Drug: abacavir solution

Generic Name: abacavir (a-BAK-a-vir)
Brand Name: Ziagen
Abacavir solution is used for: 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. Do NOT use abacavir solution if: you are allergic to any ingredient in abacavir solution you have moderate to severe liver problems you take another medicine that contains abacavir Contact your doctor or health care provider right away if any of these apply to you. Before using abacavir solution: 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: if you are pregnant, planning to become pregnant, or are breast-feeding or thinking about breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart problems (eg, heart attack), high blood pressure, liver problems (eg, hepatitis B), high cholesterol, or diabetes if you smoke, drink alcohol, or are very overweight if you have a history of autoimmune problems (eg, Graves disease, Guillain-Barré syndrome) if you have been tested and know whether or not you have a gene type called HLA-B*5701 if you have ever taken another medicine that contains abacavir Some MEDICINES MAY INTERACT with abacavir solution. Tell your health care provider if you are taking any other medicines, especially any of the following: Methadone because its effectiveness may be decreased by abacavir solution 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. How to use abacavir solution: Use abacavir solution as directed by your doctor. Check the label on the medicine for exact dosing instructions. Abacavir solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get abacavir solution refilled. Abacavir solution comes with a warning card that provides information about recognition of allergic reactions. Carry the warning card of allergy symptoms with you. Tell your health care provider immediately about any side effects you experience while taking abacavir solution. Take abacavir solution by mouth with or without food. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Taking abacavir solution at the same time(s) each day will help you to remember to take it. Take abacavir solution on a regular schedule to get the most benefit from it. Continue to take abacavir solution even if you feel well. Do not miss any doses. If you miss a dose of abacavir solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you are not sure what to do if you miss a dose, call your doctor. Ask your health care provider any questions you may have about how to use abacavir solution. Important safety information: Abacavir solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use abacavir solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tell your doctor or dentist that you take abacavir solution before you receive any medical or dental care, emergency care, or surgery. Check with your doctor before you drink alcohol while you are using abacavir solution. If you must stop taking abacavir solution for any reason other than a serious allergic reaction, do not start taking abacavir solution again without talking with your health care provider. If your health care provider decides that you may take abacavir solution again, you should do so only in a setting with other people in case you need immediate access to a doctor. When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking abacavir solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat. Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking abacavir solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Abacavir solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start abacavir solution. Abacavir solution does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others. Abacavir solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. Do NOT take more than the recommended dose, change the dose, or stop taking abacavir solution without checking with your doctor. Lab tests, including liver function tests and monitoring for hypersensitivity reactions, may be performed while you use abacavir solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. If your child is taking abacavir solution, the dose may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using abacavir solution while you are pregnant. It is not known if this medicine is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or abacavir solution to the baby. Possible side effects of 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: Diarrhea; headache; lack of energy; loss of appetite; mild nausea; tiredness; trouble sleeping; unusual dreams; vomiting. Seek medical attention right away if any of these SEVERE side effects occur: 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. If OVERDOSE is suspected: 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. General information: If you have any questions about abacavir solution, please talk with your doctor, pharmacist, or other health care provider. Abacavir solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine. 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 health care 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.

Source: http://www.drugs.com/

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. For the ConsumerApplies 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 Abdominal or stomach pain cough diarrhea difficult or labored breathing fever headache joint or muscle pain nausea numbness or tingling of the hands, feet, or face redness and soreness of the eyes skin rash sore throat sores in the mouth swelling of the feet or lower legs unusual feeling of discomfort or illness unusual tiredness vomiting Rare Abdominal or stomach swelling decreased appetite fast, shallow breathing sleepiness Incidence not known Blistering, peeling, or loosening of the skin chest pain or discomfort chills dark urine itching light-colored stools pain or discomfort in the arms, jaw, back, or neck red, irritated eyes red skin lesions, often with a purple center sores, ulcers, or white spots in the mouth or on the lips sweating unusual weakness upper right abdominal or stomach pain yellow eyes and skin 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 Headache Less common Trouble sleeping Incidence not known Breast enlargement buffalo hump central obesity facial wasting gaining weight around your neck, upper back, breast, face, or waist peripheral wasting For Healthcare ProfessionalsApplies to abacavir: oral solution, oral tabletGeneralIn 1 study, patients receiving the once-daily regimen had a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea than patients on the twice-daily regimen.[Ref]HypersensitivityCommon (1% to 10%): Drug hypersensitivity, hypersensitivity reaction (including fever, rash [usually maculopapular or urticarial], nausea, vomiting, malaise, diarrhea, pruritus, headache, fatigue, myalgia, chills, mouth and throat involvement, achiness, abdominal pain, pharyngitis, dyspnea, cough, lethargy, myolysis, edema, elevated liver function tests, mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings [mainly infiltrates, which can be localized], death)
Frequency not reported: Serious and sometimes fatal hypersensitivity reactions, abacavir hypersensitivity reaction presenting as acute fibrinous and organizing pneumonia[Ref]Serious and sometimes fatal hypersensitivity reactions have been associated with this drug. Hypersensitivity to this drug is a clinical syndrome affecting multiple organs generally characterized by a sign/symptom in 2 or more of the following groups: (1) Fever, (2) Rash, (3) Gastrointestinal (including nausea, vomiting, diarrhea, abdominal pain), (4) Constitutional (including generalized malaise, fatigue, achiness), (5) Respiratory (including dyspnea, cough, pharyngitis); infrequently reported after a single sign/symptom. Hypersensitivity was reported in up to 9% of patients during 9 clinical trials. Symptoms usually appeared within the first 6 weeks of therapy but the reaction may occur any time during therapy. Symptoms worsened with continued therapy and generally resolved when this drug was discontinued. Restarting this drug after a hypersensitivity reaction has resulted in more severe symptoms within hours and included life-threatening hypotension and death.

