Emtricitabine & Rilpivirine & Tenofovir Drug Class
Emtricitabine & Rilpivirine & Tenofovir is part of the drug class:
DIRECT ACTING ANTIVIRALS
Emtricitabine & Rilpivirine & Tenofovir and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category B. There are no well-done studies that have been done in humans with emtricitabine/rilpivirine/tenofovir. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.
There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
- Store emtricitabine/rilpivirine/tenofovir at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
- Keep emtricitabine/rilpivirine/tenofovir in its original container and keep the container tightly closed.
- Do not use emtricitabine/rilpivirine/tenofovir if the seal over the bottle opening is broken or missing.
- Keep this and all other medications out of the reach of children.
Before you take emtricitabine/rilpivirine/tenofovir, tell your healthcare provider if you:
- have liver problems, including hepatitis B or C virus infection
- have kidney problems
- have ever had a mental health problem
- have bone problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Emtricitabine & Rilpivirine & Tenofovir FDA Warning
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of emtricitabine/rilpivirine/tenofovir, in combination with other antiretrovirals.
Emtricitabine/rilpivirine/tenofovir is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine/rilpivirine/tenofovir have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of emtricitabine/rilpivirine/tenofovir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine/rilpivirine/tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.