Doravirine

Generic name: doravirine
Brand name: Pifeltro
Dosage form: oral tablet (100 mg)
Drug class: NNRTIs

Medically reviewed by  A Ras MD.

What is doravirine?

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

Description

DELSTRIGO is a fixed-dose combination, film-coated tablet, containing doravirine, lamivudine, and TDF for oral administration.

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

Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine and is an HIV-1 nucleoside analogue reverse transcriptase inhibitor.

TDF (a prodrug of tenofovir) is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo TDF is converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Tenofovir is an HIV-1 reverse transcriptase inhibitor.

Each tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The tablets are film coated with a coating material containing the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.

Before taking doravirine, tell your doctor:

• If you are allergic to doravirine; 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 doravirine.

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

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 doravirine 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 doravirine?

• Tell all of your health care providers that you take doravirine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not run out of doravirine.
• 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 doravirine while you are pregnant.

How is doravirine best taken?

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

• Take with or without food.
• Take doravirine at the same time of day.
• Keep taking doravirine 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 doravirine 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 doravirine 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 doravirine. Tell your doctor right away if you have any new signs after you start doravirine, 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 doravirine?

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 doravirine?

• 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 – 30 TABLET BOTTLE LABEL

• NDC 0006-5007-01
• Delstrigo™
  (doravirine, lamivudine, and
  tenofovir disoproxil fumarate) tablets
• 100mg/300mg/300mg
• Each tablet contains 100 mg doravirine, 300 mg
  lamivudine, and 300 mg tenofovir disoproxil fumarate
  (equivalent to 245 mg tenofovir disoproxil).
• ALERT: Find out about medicines that
  should NOT be taken with Delstrigo™.
• Rx only
• 30 Tablets

SRC: NLM .