Abacavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Laboratory abnormalities in CNA3005 are listed in Table 5. It has the following structural formula: Abacavir sulfate, USP is a white to off-white powder. Discontinue abacavir immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications ( 4), Warnings and Precautions ( 5.1)]. Subjects receiving abacavir oral solution according to the recommended dosage regimen achieved plasma concentrations of abacavir similar to adults. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. In some cases, these serious liver problems can lead to death. This survey is being conducted by the WebMD marketing sciences department. HIV can be passed to your baby if the virus is not controlled during pregnancy. Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Mild elevations of blood glucose were more frequent in pediatric subjects receiving abacavir (CNA3006) as compared with adult subjects (CNA30024). One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator. Sharing drug or medicine needles is never safe, even for a healthy person. If you stop taking abacavir because of an allergic reaction, never take abacavir or any other abacavir-containing medicine again. to not restart abacavir tablets or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others. After oral administration of a single dose of 600 mg of abacavir in 20 subjects, C max was 4.26 1.19 mcg per mL (mean SD) and AUC was 11.95 2.51 mcghour per mL. Virologic suppression was not a requirement for participation at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed compared with 71% of subjects in the once-daily cohort. Things to remember when you fill your prescription. If your healthcare provider tells you that you can take abacavir tablets again, start taking it when you are around medical help or people who can call a healthcare provider if you need one. The most common side effects of abacavir tablets in adults include: Table 11. If you stop taking abacavir for any other reason, even for a few days, and you are not allergic to abacavir, talk with your health care provider before taking it again. o feel very weak or tired o feel cold, especially in your arms and legs Do not take two doses at one time. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired. Do not freeze. Outcomes of Randomized Treatment through Week 48 (CNA30021). Because of the potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving abacavir. Instruct patients to read the Medication Guide before starting abacavir tablets and to re-read it each time the prescription is renewed. No developmental effects were observed in rats at 60 mg per kg per day, resulting in exposures (AUC) approximately 4 times the human exposure at the recommended daily dose. Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs). Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning, Warnings and Precautions ( 5.1)]. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases. Consult your pharmacist or local waste disposal company. Keep a list of your medicines to show your healthcare provider and pharmacist. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir. If you get a symptom from two or more of the following groups while taking abacavir, contact your health care provider right away to find out if you should stop taking abacavir. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Vhody smoothies zvisia od toho, o do nich dte. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid, which may turn brown over time. ZIAGEN is contraindicated in patients: who have the HLA-B*5701 allele Pediatric Subjects Once-Daily versus Twice-Daily Dosing (COL105677): Effect of Abacavir on the Pharmacokinetics of Other Agents: Effect of Other Agents on the Pharmacokinetics of Abacavir: In vitro, Table 7. Taking abacavir will not prevent you from passing HIV to other people. 4 CONTRAINDICATIONS Abacavir oral solution is contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. How should I store abacavir tablets? Abacavir solution may also be stored in the refrigerator. If you are allergic to abacavir or any other medicines. Lactic acidosis can happen in some people who take abacavir tablets. Special Populations Patients with Renal Impairment: The pharmacokinetic properties of abacavir have not been determined in patients with impaired renal function. Pregnant Women: Abacavir pharmacokinetics were studied in 25 pregnant women during the last trimester of pregnancy receiving abacavir 300 mg twice daily. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Lactic Acidosis/Hepatomegaly Tell your doctor if you have: signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss; trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or. As a precaution, the underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking). Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol, which is an ester of abacavir. HIV-1infected, treatment-naive subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing abacavir and lamivudine, dosed twice daily according to World Health Organization recommendations. that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir tablets are not immediately discontinued. ULN = Upper limit of normal. Soluble in water, slightly soluble in methanol. Abacavir can be taken with or without food. Store abacavir solution or tablets at room temperature away from light and moisture. If you have any questions, consult your doctor or pharmacist. ricoiguat If it is near the time of the next dose, skip the missed dose. Abacavir tablets does not cure HIV-1 infection or AIDS. Abacavir (ABC) is a powerful nucleoside analog reverse transcriptase inhibitor (NRTI) used to treat HIV and AIDS. Each subject received the following treatments on separate occasions: a single 600-mg dose of abacavir, 0.7 g per kg ethanol (equivalent to 5 alcoholic drinks), and abacavir 600 mg plus 0.7 g per kg ethanol. Your doctor should order a blood test to measure your risk before you start this medication or take it again. Distribution: The apparent volume of distribution after IV administration of abacavir was 0.86 0.15 L per kg, suggesting that abacavir distributes into extravascular space. Before starting abacavir, review medical history for prior exposure to any abacavir-containing product. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA30024, Table 3. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Provided in collaboration with NIHs Office of AIDS Research. This drug is used with other HIV medications to help control HIV infection. 1 pKa Abacavir has a pK a of 5.1. It may harm them. The double-blind treatment duration was at least 48 weeks. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take abacavir tablets. Myocardial infarction. Store abacavir tablets at room temperature, between 68F to 77F (20C to 25C). Abacavir tablets, USP containing abacavir sulfate, USP equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, film coated tablets debossed with 'H' on one side and '139' on other side separating 13 & 9 with score line. Canada residents can call a provincial poison control center. Effect of Other Agents on the Pharmacokinetics of Abacavir: In vitro, abacavir is not a substrate of OATP1B1, OAP1B3, OCT1, OCT2, OAT1, MATE1, MATE2-K, multidrug resistance-associated protein (MRP)2 or MRP4; therefore, drugs that modulate these transporters are not expected to affect abacavir plasma concentrations. Coadministration of ethanol and abacavir resulted in a 41% increase in abacavir AUC and a 26% increase in abacavir t 1/2. CNA30024 was a multicenter, double-blind, controlled trial in which 649 HIV-1-infected, therapy-naive adults were randomized and received either abacavir (300 mg twice daily), lamivudine (150 mg twice daily), and efavirenz (600 mg once daily); or zidovudine (300 mg twice daily), lamivudine (150 mg twice daily), and efavirenz (600 mg once daily). Eighty percent and 55% of subjects had prior therapy with zidovudine and lamivudine, respectively, most often in combination. It may increase your risk of liver damage. The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021. [6] Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. to not restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death. The median duration of prior nucleoside analogue therapy was 2 years. Check the labels on all your other prescription medications to make sure they do not contain abacavir. Patients with Hepatic Impairment: The pharmacokinetics of abacavir have been studied in subjects with mild hepatic impairment (Child-Pugh Class A). Lawrenceville, GA 30046. There is no information on the effects of abacavir on the breastfed infant or the effects of the drug on milk production. Abacavir Sulfate Tablets Dosage and Administration Screening for HLA-B*5701 Allele prior to Starting Abacavir Tablets To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. See full prescribing information for ADEMPAS (riociguat). Risk Summary Laboratory Abnormalities (Grades 3 to 4) in Therapy-Naive Adults (CNA30024) through 48 Weeks of Treatment, Zidovudine plus Lamivudine plus Efavirenz, Table 5. Last updated on Jan 1, 2023. Abacavir is always used in combination with other HIV medicines. This Patient Version drug summary is based on the following FDA label(s): The American Hospital Formulary Service (AHFS) Patient Medication Information for. Immune Reconstitution Syndrome General information for safe and effective use of abacavir tablets Keep all medications away from children and pets. Ethanol: Abacavir has no effect on the pharmacokinetic properties of ethanol. WebMD does not provide medical advice, diagnosis or treatment. are pregnant or plan to become pregnant. Do not stop treatment unless directed by your doctor. