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What is PIFELTRO?

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PIFELTRO is a prescription HIV-1 medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults who

PIFELTRO is a prescription HIV-1 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).


 

Frequently asked questions

  • 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.
  • 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.
  • Take PIFELTRO with or without food.
  • Do not change your dose or stop taking PIFELTRO without talking to your doctor. Stay under a doctor’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 doctor or pharmacist.
  • When your PIFELTRO supply starts to run low, get more from your doctor 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.

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 1 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 treatment with PIFELTRO.

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.
  • You can ask your doctor or pharmacist for a list of medicines that interact with PIFELTRO.
  • Do not start taking a new medicine without telling your doctor. Your doctor 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 under 18 years of age.

Whether you take over-the-counter or doctor-prescribed medicines for other conditions, it is important that you talk to your doctor about all of your medicines.

PIFELTRO can be taken with a wide range of common, non–HIV-1 medicines, such as:

  • Heartburn
  • PROTON PUMP INHIBITORS
  • (pantoprazole)
  • Birth Control
  • ORAL CONTRACEPTIVES
  • (ethinyl estradiol and levonorgestrel)
  • Pain
  • METHADONE
  • Cholesterol
  • STATINS
  • (atorvastatin)
  • Diabetes
  • METFORMIN
  • (metformin hydrochloride)

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 1 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 treatment with PIFELTRO.

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.
  • You can ask your doctor or pharmacist for a list of medicines that interact with PIFELTRO.
  • Do not start taking a new medicine without telling your doctor. Your doctor 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 under 18 years of age.

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

  • 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.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. 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 that you have, it may harm them. You can ask your pharmacist or doctor for information about PIFELTRO that is written for healthcare professionals.

Active ingredient: doravirine.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet film coating contains Hypromellose, lactose monohydrate, titanium dioxide and triacetin. The coated tablets are polished with carnauba wax.

HIV 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.*

PIFELTRO, as part of a treatment regimen, did not increase bad cholesterol, while the other treatment regimen* did.

The benefit of these changes has not been demonstrated.

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

Maintaining a healthy weight is an important part of taking care of your health and managing your HIV. You may have concerns about weight change. If you do, talk to your doctor.

Before treatment with PIFELTRO, tell your doctor about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if PIFELTRO can harm your unborn baby. Tell your doctor if you become pregnant during treatment with PIFELTRO.

    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 doctor about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. 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.
    • It is not known if PIFELTRO can pass into your breast milk.
    • Talk with your doctor about the best way to feed your baby.

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.
  • You can ask your doctor or pharmacist for a list of medicines that interact with PIFELTRO.
  • Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take PIFELTRO with other medicines.

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.