Label Changes for:
Epivir (lamivudine) Tablets and Oral Solution
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution
- Pediatric subjects who received EPIVIR oral solution concomitantly with other antiretroviral oral solutions at any time in the ARROW trial had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving EPIVIR tablets.
- EPIVIR scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate. Consider more frequent monitoring of HIV-1 viral load when treating with EPIVIR oral solution.
USE IN SPECIFIC POPULATIONS
- (addition) EPIVIR scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate because pediatric subjects who received EPIVIR oral solution had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving EPIVIR tablets in the ARROW trial.
PATIENT COUNSELING INFORMATION
Lactic Acidosis/Hepatomegaly (revised)
- Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking EPIVIR if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity.
Immune Reconstitution Syndrome (revised)
- Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when EPIVIR is started.
- Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EPIVIR during pregnancy.
- Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk.
- Instruct patients that if they miss a dose of EPIVIR, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose.
WARNINGS AND PRECAUTIONS
Use with Other Lamivudine- and Emtricitabine-containing Products
- Epivir should not be administered concomitantly with other lamivudine-containing products including… Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) …