CNA30021 was an international, multicenter, double-blind, controlled trial in which 770 HIV-1-infected, therapy-naive adults were randomized and received either abacavir 600 mg once daily or abacavir 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: Call your healthcare provider right away if you have any of the following signs of liver problems: You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese). Dosage Forms Tablets ZIAGEN tablets,are yellow, biconvex, capsule-shaped, and film-coated. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. The median baseline CD4+ cell count was 262 cells per mm 3 (range: 21 to 918 cells per mm 3) and the median baseline plasma HIV-1 RNA was 4.89 log 10 copies per mL (range: 2.60 to 6.99 log 10 copies per mL). The metabolites do not have antiviral activity. 1 pKa Abacavir has a pK a of 5.1. After intravenous administration, total clearance was 0.80 0.24 L per hour per kg (mean SD). You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. The tablets are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with "GX 623" on both sides. If you stop using abacavir even for a short time and then restart the drug, you have an increased chance of developing a very serious (possibly fatal) allergic reaction. In addition, non-malignant tumors also occurred in the liver and thyroid gland of female rats. The background risk for major birth defects and miscarriage for the indicated population is unknown. What should I discuss with my healthcare provider before taking abacavir? [1] Eachtablet of ZIAGEN contains 300 mgof abacavir (as 351mg abacavir sulfate). Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions ( 5.1)]. abacavir is for adults and children who are at least 3 months old. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Check the labels on all your other prescription medications to make sure they do not contain abacavir. associated with ZIAGEN (abacavir sulfate). Ethanol decreases the elimination of abacavir causing an increase in overall exposure. Abacavir can cause serious, life-threatening side effects. Thirty-nine percent (7 of 18) of the isolates from subjects who experienced virologic failure in the abacavir once-daily arm had a greater than 2.5-fold mean decrease in abacavir susceptibility with a median-fold decrease of 1.3 (range: 0.5 to 11) compared with 29% (5 of 17) of the failure isolates in the twice-daily arm with a median-fold decrease of 0.92 (range: 0.7 to 13). 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. Keep all medications away from children and pets. Lamivudine exposure (AUC decreased 15%) and zidovudine exposure (AUC increased 10%) did not show clinically relevant changes with concurrent abacavir. The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. The duration of double-blind treatment was at least 48 weeks. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Abacavir is an FDA-approved drug used to treat HIV-1 infection in conjunction with other antiretrovirals. Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes). No developmental effects were observed in rats at 100 mg per kg per day, resulting in exposures (AUC) 3.5 times the human exposure at the recommended daily dose. Your pharmacist will give you a Warning Card with a list of these symptoms. Abacavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Do not start taking a new medicine without telling your healthcare provider. Cross-resistance has been observed among NRTIs. Abacavir may increase your risk of a heart attack. The proportions of subjects with HIV-1 RNA less than 80 copies per mL through 96 weeks are shown in Table 11. Inform patients: Things to remember when you fill your prescription. If you stop abacavir tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM, TRIUMEQ, or TRIZIVIR) again. are breastfeeding or plan to breastfeed. you have had an allergic reaction to any medicine that contains abacavir (such as Ziagen, Epzicom, Triumeq, or Trizivir). People who take abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death. WebMD does not provide medical advice, diagnosis or treatment. Abacavir has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see Clinical Pharmacology ( 12.3)]. This Medication Guide has been approved by the U.S. Food and Drug Administration. Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. The double-blind treatment duration was at least 48 weeks. Abacavir belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTI.Abacavir is not a cure for HIV infection. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Abacavir is not a cure for HIV or AIDS. Do not breastfeed if you take abacavir tablets. Abacavir is present in human milk. Availability of Medication Guide Abacavir sulfate, USP is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. Five percent (5%) of subjects receiving abacavir 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving abacavir 300 mg twice daily. Batch CBD Full-Spectrum Gummies. AIDS: Abacavir sulfate (Ziagen) received accelerated approval for treatment of HIV infection from the Food and Drug Administration (FDA). Effect of Food: Bioavailability of abacavir tablets was assessed in the fasting and fed states with no significant difference in systemic exposure (AUC ); therefore, abacavir tablets may be administered with or without food. The recommended dose of abacavir tablets in patients with mild hepatic impairment (Child-Pugh Class A) is 200 mg twice daily. La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el prximo viernes 23 de junio. Abacavir did not affect male or female fertility in rats at a dose associated with exposures (AUC) approximately 3.3 times (male) or 4.1 times (female) those in humans at the clinically recommended dose. Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome. 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)]. US residents can call their local poison control center at 1-800-222-1222. