Drug Database: Doravirine

What is doravirine?What is doravirine?

What is doravirine?

Doravirine (brand name: Pifeltro) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV in adults and children who weigh at least 77 lb (35 kg) and who meet certain requirements, as determined by a health care provider. Doravirine is always used in combination with other HIV medicines.

For more information on the use of doravirine in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines 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, do not 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?

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. Talk to your health care provider about the risks and benefits of taking doravirine during pregnancy. For more information on the use of doravirine during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breast/chestfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breast/chestfeeding.
• 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 HIVinfo 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. Taking doravirine together with certain medicines or products may cause serious side effects.

How should I take doravirine?How should I take doravirine?

How should I take doravirine?

Doravirine comes as 100-mg tablets.

Take doravirine according to your health care provider’s instructions. Do not miss a dose of doravirine, and do not change your dose or stop taking doravirine without first talking with your health care provider.

Take doravirine by mouth with or without food. Always take doravirine in combination with other HIV medicines.

If you also take the medicine rifabutin during treatment with doravirine, you may not have enough doravirine in your blood. Your health care provider will prescribe an additional dose of doravirine for you to take. Follow your health care provider’s instructions about when to take doravirine and how much to take. This is usually one tablet of doravirine taken two times each day, about 12 hours apart.

If you have taken too much doravirine, contact your health care provider or local poison control center (1-800-222-1222 or online) 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?

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?

What side effects can doravirine cause?

Doravirine may cause side effects. Some side effects of doravirine can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Another possible side effect of doravirine is a change 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.

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?

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?

Where can I find more information about doravirine?

• For more information on the use of doravirine in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• This Patient Version drug summary is based on the following FDA label(s): Tablet, film-coated. The Patient Package Insert includes information for people taking doravirine.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for doravirine available from MedlinePlus.
• Doravirine-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.