Dovato Side Effects

Generic name: dolutegravir / lamivudine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 24, 2023.

Note: This document contains side effect information about dolutegravir / lamivudine. Some dosage forms listed on this page may not apply to the brand name Dovato.

Applies to dolutegravir / lamivudine: oral tablet.

Warning

Oral route (Tablet)

Warning: Patients Co-Infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV-1): Emergence of Lamivudine-Resistant HBV and Exacerbations of HBVAll patients with HIV-1 should be tested for the presence of HBV prior to or when initiating dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If dolutegravir / lamivudine is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of dolutegravir / lamivudine. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Serious side effects of Dovato

Along with its needed effects, 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 dolutegravir / lamivudine:

Less common

Black, tarry stools
bleeding gums
bloody urine
chills
cough
dark urine
decreased frequency or amount of urine
fast heartbeat
fever
hives, itching, skin rash
hoarseness
increased blood pressure
increased thirst
irritation
joint pain, stiffness, or swelling
light-colored stools
loss of appetite
lower back or side pain
nausea
painful or difficult urination
pale skin
pinpoint red spots on the skin
redness of the skin
sore throat
stomach discomfort or pain
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
trouble breathing or swallowing
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal or stomach pain
vomiting
weight gain
yellow eyes and skin

Incidence not known

Blurred vision
diarrhea
dry mouth
fast, shallow breathing
flushed, dry skin
fruit-like breath odor
headache
increased hunger
increased urination
light-colored stools
muscle cramps, pain, stiffness, or spasms
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
sleepiness
stomach pain, continuing
sweating
unexplained weight loss
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet

Other side effects of Dovato

Some side effects of 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

Abnormal dreams
anxiety
bloated or full feeling
discouragement
dizziness
excess air or gas in the stomach or bowels
feeling sad or empty
headache
loss of interest or pleasure
passing gas
thoughts or attempts at killing oneself
trouble concentrating
trouble sleeping

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
difficulty in moving
hair loss or thinning of hair
redistribution of body fat

For Healthcare Professionals

Applies to dolutegravir / lamivudine: oral tablet.

Nervous system

Very common (10% or more): Headache (up to 11%)

Common (1% to 10%): Dizziness, somnolence

Dolutegravir:

-Very common (10% or more): Headache

-Common (1% to 10%): Dizziness

Lamivudine:

-Common (1% to 10%): Headache

-Postmarketing reports: Paresthesia, peripheral neuropathy^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 12%)

Common (1% to 10%): Elevated lipase, nausea, hemorrhoids, abdominal pain, gastroenteritis

Dolutegravir:

-Very common (10% or more): Nausea, diarrhea

-Common (1% to 10%): Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting

Lamivudine:

-Common (1% to 10%): Nausea, vomiting, upper abdominal pain, diarrhea

-Postmarketing reports: Pancreatitis, elevated serum amylase^[Ref]

Grade 2 (greater than 1.5 to 3 times the upper limit of normal [1.5 to 3 x ULN]) and grade 3 to 4 (greater than 3 x ULN) elevated lipase have been reported in 6% and 2% of patients, respectively.^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, pharyngitis, bronchitis, influenza, tonsillitis, sinusitis, oropharyngeal pain, cough

Metabolic

Common (1% to 10%): Hyperglycemia, hypophosphatemia, vitamin D deficiency

Dolutegravir or lamivudine:

-Postmarketing reports: Redistribution/accumulation of body fat, hyperglycemia, lactic acidosis

Lamivudine:

-Postmarketing reports: Hyperlactatemia, lactic acidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose levels^[Ref]

Grade 2 (glucose 126 to 250 mg/dL [6.95 to 13.89 mmol/L]) and grade 3 to 4 (glucose greater than 250 mg/dL [greater than 13.89 mmol/L]) hyperglycemia have been reported in up to 9% and up to 1% of patients, respectively. Grade 2 (phosphate 1.4 to less than 2 mg/dL [0.65 to 0.81 mmol/L]) and grade 3 to 4 (phosphate less than 1.4 mg/dL [less than 0.65 mmol/L]) hypophosphatemia have been reported in up to 9% and up to 1% of patients, respectively.

