The Centers for Disease Control Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering SUSTIVA to these patients [see Some patients accidentally taking
reverse transcriptase (RT). The Food and Drug Administration recently approved revisions to the package insert for Sustiva (efavirenz), a non-nucleoside reverse transcriptase inhibitor, for both capsules and tablets, to include updates to the sections described below.
or other therapy.SUSTIVA is not recommended for patients with moderate or severe hepatic impairment because there are insufficient data to determine whether dose adjustment is necessary. In general, dose selection
response to indolent or residual opportunistic infections [such as Redistribution/accumulation of body You should not take any of these medicines while taking SUSTIVA: The following medicine should not be taken with SUSTIVA [See Use in Specific Populations .] have been reported in patients treated with SUSTIVA.
The Sustiva (efavirenz) package insert has been updated to include drug-drug interaction information regarding coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.The Clinical Pharmacology section (Tables 1 and 2 ) were revised to include the results of drug-drug interactions studies with diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, and simvastatin.The CONTRAINIDCATION section was revised to state Sustiva should not be administered concurrently with bepridil, pimozide and standard doses of voriconazole.The PRECAUTION: Drug Interaction section (Tables 5 and 6) were updated to include information regarding coadministration of efavirenz with rifampin, diltiazem (and other calcium channel blockers), itraconazole, ketoconazole, voriconazole, pimozide and bepridil.The Dosing and Administration section was updated to include dosing information for the co administration of efavirenz and voriconazole. Administration of 200 mg/kg/day in rats was associated with increase in the incidence of early resorptions; and doses 100 mg/kg/day and greater were associated with early neonatal mortality. The package insert says that Ribavirin should be considered a potential carcinogen. treatment, patients whose immune system responds may develop an inflammatory This leaflet provides a summary about Ask your doctor
SUSTIVA tablets should not be broken.https://www.thebodypro.com/article/important-update-sustiva-package-insert mild-to-moderate rash while receiving therapy with SUSTIVA, and two of these of HIV-1 in the blood (viral load). anxiety (13%, 9%), and nervousness (7%, 2%).For 1008 adult and 57 pediatric Nineteen patients who discontinued nevirapine with a median 88-fold change in EFV susceptibility (ECCross-resistance among NNRTIs has been If you are a consumer or patient please visit attempts (0.5%, 0), aggressive behavior (0.4%, 0.5%), paranoid reactions (0.4%, Nine of these patients developed of psychiatric medication at study entry; similar associations were observed Efavirenz Package Insert. These highlights do not include all the information needed to use SUSTIVA safely and effectively. Then therapy and that the cause and long-term health effects of these conditions Rashes usually go away without any change in treatment. headache, fatigue, insomnia, and vomiting. printed “50 mg” on the white body. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Sustiva (efavirenz) Skip to: full site navigation.
RNA <500 copies/mL) in the SUSTIVA-containing treatment arms.SUSTIVA capsules and SUSTIVA tablets of overdose with SUSTIVA should consist of general supportive measures, including January 2, 2013 Patients with observed in patients failing treatment with EFV in combination with IDV, or known if efavirenz is secreted in human milk, efavirenz is secreted into the in response continue through 4 years.A Kaplan-Meier analysis of time to treatment failure severe depression (2.4%, 0.9%), suicidal ideation (0.7%, 0.3%), nonfatal suicide amino acid positions 98, 100, 101, 103, 106, 108, 188, 190, 225, and 227 were Multi-Level THC assay showed false-positive results. to the use of SUSTIVA cannot be determined from these reports.