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Pronunciation(a BAK a veer, la MI vyoo deen, & zye DOE vyoo deen)
U.S. Brand NamesTrizivir®
SynonymsAzidothymidine, Abacavir, and Lamivudine; AZT, Abacavir, and Lamivudine; Compound S, Abacavir, and Lamivudine; Lamivudine, Abacavir, and Zidovudine; 3TC, Abacavir, and Zidovudine; ZDV, Abacavir, and Lamivudine; Zidovudine, Abacavir, and Lamivudine
Generic AvailableNo
UseTreatment of HIV infection (either alone or in combination with other antiretroviral agents) in patients whose regimen would otherwise contain the components of Trizivir®
Pregnancy Risk FactorC
Pregnancy ImplicationsSee individual agents.
LactationSee individual agents.
ContraindicationsHypersensitivity to abacavir, lamivudine, zidovudine, or any component of the formulation. Do not rechallenge patients who have experienced hypersensitivity to abacavir (as Trizivir® or Ziagen®); life-threatening and fatal reactions have been reported.
Warnings/PrecautionsFatal hypersensitivity reactions have occurred in patients taking abacavir (in Trizivir®). Patients exhibiting symptoms of fever, skin rash, fatigue, respiratory symptoms (eg, pharyngitis, dyspnea, cough) and/or GI symptoms (eg, abdominal pain, nausea, vomiting, diarrhea) should discontinue therapy immediately and call for medical attention. Trizivir® should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible. Trizivir® SHOULD NOT be restarted because more severe symptoms may occur within hours, including LIFE-THREATENING HYPOTENSION AND DEATH. Fatal hypersensitivity reactions have occurred following the reintroduction of abacavir in patients whose therapy was interrupted (interruption in drug supply, temporary discontinuation while treating other conditions). Reactions occurred within hours. In some cases, signs of hypersensitivity may have been previously present, but attributed to other medical conditions (acute onset respiratory diseases, gastroenteritis, reactions to other medications). If Trizivir® is to be restarted following an interruption in therapy, first evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or if hypersensitivity cannot be ruled out. To report these events on Trizivir® hypersensitivity, a registry has been established (1-800-270-0425). Trizivir®, as a fixed-dose combination tablet, should not be used in patients <40 kg or those requiring dosage adjustment; should not be used in patients with Clcr  50 mL/minute; not intended for use in pediatric patients; should not be administered concomitantly with abacavir, lamivudine, or zidovudine. Prior liver disease, prolonged use, and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis. Dose reductions may be required for zidovudine in patients with hepatic impairment. Trizivir® is a fixed-dose combination; it is not recommended (per manufacturer) in hepatic impairment. Use with caution in patients with bone marrow compromise; myopathy and myositis have been associated with prolonged use of zidovudine (in Trizivir®).
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Adverse ReactionsFatal hypersensitivity reactions have occurred in patients taking abacavir (in Trizivir®). If Trizivir® is to be restarted following an interruption in therapy, first evaluate the patient for previously unsuspected symptoms of hypersensitivity. Do not restart if hypersensitivity is suspected or if hypersensitivity cannot be ruled out. The following information is based on CNAAB3003 study data concerning effects noted in patients receiving abacavir, lamivudine, and zidovudine. See individual agent monographs for additional information.
>10%:
Endocrine & metabolic: Triglycerides increased (25%)
Gastrointestinal: Nausea (47%), nausea and vomiting (16%), diarrhea (12%), loss of appetite/anorexia (11%)
1% to 10%:
Central nervous system: Insomnia (7%)
Miscellaneous: Hypersensitivity (5% based on abacavir component)
Other (frequency unknown): Pancreatitis, GGT increased
Postmarketing and/or case reports (limited to important or life-threatening): Redistribution/accumulation of body fat, anaphylaxis, cardiomyopathy, hepatic steatosis, lactic acidosis, Stevens-Johnson syndrome
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Overdosage/ToxicologySymptoms of overdose with zidovudine include nausea, vomiting, headache, dizziness, drowsiness, lethargy, confusion, and hematologic changes. Myocardial degeneration has been documented in animals during long-term high-dose toxicology studies; clinical relevance is unknown. Peritoneal dialysis and hemodialysis have little to no effect on the removal of the components of Trizivir®.
Drug InteractionsSee individual agents.
StabilityStore at room temperature 25°C (77°F)
Mechanism of ActionThe combination of abacavir, lamivudine, and zidovudine is believed to act synergistically to inhibit reverse transcriptase via DNA chain termination after incorporation of the nucleoside analogue as well as to delay the emergence of mutations conferring resistance
Pharmacodynamics/KineticsBioavailability studies of Trizivir® show no difference in AUC or Cmax when compared to abacavir, lamivudine, and zidovudine given together as individual agents. See individual agents.
DosageOral: Adolescents and Adults: 1 tablet twice daily; Note: Not recommended for patients <40 kg Dosage adjustment in renal impairment: Because lamivudine and zidovudine require dosage adjustment in renal impairment, Trizivir® should not be used in patients with Clcr 50 mL/minute
Elderly: Use with caution
AdministrationAdminister without regard to food or water.
Dietary ConsiderationsMay be taken without regard to food or water.
Patient EducationThis is not a cure for HIV infection, nor will it reduce the risk of transmission of HIV to others. Take exactly as prescribed without regard to food or water. Do not discontinue even if feeling better. You will need to have frequent blood tests to identify possible blood cell problems. You may experience headache, muscle pain, weakness, insomnia, unusual bleeding (eg, tarry stools, easy bruising, blood in stool, urine, or mouth), dizziness, or numbness; report these to your prescriber. Note: Trizivir® contains abacavir (also called Ziagen®). About 1 in 20 patients who take abacavir will have a serious allergic reaction that can result in death if the drug is not stopped right away. You may be having this reaction if you get a skin rash or if you get one or more symptoms from at least two of the following groups: fever; nausea, vomiting, diarrhea, stomach pain; extreme tiredness, achiness, general ill feeling; or sore throat, shortness of breath, cough. If you think you are having this reaction contact your prescriber immediately. If you stop Trizivir® because of this reaction, never take Trizivir® or Ziagen® (abacavir) again or you could die within hours. If you stop Trizivir® therapy for any other reason, consult your prescriber before restarting therapy. Pregnancy/breast-feeding precautions: Inform your prescriber if you are or intend to become pregnant. Breast-feeding is not recommended. HIV-infected mothers are discouraged from breast-feeding to decrease potential transmission of HIV.
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Dental Health: Effects on Dental TreatmentNo significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic PrecautionsNo information available to require special precautions
Mental Health: Effects on Mental StatusMay cause insomnia
Mental Health: Effects on Psychiatric TreatmentGastrointestinal side effects are common; these effects may be additive with concurrent use of SSRIs, lithium, or valproate. The hypnotic effect of the benzodiazepines may be diminished. Valproic acid may decrease the clearance of zidovudine. Increase in triglycerides is common and may be additive with clozapine, olanzapine, or quetiapine. May cause pancreatitis; use caution with valproic acid and atypical antipsychotics. May increase GGT; use caution with olanzapine and valproic acid. May cause aplastic anemia; use caution with clozapine and carbamazepine. Suspected Stevens-Johnson syndrome (SJS) has been reported in patients receiving abacavir in combination with medications known to be associated with SJS (lamotrigine).
Dosage FormsTablet [film coated]: Abacavir 300 mg, lamivudine 150 mg, and zidovudine 300 mg
References"Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States," June 23, 2004. Available at: http://www.aidsinfo.nih.gov. Accessed July 1, 2004.
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