abacavir, dolutegravir, and lamivudine

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Pronunciation: a BAK a vir, DOE loo TEG ra vir, la MIV ue deen

Brand: Triumeq

What is the most important information I should know about abacavir, dolutegravir, and lamivudine (Triumeq)?

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.

Get emergency medical help if you have symptoms of lactic acidosis such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have ever had hepatitis B, this condition may come back or get worse after you stop taking this medicine.

What is abacavir, dolutegravir, and lamivudine (Triumeq)?

Abacavir, dolutegravir, and lamivudine are antiviral medications that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Abacavir dolutegravir, and lamivudine (Triumeq) is a combination medicine used to treat HIV, which can cause the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Triumeq may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Triumeq?

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

  • moderate or severe liver disease;
  • a gene variation called HLA-B*5701 allele (your doctor will test you for this); or
  • a history of allergic reaction to Combivir, Dutrebis, Epivir, Epzicom, Tivicay, Trizivir, or Ziagen.

Once you have had an allergic reaction to abacavir or dolutegravir, you must never use these medicines again.

Some medicines can cause unwanted or dangerous effects when used with Triumeq. You should not take Triumeq if you also use:

  • dofetilide (Tikosyn);
  • abacavir (Epizicom, Trizivir, Ziagen);
  • lamivudine (Combivir, Dutrebis, Epivir, Epzicom, Trizivir); or
  • emtricitabine (Emtriva, Atripla, Complera, Stribild, Truvada).

Triumeq can cause severe or life-threatening effects on your liver, especially if you have hepatitis C.

To make sure Triumeq is safe for you, tell your doctor if you have:

  • liver disease (especially hepatitis B or C);
  • kidney disease;
  • risk factors for heart disease (such as diabetes, smoking, high blood pressure, high cholesterol); or
  • if you drink alcohol.

Some people taking Triumeq develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

It is not known whether Triumeq will harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

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.

Triumeq is not approved for use by anyone younger than 18 years old.

How should I take Triumeq?

Follow all directions on your Triumeq prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take Triumeq with or without food.

Triumeq comes with a Medication Guide and a Warning Card that lists the symptoms of an allergic reaction. Carry this Warning Card with you at all times so you will know what symptoms to watch for.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

While using Triumeq, you may need frequent blood tests.

If you have ever had hepatitis B, this condition may come back or get worse during treatment or after you stop taking Triumeq. You may need frequent blood tests to check your liver function for several months after you stop using this medicine.

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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away. Do not take extra medicine to make up the missed dose. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

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

What should I avoid while taking Triumeq?

Avoid taking the following medicines within 6 hours before or 2 hours after you take Triumeq:

  • antacids or laxatives that contain aluminum or magnesium (such as Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others);
  • the ulcer medicine sucralfate (Carafate);
  • buffered medicine;
  • vitamin or mineral supplements that contain calcium or iron.

Taking Triumeq will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of Triumeq?

Stop using Triumeq and 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 Triumeq for any reason, talk to your doctor before you start taking it again.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have other serious side effects:

  • liver problems --nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Triumeq may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Triumeq. Tell your doctor if you have:

  • fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • cold sores, sores on your genital or anal area;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • headache, sleep problems (insomnia), tired feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

What other drugs will affect Triumeq?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • methadone, rifampin, St. John's wort;
  • any other medicine to treat HIV or AIDS;
  • medicine that contains metformin --Actos, Actoplus Met, Avandamet, Fortamet, Glucophage, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet, and others;
  • medicine to treat hepatitis --interferon, ribavirin; or
  • seizure medicine --carbamazepine, oxcarbazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with Triumeq, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about abacavir, dolutegravir, and lamivudine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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