How does this medication work? What will it do for me?

Doravirine-lamivudine-tenofovir disoproxil is a combination medication used to treat human immunodeficiency virus (HIV) infection and help prevent the human immunodeficiency virus (HIV) from reproducing.

HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections. Doravirine-lamivudine-tenofovir reduces the amount of HIV in the blood and increases CD4 (T) cell counts.

Lamivudine and tenofovir belong to a class of medications known as nucleoside reverse transcriptase inhibitors (NRTI). Reverse transcriptase is an enzyme that is needed by HIV for reproduction. Lamivudine and tenofovir block the action of this enzyme. Doravirine belongs to a class of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTI). It also blocks the action of this enzyme, but works at a different site from the other medications.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each yellow, oval-shaped, film-coated tablet, debossed with the corporate logo and "776" on one side and plain on the other side contains 100 mg of doravirine, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil). Nonmedicinal ingredients: carnauba wax, colloidal silicon dioxide, croscarmalose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate.

How should I use this medication?

The recommended dose of doravirine-lamivudine-tenofovir for adults and adolescents 12 years of age and above, who weigh at least 35 kg, is 1 tablet taken by mouth, once daily. It may be taken with food or on an empty stomach.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to doravirine, lamivudine, tenofovir, or any ingredients of the medication
  • are taking any of the following medications:
    • carbamazepine
    • enzalutamide
    • mitotane
    • oxcarbazepine
    • phenobarbital
    • phenytoin
    • rifampin
    • rifapentine
    • St. John's wort

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • dizziness
  • headache
  • nausea
  • nightmares
  • sleepiness
  • tiredness
  • trouble sleeping
  • unusual dreams
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bone pain or fractures
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)
  • signs of liver problems (hepatitis flare up; fatty and swollen liver; e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of autoimmune disease (e.g., high temperature, redness, rash, swelling, fatigue, joint or muscle pain, numbness or weakness in the hands and feet, rapid or pounding heart beat)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of lactic acidosis (e.g., weight loss, fatigue, nausea, vomiting, abdominal pain, shortness of breath, generally feeling unwell)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bone loss/osteoporosis: This medication may cause increased breakdown of bone by the body. If this happens, bones lose strength and bone fractures may occur. If you have osteoporosis or bone loss, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Cholesterol levels: The amount of cholesterol in the body may increase as a result of taking this medication. If you are currently taking medications for high blood cholesterol or are at risk of developing high cholesterol, discuss with your doctor whether any special monitoring is needed.

Diabetes: This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

Drowsiness/reduced alertness: Doravirine-lamivudine-tenofovir may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Hepatitis B and C: Certain medications used to treat hepatitis B and hepatitis C can cause an increase in the severe side effects of tenofovir. If you are taking other anti-viral medications, talk to your doctor or pharmacist to ensure you are not receiving two medications that will cause dangerous interactions.

People who have hepatitis B and hepatitis C are at an increased risk of experiencing a flare-up of liver symptoms caused by these infections. Serious flare-ups of chronic hepatitis B have also been reported by people who have stopped taking this medication.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes or tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: People taking tenofovir have reported decreased kidney function, including kidney failure and severe kidney damage. Decreased kidney function or kidney disease may cause this medication to build up in the body causing side effects. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acid and enlarged liver: Lamivudine can cause a rare, but serious condition called lactic acidosis (build-up of lactic acid in the blood) together with an enlarged liver. If you experience weight loss, fatigue, nausea, vomiting, abdominal pain, shortness of breath, generally feeling unwell, weakness, or diarrhea, contact your doctor immediately. Your doctor will monitor your liver function periodically by ordering laboratory tests.

Liver function: If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Other HIV medications: Doravirine-lamivudine-tenofovir is a combination medication that should not be taken at the same time as any other medication that contains the same active ingredients. This medication should also not be taken at the same time as medications containing lamivudine or adefovir.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Lamivudine and tenofovir pass into breast milk. It is not known if doravirine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children younger than 12 years of age or weighing less than 35 kg.

Seniors: Seniors may be more at risk of side effects from doravirine-lamivudine-tenofovir due to age-related decreases in kidney function.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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