The combination of doravirine, lamivudine, and tenofovir disoproxil fumarate (DF) 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 DF. If you have HBV and you take doravirine, lamivudine, and tenofovir DF, your condition may suddenly worsen when you stop taking doravirine, lamivudine, and tenofovir DF. Your doctor will examine you and order lab tests regularly for several months after you stop taking doravirine, lamivudine, and tenofovir DF.
Keep all appointments with your doctor and the laboratory. Your doctor will examine you and order lab tests before and during your treatment to check your body's response to doravirine, lamivudine, and tenofovir.
Talk to your doctor about the risk(s) of taking doravirine, lamivudine, and tenofovir.
Why is this medicine prescribed?
The combination of doravirine, lamivudine, and tenofovir DF is used to treat human immunodeficiency virus (HIV) infection. Doravirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Lamivudine and tenofovir DF are in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). The combination of doravirine, lamivudine, and tenofovir DF works by decreasing the amount of HIV in the body.
Although the combination of doravirine, lamivudine, and tenofovir DF 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.
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 DF comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take doravirine, lamivudine, and tenofovir DF at around the same time every day.
Take doravirine, lamivudine, and tenofovir DF 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, lamivudine, and tenofovir DF even if you feel well. Do not stop taking doravirine, lamivudine, and tenofovir DF without talking to your doctor. If you stop taking doravirine, lamivudine, and tenofovir DF 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.
What special precautions should I follow?
Before taking doravirine, lamivudine, and tenofovir DF,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- some medications should not be taken with doravirine, lamivudine, and tenofovir DF. Other medications may require dosing changes or extra monitoring when taken with doravirine, lamivudine, and tenofovir DF. Make sure you have discussed any medications you are currently taking or plan to take before starting doravirine, lamivudine, and tenofovir DF with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking doravirine, lamivudine, and tenofovir DF, please get the advice of your doctor or pharmacist.
- the following nonprescription or herbal products may interact with doravirine, lamivudine, and tenofovir DF: 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 DF 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 or plan to breastfeed. 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.
- 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 DF 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 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.
What side effects can this medicine cause?
Doravirine, lamivudine, and tenofovir DF 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, legs, hands, or feet; muscle pain or weakness; or bone fracture
- painful rash, fever, blisters or sores in the mouth, blisters or peeling of the skin, or redness or swelling of the eyes
Doravirine, lamivudine, and tenofovir DF 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).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.
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.
What other information should I know?
Keep a supply of doravirine, lamivudine, and tenofovir DF 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.