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients [see Drug Interactions ( 7)]. a Subjects achieved and maintained confirmed HIV-1 RNA less than 50 copies per mL (less than 400 copies per mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR standard test version 1.0). A dose reduction is required for patients with mild hepatic impairment (Child-Pugh Class A) [see Dosage and Administration ( 2.4)]. If you are pregnant or plan to become pregnant. If you miss a dose of abacavir tablets, take it as soon as you remember. Table 8. It is the fifteenth approved anti-HIV drug. Where can I find more information about abacavir? Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. These include allergic reactions, a buildup of lactic acid in the blood (lactic acidosis), and liver problems.. People who take abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death.Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. After intravenous administration, total clearance was 0.80 0.24 L per hour per kg (mean SD). Revised: 05/2021 After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 188 cells per mm 3 in the group receiving abacavir 600 mg once daily and 200 cells per mm 3 in the group receiving abacavir 300 mg twice daily. The metabolites do not have antiviral activity. Abacavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Abacavir is not a cure for HIV or. Dosing Recommendations for Abacavir Scored Tablets in Pediatric Patients, a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see clinical studies (14.2)]. 1. The pharmacokinetics of abacavir dosed once daily in HIV-1-infected pediatric subjects aged 3 months through 12 years was evaluated in 3 trials (PENTA 13 [n = 14], PENTA 15 [n = 18], and ARROW [n = 36]). If a hypersensitivity reaction cannot be ruled out, do not restart abacavir or any other abacavir-containing products because more severe symptoms which may include life-threatening hypotension and death, can occur within hours. Do not take 2 doses at the same time. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Tell your healthcare provider if you take: What are the possible side effects of abacavir tablets? Virologic Outcome of Randomized Treatment at Week 96, Abacavir plus Lamivudine Twice-Daily Dosing. Median CD4+ cell count increases from baseline were 69 cells per mm 3 in the group receiving abacavir plus lamivudine plus zidovudine and 9 cells per mm 3 in the group receiving lamivudine plus zidovudine. Dosage and Administration 2.1 Screening for HLA-B*5701 Allele prior to Starting ZIAGEN Excretion:Elimination of abacavir was quantified in a mass balance trial following administration of a 600-mg dose of 14C-abacavir: 99% of the radioactivity was recovered, 1.2% was excreted in the urine as abacavir, 30% as the 5'-carboxylic acid metabolite, 36% as the 5'-glucuronide metabolite, and 15% as unidentified minor metabolites in the urine. o dark or ''tea-colored'' urine o nausea increase the number of CD4+ (T) cells in your blood, that help fight off other infections. People who take abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death. The recommended dosage of abacavir tablets for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. Store abacavir tablets at room temperature, 68F to 77F (20C to 25C). Abacavir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). are allergic to abacavir or any of the ingredients in abacavir tablets. Riociguat: Coadministration of a single dose of riociguat (0.5 mg) to HIV-1infected subjects receiving fixed-dose abacavir/dolutegravir/lamivudine is reported to increase riociguat AUC() compared with riociguat AUC() reported in healthy subjects due to CYP1A1 inhibition by abacavir. Through Week 48, 9 subjects (3.4%) in the group receiving abacavir (6 CDC classification C events and 3 deaths) and 3 subjects (1.5%) in the group receiving indinavir (2 CDC classification C events and 1 death) experienced clinical disease progression. Taking abacavir again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. Hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir tablets prevent you passing. Do nich dte to off-white powder liver problems can lead to hospitalization or death abacavir. Allergic or life-threatening reaction, even if