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

Musculoskeletal

Common (1% to 10%): Elevated creatine phosphokinase (CPK), back pain, arthralgia

Frequency not reported: Myositis

Dolutegravir or lamivudine:

-Postmarketing reports: Arthralgia, elevated CPK, muscle weakness, myalgia, rhabdomyolysis

Dolutegravir:

-Frequency not reported: Asymptomatic CPK elevations (mainly associated with exercise)

-Postmarketing reports: Arthralgia, myalgia

Lamivudine:

-Postmarketing reports: Arthralgia, muscle disorders, rhabdomyolysis

Combination antiretroviral therapy:

-Frequency not reported: Osteonecrosis^[Ref]

Grade 2 (6 to less than 10 x ULN) and grade 3 to 4 (at least 10 x ULN) elevated CPK have been reported in 4% and up to 6% of patients, respectively.^[Ref]

Psychiatric

Suicidal ideation, attempt, behavior, or completion were reported primarily in patients with history of depression or other psychiatric illness.^[Ref]

Common (1% to 10%): Insomnia, depression, anxiety

Frequency not reported: Suicidal ideation/attempt/behavior/completion

Dolutegravir:

-Common (1% to 10%): Abnormal dreams, suicidal ideation, depression, anxiety, insomnia

-Uncommon (0.1% to 1%): Suicide attempt^[Ref]

Other

Common (1% to 10%): Fatigue (includes fatigue, asthenia, malaise), syphilis, gonorrhea, influenza-like illness, pyrexia/fever, anogenital warts

Frequency not reported: Fasted lipid values increased (including cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, triglycerides), total cholesterol/HDL cholesterol ratio decreased

Dolutegravir or lamivudine:

-Postmarketing reports: Weakness, weight increased

Dolutegravir:

-Common (1% to 10%): Fatigue

-Postmarketing reports: Weight increased

Lamivudine:

-Common (1% to 10%): Fatigue, malaise, fever

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipid levels^[Ref]

Hepatic

Common (1% to 10%): Elevated ALT, elevated AST, elevated total bilirubin

Rare (0.01% to 0.1%): Increased bilirubin (in combination with increased transaminases)

Dolutegravir or lamivudine:

-Postmarketing reports: Hepatic steatosis, posttreatment exacerbations of hepatitis B virus (HBV), acute liver failure, hepatotoxicity

Dolutegravir:

-Uncommon (0.1% to 1%): Hepatitis

-Frequency not reported: Transaminase/liver chemistry elevations (consistent with immune reconstitution syndrome or hepatitis B reactivation), hepatic toxicity (including elevated serum liver biochemistries, hepatitis, acute liver failure)

-Postmarketing reports: Acute hepatic failure

Lamivudine:

-Uncommon (0.1% to 1%): Transient elevated liver enzymes (AST, ALT)

-Postmarketing reports: Acute hepatic failure^[Ref]

Grade 2 (2.5 to less than 5 x ULN) and grade 3 to 4 (at least 5 x ULN) elevated ALT have been reported in up to 3% and 3% of patients, respectively. Grade 2 (2.5 to less than 5 x ULN) and grade 3 to 4 (at least 5 x ULN) elevated AST have been reported in up to 4% and up to 3% of patients, respectively. Grade 2 (1.6 to less than 2.6 x ULN) and grade 3 to 4 (at least 2.6 x ULN) elevated total bilirubin have been reported in up to 2% and up to 1% of patients, respectively.

Small elevations in total bilirubin (without clinical jaundice) were reported; such changes were not considered clinically relevant.

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

Severe acute exacerbations of HBV have been reported in patients coinfected with HBV and HIV-1 after discontinuation of lamivudine-containing products.

Transaminase/liver chemistry 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.^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, alopecia, herpes zoster

Rare (0.01% to 0.1%): Angioedema

Dolutegravir or lamivudine:

-Postmarketing reports: Urticaria, alopecia

Dolutegravir:

-Common (1% to 10%): Pruritus, rash

Lamivudine:

-Common (1% to 10%): Rash

-Postmarketing reports: Alopecia^[Ref]

Immunologic

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

Dolutegravir:

-Uncommon (0.1% to 1%): Immune reconstitution syndrome^[Ref]

Hematologic

Dolutegravir or lamivudine:

-Postmarketing reports: Anemia (including pure red cell aplasia and severe anemias progressing on therapy)

Lamivudine:

-Uncommon (0.1% to 1%): Anemia, neutropenia, thrombocytopenia

-Postmarketing reports: Pure red cell aplasia^[Ref]

Hypersensitivity

Dolutegravir or lamivudine:

-Postmarketing reports: Anaphylaxis

Dolutegravir:

-Uncommon (0.1% to 1%): Hypersensitivity/hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)^[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 96 weeks. A mean change from baseline of 10.3 mcmol/L (range: -36.3 mcmol/L to 55.7 mcmol/L) was reported after 48 weeks of therapy with dolutegravir plus lamivudine; a mean change from baseline of 0.138 mg/dL was reported after 96 weeks of therapy with dolutegravir plus lamivudine. These changes were not considered clinically relevant.^[Ref]

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