Dolutegravir

What it is used for

TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations.

See full prescribing information for TIVICAY (dolutegravir). TRIUMEQ and TRIUMEQ PD are a combination of dolutegravir (integrase strand transfer inhibitor [INSTI]), abacavir, and lamivudine (both nucleoside analogue reverse transcriptase inhibitors) indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg.

Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See the dolutegravir prescribing information.

The most important thing to know

TRIUMEQ and TRIUMEQ PD can cause serious side effects, including: Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with TRIUMEQ or TRIUMEQ PD and other abacavir-containing products. Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called HLA‑B*5701.

Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking TRIUMEQ or TRIUMEQ PD, call your healthcare provider right away to find out if you should stop taking TRIUMEQ or TRIUMEQ PD. Symptom(s) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you.

Carry this Warning Card with you at all times. If you stop TRIUMEQ or TRIUMEQ PD because of an allergic reaction, never take TRIUMEQ, TRIUMEQ PD (abacavir, dolutegravir and lamivudine), or any other medicine that contains abacavir or dolutegravir (DOVATO, EPZICOM, JULUCA, TIVICAY, TIVICAY PD, TRIZIVIR, or ZIAGEN) again.

If you have an allergic reaction, dispose of any unused TRIUMEQ or TRIUMEQ PD. Ask your pharmacist how to properly dispose of medicines. If you take TRIUMEQ, TRIUMEQ PD or any other abacavir‑containing medicine again after you have had an allergic reaction, within hours you may get life‑threatening symptoms that may include very low blood pressure or death.

If you stop TRIUMEQ or TRIUMEQ PD for any other reason, even for a few days, and you are not allergic to TRIUMEQ or TRIUMEQ PD, talk with your healthcare provider before taking it again. Taking TRIUMEQ or TRIUMEQ PD again can cause a serious allergic or life‑threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take TRIUMEQ or TRIUMEQ PD again, start taking it when you are around medical help or people who can call a healthcare provider if you need one. Worsening of Hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before you start treatment with TRIUMEQ or TRIUMEQ PD.

If you have HBV infection and take TRIUMEQ or TRIUMEQ PD, your HBV may get worse (flare-up) if you stop taking TRIUMEQ or TRIUMEQ PD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. o Do not run out of TRIUMEQ or TRIUMEQ PD. Refill your prescription or talk to your healthcare provider before your TRIUMEQ or TRIUMEQ PD is all gone.

o Do not stop TRIUMEQ or TRIUMEQ PD without first talking to your healthcare provider. o If you stop taking TRIUMEQ or TRIUMEQ PD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRIUMEQ or TRIUMEQ PD.

Resistant HBV. If you have human immunodeficiency virus-1 (HIV-1) and HBV, the HBV can change (mutate) during your treatment with TRIUMEQ or TRIUMEQ PD and become harder to treat (resistant). Your healthcare provider may give you other medicines to treat HBV infection if you have HIV-1 and HBV infections and take TRIUMEQ or TRIUMEQ PD.

For more information about side effects, see “

How to take it

Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to prepare a dose of TRIUMEQ PD tablets for oral suspension. Take TRIUMEQ or TRIUMEQ PD exactly as your healthcare provider tells you to take it. Do not change your dose, switch medicines or stop taking TRIUMEQ or TRIUMEQ PD without talking with your healthcare provider first.

TRIUMEQ tablets are not the same as TRIUMEQ PD tablets for oral suspension and cannot be substituted for each other. Check to make sure you receive the correct dosage form each time you or your child’s prescription is filled to avoid using the wrong medicine. Your child’s healthcare provider will prescribe TRIUMEQ or TRIUMEQ PD based on your child’s weight.

TRIUMEQ PD tablets for oral suspension should be dispersed in drinking water. Do not chew, cut, or crush TRIUMEQ tablets or TRIUMEQ PD tablets for oral suspension. Do not swallow TRIUMEQ PD tablets for oral suspension whole. TRIUMEQ or TRIUMEQ PD may be taken with or without food. If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TRIUMEQ or TRIUMEQ PD should be taken at least 2 hours before or 6 hours after you take these medicines.

If you need to take iron or calcium supplements, or multivitamin supplements that contain iron or calcium, by mouth during treatment with TRIUMEQ or TRIUMEQ PD: o If you take TRIUMEQ or TRIUMEQ PD with food, you may take these supplements at the same time that you take TRIUMEQ or TRIUMEQ PD. o If you do not take TRIUMEQ or TRIUMEQ PD with food, take TRIUMEQ or TRIUMEQ PD at least 2 hours before or 6 hours after you take these supplements.