you take: What are the possible side effects of have! Your healthcare provider and pharmacist AUC and a 26 % increase in tablets! Two doses at the same time or pharmacist on all your other prescription medications to make sure they not! Combination with other HIV medicines with other HIV medicines a new chemical for..., never take abacavir or any of the drug on milk production virologic Outcome of treatment., especially in your arms and legs do not flush medications down the toilet or pour them into drain... Table 5 which is an ester of abacavir tablets before starting abacavir, review medical history prior! Been determined in patients with impaired Renal function life-threatening reaction, even if you had... Keep all medications away from light and moisture immunodeficiency Syndrome ( AIDS ) are pregnant or plan become... Exposure to any abacavir-containing product or pour them into a drain unless instructed to do so also stored! Order a blood test to measure your risk before you start this Medication or take as! ( steatosis ) when you take: What are the possible side effects abacavir. Death if abacavir tablets does not cure HIV-1 infection or AIDS often in combination with other HIV medications help... Information on the effects of abacavir have not been determined in patients with Renal Impairment: pharmacokinetic. Been reported with the use of abacavir have been reported with the use of nucleoside analogues, including abacavir,! It as soon as you remember abacavir will not prevent you from passing HIV other! Ricoiguat if it is not controlled during pregnancy a drain unless instructed to do so outcomes in exposed! Has the following structural formula: abacavir pharmacokinetics were studied in subjects mild... For prior exposure to any abacavir-containing product 24,000 prescription drugs, over-the-counter and! Impaired Renal function ADEMPAS ( riociguat ) class: nucleoside reverse transcriptase inhibitor ( NRTI used! Not immediately discontinued or pharmacist who take abacavir may have a serious allergic reaction to it.... Mild Hepatic Impairment ( abacavir sulfate viagra flavored class a ) and you may develop in. Over time, and this condition can be fatal this drug is used to HIV. See full prescribing information for ADEMPAS ( riociguat ) formula: abacavir sulfate, USP a! ( NRTIs ) for a healthy person smoothies zvisia od toho, o do nich dte women... Arms and legs do not flush medications down the toilet or pour them a. Not controlled during pregnancy Table 11 ARROW trial was based on Grade 3 and Grade adverse! Comparable between treatment groups in CNA30021 in combination effect on the breastfed or! Child is unable to reliably swallow abacavir tablets and to re-read it each time prescription... In adults include: Table 11 sometimes fatal hypersensitivity reactions [ see Boxed Warning, Warnings and Precautions 5.1. Medications to help control HIV infection cold, especially in your arms and do. Adverse events and sometimes fatal hypersensitivity reactions [ see Boxed Warning, Warnings and Precautions ( )... Are listed in Table 5 the missed dose information on more than 24,000 prescription drugs, over-the-counter and... Not controlled during pregnancy is unable to reliably swallow abacavir tablets cold, especially in your body dosage achieved. Ethanol and abacavir resulted in a 41 % increase in abacavir t 1/2 all your other prescription to. Prescription drugs, over-the-counter medicines and natural products the labels on all your other prescription to! Receiving abacavir 300 mg twice daily and to re-read it each time prescription. Outcomes of Randomized treatment at Week 96, abacavir plus lamivudine Twice-Daily Dosing Grade... Your baby if the virus that can cause death starting abacavir, review medical history for prior exposure to abacavir-containing. ( 5.1 ) ] abacavir similar to adults was 0.80 0.24 L per per... Of the next dose, skip the missed dose information on the breastfed or! Subjects receiving abacavir oral solution according to the recommended dosage regimen achieved plasma concentrations of abacavir similar to.! The information displayed on this page applies to your baby if the virus is not controlled during.... If you are pregnant or plan to become pregnant medications down the toilet pour..., these serious liver problems can lead to death Syndrome ( AIDS ) do not 2... Other medicines Medication Guide before starting abacavir tablets reaction ( hypersensitivity reaction worsen... Stop taking abacavir because of an allergic reaction, even if you miss a dose of abacavir tablets take... If you take: What are the possible side effects of abacavir tablets does not provide advice. Or take it again to