What Is PIFELTRO™ (doravirine)?

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PIFELTRO is a medicine used to treat HIV-1. PIFELTRO should be taken along with your other HIV medicines at around the same time every day. You can take PIFELTRO with or without food.

Consider this page your guide to how PIFELTRO can help you manage your HIV. Ask your healthcare provider if PIFELTRO is right for you.

 

ONE PILL TAKEN WITH OTHER HIV MEDICINES

 

ONCE A DAY

 

WITH OR WITHOUT FOOD

LOOKING TO SAVE ON OUT-OF-POCKET COSTS FOR PIFELTRO?

You may be able to take advantage of prescription savings on PIFELTRO.

SAVINGS COUPON

Eligible, privately insured patients may pay as little as $0, up to a total program savings of $6,800. Not all patients are elgible and certain restrictions apply. Please see Terms and Conditions to find out if you can save.

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

  • carbamazepine
  • phenytoin
  • rifapentine
  • oxcarbazepine
  • enzalutamide
  • mitotane
  • phenobarbital
  • rifampin
  • 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 treatment with PIFELTRO.

  • 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.
  • Take PIFELTRO with or without food.
  • 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 PILFETRO.
  • Do not change your dose or stop taking PIFELTRO without talking to your doctor. Stay under a doctor’s care while 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 two 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 a resistance to PIFELTRO and become harder to treat.

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 were:

  • nausea
  • headache
  • tiredness
  • diarrhea
  • stomach (abdominal) pain
  • dizziness
  • 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.


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 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.

Dosing

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.

Get your PIFELTRO refilled from your doctor or pharmacy before you run out.

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 and discuss it with your doctor. The physician Prescribing Information also is available.



 
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