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (depression, anxiety). The outcomes of randomized treatment are provided in Table 7. View Alternatives . However, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (AUC) at the recommended clinical dose (see Data). Eighty percent and 55% of subjects had prior therapy with zidovudine and lamivudine, respectively, most often in combination. b Predicted difference (95% CI) of response rate is -4.5% (-11% to 2%) at Week 96. Select a condition to view a list of medication options. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making. In vivo, abacavir sulfate, USP dissociates to its free base, abacavir. Some HIV-1 medicines including abacavir tablets may increase your risk of heart attack. abacavir is for adults and children who are at least 3 months old. Refill your medication before you run out. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. Table 3. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. This medicine is for adults and children who are at least 3 months old. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease such as high blood pressure, diabetes, or high cholesterol levels. Abacavir can be taken with or without food. Table 2. Do not stop treatment unless directed by your doctor. Talk to your pharmacist for more details. Substitutions K65R, L74M, or Y115F with M184V or I conferred a 7- to 8-fold reduction in abacavir susceptibility, and combinations of three substitutions were required to confer more than an 8-fold reduction in susceptibility. This interaction has not been studied in females. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid, which may turn brown over time. Available for Android and iOS devices. ZIAGEN oral solution contains 20 mg per mL of abacavir as abacavir sulfate. Call your doctor at once if you have pain or swelling in your upper stomach, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Indications and Usage ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets [see Boxed Warning, Warnings and Precautions ( 5.1)]. Talk with your doctor about safe ways to prevent HIV transmission during sex. 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. Coadministration of ethanol and abacavir resulted in a 41% increase in abacavir AUC and a 26% increase in abacavir t 1/2. Manufactured for: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Myocardial infarction [see Warnings and Precautions ( 5.4)]. In totality, the available data from the observational studies and from controlled clinical trials show inconsistency; therefore, evidence for a causal relationship between abacavir treatment and the risk of MI is inconclusive. Molecular Weight: 670.7522. Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)]. Based on in vitro study results, abacavir at therapeutic drug exposures is not expected to affect the pharmacokinetics of drugs that are substrates of the following transporters: organic anion transporter polypeptide (OATP)1B1/3, breast cancer resistance protein (BCRP) or P-glycoprotein (P-gp), organic cation transporter (OCT)1, OCT2, or multidrug and toxic extrusion protein (MATE)1 and MATE2-K. Abacavir comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. See also Warning and How to Use sections. Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans at a dose of 600 mg. Two hundred and five therapy-experienced pediatric subjects were enrolled: female (56%), white (17%), black (50%), Hispanic (30%), median age of 5.4 years, baseline CD4+ cell percent greater than 15% (median = 27%), and median baseline plasma HIV-1 RNA of 4.6 log 10 copies per mL. This Patient Version drug summary is based on the following FDA label(s): The American Hospital Formulary Service (AHFS) Patient Medication Information for. Each tablet contains abacavir sulfate, USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Pregnant Women: Abacavir pharmacokinetics were studied in 25 pregnant women during the last trimester of pregnancy receiving abacavir 300 mg twice daily. Other possible side effects of abacavir include: Tell your health care provider if you have any side effect that bothers you or that does not go away. Carry this Warning Card with you at all times. 155 Commerce Drive, Hauppauge, Do not use abacavir if the original seal over the container opening is broken or missing. 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. Your healthcare provider will test you for this before prescribing treatment with abacavir tablets. Several prospective, observational, epidemiological studies have reported an association with the use of abacavir and the risk of myocardial infarction (MI). We comply with the HONcode standard for trustworthy health information. Warnings Do not give abacavir tablets to other people, even if they have the same symptoms that you have. Do not use abacavir tablets for a condition for which it was not prescribed. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir. 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. Like other nucleoside reverse-transcriptase inhibitors (NRTIs), abacavir use is typically combined with other HIV medications. Through Week 48, an overall mean increase in CD4+ cell count of about 150 cells per mm 3 was observed in both treatment arms. Stay under the care of a healthcare provider while taking abacavir tablets. Metabolism : In humans, abacavir is not significantly metabolized by cytochrome P450 enzymes. 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. are allergic to abacavir or any of the ingredients in abacavir tablets. and the last available HIV-1 RNA less than 80 copies per mL (or missing). Myocardial degeneration was found in mice and rats following administration of abacavir for 2 years. It is the fifteenth approved anti-HIV drug. Enter your medication into the WebMD interaction checker, Testing Positive for CMV During Pregnancy, PrEP & the LGBTQ+ Community: What to Know. Where can I find more information about abacavir? Chemically, it is a synthetic carbocyclic nucleoside and is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. 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. increase the number of CD4+ (T) cells in your blood, that help fight off other infections. Read this information and learn what symptoms to watch for. The tour begins on Aug. 3 in Sterling . Talk to your healthcare provider if you are pregnant or plan to become pregnant. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Clinicalinfo provides the following link to the DailyMed drug label solely as an example of the labels available for abacavir. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. Trial participants were male (87%), white (73%), black (15%), and Hispanic (9%). Carry the Warning Card with you at all times. Your healthcare provider can determine with a blood test if you have this gene variation. There is no information on the effects of abacavir on the breastfed infant or the effects of the drug on milk production. Antiviral Activity Canada residents can call a provincial poison control center. Once-Daily Dosing If you have any questions, ask your doctor or pharmacist. Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. to carry the Warning Card with them. There is no known specific treatment for overdose with abacavir. Hypersensitivity to abacavir is a multi-organ clinical syndrome usually characterized by a sign or symptom in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal (including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional (including generalized malaise, fatigue, or achiness), and (5) respiratory (includ. If you miss a dose of abacavir tablets, take it as soon as you remember. you have moderate or severe liver disease; you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or. Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol, which is an ester of abacavir. o unusual (not normal) muscle pain o feel dizzy or light-headed pain Get medical help right away if you have any of the following serious symptoms, including: symptoms of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting). Abacavir tablets can cause serious side effects, including: Serious allergic reaction (hypersensitivity reaction). Table 9. Instruct patients to read the Medication Guide before starting abacavir tablets and to re-read it each time the prescription is renewed. Mutagenicity o trouble breathing o have a fast or irregular heartbeat c Includes consent withdrawn, lost to follow up, protocol violations, those with missing data, clinical progression, and other. Group 3: nausea, vomiting, diarrhea, or stomach area pain. Read the Medication Guide and Warning Card provided by your pharmacist before you start taking abacavir and each time you get a refill. Use the medicine exactly as directed. Abacavir doses are based on weight in children and/or teenagers. Binding of abacavir to human plasma proteins is approximately 50% and was independent of concentration. Risk Summary The solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid, which may turn brown over time. For children aged 3 months and older, your healthcare provider will prescribe a dose of abacavir based on your childs body weight. 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. Pronunciation: a BAK a veer Brand: Ziagen Ziagen 300 mg, capsule, yellow, imprinted with GX623 slide 1 of 4 > What is the most important information I should know about abacavir? that if they develop symptoms consistent with a hypersensitivity reaction they should call their healthcare provider right away to determine if they should stop taking abacavir tablets. What should I tell my healthcare provider before taking abacavir tablets? To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Discuss the risks and benefits with your doctor. Sharing drug or medicine needles is never safe, even for a healthy person. Do not breastfeed if you take abacavir tablets. Proportions of subjects with plasma HIV-1 RNA less than 400 copies per mL (using Roche AMPLICOR HIV-1 MONITOR Test) through 48 weeks of treatment are summarized in Table 8. If you get a symptom from 2 or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets. NEVER restart abacavir or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status. Does Abacavir interact with other drugs you are taking? If you would like more information, talk with your healthcare provider. 1, 7 Solubility Abacavir sulfate has a solubility of approximately 77 mg/mL in distilled water at 25C. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Experienced Pediatric Subjects (CNA3006) through 16 Weeks of Treatment. Abacavir solution may also be stored in the refrigerator. Trial participants were male (81%), white (51%), black (21%), and Hispanic (26%). ULN = Upper limit of normal. The recommended dosage of abacavir oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents. Do not double the dose to catch up. Abacavir Once Daily Versus Abacavir Twice Daily (CNA30021): Table 4. 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. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Outcomes of Randomized Treatment through Week 48 (CNA30021), Table 11. The following adverse reactions have been identified during postmarketing use of abacavir. Active ingredient: Abacavir sulfate, USP Table 6. Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The complete text of the Medication Guide is reprinted at the end of this document. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not change your dose or dosing schedule without your doctor's advice. During the blinded portion of the trial, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 subjects in the abacavir group and 3% of 325 subjects in the zidovudine group. b Includes viral rebound, insufficient viral response according to the investigator, and failure to achieve confirmed less than or equal to 50 copies per mL by Week 48. Genotypic analysis of isolates selected in cell culture and recovered from abacavir-treated subjects demonstrated that amino acid substitutions K65R, L74V, Y115F, and M184V/I emerged in HIV-1 RT. Dosage and Administration 2.1 Screening for HLA-B*5701 Allele prior to Starting ZIAGEN Drug Interaction Studies Call your doctor immediately if you develop one symptom from two or more of the following groups to see if you should stop taking abacavir: Group 1: fever. Pharmacist will give you a Warning Card with you at all times or Dosing schedule without your doctor pharmacist! 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