Risk lists for informed consent national institutes of health. Learn more about triumeq, a combination of abacavir, dolutegravir, and lamivudine for the treatment of human immunodeficiency virus type 1 hiv1 infection. Highlights of prescribing information preexisting conduction. Abacavir and lamivudine tablets fda prescribing information.
Adult dosing, dosage form modifications, adverse reactions and interaction potential. Full prescribing information 1 indications and usage fuzeonin combination with other antiretroviral agents is indicated for the treatment of hiv1 infection in treatmentexperienced patientswith evidence of hiv1 replication despite ongoing antiretroviral therapy. Similar recommendations were made by the department of health and human services dhhs guidelines for the. Patients should contact their health care provider if symptoms persist if the pain lasts for more than 10 days, if there is redness or fever lasts more than 3 days. Ziagen abacavir tablets, for oral use ziagen abacavir oral solution initial u. Highlights of prescribing information these highlights. Drugdrug interactions of ombitasvirparitaprevirr plus dasabuvir with dolutegravir or abacavir plus lamivudine. Food and drug administration for use by people living with hiv in august 2004.
If you get a symptom from 2 or more of the following groups while taking triumeq, call your healthcare provider right away to find out if you should stop taking triumeq. This package insert must be read carefully before product use. Abacavir was mutagenic in the absence of metabolic activation, although it was not mutagenic in the presence of metabolic activation in an l5178y mouse lymphoma assay. Discontinue abacavir, lamivudine and zidovudine tablets immediately if a. Your healthcare provider will test you for this before prescribing treatment with ziagen. The tablets are orange colored, modified capsule shaped, filmcoated tablets debossed with h on one side and 27 on other side. Nd no data available, tn treatmentnaive, te treatmentexperienced, n nausea, d diarrhea, v vomiting, ha headache, r rash. Abacavir and lamivudine tablet, film coated dailymed. Epzicom abacavir sulfate and lamivudine tablet, film. On july 18, 2008, the food and drug administration fda approved changes to the package insert for abacavir sulfate ziagen highlighting information about the association of the hlab5701 allele a part of a gene and hypersensitivity reactions hsr caused by abacavircontaining therapy.
Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate acitretin capsule 3 soriatane universal moderate anastrazole tablet 1 arimidex low moderate high android capsule 3 methyltestosterone universal moderate. Ziagen oral solution, each ml containing abacavir sulfate equivalent to 20 mg of. Ziagen tablets, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow, biconvex, capsuleshaped, filmcoated, and imprinted with gx 623 on one side. The chemical name of abacavir sulfate is 1 s,cis42amino6cyclopropylamino9 hpurin9yl2cyclopentene1methanol sulfate salt 2. Highlights of prescribing information these highlights do not include all the information needed to use baraclude safely and effectively. Abacavir sulfate is a white to offwhite solid and is soluble in water. Each pharmacy bulk package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin. Highlights of prescribing information these highlights do not include all the information needed to use zepatiersafely and effectively. Abacavir pharmacokinetics were studied in 25 pregnant women during the last trimester of pregnancy receiving abacavir 300 mg twice daily.
Highlights of prescribing information baraclude see full. Highlights of prescribing information because triumeq is a. See full prescribing information for complete boxed warning. Abacavirresistant isolates of hiv1 have been selected in vitro and are associated with specific. Dosing considerations triumeq official hcp website. Review side effects, drug interactions, dosage, and pregnancy. Dolutegravir plus abacavirlamivudine for the treatment of hiv1 infection in antiretroviral therapynaive patients. Several fdaapproved drug labels may be available for abacavir.
