What is Triumeq?
Triumeq is a prescription HIV‑1 (Human Immunodeficiency Virus type 1) medicine used to treat HIV-1 infection in adults and children who weigh at least 88 pounds (40 kg).
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Triumeq contains 3 prescription medicines, abacavir (Ziagen), dolutegravir (Tivicay) and lamivudine (Epivir).
- Triumeq is not for use by itself in people who have or have had resistance to abacavir, dolutegravir, or lamivudine.
It is not known if Triumeq is safe and effective in children who weigh less than 88 pounds (40 kg).
What is the most important information I should know about Triumeq?
Triumeq can cause serious side effects, including:
1. Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with Triumeq 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, call your healthcare provider right away to find out if you should stop taking Triumeq.
|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 because of an allergic reaction, never take Triumeq (abacavir, dolutegravir and lamivudine) or any other medicine that contains abacavir or dolutegravir (Epzicom, Tivicay, Trizivir, or Ziagen) again.
- If you have an allergic reaction, dispose of any unused Triumeq. Ask your pharmacist how to properly dispose of medicines.
- If you take Triumeq 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 for any other reason, even for a few days, and you are not allergic to Triumeq, talk with your healthcare provider before taking it again. Taking Triumeq 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 again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.
2. Worsening of hepatitis B virus in people who have HIV-1 infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking Triumeq. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Worsening liver disease can be serious and may lead to death.
- Do not run out of Triumeq. Refill your prescription or talk to your healthcare provider before your Triumeq is all gone.
- Do not stop Triumeq without first talking to your healthcare provider.
- If you stop taking Triumeq, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment with Triumeq and become harder to treat (resistant).
Who should not take Triumeq?
Do not take Triumeq 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.
- are allergic to abacavir, dolutegravir, lamivudine, or any of the ingredients in Triumeq. See the end of this Medication Guide for a complete list of ingredients in Triumeq.
- take dofetilide (Tikosyn). Taking Triumeq and dofetilide (Tikosyn) can cause serious side effects that may be serious or life-threatening.
- have certain liver problems.
What should I tell my healthcare provider before taking Triumeq?
Before you take Triumeq, 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. One of the medicines in Triumeq called dolutegravir may harm your unborn baby.
- Your healthcare provider may prescribe a different medicine than Triumeq if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.
- If you can become pregnant, your healthcare provider will perform a pregnancy test before you start treatment with Triumeq.
- If you can become pregnant, you should consistently use effective birth control (contraception) during treatment with Triumeq.
- Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with Triumeq.
Pregnancy Registry. There is a pregnancy registry for individuals who take antiretroviral medicines, including 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. Do not breastfeed if you take Triumeq.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
- Two of the medicines in Triumeq (abacavir and lamivudine) pass into your breastmilk.
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. 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.
- 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 with other medicines.
How should I take Triumeq?
- Take Triumeq exactly as your healthcare provider tells you to take it.
- Do not change your dose or stop taking Triumeq without talking with your healthcare provider.
- Triumeq may be taken with or without food.
- If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, Triumeq 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 by mouth during treatment with Triumeq:
- If you take Triumeq with food, you may take these supplements at the same time that you take Triumeq.
- If you do not take Triumeq with food, take Triumeq at least 2 hours before or 6 hours after you take these supplements.
- If you miss a dose of Triumeq, 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.
- Do not run out of Triumeq. 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, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of Triumeq?
Triumeq can cause serious side effects including:
- See “What is the most important information I should know about Triumeq?”
- Serious liver problems can happen in people who take Triumeq. 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. Liver problems including liver failure have also happened with Triumeq 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 function. 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
- Build-up of acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Triumeq. Lactic acidosis is a serious medical emergency that can cause 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 serious liver problems, which can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the signs or symptoms of liver problems which are listed above under “Serious liver problems”. You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking Triumeq.
- Heart attack (myocardial infarction). Some HIV-1 medicines including Triumeq may increase your risk of heart attack.
- The most common side effects of Triumeq include:
- trouble sleeping
These are not all the possible side effects of Triumeq. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
General information about the safe and effective use of Triumeq
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Triumeq for a condition for which it was not prescribed. Do not give Triumeq to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Triumeq that is written for health professionals.
How should I store Triumeq?
- Store Triumeq at room temperature between 68°F to 77°F (20°C to 25°C).
- Store Triumeq in the original bottle.
- Keep the bottle of Triumeq tightly closed and protect it from moisture.
- The bottle of Triumeq 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 and all medicines out of the reach of children.
What are the ingredients in Triumeq?
Active ingredients: abacavir, dolutegravir, and lamivudine
Inactive ingredients: D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
Tablet film‑coating contains: iron oxide black, iron oxide red, macrogol/PEG, polyvinyl alcohol–part hydrolyzed, talc, and titanium oxide.
For more information go to WWW.TRIUMEQ.COM or call 1-877-844-8872.