Doravirine, lamivudine, and tenofovir (Oral)
Generic Name: doravirine/lamivudine/tenofovir (dor-a-VIR-een, la-MIV-ue-deen, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)
Warning: Posttreatment Acute Exacerbations of Hepatitis BSevere acute exacerbations of hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir disoproxil fumarate (TDF), two of the components of doravirine/lamivudine/tenofovir disoproxil fumarate oral tablets. Closely monitor hepatic function in these patients. If appropriate, initiation of antihepatitis B therapy may be warranted..
Medically reviewed by Drugs.com. Last updated on Feb 17, 2021.
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor
Uses for doravirine, lamivudine, and tenofovir
Doravirine, lamivudine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection in patients who have not been treated with antiviral medicines before, or in patients to replace their current HIV-1 medicines who have met certain doctor's requirements. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Doravirine, lamivudine, and tenofovir does not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive doravirine, lamivudine, and tenofovir may continue to have other problems usually related to AIDS or HIV disease.
Doravirine, lamivudine, and tenofovir is available only with your doctor's prescription.
Before using doravirine, lamivudine, and tenofovir
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For doravirine, lamivudine, and tenofovir, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to doravirine, lamivudine, and tenofovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of doravirine, lamivudine, and tenofovir combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of doravirine, lamivudine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving doravirine, lamivudine, and tenofovir combination.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking doravirine, lamivudine, and tenofovir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using doravirine, lamivudine, and tenofovir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- St John's Wort
Using doravirine, lamivudine, and tenofovir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Choline Salicylate
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
Using doravirine, lamivudine, and tenofovir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with food/tobacco/alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of doravirine, lamivudine, and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:
- Bone problems (eg, osteoporosis), history of or
- Hepatitis B infection, history of—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe—Use is not recommended in patients with this condition.
Proper use of doravirine, lamivudine, and tenofovir
Take doravirine, lamivudine, and tenofovir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Doravirine, lamivudine, and tenofovir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Do not stop using doravirine, lamivudine, and tenofovir without checking first with your doctor. When your supply of doravirine, lamivudine, and tenofovir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of doravirine, lamivudine, and tenofovir.
Take doravirine, lamivudine, and tenofovir with or without food.
Keep taking doravirine, lamivudine, and tenofovir for the full time of treatment even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.
If you are also using rifabutin, take doravirine/lamivudine/tenofovir once a day, followed by doravirine (Pifeltro™) after about 12 hours.
The dose of doravirine, lamivudine, and tenofovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of doravirine, lamivudine, and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of HIV infection:
- Adults—1 tablet once a day. Each tablet contains 100 milligrams (mg) of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate.
- Children—Use and dose must be determined by your doctor.
- For treatment of HIV infection:
If you miss a dose of doravirine, lamivudine, and tenofovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the bottle tightly closed. Keep the medicine in its original bottle.
Precautions while using doravirine, lamivudine, and tenofovir
It is very important that your doctor check your progress at regular visits to make sure doravirine, lamivudine, and tenofovir is working properly. Blood and urine tests may be needed to check for any unwanted effects.
Do not use doravirine, lamivudine, and tenofovir together with carbamazepine (Tegretol®), enzalutamide (Xtandi®), mitotane (Lysodren®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifampin (Rifadine®), rifapentine (Priftin®), or St. John's wort.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Doravirine, lamivudine, and tenofovir may increase the risk of kidney problems. To lower this risk, avoid other medicines that can be harmful to the kidneys such as aminoglycoside antibiotics, certain other antiviral medicines, and NSAID pain medicines.
Doravirine, lamivudine, and tenofovir may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
Doravirine, lamivudine, and tenofovir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Doravirine, lamivudine, and tenofovir side effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- bloody urine
- blurred vision
- bone fractures, especially of the femur bone
- cloudy urine
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- difficult or labored breathing
- difficulty swallowing
- dry mouth
- fast heartbeat
- fast, shallow breathing
- flushed, dry skin
- fruit-like breath odor
- general feeling of discomfort
- hives, itching, skin rash
- increased hunger
- increased thirst
- increased urination
- irregular heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- loss of appetite
- lower back or side pain
- mood changes
- muscle cramps, spasms, pain, or stiffness
- numbness or tingling in the hands, feet, or lips
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain or discomfort
- swelling of the face, fingers, lower legs
- tightness in the chest
- troubled breathing
- troubled breathing with exertion
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- weight gain
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Trouble sleeping
- Abnormal dreams
Incidence not known
- Accumulation of body fat
- lack or loss of strength
- thinning or loss of hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Frequently asked questions
More about doravirine / lamivudine / tenofovir
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- During Pregnancy
- Dosage Information
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- Drug class: antiviral combinations
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