Doravirine, Lamivudine, and Tenofovir

The combination of doravirine, lamivudine, and tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with doravirine, lamivudine, and tenofovir. If you have HBV and you take doravirine, lamivudine, and tenofovir, your condition may suddenly worsen when you stop taking doravirine, lamivudine, and tenofovir.

Keep all appointments with your doctor and the laboratory. Your doctor will examine you and order lab tests before, during, and regularly for several months after you stop taking doravirine, lamivudine, and tenofovir.

Talk to your doctor about the risk(s) of taking doravirine, lamivudine, and tenofovir.

The combination of doravirine, lamivudine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults and children weighing more than 77 pounds (35 kg) who have not been treated with other HIV medications. The combination is also used to replace current medication therapy in certain adults and children weighing more than 77 pounds (35 kg) 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.

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.

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

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.
• Some medications should not be taken with doravirine, lamivudine, and tenofovir. Make sure you have discussed any medications you are currently taking or plan to take before starting doravirine, lamivudine, and tenofovir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking doravirine, lamivudine, and tenofovir, please get the advice of your doctor or pharmacist.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with doravirine, lamivudine, and tenofovir: St. John's Wort or aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking doravirine, lamivudine, and tenofovir. Do not start these medications while taking doravirine, lamivudine, and tenofovir without discussing it with your healthcare provider.
• 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) or bone fractures; 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); 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), or autoimmune hepatitis (condition in which the cells of the immune system attack the liver); or kidney disease.
• 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.

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

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, 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
• headache

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 (http://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.

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. http://www.upandaway.org

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 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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