity have included lethargy, myolysis, edema, abnormal chest X-ray (infiltrates), paresthesia, anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions (conjunctivitis and stomatitis), elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, and lymphopenia.
In one case report a 57-year-old HIV positive male presented to medical attention with a 2-day history of fever, malaise, and diarrhea related to initiation of abacavir. Six days prior to the onset of symptoms the patient's antiretroviral therapy was switched from efavirenz and lamivudine-zidovudine to zidovudine, abacavir, and lopinavir-ritonavir after a drop in his CD4 cell count. The patient developed acute dyspnea and severe hypoxemia, hemoptysis, and diffuse bilateral pulmonary infiltrates within 72 hours of admission and abacavir was discontinued due to suspicion of a hypersensitivity reaction. Three days following discontinuation of abacavir the patient's status improved and chest films showed resolution of infiltrates.
Abacavir hypersensitivity is a clinical syndrome affecting multiple organs generally characterized by a sign or symptom in two or more of the following groups:
(3) Gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain)
(4) Constitutional (including generalized malaise, fatigue, or achiness)
(5) Respiratory (including dyspnea, cough, or pharyngitis)
A strong predictor of hypersensitivity reaction may be the presence of human leukocyte antigen subtype B*5701 (HLA-B*5701). Analyzing past studies, patients testing positive for the HLA-B*5701 allele had a greater risk (61% to about 70%) of developing hypersensitivity reactions with abacavir, while patients without the HLA-B*5701 allele had a low risk (less than 1% to 4%); therefore, screening for the HLA-B*5701 allele is recommended prior to starting abacavir treatment. Therapy with an abacavir-containing regimen is not recommended for HLA-B*5701-positive patients and should be considered only with close medical supervision under exceptional conditions where potential benefit outweighs the risk. Considerably less frequently, HLA-B*5701-negative patients may experience hypersensitivity reaction with abacavir.
Abacavir should be permanently discontinued as soon as a hypersensitivity reaction is suspected. Severe or fatal hypersensitivity reactions can also occur within hours after restarting abacavir in patients who have no identified history or unrecognized symptoms of this reaction. It should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible, to minimize the risk of a life-threatening hypersensitivity reaction.[Ref]
The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.
Increased gamma-glutamyltransferase was observed in the expanded access program.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretroviral agents.[Ref]
Common (1% to 10%): Elevated ALT (greater than 5 times ULN; 6%), elevated AST (greater than 5 times ULN; up to 6%)
Frequency not reported: Increased gamma-glutamyltransferase, severe hepatomegaly with steatosis
Postmarketing reports: Lactic acidosis, hepatic steatosis[Ref]
Pancreatitis was observed in the expanded access program.[Ref]
Very common (10% or more): Nausea (at least moderate intensity: up to 19%), nausea and vomiting (at least moderate intensity: 10%)
Common (1% to 10%): Diarrhea (at least moderate intensity: 7%), abdominal pain/gastritis/gastrointestinal signs and symptoms (at least moderate intensity: 6%), vomiting (at least moderate intensity: 2%)
Frequency not reported: Loss of appetite/anorexia, pancreatitis[Ref]
Very common (10% or more): Headache (at least moderate intensity: 13%)
Common (1% to 10%): Headaches/migraine (at least moderate intensity: 7%), dizziness (at least moderate intensity: 6%)
Frequency not reported: Insomnia, other sleep disorders[Ref]
Very common (10% or more): Malaise and fatigue (at least moderate intensity: 12%)
Common (1% to 10%): Fatigue/malaise (at least moderate intensity: 7%), fever and/or chills (at least moderate intensity: 6%), ear/nose/throat infections (at least moderate intensity: 5%)
Uncommon (0.1% to 1%): Non-site-specific pain (at least moderate intensity: less than 1%)
Frequency not reported: Asthenia, reduced alcohol tolerance, disulfiram-like reaction[Ref]
In one case report, a 31-year-old HIV-infected male patient switched to abacavir and experienced a disulfiram-like reaction with nausea, facial flushing, and tachycardia following alcohol consumption. When the patient was rechallenged with a shot of vodka, the same reaction occurred.
In another case, a 27-year-old HIV-infected male patient switched to abacavir and noticed reduced alcohol tolerance. The patient reported that he felt as if he had ingested 1.5 bottles of wine following 3 glasses, with loss of memory until the next morning and vomiting. The patient was able to tolerate small quantities of alcohol or alcohol consumed with food.[Ref]
Very common (10% or more): Dreams/sleep disorders (at least moderate intensity: 10%)
Common (1% to 10%): Depressive disorders (at least moderate intensity: 6%), anxiety (at least moderate intensity: 5%)
Frequency not reported: Mania, worsening of preexisting depression, lethargy[Ref]
Common (1% to 10%): Rashes (at least moderate intensity: 6%), skin rashes (at least moderate intensity: 5%)
Frequency not reported: Sweet's syndrome
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme[Ref]
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. Due to overlap of clinical signs and symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be permanently discontinued in such cases.[Ref]
Common (1% to 10%): Elevated creatine phosphokinase (greater than 4 times ULN; up to 8%), hypertriglyceridemia (greater than 750 mg/dL; up to 6%), hyperamylasemia (greater than 2 times ULN; up to 4%)
Uncommon (0.1% to 1%): Hyperglycemia (greater than 13.9 mmol/L; less than 1%)
Rare (less than 0.1%): Hypoglycemia (at least 1 case)
Frequency not reported: Mild elevations of blood glucose
Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[Ref]
The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.
Agranulocytosis has been reported after the addition of abacavir to a multi-drug regimen.[Ref]
Common (1% to 10%): Neutropenia (ANC less than 750/mm3; up to 5%), thrombocytopenia (platelets less than 50,000/mm3; 1%)
Uncommon (0.1% to 1%): Anemia (Hgb 6.9 g/dL or less; less than 1%), leukopenia (WBC 1500/mm3 or less; less than 1%)
Rare (less than 0.1%): Eosinophilia
Frequency not reported: Agranulocytosis, increased platelet reactivity[Ref]
Common (1% to 10%): Musculoskeletal pain (at least moderate intensity: up to 6%)[Ref]
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, and Guillain-Barre syndrome)
Common (1% to 10%): Viral respiratory infections (at least moderate intensity: 5%), bronchitis (at least moderate intensity: 4%)
Frequency not reported: Tachypnea, cough, pharyngitis[Ref]
A study investigating the frequency of myocardial infarction (MI) in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results are not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis are inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.[Ref]
Rare (less than 0.1%): Peripheral arterial disease (at least 2 cases), coronary bypass surgery (at least 1 case), ischemic stroke (at least 1 case), deep venous thrombosis (at least 1 case), angina (at least 1 case), transient ischemic attack (at least 1 case)
Frequency not reported: Endothelial dysfunction
Postmarketing reports: Myocardial infarction[Ref]
Uncommon (0.1% to 1%): Renal signs/symptoms (at least moderate intensity: less than 1%)
Frequency not reported: Acute renal failure, interstitial nephritis[Ref]
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