Doravirine, lamivudine, and tenofovir

Doravirine, lamivudine, and tenofovir are antiviral medicines that stop human immunodeficiency virus (HIV) from making more copies of itself in your body.

Doravirine, lamivudine, and tenofovir is a combination medicine used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). doravirine, lamivudine, and tenofovir is not a cure for HIV or AIDS.

Doravirine, lamivudine, and tenofovir may also be used for reasons that are 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.

If you also take a medicine called rifabutin, you may need to take an extra dose of doravirine (Pifeltro) about 12 hours after you take the doravirine, lamivudine, and tenofovir combination (Delstrigo). 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.

Your doctor may perform blood and urine tests to make sure you do not have conditions that would prevent you from safely using doravirine, lamivudine, and tenofovir. You may also need bone mineral density testing.

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.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using this medicine. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Tell your doctor about all the medicines you are currently taking and any that you start or stop. Many drugs can interact, and some should not be used together.

If you have ever had hepatitis B, it may become active or worsen after you stop taking doravirine, lamivudine, and tenofovir. You may need to have liver function tests often for several months.

You should not use this medicine if you are allergic to doravirine, lamivudine, or tenofovir.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with doravirine, lamivudine, and tenofovir. 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 have ever had:

• hepatitis B;
• kidney disease; or
• bone problems (including a broken bone, or osteoporosis).

You may be more likely to have a broken bone while using doravirine, lamivudine, and tenofovir. Talk with your doctor about ways to keep your bones healthy.

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.

This medicine 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, lamivudine, and tenofovir may cause serious side effects. Call your doctor at once if you have:

• urinating more or less than usual;
• increased thirst;
• new or worsening bone pain;
• muscle pain or weakness; or
• pain in your arms, legs, hands, or feet.

Doravirine, lamivudine, and tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). 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, lamivudine, and tenofovir may include:

• nausea;
• dizziness; 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:

1 tablet orally once a dayUse: As a complete regimen, 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 the components of this drug

Usual Pediatric Dose for HIV Infection:

At least 35 kg: 1 tablet orally once a dayUse: As a complete regimen, 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 the components of this drug

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

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

Doravirine, lamivudine, and tenofovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

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, lamivudine, and tenofovir, 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?