Abacavir, dolutegravir, and lamivudine

Name: Abacavir, dolutegravir, and lamivudine

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.

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.

abacavir, dolutegravir, and lamivudine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare
  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • nausea and vomiting
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Incidence not known
  • Abdominal or stomach pain or discomfort
  • blistering, peeling, or loosening of the skin
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning, dry, or itching eyes
  • chills
  • confusion
  • cough
  • decreased appetite
  • decreased frequency or amount of urine
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • discharge or excessive tearing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • general feeling of discomfort or illness
  • headache
  • hives, itching, or rash
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • lower back or side pain
  • muscle pain, cramping, or stiffness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, shallow breathing
  • red, irritated eyes
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain, continuing
  • sweating
  • swelling of the face, fingers, lower legs
  • swelling or puffiness of the face
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Discouragement
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
Less common or rare
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • full or bloated feeling
  • heartburn
  • indigestion
  • passing gas
  • pressure in the stomach
  • sleepiness or unusual drowsiness
  • stomach upset
  • swelling of the abdominal or stomach area
  • weight loss
Incidence not known
  • Hair loss
  • thinning of the hair
  • weight gain around your neck, upper back, breast, or waist

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time abacavir, dolutegravir, and lamivudine is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take abacavir, dolutegravir, and lamivudine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to abacavir, dolutegravir, and lamivudine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Administration

Oral: Administer with or without food. If patient is on concomitant therapy with efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin an additional daily single-component dolutegravir tablet should be administered 12 hours after Triumeq.

For Healthcare Professionals

Applies to abacavir / dolutegravir / lamivudine: oral tablet

General

The most common side effects were insomnia, headache, fatigue, nausea, and dizziness.

Many of the side effects listed occurred commonly in patients with abacavir hypersensitivity (e.g., nausea, vomiting, diarrhea, fever, lethargy, rash).[Ref]

Hypersensitivity

Hypersensitivity reactions were reported with abacavir and dolutegravir and shared some common features (e.g., fever and/or rash with other symptoms that indicated multi-organ involvement). In general, time to onset was 10 to 14 days for both abacavir- and dolutegravir-associated reactions.

Serious and sometimes fatal hypersensitivity reactions have been reported with abacavir. Such reactions have included multi-organ failure and anaphylaxis and usually occurred within the first 6 weeks of abacavir therapy; however, abacavir hypersensitivity reactions have occurred any time during therapy.

Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. Abacavir hypersensitivity was reported in about 8% of patients in 9 clinical trials with abacavir-containing products where patients were not screened for the HLA-B*5701 allele; incidence of suspected abacavir hypersensitivity reactions was 1% in clinical trials where HLA-B*5701 carriers were excluded.

Abacavir hypersensitivity reactions have been characterized by at least 2 of the following key signs/symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, achiness); (5) respiratory symptoms (including dyspnea, cough, pharyngitis). Almost all reactions have included fever and/or rash (usually maculopapular or urticarial); however, reactions also reported without fever or rash. Signs/symptoms reported in at least 10% of patients with hypersensitivity reaction have included rash, nausea, vomiting, diarrhea, abdominal pain, dyspnea, cough, fever, fatigue/lethargy, malaise, headache, elevated liver function tests, and myalgia. Other signs/symptoms of hypersensitivity have included mouth ulceration, sore throat, adult respiratory distress syndrome, respiratory failure, edema, lymphadenopathy, hypotension, conjunctivitis, anaphylaxis, paresthesia, lymphopenia, hepatitis, liver failure, myolysis, arthralgia, elevated creatine phosphokinase, elevated creatinine, renal failure, abnormal chest x-ray findings (mainly infiltrates, which were localized), and death.

Symptoms of abacavir hypersensitivity reaction worsened with continued therapy and generally resolved when abacavir was discontinued. Restarting abacavir after a hypersensitivity reaction has resulted in more severe symptoms within hours and included life-threatening hypotension and death. Rarely, life-threatening reactions have occurred within hours after restarting abacavir in patients who stopped it for reasons other than symptoms of hypersensitivity (or who stopped it with only 1 key symptom of hypersensitivity).[Ref]

Common (1% to 10%): Hypersensitivity
Frequency not reported: Hypersensitivity reaction (with rash and severe liver effects)

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

Abacavir:
-Common (1% to 10%): Hypersensitivity reactions (including fever, rash [maculopapular, urticarial], generalized malaise, fatigue, achiness, nausea, vomiting, diarrhea, abdominal pain, pharyngitis, dyspnea, cough, lethargy, headache, myalgia, myolysis, edema, abnormal chest x-ray findings [mainly localized infiltrates], arthralgia, paresthesia, anaphylaxis, hepatitis, liver failure, renal failure, hypotension, sore throat, adult respiratory distress syndrome, respiratory failure, death, lymphadenopathy, mucous membrane lesions [conjunctivitis, mouth ulcerations], erythema multiforme, elevated liver function tests, elevated creatine phosphokinase, elevated creatinine, lymphopenia)

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
Uncommon (0.1% to 1%): Hepatitis

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

Abacavir:
-Frequency not reported: Liver function test abnormalities, elevated liver chemistries (AST, ALT, alkaline phosphatase, bilirubin)

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, at week 96. Grade 2 and grade 3 to 4 elevations in ALT were reported in 2% and less than 1% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.

