Doravirine

Doravirine is an antiviral medicine that stops human immunodeficiency virus (HIV) from growing in your body.

Doravirine is used with other medicines to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). Doravirine is not a cure for HIV or AIDS.

Doravirine may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Doravirine is usually taken once per day. If you also take a medicine called rifabutin, you may need to take doravirine twice per day. Follow your doctor's dosing instructions very carefully.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store tablets at room temperature, away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Do not put the tablets into a daily pill box.

Tell your doctor about all the medicines you are currently taking, as well as any that you start or stop. Some drugs can interact with each other, and some should not be taken together.

You should not use doravirine if you are allergic to it.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with doravirine. Your doctor may change your treatment plan if you have used any of the following medicines in the past 4 weeks:

• enzalutamide;
• mitotane;
• rifampin;
• rifapentine;
• St. John's wort; or
• seizure medicine--carbamazepine, phenobarbital, phenytoin, or oxcarbazepine.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

doravirine is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Doravirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken doravirine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of doravirine may include:

• nausea, diarrhea, stomach pain;
• headache, dizziness;
• tiredness; or
• strange dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

100 mg orally once a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to this drug

Usual Pediatric Dose for HIV Infection:

At least 35 kg: 100 mg orally once a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to this drug

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Make sure to get your prescription refilled before you run out of medicine completely. Skipping doses may increase the risk of your virus becoming resistant to the medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all your other medicines, especially:

• rifabutin (or if you have taken it in the past 4 weeks).

This list is not complete. Other drugs may affect doravirine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• What drugs are contained in the HIV treatment Delstrigo?
• What type of drug is Pifeltro (doravirine)?