Risks and Side Effects
What you should know
These are not all the risks and side effects of TRIUMEQ, and this information does not replace talking with your healthcare provider about your medical conditions or treatment. For more information, talk to your healthcare provider and refer to the Medication Guide for TRIUMEQ.
What is the most important information I should know about TRIUMEQ?
TRIUMEQ can cause serious side effects, including:
- 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.
- Worsening of Hepatitis B virus (HBV) infection. If you have HBV infection and take TRIUMEQ, 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.
- 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 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.
- Resistant HBV. If you have human immunodeficiency virus-1 (HIV-1) and HBV, the HBV can change (mutate) during your treatment with TRIUMEQ and become harder to treat (resistant).
- For more information about side effects, see “What are the possible side effects of TRIUMEQ?”
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. Taking TRIUMEQ and dofetilide can cause 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 may perform a pregnancy test before you start treatment with TRIUMEQ.
- If you can become pregnant, you and your healthcare provider should talk about the use of 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 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.
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?”
- 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. 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. 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 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 severe 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 “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. 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.