Pifeltro

Generic name: doravirine
Drug class: NNRTIs

Medically reviewed by  A Ras MD.

What is Pifeltro used for?

Pifeltro is a prescription medicine that is used to treat HIV infection.

Description

PIFELTRO is a film-coated tablet containing doravirine for oral administration.

Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).

Each tablet contains 100 mg of doravirine as the active ingredient. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film coated with a coating material containing the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.

The chemical name for doravirine is 3-chloro-5-[[1-[(4,5-dihydro-4-methyl-5-oxo-1H-1,2,4-triazol-3-yl)methyl]-1,2-dihydro-2-oxo-4-(trifluoromethyl)-3-pyridinyl]oxy]benzonitrile.

It has a molecular formula of C17H11ClF3N5O3 and a molecular weight of 425.75.

It has the following structural formula:

Chemical Structure

Doravirine is practically insoluble in water.

Before taking Pifeltro, tell your doctor:

  • If you are allergic to Pifeltro; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you are taking any of these drugs or have taken any of these drugs in the last 4 weeks: Carbamazepine, enzalutamide, mitotane, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or St. John’s wort.
  • If you are taking any of these drugs: Efavirenz, etravirine, or nevirapine.
  • If you are breast-feeding. Do not breast-feed while you take Pifeltro.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Pifeltro with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pifeltro?

  • Tell all of your health care providers that you take Pifeltro. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not run out of Pifeltro.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine is not a cure for HIV. Stay under the care of your doctor.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Pifeltro while you are pregnant.

How is Pifeltro best taken?

Use Pifeltro as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Take Pifeltro at the same time of day.
  • Keep taking Pifeltro as you have been told by your doctor or other health care provider, even if you feel well.
  • It is important that you do not miss or skip a dose of Pifeltro during treatment.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of Pifeltro that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Pifeltro. Tell your doctor right away if you have any new signs after you start Pifeltro, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.

What are some other side effects of Pifeltro?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach.
  • Feeling dizzy, tired, or weak.
  • Strange or odd dreams.
  • Trouble sleeping.
  • Stomach pain or diarrhea.
  • Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Pifeltro?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 100 MG BOTTLE LABEL

  • NDC 0006-3069-01
  • Pifeltro™
    (doravirine) tablets
  • 100 mg
  • Each tablet contains 100 mg doravirine.
  • ALERT: Find out about medicines that
    should NOT be taken with Pifeltro™.
  • Rx only
  • 30 Tablets
Pifeltro 100 mg
Imprint Logo 700 - Pifeltro 100 mg

SRC: NLM .

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