Doravirine and Islatravir

Doravirine and islatravir is used to treat human immunodeficiency virus (HIV) infection. Doravirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Islatravir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). The combination of doravirine and islatravir works by decreasing the amount of HIV in the body.

Although the combination of doravirine and islatravir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications along and making other lifestyle changes may decrease the risk of giving the HIV virus to other people.

Doravirine and islatravir comes as a tablet ot take by mouth. Take once a day with or without food. Take doravirine and islatravir at around the same time every day.

Take doravirine and islatravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take doravirine and islatravir even if you feel well. Do not stop taking doravirine and islatravir without talking to your doctor. If you stop taking doravirine and islatravir or miss doses, your condition may become more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking doravirine and islatravir,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with doravirine and islatravir. Other medications may cause dosing changes or extra monitoring when taken with doravirine and islatravir. Make sure you have discussed any medications you are currently taking or plan to take before starting doravirine and islatravir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking doravirine and islatravir, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with doravirine and islatravir: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking doravirine and islatravir. Do not start any of these medications while taking doravirine and islatravir without discussing with your healthcare provider.
• tell your doctor if you have or have ever had hepatitis B virus infection (HBV; an ongoing liver infection) or kidney or liver problems.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking doravirine and islatravir, call your doctor.
• tell your doctor if you are breast-feeding or plan to breast-feed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking doravirine and islatravir.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Doravirine and islatravir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• bloating
• dizziness
• unusual tiredness
• headache
• weight gain

Some side effects can be serious. If you experience any of these symptoms, stop taking doravirine and islatravir and call your doctor immediately or get emergency medical treatment:

• rash
• painful rash with fever, swollen glands, tiredness, feeling unwell, swelling of the face, blisters or sores in the mouth, blisters or peeling of the skin, or redness or swelling of the eyes

Doravirine and islatravir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to doravirine and islatravir.

Keep a supply of doravirine and islatravir on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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