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: tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking dolutegravir (the active ingredient contained in Tivicay)
Headache; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; fever, chills, or persistent sore throat; general feeling of being unwell; mouth sores or blisters; muscle or joint aches; red, swollen, blistered, or peeling skin; redness or swelling of the eyes; severe or persistent tiredness or weakness; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or vomiting, stomach pain, yellowing of the skin or eyes).
For Healthcare Professionals
Applies to dolutegravir: oral tablet
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.
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.
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.
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%)
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
Common (1% to 10%): Elevated creatine kinase (Grade 3 to 4: up to 4%; Grade 2: up to 3%), myositis (less than 2%)
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.
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%)
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%)
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.
Common (1% to 10%): Fatigue (less than 2%)
Uncommon (0.1% to 1%): Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury; up to 1%)
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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