Pronunciation:

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

Brand Names:

• Triumeq

Dosage Forms:

• Tablet
• Tablet for Suspension

Warnings:

Hypersensitivity ReactionsSerious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of the abacavir, dolutegravir, and lamivudine combination. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele.The abacavir, dolutegravir, and lamivudine combination is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir, dolutegravir, and lamivudine or reinitiation of therapy with abacavir, dolutegravir, and lamivudine, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir, dolutegravir, and lamivudine combination immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible.Following a hypersensitivity reaction to abacavir, dolutegravir, and lamivudine combination, never restart abacavir, dolutegravir, and lamivudine or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.Exacerbations of Hepatitis BAll patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating abacavir, dolutegravir, and lamivudine combination. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If abacavir, dolutegravir, and lamivudine combination is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate chronic HBV; otherwise, consider an alternative regime.Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued lamivudine, a component of abacavir, dolutegravir, and lamivudine combination. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

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. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. Abacavir, dolutegravir, and lamivudine combination will not keep you from spreading HIV to other people.

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 abacavir, dolutegravir, and lamivudine combination in children younger than 3 months of age and weighing less than 6 kilograms (kg). Safety and efficacy have not been established.

Older adults—

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.

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.

• Dofetilide

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.

• Abametapir
• Aluminum
• Amprenavir
• Cabotegravir
• Calcium
• Carbamazepine
• Dabrafenib
• Dalfampridine
• Dasabuvir
• Efavirenz
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Horsetail
• Iron
• Itraconazole
• Levoketoconazole
• Magaldrate
• Magnesium
• Mavacamten
• Metformin
• Methotrexate
• Nevirapine
• Omaveloxolone
• Orlistat
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Primidone
• Ribavirin
• Rifampin
• Sorbitol
• St John's Wort
• Sucralfate
• Tacrolimus
• Tipranavir
• Zinc

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.

• Methadone
• Riociguat
• 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:

• 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 This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not change the dose, switch medicines, 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.

Abacavir, dolutegravir, and lamivudine combination contains a fixed amount of each medicine in the tablet and the tablet for suspension (oral liquid). Do not substitute these dosage forms for each other. Always check your medicine each time your prescription is filled to make sure you receive the correct dosage form.

This medicine should come with a Medication Guide and instructions for use. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keep taking this medicine for the full time of treatment, even if you begin to feel better. It is also important to take this medicine 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.

You may take this medicine with or without food.

Swallow the tablet whole. Do not chew, cut, or crush it.

To use the oral liquid:

• Mix the tablet for suspension with 20 milliliters (mL) of drinking water (for 4, 5, or 6 tablets) or 15 mL (for 3 tablets) in the supplied cup. Use drinking water only. Do not mix this medicine with any other drink or food.
• If your child cannot use the supplied cup, you may use an oral syringe to give the medicine.
• Swirl the cup gently for 1 to 2 minutes to dissolve the tablet. The medicine will become cloudy. Swirl the cup again to make sure there are no lumps of the tablet remain.
• Swallow the liquid within 30 minutes of mixing. If the medicine has not been taken after 30 minutes, wash away all the liquid in the cup with water and prepare a new dose.
• You may add another 15 mL or less of drinking water to the cup to make sure your child gets the full dose.
• Do not chew, cut, or crush the tablet for suspension.

Take this medicine 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 this medicine if you take them with food. If not, take this medicine 2 hours before or 6 hours after you take these supplements.

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 HIV infection:
  • For oral dosage form (tablets):
    • Adults and children weighing 25 kilograms (kg) or more—One tablet once a day. Each tablet contains 600 milligrams (mg) abacavir, 50 mg dolutegravir, and 300 mg lamivudine.
    • Children weighing less than 25 kg—Use of tablets for suspension is recommended.
  • For oral dosage form (tablets for suspension):
    • Children 3 months of age and older weighing less than 25 kg—Dose is base on body weight and must be determined by your doctor. Each tablet contains 60 milligrams (mg) abacavir, 5 mg dolutegravir, and 30 mg lamivudine.
      • Weighing 20 kg to less than 25 kg—6 tablets (360 mg abacavir, 30 mg dolutegravir, and 180 mg lamivudine) once a day. If you are taking this medicine together with carbamazepine, efavirenz, fosamprenavir/ritonavir, rifampin, or tipranavir/ritonavir, you will need to take another 30 mg of Tivicay® 12 hours after taking this medicine.
      • Weighing 14 kg to less than 20 kg—5 tablets (300 mg abacavir, 25 mg dolutegravir, and 150 mg lamivudine) once a day. If you are taking this medicine together with carbamazepine, efavirenz, fosamprenavir/ritonavir, rifampin, or tipranavir/ritonavir, you will need to take another 25 mg of Tivicay® 12 hours after taking this medicine.
      • Weighing 10 kg to less than 14 kg—4 tablets (240 mg abacavir, 20 mg dolutegravir, and 120 mg lamivudine) once a day. If you are taking this medicine together with carbamazepine, efavirenz, fosamprenavir/ritonavir, rifampin, or tipranavir/ritonavir, you will need to take another 20 mg of Tivicay® 12 hours after taking this medicine.
      • Weighing 6 kg to less than 10 kg—3 tablets (180 mg abacavir, 15 mg dolutegravir, and 90 mg lamivudine) once a day. If you are taking this medicine together with carbamazepine, efavirenz, fosamprenavir/ritonavir, rifampin, or tipranavir/ritonavir, you will need to take another 15 mg of Tivicay® 12 hours after taking this medicine.
    • Children younger than 3 months of age weighing less than 6 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.

Store the medicine in its original bottle. Keep it tightly closed and protect from moisture.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You should not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first 12 weeks of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious allergic reactions may occur while taking this medicine. These usually occur within 6 weeks after the medicine is started, but may occur at any time. Check with your doctor right away if you or your child have 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 this medicine, 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 this medicine 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 this medicine 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 dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notices any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine 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.

This medicine may increase your risk of having a heart attack. This is more likely if you smoke regularly or if you have diabetes, heart disease, high blood pressure, or high cholesterol. Call your doctor right away if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, nausea, sweating, or vomiting.

This medicine 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. This medicine 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.

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:

Less common

Changes in weight

dark or bloody urine

decreased frequency or amount of urine

fever

increased blood pressure

increased thirst

itching skin

light-colored stools

loss of appetite

lower back or side pain

nausea

stomach discomfort, upset, or pain

swelling of the face, fingers, or lower legs

trouble breathing

unusual drowsiness, dullness, or feeling of sluggishness

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

yellow eyes and skin

Rare

Rash

Incidence not known

Blistering, peeling, or loosening of the skin

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

chest tightness

chills

confusion

cough

decreased appetite

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

general feeling of discomfort or illness

headache

hives

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

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 or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

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

Belching

discouragement

excess air or gas in the stomach or bowels

feeling sad or empty

full or bloated feeling

heartburn

indigestion

irritability

loss of interest or pleasure

passing gas

pressure in the stomach

swelling of the stomach area

thoughts or attempts of killing oneself

trouble concentrating

trouble sleeping

Rare

Abnormal dreams

Incidence not known

Anxiety

loss or 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.