Frequently asked questions about PIFELTRO

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How do I take PIFELTRO?

  • Take PIFELTRO every day exactly as your healthcare provider tells you to take it.
  • Take PIFELTRO 1 time each day, at about the same time every day.
  • If you take the medicine rifabutin during treatment with PIFELTRO, take PIFELTRO 2 times each day, about 12 hours apart, as prescribed by your healthcare provider. You may not have enough doravirine in your blood if you take rifabutin during treatment with PIFELTRO.
  • Take PIFELTRO with or without food.
  • Do not change your dose or stop taking PIFELTRO without talking to your healthcare provider. Stay under a healthcare provider’s care when taking PIFELTRO.
  • It is important that you do not miss or skip doses of PIFELTRO.
  • 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.
  • If you have any questions, call your healthcare provider or pharmacist.
  • 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.
Taking PIFELTRO
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Who should not take PIFELTRO?

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 healthcare 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 healthcare provider or pharmacist before starting treatment with PIFELTRO.

Tell your healthcare 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 healthcare provider and pharmacist.
  • Tell your healthcare provider if you have taken rifabutin in the past 4 weeks.
  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PIFELTRO.
  • Do not start taking a new medicine without telling your healthcare provider . Your healthcare provider can tell you if it is safe to take PIFELTRO with other medicines.

It is not known if PIFELTRO is safe and effective in children who weigh less than 77 pounds (35 kg).

Taking PIFELTRO
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What should I tell my healthcare provider before taking PIFELTRO?

Before starting PIFELTRO, tell your healthcare provider about:

  • Any health conditions you have.
  • Any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • If you have taken rifabutin in the past 4 weeks.

You should also tell your healthcare provider if you:

  • Are pregnant or plan to become pregnant. It is not known if PIFELTRO can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking PIFELTRO.
  • Are breastfeeding or plan to breastfeed. It is not known if PIFELTRO can pass into your breast milk. Do not breastfeed if you take PIFELTRO.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

Pregnancy registry: There is a pregnancy registry for people who take PIFELTRO 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 sign up.

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What medicines can be taken with PIFELTRO?

Non-HIV-1 medicines, treating conditions such as:

  • Heartburn
    Proton pump inhibitors (pantoprazole)
  • Birth Control
    Oral contraceptives (ethinyl estradiol and levonorgestrel)
  • Pain
    Methadone
  • Cholesterol
    Statins (atorvastatin)
  • Diabetes
    Metformin

Important

Do not take PIFELTRO if you are taking one of the following medicines: carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, or St. John’s wort. Ask your healthcare 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 healthcare provider or pharmacist before starting PIFELTRO.

Whether you take over-the-counter or healthcare provider prescription medicines for other conditions, it is important to talk to your healthcare provider about all of your medicines before starting treatment with PIFELTRO.

Taking PIFELTRO
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What are the possible side effects of PIFELTRO?

PIFELTRO can cause serious side effects, including:

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 healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.

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 healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

About PIFELTRO
Safety information
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How should I store PIFELTRO?

Store PIFELTRO tablets at room temperature, between 68°F to 77°F.

Keep it in the original bottle.

Do not take the tablets out of the bottle to store in another container, such as a pill box.

Keep the bottle tightly closed to protect PIFELTRO from moisture.

The PIFELTRO bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant.

Keep PIFELTRO and all medicines out of the reach of children.

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What are the ingredients in PIFELTRO?

Active ingredient: doravirine.

Inactive ingredients:

  • Colloidal silicon dioxide
  • Croscarmellose sodium
  • Hypromellose acetate succinate
  • Lactose monohydrate
  • Magnesium stearate
  • Microcrystalline cellulose

The tablet film coating contains:

  • Hypromellose
  • Lactose monohydrate
  • Titanium dioxide
  • Triacetin

The coated tablets are polished with carnauba wax.

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How may PIFELTRO affect my cholesterol level?

HIV and/or HIV treatments may have a negative impact on your “bad” cholesterol (LDL-C). In a 96-week study of adults who had never been on an HIV-1 treatment before, 320 adults received PIFELTRO as part of a treatment regimen and 311 adults received another treatment regimen.a

PIFELTRO, as part of a treatment regimen, did not raise “bad” cholesterol, while the other treatment regimen did.

The benefit of these changes has not been demonstrated.

Effect on “bad” cholesterol (LDL-C) at week 48:

aThe other treatment regimen included darunavir plus a ritonavir boost (PI + ritonavir boost), once daily.

About PIFELTRO
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What else do I need to know about PIFELTRO?

Sometimes, doctors prescribe medicines to treat health problems other than the main condition they are for. Always use PIFELTRO exactly as your healthcare provider tells you to — do not use PIFELTRO for a condition for which it was not prescribed.

Do not give PIFELTRO to other people, even if they have the same symptoms as you. It may harm them.

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
    • rifampin
    • oxcarbazepine
    • rifapentine
    • phenobarbital
    • mitotane
    • phenytoin
    • St. John’s wort
    • enzalutamide

    Ask your healthcare 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 healthcare 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 healthcare 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 healthcare provider or pharmacist.
  • Before starting PIFELTRO, tell your healthcare 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 healthcare 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 healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PIFELTRO with those other medicines.
  • Take PIFELTRO every day exactly as your healthcare provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.
  • Tell your healthcare 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 healthcare 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 healthcare provider. Stay under a healthcare provider’s care when taking PIFELTRO.
  • Take PIFELTRO on a regular dosing schedule as instructed by your healthcare 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 healthcare 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 fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for PIFELTRO® (doravirine) and discuss it with your healthcare provider. 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
    • rifampin
    • oxcarbazepine
    • rifapentine
    • phenobarbital
    • mitotane
    • phenytoin
    • St. John’s wort
    • enzalutamide

    Ask your healthcare 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 healthcare 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 healthcare 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 healthcare provider or pharmacist.
  • Before starting PIFELTRO, tell your healthcare 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 healthcare 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 healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PIFELTRO with those other medicines.
  • Take PIFELTRO every day exactly as your healthcare provider tells you to take it. Take PIFELTRO 1 time each day, at about the same time every day.
  • Tell your healthcare 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 healthcare 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 healthcare provider. Stay under a healthcare provider’s care when taking PIFELTRO.
  • Take PIFELTRO on a regular dosing schedule as instructed by your healthcare 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 healthcare 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 fda.gov/medwatch, or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information for PIFELTRO® (doravirine) and discuss it with your healthcare provider. 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 healthcare 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 healthcare provider or pharmacist