doravirine, lamivudine, and tenofovir

What is the most important information I should know about doravirine, lamivudine, and tenofovir?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You may need frequent liver function tests for several months.

What is doravirine, lamivudine, and tenofovir?

Doravirine, lamivudine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

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

Doravirine, lamivudine, and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking doravirine, lamivudine, and 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.

How should I take doravirine, lamivudine, and tenofovir?

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 this medicine. You may also need bone mineral density testing.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking doravirine, lamivudine, and tenofovir?

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

What are the possible side effects of doravirine, lamivudine, and tenofovir?

• 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 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.

What other drugs will affect doravirine, lamivudine, and tenofovir?

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

Where can I get more information?

Your pharmacist can provide more information about doravirine, lamivudine, and tenofovir.