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abacavir, dolutegravir, and lamivudine (Oral route)

a-BAK-a-vir, doe-loo-TEG-ra-vir, la-MIV-ue-deen

Oral route(Tablet)

Serious and fatal hypersensitivity reactions have been reported with abacavir; discontinue if hypersensitivity reaction suspected; never restart an abacavir-containing product after hypersensitivity reaction as potentially fatal reactions may recur within hours. Patients with HLA-B*5701 allele have a higher risk for abacavir-related hypersensitivity; screening for allele is recommended prior to initiating or reinitiation of therapy unless previous allele assessment is documented. Use is contraindicated in those with the HLA-B*5701 allele or with a previous hypersensitivity reaction to abacavir. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogues, including abacavir and lamivudine alone or in combination with other antiretrovirals. Discontinue if these conditions are suspected. Severe acute exacerbations of hepatitis B have been reported in patients co-infected with HBV and HIV-1 who have discontinued lamivudine; monitor hepatic function closely for several months upon discontinuation of therapy; initiation of anti-HBV therapy may be needed .

Commonly used brand name(s)

In the U.S.

  • Triumeq

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For abacavir, dolutegravir, and lamivudine

Abacavir, dolutegravir, and lamivudine combination is used for the treatment of the infection caused by human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir, dolutegravir, and lamivudine combination will not cure or prevent HIV infection or AIDS; however, 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. Abacavir, dolutegravir, and lamivudine combination will not keep you from spreading HIV to other people. People who receive abacavir, dolutegravir, and lamivudine may continue to have some of the problems usually related to AIDS or HIV disease.

abacavir, dolutegravir, and lamivudine is available only with your doctor's prescription.

Before Using abacavir, dolutegravir, and lamivudine

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 abacavir, dolutegravir, and lamivudine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abacavir, dolutegravir, and lamivudine 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of abacavir, dolutegravir, and lamivudine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of abacavir, dolutegravir, and lamivudine combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving abacavir, dolutegravir, and lamivudine combination.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

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 abacavir, dolutegravir, and lamivudine, 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 abacavir, dolutegravir, and lamivudine 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.

  • Dofetilide

Using abacavir, dolutegravir, and lamivudine 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.

  • Amprenavir
  • Carbamazepine
  • Dabrafenib
  • Dasabuvir
  • Efavirenz
  • Enzalutamide
  • Eslicarbazepine Acetate
  • Etravirine
  • Fosamprenavir
  • Fosphenytoin
  • Metformin
  • Nevirapine
  • Orlistat
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Ribavirin
  • Rifampin
  • Rifapentine
  • St John's Wort
  • Tipranavir

Using abacavir, dolutegravir, and lamivudine 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.

  • Aluminum
  • Calcium
  • Iron
  • Magaldrate
  • Magnesium
  • Methadone
  • Sucralfate
  • Tipranavir
  • Zinc

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 abacavir, dolutegravir, and lamivudine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Heart disease or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Hypertension (high blood pressure)—May increase risk for heart attack.
  • Genetic condition (eg, gene variation called HLA-B*5701)—This condition may increase the risk for serious and life-threatening side effects.
  • Hepatitis B or C, or history of—Use with caution. May make this condition worse.
  • Kidney disease or
  • Liver disease, mild—Use is not recommended in patients with these conditions.
  • Liver disease, moderate or severe—Should not be used in patients with these conditions.

Proper Use of abacavir, dolutegravir, and lamivudine

Take abacavir, dolutegravir, and lamivudine 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. Also, do not change the dose or stop taking abacavir, dolutegravir, and lamivudine without checking first with your doctor. When your supply of abacavir, dolutegravir, and lamivudine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of abacavir, dolutegravir, and lamivudine.

abacavir, dolutegravir, and lamivudine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keep taking Triumeq® for the full time of treatment, even if you begin to feel better. It is also important to take abacavir, dolutegravir, and lamivudine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

Abacavir, dolutegravir, and lamivudine combination contains a fixed amount of each medicine in the tablet.

Take Triumeq® at least 2 hours before or 6 hours after you take sucralfate, an antacid or laxative that contains aluminum, calcium, or magnesium, or a buffered medicine. You may take calcium or iron supplements together with abacavir, dolutegravir, and lamivudine if you take them with food. If not, take Triumeq® 2 hours before or 6 hours after you take these supplements.

Dosing

The dose of abacavir, dolutegravir, and lamivudine 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 abacavir, dolutegravir, and lamivudine. 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 HIV infection:
      • Adults—600 milligrams (mg) of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine (equal to one tablet) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of abacavir, dolutegravir, and lamivudine, 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.

If it is less than 4 hours until your next dose, skip the missed dose and just take your regular dose at that time. Do not take extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using abacavir, dolutegravir, and lamivudine

It is very important that your doctor check your progress at regular visits to make sure abacavir, dolutegravir, and lamivudine is working properly. Blood tests may be needed to check for unwanted effects.

You should not use abacavir, dolutegravir, and lamivudine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

Serious allergic reactions may occur while taking abacavir, dolutegravir, and lamivudine. This reaction usually occurs within 6 weeks after the medicine is started, but may occur at any time. Check with your doctor right away if you have the following symptoms: a severe rash or rash with fever, blistering or peeling skin, diarrhea, nausea, vomiting, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

When you begin taking abacavir, dolutegravir, and lamivudine, you will be given a warning card which describes symptoms of severe allergic reactions that may be caused by Triumeq®. The warning card also provides information about how to treat these allergic reactions. For your safety, you should carry the warning card with you at all times.

If you must stop using abacavir, dolutegravir, and lamivudine because of an allergic reaction, you should never use the medicine again. Return the unused medicine to your doctor or pharmacist. A worse reaction, possibly even death, can occur if you use the medicine again. Tell your doctor right away if you have ever taken abacavir, especially if you have experienced an allergic reaction to it in the past.

Two rare but serious reactions to abacavir, dolutegravir, and lamivudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Tell your doctor right away if you notice any changes in your health.

abacavir, dolutegravir, and lamivudine may cause you to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

abacavir, dolutegravir, and lamivudine may increase your risk of having a heart attack. Symptoms include: chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, shortness of breath, nausea, sweating, or vomiting.

abacavir, dolutegravir, and lamivudine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. abacavir, dolutegravir, and lamivudine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

abacavir, dolutegravir, and lamivudine 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:

Less common or rare
  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • nausea and vomiting
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Incidence not known
  • Abdominal or stomach pain or discomfort
  • blistering, peeling, or loosening of the skin
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • chills
  • confusion
  • cough
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • discharge or excessive tearing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort or illness
  • headache
  • hives, itching, or rash
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • lower back or side pain
  • muscle pain, cramping, or stiffness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • red, irritated eyes
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • sweating
  • swelling of the face, fingers, lower legs
  • swelling or puffiness of the face
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • weight gain

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:

Less common
  • Discouragement
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
Less common or rare
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • full or bloated feeling
  • heartburn
  • indigestion
  • passing gas
  • pressure in the stomach
  • sleepiness or unusual drowsiness
  • stomach upset
  • swelling of the abdominal or stomach area
  • weight loss
Incidence not known
  • Hair loss
  • thinning of the hair
  • weight gain around your neck, upper back, breast, or waist

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.

See also: Side effects (in more detail)

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