Safety information

You and your doctor can decide if PIFELTRO could be right for you.

Side Effects of PIFELTRO™ (doravirine)

A low rate of discontinuation due to side effects

 

In a 96-week study of adults who had never been on an HIV-1 treatment before, 364 adults received a PIFELTRO-based single-tablet regimen, while 364 adults received an Atripla once-daily tablet. In this study, fewer adults stopped taking a PIFELTRO-based single-tablet regimen than Atripla because of side effects.

continued with a PIFELTRO-based single-tablet regimen

3% discontinued treatment due to side effects

93% continued with Atripla (EFV/FTC/TDF)

7% discontinued treatment due to side effects

Definitions

EFV, efavirenz; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate.

What are the most common side effects?

 

In the same 96-week study of adults who had never been on an HIV-1 treatment before, the most common side effects of the PIFELTRO-based single-tablet regimen were:

DIZZINESS

NAUSEA

ABNORMAL DREAMS

The most common side effects of PIFELTRO include nausea, dizziness, headache, tiredness, diarrhea, stomach (abdominal) pain, and abnormal dreams. These are not all the possible side effects of PIFELTRO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having any new symptoms after starting your HIV-1 medicine.


Important Safety Information
  • Do not take PIFELTRO if you take any of the following medicines:
  • -carbamazepine
    -oxcarbazepine
    -phenobarbital
    -phenytoin
    -enzalutamide
    -rifampin
    -rifapentine
    -mitotane
    -St. John’s wort
  • Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your doctor or pharmacist before starting PIFELTRO.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine.
  • The most common side effects of PIFELTRO include: nausea, dizziness, headache, tiredness, diarrhea, stomach (abdominal) pain, and abnormal dreams.
  • These are not all the possible side effects of PIFELTRO. For more information, ask your doctor or pharmacist.
  • Before starting PIFELTRO, tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. It is not known if PIFELTRO can harm your unborn baby. Do not breastfeed if you take PIFELTRO. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PIFELTRO. Keep a list of your medicines to show your doctor and pharmacist. Tell your doctor if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take PIFELTRO with those other medicines.
  • Take PIFELTRO every day exactly as your doctor tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.
  • Tell your doctor if you have taken rifabutin in the past 4 weeks.
  • If you take the medicine rifabutin during treatment with PIFELTRO, take PIFELTRO 2 times each day, about 12 hours apart, as prescribed by your doctor. You may not have enough doravirine in your blood if you take rifabutin during treatment with PIFELTRO.
  • Do not change your dose or stop taking PIFELTRO without talking to your doctor. Stay under a healthcare provider's care when taking PIFELTRO.
  • Take PIFELTRO on a regular dosing schedule as instructed by your doctor. Do not miss doses.
  • If you miss a dose of PIFELTRO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses of PIFELTRO at the same time.
  • Get your PIFELTRO refilled from your doctor or pharmacy before you run out.
  • When your PIFELTRO supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to PIFELTRO and become harder to treat.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.

Please read the Patient Information for PIFELTROTM (doravirine) and discuss it with your doctor. The physician Prescribing Information also is available.