Abacavir, dolutegravir, and lamivudine is a combination medicine used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). abacavir, dolutegravir, and lamivudine is not a cure for HIV or AIDS.

Abacavir, dolutegravir, and lamivudine is for use in adults and children who weigh at least 22 pounds (10 kilograms).

Abacavir, dolutegravir, and lamivudine should not be used by itself in those who are resistant to certain types of medicine.

Abacavir, dolutegravir, and lamivudine may also be used for purposes not listed in this medication guide.

You should not take abacavir, dolutegravir, and lamivudine if you have ever had an allergic reaction to any medicine that contains abacavir, or if you have a gene variation called HLA-B*5701 allele. Also, you should not use this medicine if you have moderate or severe liver disease, or if you are also taking dofetilide (Tikosyn).

Stop using this medicine and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general ill feeling, extreme tiredness, body aches; shortness of breath, cough, sore throat.

If you've had hepatitis B, it may come back or get worse after you stop using abacavir, dolutegravir, and lamivudine. You may need frequent liver function tests for several months.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Triumeq tablets are not the same as Triumeq PD tablets for oral suspension and should not be substituted for each other. Make sure you receive the correct dosage form each time your prescription is filled to avoid using the wrong medicine.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Do not swallow, cut, crush, or chew a dispersible tablet. Dissolve the tablet in a small amount of water. Stir and drink this mixture right away.

You may take abacavir, dolutegravir, and lamivudine with or without food.

Abacavir, dolutegravir, and lamivudine comes with a Medication Guide and a Warning Card listing symptoms of an allergic reaction. Read this information and learn what symptoms to watch for. Keep the Wallet Card with you at all times.

You may need to take an extra daily dose of dolutegravir (Tivicay) if you take abacavir, dolutegravir, and lamivudine with certain other medicines.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you've had hepatitis B, it may come back or get worse after you stop using abacavir, dolutegravir, and lamivudine. You may need frequent liver function tests for several months.

Usual Adult Dose for HIV Infection:

Tablets: 1 tablet orally once a day

Comments:
-The tablets for oral suspension must not be used in adults.

Usual Pediatric Dose for HIV Infection:

Tablets for Oral Suspension:
-Weight 10 to less than 14 kg: 4 tablets orally once a day
-Weight 14 to less than 20 kg: 5 tablets orally once a day
-Weight 20 to less than 25 kg: 6 tablets orally once a day

Tablets:
-At least 25 kg: 1 tablet orally once a day

Comments:
-The tablets are not recommended for patients weighing less than 25 kg.
-The tablets for oral suspension are not recommended for patients weighing at least 25 kg.

Use: For the treatment of HIV-1 infection

You should not use abacavir, dolutegravir, and lamivudine if you are allergic to abacavir, dolutegravir, or lamivudine, or if:

• you also take dofetilide (Tikosyn);

• you have moderate or severe liver disease;

• you have a gene variation called HLA-B*5701 allele (your doctor will test you for this); or

• you have a history of allergic reaction to Combivir, Dutrebis, Epivir, Epzicom, Tivicay, Trizivir, or Ziagen.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• heart problems or risk factors such as diabetes, smoking, high blood pressure, high cholesterol; or

• kidney disease.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting this treatment.

Abacavir, dolutegravir, and lamivudine may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely. If you miss several doses, you may have a dangerous or even fatal allergic reaction once you start taking this medication again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with medication to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Using abacavir, dolutegravir, and lamivudine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

• Group 1 - fever;

• Group 2 - rash;

• Group 3 - nausea, vomiting, diarrhea, stomach pain;

• Group 4 - general ill feeling, extreme tiredness, body aches;

• Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to a medicine that contains abacavir or dolutegravir, you must never use it again. If you stop taking abacavir, dolutegravir, and lamivudine for any reason, talk to your doctor before you start taking it again.

Abacavir, dolutegravir, and lamivudine may cause serious side effects. Call your doctor at once if you have:

• other signs of allergic reaction--skin blisters or peeling, eye redness, swelling in your face or throat, trouble breathing;

• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Abacavir, dolutegravir, and lamivudine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of abacavir, dolutegravir, and lamivudine may include:

• headache;

• tiredness; or

• trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Some medicines can make abacavir, dolutegravir, and lamivudine much less effective when taken at the same time. If you take any of the following medicines, take your abacavir, dolutegravir, and lamivudine dose 2 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain aluminum or magnesium (Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, and others);

• the ulcer medicine sucralfate (Carafate);

• buffered medicine; or

• vitamin or mineral supplements that contain calcium or iron (can be taken at the same time with abacavir, dolutegravir, and lamivudine if you take with food).

Many drugs can affect abacavir, dolutegravir, and lamivudine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of abacavir, dolutegravir, and lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.