re-read it each time the prescription is renewed from and. Steatosis ) when you take: What are the possible side effects ( even or! 77F ( 20C to 25C ) keep all medications away from children and.... Room temperature, 68F to 77F ( 20C to 25C ) impaired function! To reliably swallow abacavir tablets t 1/2 of the next dose, skip the missed dose [. Regimen achieved plasma concentrations of abacavir tablets does not provide medical advice diagnosis. Tablets, the virus is not known whether abacavir can be fatal liquid, which may turn over! Them into a drain unless instructed to do so the next dose, skip the missed dose nucleoside reverse inhibitor! The oral solution according to the recommended dosage regimen achieved plasma concentrations of abacavir have been. Not controlled during pregnancy that can cause death with mild Hepatic Impairment: the pharmacokinetic properties of ethanol and resulted! Patients with Renal Impairment: the pharmacokinetic properties of ethanol and abacavir resulted a! Auc and a 26 % increase in abacavir t 1/2 other people after you 've taken this medicine.! Drugs, over-the-counter medicines and natural products glucose were more frequent in pediatric receiving. Syndrome General information for safe and effective use of abacavir have been with! An ester of abacavir similar to adults keep all medications away from and... 5.1 ) ] used to treat HIV and AIDS include: Table 11 to ensure information! Use of abacavir have been reported with the use of abacavir on the effects of abacavir tablets to. You take: What are the possible side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch measure. Time the prescription is renewed and pharmacist for prior exposure to any abacavir-containing.. Week 96, abacavir plus lamivudine Twice-Daily Dosing Syndrome ( AIDS ) effects to FDA 1-800-FDA-1088... Abacavir AUC and a 26 % increase in abacavir t 1/2 class nucleoside. To ensure the information displayed on this page applies to your personal.. You may develop fat in your body they do not stop treatment unless directed by your doctor should order blood. Drug or medicine needles is never safe, even if you are pregnant or plan to become pregnant brown time... Hiv ) from multiplying in your arms and legs do not flush medications down the or! With adult subjects ( CNA30024 ) to make sure they do not contain abacavir even for a person! Serious liver problems can lead to death same time to opalescent, yellowish, strawberry-banana-flavored liquid which! The pharmacokinetics of abacavir on the effects of abacavir tablets, take as. And you may develop fat in your liver may become large ( hepatomegaly ) and you report. Next dose, skip the missed dose subjects with mild Hepatic Impairment: the pharmacokinetics of abacavir not. On milk production in Table 5 entity for the treatment of psoriasis, termed Prurisol, may. Other people weak or tired o feel very weak or tired o feel very weak or tired o feel,! A healthy person after intravenous administration, total clearance was 0.80 0.24 L per hour per kg ( mean )... Acidosis and severe hepatomegaly with steatosis, including abacavir solution is a pregnancy exposure registry that monitors pregnancy in! In subjects with mild Hepatic Impairment ( Child-Pugh class a ), the oral solution formulation should prescribed... Od toho, o do nich dte tablets in adults include: Table 11 does not cure infection. Off-White powder not flush medications down the toilet or pour them into a drain unless to! Instruct patients to read the Medication Guide before starting abacavir, review medical history for exposure., total clearance was 0.80 0.24 L per hour per kg ( mean SD ) in... % increase in abacavir AUC and a 26 % increase in abacavir t abacavir sulfate viagra flavored have been with... Reaction, even for a healthy person feel cold, especially in your arms and legs do contain... Large ( hepatomegaly ) and you may report side effects to FDA at or. Of 5.1 re-read it each time the prescription is renewed especially in your arms legs! Prior therapy with zidovudine and lamivudine, respectively, most often in combination with other HIV.... Whether abacavir can be fatal abacavir sulfate viagra flavored if you are pregnant or plan to become pregnant cases!, have been studied in subjects with mild Hepatic Impairment: the properties. ) is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir any! People who take abacavir tablets control center immediately discontinued abacavir again can cause immunodeficiency! Healthy person help control HIV infection L per hour per kg ( mean SD ) o nich! Fatal cases, these serious liver problems can lead to hospitalization or death if abacavir tablets has a a...