Generic Name: abacavir, dolutegravir, and lamivudine
Date of Approval: August 22, 2014
Company: ViiV Healthcare
Treatment for: HIV-1 infection
FDA Approves Triumeq
A new combination HIV pill has been given the nod by the FDA. Triumeq is a once-daily combo of Tivicay (dolutegravir) and Epzicom (abacavir/lamivudine), becoming the fourth all-in-one HIV treatment approved after Atripla (2006), Complera (2011) and Stribild (2012). Unlike its predecessors, Triumeq does not contain the nucleoside reverse transcriptase inhibitor (NRTI) tenofovir (Viread).
Triumeq is a fixed-dose combination containing the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Dolutegravir was approved in the U.S. in August 2013 under the brand name Tivicay. Abacavir (Ziagen) and lamivudine (Epivir) have been on the market for many years as single ingredient formulations and fixed-dose combinations.
Triumeq comes with a boxed warning stating the risk of hypersensitivity reactions, lactic acidosis and severe hepatomegaly, and exacerbations of hepatitis B. Patients are issued with a Triumeq Warning Card which should be carried at all times.
The most commonly reported side effects include insomnia, headache, and fatigue.
Read this Medication Guide before you start taking this medicine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to carry your Triumeq Warning Card with you at all times.
- Serious allergic reaction (hypersensitivity reaction). Triumeq contains abacavir (also contained in Epzicom, Trizivir, and Ziagen). Patients taking Triumeq may have a serious allergic reaction (hypersensitivity reaction) that can cause death. 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 two or more of the following groups while taking Triumeq, call your healthcare provider right away to find out if you should stop taking it.
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 taking this medicine because of an allergic reaction, never take Triumeq or any other medicines that contain abacavir or dolutegravir (Epzicom, Ziagen, Trizivir, or Tivicay) again.
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 this medicine for any other reason, even for a few days, and you are not allergic to it, 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.
- Build-up of acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get the following symptoms that could be signs of lactic acidosis:
- feel very weak or tired
- have unusual (not normal) muscle pain
- have trouble breathing
- have stomach pain with nausea and vomiting
- feel cold, especially in your arms and legs
- feel dizzy or lightheaded
- have a fast or irregular heartbeat
- Severe liver problems. Severe liver problems. In some cases these severe liver problems 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 following signs or symptoms of liver problems:
- your skin or the white part of your eyes turns yellow
- dark “tea-colored” urine
- light colored stools (bowel movements)
- stomach-area pain
- Worsening of hepatitis B virus in people who have HIV-1 infection. If you have HIV-1 and hepatitis B virus infections, your hepatitis virus infection may get worse if you stop taking Triumeq. To help avoid this: Take exactly as prescribed.
- Do not run out of the tablets.
- Do not stop taking this medicine without talking to your healthcare provider.
- Your healthcare provider should monitor your health and do regular blood tests to check your liver for at least several months if you stop treatment.
- Resistant Hepatitis B Virus (HBV). If you have HIV-1 and hepatitis B, the hepatitis B virus can change (mutate) during your treatment, and become harder to treat (resistant).
- Use with interferon and ribavirin-based regimens. Worsening of liver disease has happened in people infected with HIV-1 and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking Triumeq and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.
What is Triumeq?
Triumeq is a prescription medicine used to treat HIV-1 (Human Immunodeficiency Virus-type 1) infection. Each tablet contains three 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 it is safe and effective in children.
Triumeq may help:
- reduce the amount of HIV-1 in your blood. This is called “viral load”.
- increase the number of white blood cells called CD4+ (T) cells in your blood, which help fight off other infections
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Triumeq does not cure HIV-1 infection or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others.
- Do not share or re-use needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Ask your healthcare provider if you have any questions about how to prevent passing HIV to other people.
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.
- have ever had an allergic reaction to abacavir, dolutegravir, or lamivudine
- take dofetilide (Tikosyn). Taking Triumeq and dofetilide (Tikosyn) can cause side effects that may be life-threatening.
- have certain liver problems.
Before taking Triumeq
Tell your healthcare provider if you:
- have been tested and know whether or not you have a particular gene variation called HLA-B*5701
- have or 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 alcoholic beverages
- have any other medical condition
- are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.
Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to 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 because of the risk of passing HIV-1 to your baby. It is not known if abacavir or dolutegravir passes into your breast milk. Lamivudine can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Triumeq may affect the way other medicines work, and vice versa. You should not take TRIUMEQ if you also take:
- abacavir (Epzicom, Trizivir, or Ziagen)
- lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir)
- emtricitabine (Emtriva, Atripla, Complera, Stribild, Truvada)
Tell your healthcare provider if you take:
- antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate), or buffered medicines. Triumeq should be taken at least 2 hours before or 6 hours after you take these medicines.
- anti-seizure medicines:
- oxcarbazepine (Trileptal)
- phenytoin (Dilantin, Dilantin-125, Phenytek)
- carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
- any other medicine to treat HIV-1
- iron or calcium supplements taken by mouth. Supplements containing calcium or iron may be taken at the same time with Triumeq if taken with food. Otherwise, Triumeq should be taken at least 2 hours before or 6 hours after you take these medicines.
- medicines used to treat hepatitis virus infections, such as interferon or ribavirin
- a medicine that contains metformin
- rifampin (Rifater, Rifamate, Rimactane, Rifadin)
- St. John’s wort (Hypericum perforatum)
Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and pharmacist when you get a new medicine.
Ask your healthcare provider or pharmacist if you are not sure if you take one of the medicines listed above.
How should I take Triumeq?
- Take this medicine exactly as your healthcare provider tells you.
- Do not change your dose or stop taking it without talking with your healthcare provider.
- Stay under the care of a healthcare provider during treatment.
- You can take the tablets with or without food.
- If you miss a dose, take it as soon as you remember. If it is within 4 hours of your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about your dosing, call your healthcare provider.
- Do not run out of Triumeq. The virus in your blood may become resistant to other HIV-1 medicines if treatment is stopped for even a short time. When your supply starts to run low, get more from your healthcare provider or pharmacy.
- If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
Triumeq side effects
Serious side effects include:
- See Important information
- Changes in liver tests. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment. Your healthcare provider may do tests to check your liver function before and during treatment.
- 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 starting your HIV-1 medicine.
- Changes in body fat (fat redistribution) can happen in people who take HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
- Heart attack (myocardial infarction). Some HIV medicines including Triumeq may increase your risk of heart attack.
The most common side effects include:
- trouble sleeping
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects. 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.
How should I store Triumeq?
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Store tablets in the original bottle.
- Keep the bottle tightly closed and protect from moisture.
- The bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not remove the desiccant packet.
- Keep all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for health professionals.
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. The tablet film-coating contains iron oxide black, iron oxide red, macrogol/PEG, polyvinyl alcohol–part hydrolyzed, talc, and titanium oxide.