The symptoms reported most often in the first 406 patients with hypersensitivity reaction were fever (83%), rash (usually maculopapular or urticarial; 68%), nausea (38%), vomiting (25%), malaise (19%), diarrhea (18%), pruritus (17%), headache (17%), fatigue (15%), myalgia (13%), chills (12%), and mouth and throat involvement (11%). Abdominal pain, dyspnea, cough, lethargy, and elevated liver function tests were reported in at least 10% of patients. Other signs/symptoms of hypersensitivity have included mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, edema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, myolysis, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings (mainly infiltrates, which can be localized), and death.

In a clinical trial, 3.4% of human leukocyte antigen subtype B*5701 (HLA-B*5701)-negative patients using this drug had a hypersensitivity reaction. Studies showed that patients testing positive for the HLA-B*5701 allele had a significantly greater risk of hypersensitivity reactions to this drug. Based on a prospective study, screening for the HLA-B*5701 allele prior to therapy and then avoiding this drug in HLA-B*5701-positive patients significantly lowered the incidence of abacavir hypersensitivity reactions. It has been estimated that 48% to 61% of HLA-B*5701-positive patients will develop a hypersensitivity reaction during use of this drug compared with 0% to 4% of HLA-B*5701-negative patients; such results were consistent with prior retrospective studies.

Hypersensitivity reactions with rapid onset (including life-threatening reactions) have occurred after restarting this drug in patients with only 1 key symptom of hypersensitivity before stopping therapy; very rarely, hypersensitivity reactions were reported with resumption of therapy in patients previously considered tolerant to this drug (i.e., had no prior hypersensitivity symptoms).

In 1 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 this drug. 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 this drug was discontinued due to suspicion of a hypersensitivity reaction. Three days after drug discontinuation, the patient's status improved and chest films showed resolution of infiltrates.[Ref]GastrointestinalPancreatitis was observed in the expanded access program.[Ref]Very common (10% or more): Nausea (up to 47%), nausea and vomiting (up to 38%), diarrhea (up to 16%)
Common (1% to 10%): Abdominal pain/gastritis/gastrointestinal signs and symptoms, vomiting, abdominal discomfort and pain, abnormal amylase
Rare (0.01% to 0.1%): Pancreatitis[Ref]OtherVery common (10% or more): Malaise and fatigue (up to 34%), temperature regulation disturbance (up to 19%)
Common (1% to 10%): Fever/pyrexia, lethargy, fatigue, fatigue/malaise, fever and/or chills
Uncommon (0.1% to 1%): Non-site-specific pain
Frequency not reported: Asthenia, reduced alcohol tolerance, disulfiram-like reaction[Ref]In 1 case report, a 31-year-old HIV-infected male patient switched to this drug and experienced a disulfiram-like reaction with nausea, facial flushing, and tachycardia after 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 this drug and noticed reduced alcohol tolerance. The patient reported that he felt as if he had ingested 1.5 bottles of wine after 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]Nervous systemVery common (10% or more): Headache (up to 31%)
Common (1% to 10%): Headaches/migraine, dizziness, neuropathy[Ref]RespiratoryVery common (10% or more): Cough (up to 24%), ear/nose/throat infections (up to 19%), nasal signs/symptoms (up to 11%)
Common (1% to 10%): Viral respiratory infections (including viral ear, nose, and throat infection), bronchitis
Frequency not reported: Tachypnea, pharyngitis[Ref]MusculoskeletalElevated creatine phosphokinase (greater than 4 times the upper limit of normal [4 x ULN]) has been reported in up to 8% of patients.[Ref]Very common (10% or more): Elevated creatine phosphokinase (up to 12%)
Common (1% to 10%): Musculoskeletal pain
Frequency not reported: Osteonecrosis[Ref]DermatologicVery common (10% or more): Skin rashes (maculopapular, urticarial, or variable appearance; up to 11%)
Common (1% to 10%): Rash (without systemic symptoms)
Frequency not reported: Sweet's syndrome
Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme[Ref]Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported during postmarketing experience in patients receiving this drug primarily in combination with medications known to be associated with SJS and TEN, respectively. Due to overlap of clinical signs/symptoms between abacavir hypersensitivity and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, this drug should be permanently discontinued in such cases.[Ref]MetabolicVery common (10% or more): Feeding problems (up to 11%)
Common (1% to 10%): Hypertriglyceridemia, hyperamylasemia, anorexia, abnormal triglycerides, hyperlactatemia
Uncommon (0.1% to 1%): Hyperglycemia, abnormal alkaline phosphatase, abnormal glucose, abnormal sodium
Rare (0.01% to 0.1%): Lactic acidosis
Frequency not reported: Mild elevations of blood glucose, hypoglycemia, loss of appetite
Postmarketing reports: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Combination antiretroviral therapy:
-Frequency not reported: Metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)[Ref]Hypertriglyceridemia (greater than 750 mg/dL), hyperamylasemia (greater than 2 x ULN), and hyperglycemia (greater than 13.9 mmol/L) have been reported in up to 6%, up to 4%, and less than 1% of patients, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.[Ref]PsychiatricVery common (10% or more): Dreams/sleep disorders (10%)
Common (1% to 10%): Depression, anxiety, sleep disorders, insomnia, abnormal dreams
Frequency not reported: Mania, worsening of preexisting depression, lethargy[Ref]HepaticCommon (1% to 10%): Elevated ALT, elevated AST
Uncommon (0.1% to 1%): Abnormal bilirubin
Frequency not reported: Increased GGT, severe hepatomegaly with steatosis
Postmarketing reports: Lactic acidosis, hepatic steatosis[Ref]Elevated ALT (greater than 5 x ULN) and AST (greater than 5 x ULN) have been reported in 6% and up to 6% of patients, respectively.

