Drugs

Doravirine

Doravirine

Brand Name: Pifeltro Other Names: DOR Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors

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What are the most important things to know about doravirine?

What are the most important things to know about doravirine?

Doravirine can cause serious side effects. These include changes in your immune system, called immune reconstitution inflammatory syndrome or IRIS. IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.

Contact your health care provider right away if you start having any new symptoms after starting doravirine.

While taking doravirine, it is important to keep all of your appointments with your health care provider.

What is doravirine?

What is doravirine?

Doravirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who have never taken HIV medicines before. Doravirine is always used in combination with other HIV medicines.
 
Doravirine belongs to a group of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs attach to and block an HIV enzyme called reverse transcriptase. By blocking reverse transcriptase, NNRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including doravirine, don’t cut down on, skip, or stop taking them unless your health care provider tells you to. 

What should I tell my health care provider before taking doravirine?

What should I tell my health care provider before taking doravirine?

Before taking doravirine, tell your health care provider:

  • If you are allergic to doravirine or any other medicines. 
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether doravirine can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking doravirine when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking doravirine. 
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John's wort) you are taking or plan to take. Doravirine may affect the way other medicines or products work, and other medicines or products may affect how doravirine works. 

How should I take doravirine?

How should I take doravirine?

Doravirine (brand name: Pifeltro) comes in 100-mg tablets. 

Take doravirine according to your health care provider’s instructions. Doravirine can be taken with or without food. 

If you also take the medicine rifabutin, take doravirine twice each day, about 12 hours apart, according to your health care provider’s instructions. 

Always take doravirine in combination with other HIV medicines.

If you take too much doravirine, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take doravirine, see the FDA drug label

What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of doravirine, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can doravirine cause?

What side effects can doravirine cause?

Doravirine may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of doravirine can be serious. A serious side effect of doravirine is immune reconstitution inflammatory syndrome, or IRIS. IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. (See section above: What are the most important things to know about doravirine?)

Other possible side effects of doravirine include:

  • Headache
  • Tiredness
  • Diarrhea
  • Stomach (abdominal) pain
  • Abnormal dreams
Tell your health care provider if you have any side effect that bothers you or that does not go away. 

These are not all the possible side effects of doravirine. To learn more about possible side effects of doravirine, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should doravirine be stored?

How should doravirine be stored?

  • Store doravirine at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep doravirine in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use doravirine if the original seal over the container opening is broken or missing.
  • Throw away doravirine that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep doravirine and all medicines out of reach of children.

Where can I find more information about doravirine?

Where can I find more information about doravirine?

More information about doravirine is available:

 

Manufacturer Information

Merck & Co., Inc.
Main number: 877-888-4231
Patient assistance: 800-444-2080 

 

The above Patient Version drug summary is based on the following FDA label(s): Tablet, film-coated.

Last Reviewed: November 9, 2018