Delstrigo

Delstrigo contains a combination of doravirine, lamivudine and tenofovir disoproxil fumarate. Doravirine, lamivudine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus - 1 (HIV-1), the virus that causes acquired immunodeficiency syndrome (AIDS), from multiplying in your body.

Delstrigo may be used to treat HIV-1 infection in adults and pediatric patients weighing at least 35 kg:

• with no antiretroviral treatment history, OR
• to replace their current antiretroviral regimen as long as certain criteria are met.

Delstrigo is not a cure for HIV or AIDS.

Take Delstrigo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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 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.

Store Delstrigo 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 your current medicines and any you start or stop using. Many drugs can interact with Delstrigo, 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.

You should not use Delstrigo 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 Delstrigo. 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.

To make sure Delstrigo is safe for you, 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 Delstrigo. 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.

Talk with your doctor about the risks to your baby from breastfeeding during treatment with Delstrigo. The HIV virus may pass to your baby if they do not have it, or become harder to treat if they do, and your baby may get side effects from this medicine.

Delstrigo is not approved for use by anyone who weighs less than 35kg (77 pounds).

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

Stop taking Delstrigo and get medical help right away if you develop a painful rash with any of the following symptoms: fever, blisters or peeling of the skin, feeling tired or generally ill, blisters or sores in the mouth, swelling of the face or lymph nodes, or redness or swelling of the eyes.

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 affect 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 Delstrigo 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.

Usual Adult and Pediatric (over 35 kg) Dosage for HIV-1 Infection:

1 tablet orally once a day Use: As a complete regimen, for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or who met certain criteria for changing from another antiretroviral regimen.

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.

Delstrigo 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 interact with doravirine, lamivudine, and tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredients: doravirine (100mg), lamivudine (300mg), and TDF (300mg equivalent to 245 mg of tenofovir disoproxil).

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. The film coating contains hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin. The coated tablets are polished with carnauba wax.

Merck Sharp & Dohme LLC.

• What drugs are contained in the HIV treatment Delstrigo?