The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.

Increased GGT 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.[Ref]HematologicNeutropenia (absolute neutrophil count less than 750/mm3), thrombocytopenia (platelets less than 50,000/mm3), anemia (hemoglobin 6.9 g/dL or less), and leukopenia (WBC 1500/mm3 or less) have been reported in up to 5%, 1%, less than 1%, and less than 1% of patients, respectively.

The reported frequencies were similar to those observed during clinical trials with zidovudine and lamivudine administration.

Agranulocytosis has been reported after the addition of this drug to a multi-drug regimen.[Ref]Common (1% to 10%): Neutropenia, thrombocytopenia, decreased white cells, abnormal absolute neutrophils
Uncommon (0.1% to 1%): Anemia, leukopenia, abnormal hemoglobin, abnormal platelets, abnormal WBC
Rare (less than 0.1%): Eosinophilia
Frequency not reported: Agranulocytosis, increased platelet reactivity[Ref]RenalUncommon (0.1% to 1%): Renal signs/symptoms, abnormal creatinine
Frequency not reported: Acute renal failure, interstitial nephritis[Ref]ImmunologicFrequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)CardiovascularAn observational study investigating the rate of MI in patients on combination antiretroviral therapy showed an increased risk of MI with the use of this drug within the previous 6 months. A sponsor-conducted pooled analysis of clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from the observational cohort and from clinical trials were inconclusive.[Ref]Frequency not reported: Endothelial dysfunction, peripheral arterial disease, coronary bypass surgery, ischemic stroke, deep venous thrombosis, angina, transient ischemic attack
Postmarketing reports: Myocardial infarction (MI)[Ref]

Source: http://www.drugs.com/

Abacavir Pregnancy Warnings This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned. Animal studies (high-dose) have revealed evidence of developmental toxicity, fetal anasarca, skeletal malformations, and increased incidence of stillbirth. Placental transfer has been observed in humans. There are no controlled data in human pregnancy; however, based on observed outcomes (more than 800 after first-trimester exposure and more than 1000 after second-/third-trimester exposure), the malformative risk is unlikely in humans. To monitor maternal-fetal outcome of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com The APR has received prospective reports of over 2000 exposures to this drug (over 900 exposed in the first trimester); there was no difference between abacavir and overall birth defects compared with the background birth defect rate of 2.7% in the US reference population of the Metropolitan Atlanta Congenital Defects Program. The prevalence of defects in the first trimester was 3%. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out. Abacavir Breastfeeding Warnings Breast milk from 15 women and blood samples from 9 of their partially or exclusively breastfed infants were collected about 1 month postpartum; the mothers were using abacavir 300 mg twice a day (with lamivudine and zidovudine). Breast milk was obtained right before a dose; whole breast milk abacavir levels averaged 0.057 mg/L (about 85% of maternal blood levels). Infant blood was obtained 11 to 18 hours after the last maternal dose and about 1 hour (range: 6 minutes to 35 hours) after the last breastfeeding; plasma drug levels were undetectable (less than 16 mcg/L) in 8 of 9 infants. Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.

Source: http://www.drugs.com/

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