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abacavir, dolutegravir, and lamivudine

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Triumeq

Antiviral combinations


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

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

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

Abacavir, dolutegravir, and lamivudine may also be used for purposes not listed in this medication guide.

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Triumeq may also cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms 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 Triumeq.

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, 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, 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.

FDA pregnancy category C. 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?

HIV/AIDS is usually treated with a combination of drugs. 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.

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

The usual dose of Triumeq is 1 tablet per day. However, you may need to take a separate dolutegravir tablet (Tivicay) 12 hours after taking Triumeq if you also take certain other HIV medicines as part of your complete treatment plan. Follow your doctor's dosing instructions very carefully.

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.

While using Triumeq, you may need frequent blood tests. You may need a blood test before you start taking this medicine for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction.

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

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.

Triumeq side effects

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.

Triumeq can cause other serious side effects that may not be signs of an allergic reaction or lactic acidosis. Call your doctor at once if you have:

  • liver problems--nausea, upper stomach pain, itching, tired feeling, 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;

  • tired feeling; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

Abacavir, dolutegravir, and lamivudine dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Use: For the treatment of HIV-1 infection

What other drugs will affect Triumeq?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Triumeq, 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-10-09, 4:14:35 PM.

Not all side effects for abacavir / dolutegravir / lamivudine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abacavir / dolutegravir / lamivudine: tablet oral

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur while taking abacavir / dolutegravir / lamivudine:

Severe allergic reactions (fever; rash; tiredness; achiness; nausea; diarrhea; vomiting; stomach pain; sore throat; hives; itching; difficulty breathing; cough; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest, jaw, or arm pain or discomfort; decreased urination; fainting; mouth or eye sores or blisters; muscle or joint aches; red, swollen, blistered, or peeling skin; redness or swelling of the eyes; severe or persistent dizziness; shortness of breath; swelling; swollen lymph nodes.

For Healthcare Professionals

Applies to abacavir / dolutegravir / lamivudine: oral tablet

Hypersensitivity

Abacavir and/or lamivudine:
-Postmarketing reports: Sensitization reactions (including anaphylaxis)

Abacavir:
-Frequency not reported: Serious and sometimes fatal hypersensitivity reaction

Dolutegravir:
-Frequency not reported: Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)[Ref]

Hepatic

Very common (10% or more): ALT abnormalities (up to 15%)
Common (1% to 10%): Elevated AST, elevated ALT, AST abnormalities
Frequency not reported: Hepatitis

Abacavir and/or lamivudine:
-Frequency not reported: Liver function test abnormalities, severe hepatomegaly with steatosis

Abacavir:
-Frequency not reported: Liver function test abnormalities

Dolutegravir:
-Frequency not reported: Transaminase elevations consistent with immune reconstitution syndrome

Lamivudine:
-Frequency not reported: Elevated bilirubin, hepatic decompensation, severe acute exacerbations of hepatitis[Ref]

Grade 2 and grade 3 to 4 elevations in AST were reported in 3% and less than 1% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in ALT were reported in 2% and less than 1% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.

The rates of AST and ALT abnormalities were higher in patients coinfected with hepatitis C virus (HCV). ALT abnormalities (grade 2 to 4) in HIV/HCV coinfected patients compared with HIV monoinfected patients were reported in 15% and 2%, respectively.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Transaminase elevations were consistent with immune reconstitution syndrome or hepatitis B reactivation in some patients with underlying hepatitis B and/or C, especially when antihepatitis therapy was stopped.

Hepatic decompensation (some fatal) has been reported in patients coinfected with HIV-1 and hepatitis C receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin.

