Safety information

Learn about common side effects of PIFELTRO.

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.

97% Of Participants in a 96-Week Study Continued Taking a PIFELTRO® (doravirine)-Based Single Tablet Regimen

What are the most common side effects?

The most common side effects of PIFELTRO include:

  • nausea
  • dizziness
  • headache
  • tiredness
  • diarrhea
  • stomach (abdominal) pain
  • 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 the 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 new symptoms after starting your HIV-1 medicine.

What is PIFELTRO?

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Important Safety Information

  • Do not take PIFELTRO if you are currently taking any of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John’s wort.
  • Ask your health care provider 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 health care provider 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 health care provider 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 health care provider or pharmacist.
  • Before starting PIFELTRO, tell your health care provider 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 health care provider 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 health care provider and pharmacist. Tell your health care provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your health care provider. Your health care provider can tell you if it is safe to take PIFELTRO with those other medicines.
  • Take PIFELTRO every day exactly as your health care provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.
  • Tell your health care provider 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 health care provider. 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 health care provider. Stay under a healthcare provider’s care when taking PIFELTRO.
  • Take PIFELTRO on a regular dosing schedule as instructed by your health care provider. 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 health care provider 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 PIFELTRO® (doravirine) and discuss it with your doctor. The physician Prescribing Information also is available.

What is PIFELTRO?

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines

PIFELTRO is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired

Important Safety Information for PIFELTRO (doravirine)

  • Do not take PIFELTRO if you are currently taking any of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John’s wort.
  • Ask your health care provider 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 health care provider 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 health care provider 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 health care provider or pharmacist.
  • Before starting PIFELTRO, tell your health care provider 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 health care provider 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 health care provider and pharmacist. Tell your health care provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your health care provider. Your health care provider can tell you if it is safe to take PIFELTRO with those other medicines.
  • Take PIFELTRO every day exactly as your health care provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.
  • Tell your health care provider 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 health care provider. 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 health care provider. Stay under a healthcare provider’s care when taking PIFELTRO.
  • Take PIFELTRO on a regular dosing schedule as instructed by your health care provider. 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 health care provider 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 PIFELTRO® (doravirine) and discuss it with your doctor. The physician Prescribing Information also is available.

Do not take PIFELTRO if you are currently taking any of the following medicines:

Do not take PIFELTRO if you are currently taking 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