If you miss a dose of TRIUMEQ or TRIUMEQ PD, take it as soon as you remember. Do not take 2 doses at the same time or take more than your healthcare provider tells you to take. Stay under the care of a healthcare provider during treatment with TRIUMEQ or TRIUMEQ PD. Do not run out of TRIUMEQ or TRIUMEQ PD. The virus in your blood may increase and the virus may become harder to treat.

When your supply starts to run low, get more from your healthcare provider or pharmacy. If you take too much TRIUMEQ or TRIUMEQ PD, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of TRIUMEQ or TRIUMEQ PD? TRIUMEQ or TRIUMEQ PD can cause serious side effects, including: Liver problems.

People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver function tests during treatment with TRIUMEQ or TRIUMEQ PD. Liver problems including liver failure have also happened with TRIUMEQ or TRIUMEQ PD in people without a history of liver disease or other risk factors.

Liver failure resulting in liver transplant has also been reported with TRIUMEQ. Your healthcare provider may do blood tests to check your liver. Call your healthcare provider right away if you develop any of the signs or symptoms of liver problems listed below. your skin or the white part of your eyes turns yellow (jaundice) dark or “tea-colored” urine light colored stools (bowel movements) loss of appetite nausea or vomiting pain, aching, or tenderness on the right side of your stomach area Too much lactic acid in your blood (lactic acidosis).

Too much lactic acid is a serious medical emergency that can lead to death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: feel very weak or tired unusual (not normal) muscle pain trouble breathing stomach pain with nausea and vomiting feel cold, especially in your arms and legs feel dizzy or lightheaded have a fast or irregular heartbeat Lactic acidosis can also lead to severe liver problems, which can lead to death.

Your liver may become large (hepat

Side effects, and when to stop

” What is TRIUMEQ and TRIUMEQ PD? TRIUMEQ and TRIUMEQ PD are prescription medicines used to treat HIV-1 infection in adults and children who are at least 3 months of age and weigh at least 13.2 pounds (6 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). TRIUMEQ and TRIUMEQ PD contain the prescription medicines abacavir, dolutegravir, and lamivudine.

TRIUMEQ or TRIUMEQ PD should not be used by itself in people who have resistance to certain types of medicines. It is not known if TRIUMEQ PD is safe and effective in children who are less than 3 months of age or weigh less than 13.2 pounds (6 kg).

Who should not take it

Do not take TRIUMEQ or TRIUMEQ PD if you: have a certain type of gene variation called the HLA‑B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with TRIUMEQ or TRIUMEQ PD. are allergic to abacavir, dolutegravir, lamivudine, or any of the ingredients in TRIUMEQ or TRIUMEQ PD. See the end of this Medication Guide for a complete list of ingredients in TRIUMEQ and TRIUMEQ PD.

take dofetilide. Taking TRIUMEQ or TRIUMEQ PD and dofetilide can cause side effects that may be serious or life-threatening. have certain liver problems. Before you take TRIUMEQ or TRIUMEQ PD, tell your healthcare provider about all of your medical conditions, including if you: have been tested and know whether or not you have a particular gene variation called HLA‑B*5701.

have or have had liver problems, including hepatitis B or C virus infection. have kidney problems. have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes. drink alcohol or take medicines that contain alcohol. are pregnant or plan to become pregnant.

Talk to your healthcare provider about the benefits and risks of treatment with TRIUMEQ during pregnancy. Pregnancy Registry. There is a pregnancy registry for those who take TRIUMEQ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. TRIUMEQ passes to your baby in your breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment with TRIUMEQ: o the HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection. o the HIV-1 virus may become harder to treat if your baby has HIV-1 infection.

o your baby may get side effects from TRIUMEQ. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TRIUMEQ or TRIUMEQ PD. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with TRIUMEQ or TRIUMEQ PD. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TRIUMEQ or TRIUMEQ PD with other medicines.

Storing it

Store TRIUMEQ and TRIUMEQ PD at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle. Keep the bottle tightly closed and protect it from moisture. The bottle of TRIUMEQ and TRIUMEQ PD contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.

Keep TRIUMEQ, TRIUMEQ PD, and all medicines out of the reach of children.