Medication Guide App

Tivicay Side Effects

Generic Name: dolutegravir

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

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

For the Consumer

Applies to dolutegravir: oral tablet

Along with its needed effects, dolutegravir (the active ingredient contained in Tivicay) 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:

Less common
  • Black, tarry stools
  • blistering or peeling skin
  • bloody urine
  • burning, dry, or itching eyes
  • chest pain
  • chills
  • cough
  • dark urine
  • decreased frequency or amount of urine
  • difficulty with breathing
  • discharge or excessive tearing
  • fever
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle or joint aches
  • nausea and vomiting
  • painful or difficult urination
  • rash with fever
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • severe rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, or lower legs
  • swollen glands
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weight gain
  • yellow eyes and skin

Some side effects of dolutegravir 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
  • Abdominal or stomach pain or discomfort
  • headache
  • itching skin
  • trouble sleeping
Rare
  • Abnormal dreams
  • diarrhea
  • dizziness
Incidence not known
  • Weight gain around your neck, upper back, breast, face, or waist

For Healthcare Professionals

Applies to dolutegravir: oral tablet

General

Discontinuation due to side effects was reported in 2% of therapy-naive patients, 2% of therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients, and 3% of therapy-experienced INSTI-experienced patients.

Gastrointestinal

Common (1% to 10%): Elevated lipase (Grade 2: up to 8%; Grade 3 to 4: up to 3%), abdominal pain (less than 2%), abdominal discomfort (less than 2%), flatulence (less than 2%), upper abdominal pain (less than 2%), vomiting (less than 2%)
Uncommon (0.1% to 1%): Nausea (Grade 2 to 4: up to 1%), diarrhea (Grade 2 to 4: up to 1%)

Elevated lipase was reported in 8% of therapy-experienced INSTI-experienced patients.

Metabolic

Common (1% to 10%): Hyperglycemia (Grade 2: up to 7%)
Uncommon (0.1% to 1%): Hyperglycemia (Grade 3: up to 1%)
Frequency not reported: Fasted lipid values increased (including cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Hyperglycemia and elevated cholesterol were reported in 12% and 8% of therapy-experienced INSTI-experienced patients, respectively.

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

Psychiatric

Common (1% to 10%): Insomnia (Grade 1: up to 7%; Grade 2 to 4: up to 3%)
Uncommon (0.1% to 1%): Abnormal dreams (Grade 2 to 4: less than 1%)

Hepatic

Elevated ALT and AST were reported in 8% and 6% of therapy-experienced INSTI-experienced patients, respectively.

The rates of AST and ALT abnormalities were higher patients coinfected with hepatitis B and/or C virus. ALT abnormalities (Grade 2 to 4) in hepatitis B and/or C coinfected patients compared with HIV monoinfected patients were reported in 16% versus 2% with 50 mg once a day and 8% versus 7% with 50 mg twice a day.

Liver chemistry elevations consistent with immune reconstitution syndrome were reported in some patients with hepatitis B and/or C at the start of dolutegravir (the active ingredient contained in Tivicay) therapy, especially when antihepatitis therapy was stopped.

Common (1% to 10%): Elevated AST (Grade 2: up to 3%; Grade 3 to 4: up to 2%), elevated ALT (Grade 2: 2%; Grade 3 to 4: up to 2%), elevated total bilirubin (Grade 2: up to 2%), hepatitis (less than 2%)
Uncommon (0.1% to 1%): Elevated total bilirubin (Grade 3 to 4: less than 1%)
Frequency not reported: Liver chemistry elevations consistent with immune reconstitution syndrome

Musculoskeletal

Common (1% to 10%): Elevated creatine kinase (Grade 3 to 4: up to 4%; Grade 2: up to 3%), myositis (less than 2%)

Hematologic

Common (1% to 10%): Decreased total neutrophils (Grade 2: up to 3%; Grade 3 to 4: 2%), hematology laboratory abnormality

Hematology laboratory abnormality (Grade 3 to 4) was reported in 2% of therapy-experienced INSTI-experienced patients, with neutropenia (1%) reported most often.

Nervous system

Common (1% to 10%): Headache (Grade 2 to 4: up to 2%)
Uncommon (0.1% to 1%): Dizziness (Grade 2 to 4: less than 1%)

Dermatologic

Common (1% to 10%): Pruritus (less than 2%)
Uncommon (0.1% to 1%): Rash (includes rash, generalized rash, macular rash, maculopapular rash, pruritic rash, drug eruption; Grade 2 to 4: less than 1%)

Renal

Common (1% to 10%): Renal impairment (less than 2%)
Frequency not reported: Increased serum creatinine (due to inhibition of tubular secretion of creatinine)

Increased serum creatinine occurred 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 48 weeks. A mean change of 0.11 mg/dL (range of -0.6 to 0.62 mg/dL) was reported after 48 weeks of therapy in therapy-naive patients.

Other

Common (1% to 10%): Fatigue (less than 2%)

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury; up to 1%)

Immunologic

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

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