Doravirine, Lamivudine, and Tenofovir

pronounced as (dor" a vir' een) (la mi' vyoo deen) (te noe' fo veer)

Brand Name(s): Delstrigo®

Why is this medicine prescribed?

The combination of doravirine, lamivudine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults who have not been treated with other HIV medications. The combination is also used to replace current medication therapy in certain people already taking HIV medications. Doravirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Lamivudine and tenofovir are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). The combination of doravirine, lamivudine, and tenofovir works by decreasing the amount of HIV in the body. Although the combination of doravirine, lamivudine, and tenofovir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there other uses for this medicine?

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

How should this medicine be used?

The combination of doravirine, lamivudine, and tenofovir comes as a table to take by mouth. It is usually taken with or without food once daily. Take doravirine, lamivudine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doravirine, lamivudine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The combination of doravirine, lamivudine, and tenofovir helps to control HIV infection but does not cure it. Continue to take doravirine, lamivudine, and tenofovir even if you feel well. Do not stop taking doravirine, lamivudine, and tenofovir without talking to your doctor. If you stop taking doravirine, lamivudine, and tenofovir or miss doses, your condition may become more difficult to treat. When your supply of doravirine, lamivudine, and tenofovir starts to run low, get more from your doctor or pharmacist.

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

What special precautions should I follow?

Before taking doravirine, lamivudine, and tenofovir,

  • tell your doctor and pharmacist if you are allergic to doravirine, lamivudine, and tenofovir, any other medications, or any of the ingredients in doravirine, lamivudine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), enzalutamide (Xtandi), mitotane (Lysodren), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rifapentine (Priftin), or St. John's wort. Your doctor will probably tell you not to take doravirine, lamivudine, and tenofovir if you are currently taking one or more of these medications or have taken one of them within the past 4 weeks.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acyclovir (Sitavig, Zovirax); aminoglycosides such as amikacin, gentamicin, streptomycin, and tobramycin; aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cidofovir; ganciclovir (Cytovene); ledipasvir/sofosbuvir (Harvoni); sofosbuvir/velpatasvir (Epculsa); sorbitol or medications that contain sorbitol; valacyclovir (Valtrex); and valganciclovir (Valcyte). Tell your doctor if are taking rifabutin (Mycobutin) or have taken it within the past 4 weeks. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with doravirine, lamivudine, and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section, or if you have or have ever had bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily), bone fractures, or kidney disease.
  • tell your doctor if you have or have ever had an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection); or an autoimmune disease (conditions that develop when the immune system attacks healthy cells in the body by mistake) such as Graves' disease (condition where the body attacks the thyroid gland causing it to be overactive), polymyositis (condition that causes muscle weakness but not skin rash), Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage), and autoimmune hepatitis (condition in which the cells of the immune system attack the liver).
  • tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking doravirine, lamivudine, and tenofovir, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking doravirine, lamivudine, and tenofovir.
  • you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with doravirine, lamivudine, and tenofovir be sure to tell your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

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.

What should I do in case of overdose?

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

What side effects can this medicine cause?

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

  • dizziness
  • nausea
  • abnormal dreams
  • difficulty falling asleep or staying asleep
  • drowsiness
  • diarrhea

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

  • decreased urination or swelling of legs
  • bone pain; pain in arms or legs; muscle pain or weakness; or bone fracture

Doravirine, lamivudine, and tenofovir 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 ( ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( ) for more information if you do not have access to a take-back program.

What other information should I know?

Keep a supply of doravirine, lamivudine, and tenofovir 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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