Note: This document contains side effect information about abacavir / dolutegravir / lamivudine. Some dosage forms listed on this page may not apply to the brand name Triumeq PD.
Applies to abacavir / dolutegravir / lamivudine: oral tablet, oral tablet for suspension.
Warning
Oral route (Tablet; Tablet for Suspension)
Hypersensitivity ReactionsSerious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of the abacavir, dolutegravir, and lamivudine combination. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele.The abacavir, dolutegravir, and lamivudine combination is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir, dolutegravir, and lamivudine or reinitiation of therapy with abacavir, dolutegravir, and lamivudine, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir, dolutegravir, and lamivudine combination immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible.Following a hypersensitivity reaction to abacavir, dolutegravir, and lamivudine combination, never restart abacavir, dolutegravir, and lamivudine or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity.Exacerbations of Hepatitis BAll patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating abacavir, dolutegravir, and lamivudine combination. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If abacavir, dolutegravir, and lamivudine combination is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate chronic HBV; otherwise, consider an alternative regime.Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued lamivudine, a component of abacavir, dolutegravir, and lamivudine combination. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
Serious side effects of Triumeq PD
Along with its needed effects, abacavir/dolutegravir/lamivudine 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 while taking abacavir / dolutegravir / lamivudine:
Less common
- Changes in weight
- dark or bloody urine
- decreased frequency or amount of urine
- fever
- increased blood pressure
- increased thirst
- itching skin
- light-colored stools
- loss of appetite
- lower back or side pain
- nausea
- stomach discomfort, upset, or pain
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual drowsiness, dullness, or feeling of sluggishness
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- yellow eyes and skin
Rare
- Rash
Incidence not known
- Blistering, peeling, or loosening of the skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, dry, or itching eyes
- chest tightness
- chills
- confusion
- cough
- decreased appetite
- 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
- general feeling of discomfort or illness
- headache
- hives
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- 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 or puffiness of the face
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
Other side effects of Triumeq PD
Some side effects of abacavir / dolutegravir / lamivudine 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
- Belching
- discouragement
- excess air or gas in the stomach or bowels
- feeling sad or empty
- full or bloated feeling
- heartburn
- indigestion
- irritability
- loss of interest or pleasure
- passing gas
- pressure in the stomach
- swelling of the stomach area
- thoughts or attempts of killing oneself
- trouble concentrating
- trouble sleeping
Rare
- Abnormal dreams
Incidence not known
- Anxiety
- loss or thinning of the hair
- weight gain around your neck, upper back, breast, or waist
For Healthcare Professionals
Applies to abacavir / dolutegravir / lamivudine: oral tablet, oral tablet dispersible.
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, dolutegravir, 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
Grade 2 and grade 3 to 4 elevations in AST were reported in up to 3% and up to 1% of therapy-naive patients, respectively. Grade 2 and grade 3 to 4 elevations in ALT were reported in up to 3% and up to 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 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.
Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of lamivudine.[Ref]
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
Rare (0.01% to 0.1%): Increased bilirubin (in combination with increased transaminases)
Frequency not reported: Drug-induced liver injury leading to liver transplant
Postmarketing reports: Acute liver failure
Abacavir, dolutegravir, and/or lamivudine:
-Frequency not reported: Liver function test abnormalities, severe hepatomegaly with steatosis
-Postmarketing reports: Acute liver failure, liver transplant
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 or hepatitis B reactivation), hepatic toxicity (including elevated serum liver biochemistries, hepatitis, acute liver failure)
Lamivudine:
-Frequency not reported: Elevated bilirubin, hepatic decompensation, severe acute exacerbations of hepatitis[Ref]
Gastrointestinal
Grade 2 and grade 3 to 4 elevations in lipase were reported in up to 11% and up to 5% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]
Very common (10% or more): Nausea, diarrhea, elevated lipase