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

Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Elevated lipase, abdominal pain, abdominal distention, abdominal discomfort, dyspepsia, flatulence, gastroesophageal reflux disease, upper abdominal pain, vomiting
Rare (0.01% to 0.1%): Pancreatitis

Abacavir and/or lamivudine:
-Postmarketing reports: Stomatitis

Abacavir:
-Postmarketing reports: Pancreatitis (rare)

Lamivudine:
-Frequency not reported: Elevated lipase
-Postmarketing reports: Elevated amylase (rare), pancreatitis (rare)[Ref]

Grade 2 and grade 3 to 4 elevations in lipase were reported in 9% and 4% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Uncommon (0.1% to 1%): Hypertriglyceridemia
Frequency not reported: Anorexia, 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, anorexia (common)

Abacavir:
-Frequency not reported: Elevated blood glucose, elevated triglycerides
-Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare)

Lamivudine:
-Postmarketing reports: Hyperlactatemia (common), lactic acidosis (rare)

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"), metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia)[Ref]

Grade 2 and grade 3 hyperglycemia were reported in 7% and 2% of therapy-naive patients, respectively, at week 96. 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 CPK were reported in 4% and 5% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.

Asymptomatic CPK elevations, mainly associated with exercise, have been reported with dolutegravir.[Ref]

Common (1% to 10%): Elevated creatine phosphokinase (CPK), arthralgia
Frequency not reported: Myositis
Rare (0.01% to 0.1%): Rhabdomyolysis

Abacavir and/or lamivudine:
-Postmarketing reports: Muscle weakness, elevated CPK

Abacavir:
-Frequency not reported: Elevated CPK

Dolutegravir:
-Frequency not reported: Asymptomatic CPK elevations

Lamivudine:
-Postmarketing reports: Muscle disorders (common), arthralgia (common), rhabdomyolysis (rare)

Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]

Hematologic

Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in 3% and 2% of therapy-naive patients, respectively, at week 96. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]

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

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

Abacavir:
-Uncommon (0.1% to 1%): Anemia, neutropenia
-Frequency not reported: Thrombocytopenia, low WBC count

Lamivudine:
-Uncommon (0.1% to 1%): Thrombocytopenia
-Postmarketing reports: Pure red cell aplasia (very rare)[Ref]

Psychiatric

Suicidal ideation, attempt, behavior, and completion have been reported, mainly in patients with history of depression or other psychiatric illness.[Ref]

Very common (10% or more): Insomnia
Common (1% to 10%): Depression, abnormal dreams, nightmare, sleep disorder
Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt
Frequency not reported: Suicidal behavior, suicide completion[Ref]

Nervous system

Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence, lethargy

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

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Fever, asthenia, malaise

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

Dermatologic

Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients using abacavir primarily in combination with agents known to be associated with SJS and TEN, respectively.

Cases of erythema multiforme, SJS, or TEN have been reported very rarely when abacavir hypersensitivity could not be ruled out.[Ref]

Common (1% to 10%): Rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption), pruritus, alopecia

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

Abacavir:
-Postmarketing reports: Rash without systemic symptoms (common), erythema multiforme (very rare), Stevens-Johnson syndrome (very rare), toxic epidermal necrolysis (very rare)

Lamivudine:
-Postmarketing reports: Alopecia (common)[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

Uncommon (0.1% to 1%): Immune reconstitution/reactivation syndrome
Frequency not reported: Autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]

Respiratory

Common (1% to 10%): Cough

Abacavir and/or lamivudine:
-Postmarketing reports: Abnormal breath sounds/wheezing, nasal symptoms (common)[Ref]

Cardiovascular

An observational study investigating the rate of MI in patients on combination antiretroviral therapy showed an increased risk of MI with the use of abacavir within the previous 6 months. A sponsor-conducted pooled analysis of clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from the observational cohort and from clinical trials were inconclusive.[Ref]

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

Some side effects of abacavir / dolutegravir / lamivudine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): Not recommended; individual components should be used.
Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated

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