Ziagen abacavir sulfate tablets ziagen prescribing. Abacavir induced chromosomal aberrations both in the presence and absence of metabolic activation in an in vitro cytogenetic study in human lymphocytes. Your healthcare provider can determine with a blood test if you have this gene variation. One of the recommended and commonly used therapies in this class is the oncedaily fixeddose combination of abacavirlamivudine. Abacavir sulfate is the enantiomer with 1s, 4r absolute configuration on the cyclopentene ring. One of the recommended and commonly used therapies in this class is the oncedaily fixeddose combination of abacavir lamivudine. Nucleoside reverse transcriptase inhibitors are the backbone of combination antiretroviral therapy for the treatment of hiv. Ziagen, abacavir dosing, indications, interactions. Patients who carry the hlab5701 allele are at a higher risk of a hypersensitivity reaction to abacavir. Read all of this leaflet carefully before you start taking this medicine because it.
Reintroduction of triumeq or any other abacavir containing product can result in lifethreatening or fatal hypersensitivity reactions, even in patients who have no history of hypersensitivity to abacavir therapy. In this insert, all dosages for ziagen are expressed in terms of abacavir. This includes any possible side effects not listed in this leaflet. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by a. Mar 15, 2005 shortly after this article was accepted for publication, the manufacturer of abacavir, glaxosmithkline, published an updated version of the package insert for abacavir that included new data on the effect of hepatic dysfunction on abacavir pharmacokinetics, as well as new recommendations for dosing adjustments in this situation. The use of reyataz in treatmentexperienced adult patients without ritonavir is not recommended. Jun 01, 2019 have a certain type of gene variation called the hla. Epzicom abacavir and lamivudine tablets, for oral use.
Abacavir is a rare cause of clinically apparent drug induced liver injury. Abacavir exposure auc during pregnancy was similar to those in postpartum and in hivinfected nonpregnant historical controls. The abacavir package insert and antiretroviral treatment guidelines recommend screening for hla b. Ziagen tablets contain 300 mg of abacavir as abacavir sulfate. Niosh list of antineoplastic and other hazardous drugs in. Your doctor may want to test your blood for hlab5701. Abacavir pharmacokinetics in hepatic dysfunction clinical.
Highlights of prescribing information zepatier is recommended. These highlights do not include all the information needed. Abacavirlamivudine fixeddose combination antiretroviral. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Minimum ppe required ppe requirements hazardous drug. For full prescribing information refer to the package insert approved by the mcc. Key to symbols used list number in vitro diagnostic medical device lot number expiration date store at 28c.
Dailymed epzicom abacavir sulfate and lamivudine tablet. Viread oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring chewing e. Highlights of prescribing information dosage adjustment with. Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called hlab5701. A more severe or fatal allergictype reaction can occur within hours if abacavir is restarted in patients who have interrupted abacavir therapy for any reason. Revised august 2008 based on package insert dated 72008 ver fe rash upset stomach, vomiting, loose or watery stools, abdominal pain general feeling of illness, extreme tiredness, achiness. Current hiv treatment guidelines include abacavir in alternative nonnucleoside reverse transcriptase inhibitor nnrti or protease inhibitor pi based treatment. Ampicillin for injection, usp is white to offwhite crystalline powder. Zepatier elbasvir and grazoprevirtablets, for oral use initial u. Epzicom abacavir sulfate and lamivudine tablet, film coated if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such.
These are not all the possible side effects of abacavir. Reintroduction of triumeq or any other abacavircontaining product can result in lifethreatening or fatal hypersensitivity reactions, even in patients who have no history of hypersensitivity to abacavir therapy. Jan 06, 2020 these are not all the possible side effects of abacavir. Important safety information for patients do not take apokyn if you are being treated with certain drugs called 5ht 3 antagonists including anzemet, kytril, zofran, lotronex, and aloxi that are used for nausea and vomiting or irritable bowel syndrome. Sep 01, 2008 abacavir package insert changes approved.
