Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate Tablets

What is this medication?

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (door ah VIR een; la ME vyoo deen; te NOE fo veer) helps manage the symptoms of HIV infection. It works by limiting the spread of HIV in the body. It is a combination of three antiretroviral medications. This medication is not a cure for HIV or AIDS and it may still be possible to spread HIV to others while taking it. It does not prevent other sexually transmitted infections (STIs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): DELSTRIGO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone problems
• Hepatitis B infection
• Kidney disease
• Liver disease
• An unusual or allergic reaction to doravirine, lamivudine, tenofovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Any medication that contains efavirenz, etravirine, or nevirapine
• Apalutamide
• Certain antibiotics, such as rifapentine, rifampin
• Enzalutamide
• Medications for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone
• Mitotane
• St. John's wort

This medication may also interact with the following:

• Aminoglycosides
• Medications for viral infections, such as adefovir, ledipasvir; sofosbuvir, sofosbuvir; velpatasvir, ribavirin, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen
• Other medications for HIV
• Rifabutin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms get worse or if you have new symptoms.

You may need blood work done while you are taking this medication.

If you have hepatitis B, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Nausea
• Trouble sleeping
• Vivid dreams or nightmares

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.