This section contains information intended for healthcare professionals in the United States only and is not intended for the general public.
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What is PIFELTRO® (doravirine)?
What is PIFELTRO?
What is PIFELTRO?
Important Safety Information for PIFELTRO® (doravirine)
Important Safety Information
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 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 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 for PIFELTRO® (doravirine)
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 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.
PIFELTRO can cause serious side effects, including:
Severe skin reactions have happened in people treated with PIFELTRO. Call your healthcare provider right away if you develop a rash during treatment with PIFELTRO. Stop taking PIFELTRO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, swelling of the face or lymph nodes, feeling tired or generally ill, or redness or swelling of the eyes (conjunctivitis).
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. It is not known if PIFELTRO can harm your unborn baby. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. PIFELTRO may pass to your baby in your breast milk. HIV may pass to your baby through your breast milk if your baby does not have HIV.
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.
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 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: 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 PIFELTRO.
PIFELTRO can cause serious side effects, including:
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 before starting PIFELTRO.
PIFELTRO can cause serious side effects, including:
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 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 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 for PIFELTRO® (doravirine) 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 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.
PIFELTRO can cause serious side effects, including:
Severe skin reactions have happened in people treated with PIFELTRO. Call your healthcare provider right away if you develop a rash during treatment with PIFELTRO. Stop taking PIFELTRO and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or sores in the mouth, blisters or peeling of the skin, swelling of the face or lymph nodes, feeling tired or generally ill, or redness or swelling of the eyes (conjunctivitis).
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. It is not known if PIFELTRO can harm your unborn baby. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. PIFELTRO may pass to your baby in your breast milk. HIV may pass to your baby through your breast milk if your baby does not have HIV.
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.
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 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: 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 PIFELTRO.
PIFELTRO can cause serious side effects, including:
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 before starting PIFELTRO.
PIFELTRO can cause serious side effects, including:
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