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Overview: Pifeltro is used to treat human immunodeficiency virus (HIV). It works by helping stop the spread of HIV in your body. Common side effects include nausea, dizziness, headache, tiredness, diarrhea, stomach pain, and unusual dreams. Pifeltro interacts with many other medicines. Tell your health care providers about all the medicines and supplements you take.

Uses

What is Pifeltro used for?

Pifeltro (doravirine) is commonly used to treat human immunodeficiency virus (HIV).

Pifeltro may also be used for other conditions as determined by your health care provider.

How does Pifeltro work (mechanism of action)?

Pifeltro works to help stop the spread of HIV in your body. A lower amount of HIV in your body helps protect and preserve the immune system.

How is Pifeltro supplied (dosage forms)?

Brands and other names

  • Pifeltro

Dosage forms and strengths

  • 100 mg oral tablets

How should I store Pifeltro?

Pifeltro should be stored tightly closed in the original container at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. The bottle contains a desiccant, which helps protect it from moisture. Do not remove the desiccant.

Side Effects

What are the most common side effects of Pifeltro?

The most common side effects of Pifeltro are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea
  • Dizziness
  • Headache
  • Tiredness
  • Diarrhea
  • Stomach pain
  • Unusual dreams

There may be other side effects of Pifeltro that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Pifeltro?

While less common, the most serious side effects of Pifeltro are described below, along with what to do if they happen.

Severe Skin Reactions. Pifeltro can cause severe skin reactions, such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), which can lead to death if not treated. If you get a rash, call your health care provider right away. Stop taking Pifeltro and get emergency help if you have a painful rash and any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Immune System Changes. When you start Pifeltro, your immune system might get stronger and start fighting infections that have been hiding inside your body for a long time. The type of symptoms you may have will depend on the infection. Tell your health care provider right away if you notice any of the following new symptoms of infection.

  • Fever, sweats, chills, or muscle aches
  • Swollen lymph nodes
  • Vision problems
  • Confusion, problems talking, or headache
  • Skin problems, such as a painful rash or warts
  • Cough or coughing up blood
  • Weakness or coordination problems

Severe Allergic Reactions. Pifeltro may cause allergic reactions, which can be serious. Stop taking Pifeltro and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Warnings & Precautions

Who should not use Pifeltro?

Allergies to Ingredients. People who are allergic to any of the following should not take Pifeltro.

  • Doravirine
  • Pifeltro
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Pifeltro.

Drug Interactions. Pifeltro should not be taken while you are using certain other medicines. Before taking Pifeltro, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Pifeltro before using it?

Do not take Pifeltro unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Pifeltro with other people, even if they have the same condition as you. It may harm them.

Keep Pifeltro out of the reach of children.

Pifeltro may cause dizziness. Do not drive or do other activities that require alertness or coordination until you know how Pifeltro affects you.

While Pifeltro can help keep the HIV infection under control, it does not cure it. Pifeltro does not help protect against or prevent the spread of sexually transmitted infections (STIs), like herpes, gonorrhea, or chlamydia.

What should I tell my health care provider before using Pifeltro?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Pifeltro is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. It is not known if or how Pifeltro could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Pifeltro while you are pregnant or trying to get pregnant. If you become pregnant while taking Pifeltro, you can register for the Antiretroviral Pregnancy Registry by calling 800-258-4263 or at www.apregistry.com. This registry collects safety information about the use of HIV medicines during pregnancy.

Breastfeeding. It is not known if Pifeltro passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Pifeltro while breastfeeding. There may be risks with breastfeeding while taking Pifeltro and having HIV.

How can I get more information about Pifeltro?

For more information about Pifeltro, you can visit the drugmaker’s website at www.pifeltro.com or call them at 877-888-4231.

Interactions

Does Pifeltro interact with foods or drinks?

There are no known interactions between Pifeltro and foods or drinks.

It is unknown if drinking alcohol will affect Pifeltro. The risk of dizziness may increase if you drink alcohol while taking Pifeltro.

Does Pifeltro interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Pifeltro.

  • Any medicine for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
  • Enzalutamide (Xtandi), which is a medicine used for prostate cancer
  • Rifampin (Rifadin) or rifapentine (Priftin), which are medicines commonly used to treat an infection called tuberculosis
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection
  • Mitotane (Lysodren), which is a medicine used for cancer of the adrenal gland 
  • St. John’s wort, which is a supplement that may be used for depression
  • Any other medicines for HIV or AIDS

Some other medicines may alter the blood levels of Pifeltro. Tell your health care provider about all the medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Pifeltro. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Pifeltro?

If you or someone else has used too much Pifeltro, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Pifeltro?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

Missing doses of Pifeltro can cause it to not work as well over time. So it is important not to miss or skip doses.