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine.[Ref]

Gastrointestinal

Common (1% to 10%): Elevated lipase
Uncommon (0.1% to 1%): Nausea, diarrhea
Frequency not reported: Abdominal pain, abdominal distention, abdominal discomfort, dyspepsia, flatulence, gastroesophageal reflux disease, upper abdominal pain, vomiting

Abacavir and/or lamivudine:
-Postmarketing reports: Stomatitis, pancreatitis

Lamivudine:
-Frequency not reported: Elevated amylase, elevated lipase[Ref]

Grade 2 and grade 3 to 4 elevations in lipase were reported in 9% and 4% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Frequency not reported: Anorexia, hypertriglyceridemia, fasted lipid values increased (including cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, triglycerides)

Abacavir and/or lamivudine:
-Frequency not reported: Lactic acidosis
-Postmarketing reports: Hyperlactemia

Abacavir:
-Frequency not reported: Elevated blood glucose, elevated triglycerides

Combination antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")[Ref]

Grade 2 and grade 3 hyperglycemia were reported in 7% and 2% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

Redistribution/accumulation of body fat has been reported with antiretroviral therapy; causality has not been established.[Ref]

Musculoskeletal

Grade 2 and grade 3 to 4 elevations in creatine kinase were reported in 4% and 5% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Common (1% to 10%): Elevated creatine kinase
Frequency not reported: Arthralgia, myositis

Abacavir and/or lamivudine:
-Postmarketing reports: Muscle weakness, elevated creatine phosphokinase, rhabdomyolysis

Abacavir:
-Frequency not reported: Elevated creatine phosphokinase[Ref]

Hematologic

Common (1% to 10%): Decreased total neutrophils

Abacavir and/or lamivudine:
-Postmarketing reports: Aplastic anemia, anemia (including pure red cell aplasia, severe anemias progressing on therapy), lymphadenopathy, splenomegaly

Abacavir:
-Frequency not reported: Anemia, neutropenia

Lamivudine:
-Frequency not reported: Thrombocytopenia[Ref]

Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in 3% and 2% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depression, abnormal dreams
Frequency not reported: Nightmare, sleep disorder[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Somnolence

Abacavir and/or lamivudine:
-Postmarketing reports: Paresthesia, peripheral neuropathy, seizures[Ref]

Other

Common (1% to 10%): Fatigue
Frequency not reported: Fever, lethargy

Abacavir and/or lamivudine:
-Postmarketing reports: Weakness[Ref]

Dermatologic

Suspected SJS and TEN have been reported in patients using abacavir primarily in combination with agents known to be associated with SJS and TEN, respectively.[Ref]

Uncommon (0.1% to 1%): Rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption)
Frequency not reported: Pruritus

Abacavir and/or lamivudine:
-Postmarketing reports: Urticaria, alopecia, erythema multiforme

Abacavir:
-Postmarketing reports: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)[Ref]

Renal

Frequency not reported: Renal impairment, increased serum creatinine (due to inhibition of tubular secretion of creatinine)[Ref]

Dolutegravir was shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported within the first 4 weeks of therapy and remained stable through 24 to 96 weeks. In 1 trial, a mean change from baseline of 0.14 mg/dL (range: -0.32 to 0.59 mg/dL) was reported after 96 weeks of therapy in therapy-naive patients. Creatinine increases were similar in therapy-experienced patients.[Ref]

Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]

Respiratory

Abacavir and/or lamivudine:
-Postmarketing reports: Abnormal breath sounds/wheezing[Ref]

Cardiovascular

A study investigating the rate of MI in patients taking combination antiretroviral treatment showed an increased risk of MI with the use of abacavir within the previous 6 months; however, these results were not conclusive. The manufacturer reviewed its own clinical study databases and although the results of the analysis were inconclusive, they did not show an excess risk of MI. A meta-analysis conducted by the FDA showed no statistically significant difference in MI events between patients who received abacavir and those who did not.[Ref]

Abacavir:
-Frequency not reported: Myocardial infarction (MI)[Ref]

References

1. "Product Information. Triumeq (abacavir/dolutegravir/lamiVUDine)." ViiV Healthcare, Research Triangle Park, NC.

More about abacavir/dolutegravir/lamivudine

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Interactions
  • Support Group
  • En Espanol
  • 2 Reviews - Add your own review/rating

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  • Abacavir, dolutegravir, and lamivudine (Advanced Reading)
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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.