Pronunciation:

dor-a-VIR-een, la-MIV-ue-deen, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Brand Names:

• Delstrigo

Dosage Forms:

• Tablet

Warnings:

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..

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Non-Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

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 combination will not cure or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and will also help your immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of doravirine, lamivudine, and tenofovir combination in children weighing less than 35 kilograms (kg). Safety and efficacy have not been established.

Older adults—

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 this medicine.

Breast-feeding—

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.

Other 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 this medicine, 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 this medicine 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.

• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Lumacaftor
• Mitotane
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine
• St John's Wort

Using this medicine 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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Bromfenac
• Bufexamac
• Cabotegravir
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Didanosine
• Diflunisal
• Dipyrone
• Droxicam
• Efavirenz
• Etodolac
• Etofenamate
• Etoricoxib
• Etravirine
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Horsetail
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Ketorolac
• Ledipasvir
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nevirapine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Rifabutin
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sorbitol
• Sulindac
• Tacrolimus
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using this medicine 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.

• Darunavir
• Lopinavir
• Nirmatrelvir
• Ritonavir
• Tipranavir

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (eg, osteoporosis, osteomalacia), 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 This Medicine:

Take this medicine 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.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Do not change or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

You may take this medicine with or without food.

Keep taking this medicine 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.

Dosing—

The dose of this medicine 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 this medicine. 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 and children weighing 35 kilograms (kg) or more—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 weighing less than 35 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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.

Storage—

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 This Medicine:

Your doctor will want to check your or your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine together with carbamazepine (Tegretol®), enzalutamide (Xtandi®), mitotane (Lysodren®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifampin (Rifadine®), rifapentine (Priftin®), or St John's wort. Tell your doctor if your have taken any of these medicines within the past 4 weeks before you start treatment with this medicine.

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.

This medicine may increase the risk of kidney problems (eg, acute kidney failure, Fanconi syndrome). To lower this risk, avoid other medicines that can be harmful to the kidneys including aminoglycoside antibiotics, certain other antiviral medicines, and NSAID pain medicines.

This medicine 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, autoimmune hepatitis, and Guillain-Barré syndrome) may also occur.

This medicine 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.

Side Effects of This Medicine:

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

Bloating

bloody urine

blurred vision

bone fractures, especially of the femur bone

chest tightness

chills

cloudy urine

constipation

cough

dark urine

decreased appetite

decreased frequency or amount of urine

diarrhea

difficult or labored breathing

difficulty swallowing

dizziness

dry mouth

fast heartbeat

fast, shallow breathing

fever

flushed, dry skin

fruit-like breath odor

general feeling of discomfort

hives, itching, skin rash

increased hunger

increased thirst

increased urination

indigestion

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

nausea

numbness or tingling in the hands, feet, or lips

pain

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

seizures

sleepiness

stomach pain or discomfort

swelling of the face, fingers, lower legs

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

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:

More common

Trouble sleeping

Less common

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.