You can report side effects to fda at 1800fda1088 18003321088 or online. Highlights of prescribing information these highlights do not. Epzicom should be prescribed by a healthcare provider for patients who need both of these drugs. Sections or subsections omitted from the full prescribing information are not listed. Intracellularly, abacavir is converted by cellular enzymes to the active metabolite carbovir triphosphate. These highlights do not include all the information needed to use abacavir and lamivudine tablets safely and effectively. Ziagen, abacavir dosing, indications, interactions, adverse. Abacavir fda label solution, tablet film coated aidsinfo. Abacavir package insert abacavir package insert download the pdf. Dpi drug package insert epa environmental protection agency. To learn more about possible side effects of abacavir, read the drug label or package insert or talk to your health care provider or pharmacist.
If you interrupt abacavir, immediately contact the medical staff at the site before restarting abacavir. These results established the effectiveness of prospective hlab. It has a molecular formula of c 14 h 18 n 6 o 2 h 2 so 4 and a molecular weight of 670. Minimum ppe required handling only no alteration contained crushsplit crushsplit minimum ppe required abacavir susp 2 ziagenepzicomtrizivir low abacavir tablet 2 ziagenepzicomtrizivir universal low moderate. Abacavir prevents reverse transcriptase from working properly. The solution after constitution is clear and colorless.
Contains sunset yellow e110, see package leaflet for further information. One level scoop delivers 1 g of powder, which contains 40 mg of tdf. See the end of this medication guide for a complete list of ingredients in ziagen. The tablets are yellow, biconvex, scored, capsuleshaped, filmcoated, and imprinted with gx 623 on both sides. Ziagen fda prescribing information, side effects and uses. In 2008, the united states food and drug administration fda approved a change in the abacavir package insert that recommended hlab. Abacavir and lamivudine tablets are contraindicated in patients. Specific package insert requirement for paracetamol keep out of reach of children. Official site apokyn apomorphine hydrochloride injection. Dolutegravir plus abacavir lamivudine for the treatment of hiv1 infection in antiretroviral therapynaive patients.
What aspen abacavir contains each 1 ml of liquid contains 20 mg of the active substance, abacavir. These highlights do not include all the information needed to. Sep 07, 2019 abacavir induced chromosomal aberrations both in the presence and absence of metabolic activation in an in vitro cytogenetic study in human lymphocytes. Kivexa, innabacavirlamivudine european medicines agency. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Abacavir ziagen is a drug prescribed in combination with other antihiv drugs to treat hiv infection. Minimum ppe required ppe requirements hazardous drug handling. Recommended reyataz and ritonavir dosage in adults.
Aidsinfo provides the following drug label solely as an example of the labels available for abacavir. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients. Risk lists for informed consent national institutes of. Triumeq, a combination of dolutegravir integrase strand transfer inhibitor. The concomitant use of pifeltro and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of pifeltro and possible development of resistance see dosage and administration 2.
Shortly after this article was accepted for publication, the manufacturer of abacavir, glaxosmithkline, published an updated version of the package insert for abacavir that included new data on the effect of hepatic dysfunction on abacavir pharmacokinetics, as well as new recommendations for dosing adjustments in this situation. Viread is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 hiv1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. Abacavir is a carbocyclic synthetic nucleoside analogue. The other ingredients are banana flavour, citric acid monohydrate, noncrystallising sorbitol solution, saccharin sodium, sodium citrate dihydrate strawberry flavour and water.
The package insert states that abacavir is contraindicated in people with moderate to severe hepatic impairment because of a lack of data 2, and. Highlights of prescribing information pediatric patients. Baraclude entecavir is indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases alt or ast or histologically active disease. See full prescribing information for complete boxed. Highlights of prescribing information these highlights do not include all the information needed to use ziagen safely and effectively. In vivo, abacavir sulfate dissociates to its free base, abacavir. Such reactions can occur within hours see warnings and precautions 5. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. Insti, abacavir, and lamivudine both nucleoside analogue reverse. Viread oral powder should be measured only with the supplied dosing scoop. Baraclude entecavir tablets, for oral use baraclude entecavir. Nov 01, 2019 abacavir and lamivudine tablets usp 600 mg300 mg contain 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. Fixeddose combination dolutegravir, abacavir, and lamivudine versus ritonavirboosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with hiv1 infection aria.