Common (1% to 10%): Abdominal pain, abdominal distention, abdominal discomfort, dyspepsia, flatulence, gastroesophageal reflux disease, upper abdominal pain, vomiting
Rare (0.01% to 0.1%): Pancreatitis
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Stomatitis, pancreatitis
Abacavir:
-Postmarketing reports: Pancreatitis
Lamivudine:
-Frequency not reported: Elevated lipase
-Postmarketing reports: Elevated amylase, pancreatitis[Ref]
Psychiatric
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
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Anxiety
Dolutegravir:
-Postmarketing reports: Anxiety[Ref]
Suicidal ideation, attempt, behavior, and completion have been reported, mainly in patients with history of depression or other psychiatric illness.[Ref]
Nervous system
Very common (10% or more): Headache
Common (1% to 10%): Dizziness, somnolence, lethargy
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Paresthesia, peripheral neuropathy, seizures
Lamivudine:
-Postmarketing reports: Paresthesia, peripheral neuropathy[Ref]
Other
Very common (10% or more): Fatigue
Common (1% to 10%): Fever, asthenia, malaise
Frequency not reported: Fasted lipid values increased (including cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, triglycerides)
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Weakness
Dolutegravir:
-Frequency not reported: Decreased blood bicarbonate
-Postmarketing reports: Increased weight
Antiretroviral therapy:
-Frequency not reported: Increased weight, increased blood lipid levels[Ref]
Metabolic
Grade 2 and grade 3 hyperglycemia were reported in up to 9% and up to 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.[Ref]
Common (1% to 10%): Hyperglycemia
Uncommon (0.1% to 1%): Hypertriglyceridemia
Frequency not reported: Anorexia
Abacavir, dolutegravir, and/or lamivudine:
-Frequency not reported: Lactic acidosis
-Postmarketing reports: Hyperlactatemia, anorexia
Abacavir:
-Frequency not reported: Elevated blood glucose, elevated triglycerides
-Postmarketing reports: Hyperlactatemia, lactic acidosis
Lamivudine:
-Postmarketing reports: Hyperlactatemia, lactic acidosis
Antiretroviral therapy:
-Frequency not reported: Increased glucose levels[Ref]
Musculoskeletal
Common (1% to 10%): Elevated creatine phosphokinase (CPK), arthralgia
Frequency not reported: Myositis
Rare (0.01% to 0.1%): Rhabdomyolysis
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Muscle weakness, elevated CPK, myalgia, rhabdomyolysis
Abacavir:
-Frequency not reported: Elevated CPK
Dolutegravir:
-Frequency not reported: Asymptomatic CPK elevations
-Postmarketing reports: Arthralgia, myalgia
Lamivudine:
-Postmarketing reports: Muscle disorders, arthralgia, rhabdomyolysis
Combination antiretroviral therapy:
-Frequency not reported: Osteonecrosis[Ref]
Grade 2 and grade 3 to 4 elevations in CPK were reported in up to 5% and up to 7% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.
Asymptomatic CPK elevations, mainly associated with exercise, have been reported with dolutegravir.[Ref]
Hematologic
Grade 2 and grade 3 to 4 reductions in total neutrophils were reported in up to 4% and up to 3% of therapy-naive patients, respectively. In general, laboratory abnormalities were similar in therapy-experienced patients.[Ref]
Common (1% to 10%): Decreased total neutrophils
Abacavir, dolutegravir, 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[Ref]
Dermatologic
Common (1% to 10%): Rash (included rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption), pruritus, alopecia
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Urticaria, alopecia, erythema multiforme
Abacavir:
-Postmarketing reports: Rash (without systemic symptoms), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Lamivudine:
-Postmarketing reports: Alopecia[Ref]
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]
Respiratory
Common (1% to 10%): Cough
Abacavir, dolutegravir, and/or lamivudine:
-Postmarketing reports: Abnormal breath sounds/wheezing, nasal symptoms[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, autoimmune hepatitis)[Ref]
Renal
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 144 weeks. In 1 trial, a mean change from baseline of 0.14 mg/dL (range: -0.25 to 0.81 mg/dL) was reported after 144 weeks of therapy in therapy-naive patients. Creatinine increases were similar in therapy-experienced patients.[Ref]
Frequency not reported: Renal impairment, increased serum creatinine (due to inhibition of tubular secretion of creatinine)[Ref]
Cardiovascular
Several prospective, observational, epidemiological studies reported an association with the use of abacavir and the risk of MI. Meta-analysis of randomized, controlled clinical trials showed no excess risk of MI in abacavir-treated patients as compared with control subjects. Overall, available data from observational studies and controlled clinical trials showed inconsistency; evidence for causal relationship between abacavir and risk of MI was inconclusive.[Ref]
Abacavir:
-Frequency not reported: Myocardial infarction (MI)[Ref]
