Tivicay Side Effects

Generic Name: dolutegravir

Note: This page contains side effects data for the generic drug dolutegravir. It is possible that some of the dosage forms included below may not apply to the brand name Tivicay.

It is possible that some side effects of Tivicay may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to dolutegravir: oral tablet

As well as its needed effects, dolutegravir (the active ingredient contained in Tivicay) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking dolutegravir, check with your doctor immediately:

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 dolutegravir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Very common (10% or more): Diarrhea (up to 16%), nausea (up to 15%)
Common (1% to 10%): Elevated lipase, abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting

Grade 2 and Grade 3 to 4 elevations in lipase were reported in up to 8% and up to 3% of therapy-naive patients, respectively. Elevated lipase was reported in 8% of therapy-experienced INSTI-experienced patients.

Metabolic

Common (1% to 10%): Hyperglycemia
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")

Grade 2 and Grade 3 hyperglycemia were reported in up to 7% and up to 1% of therapy-naive patients, respectively. 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, abnormal dreams

Hepatic

Grade 2 and Grade 3 to 4 elevations in AST were reported in up to 3% and up to 2% of therapy-naive patients, respectively. Grade 2 and Grade 3 to 4 elevations in ALT were reported in 2% and up to 2% of therapy-naive patients, respectively. Grade 2 and Grade 3 to 4 elevations in total bilirubin were reported in up to 2% and less than 1% of therapy-naive patients, respectively. 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, elevated ALT, elevated total bilirubin, hepatitis
Frequency not reported: Liver chemistry elevations consistent with immune reconstitution syndrome

Musculoskeletal

Grade 2 and Grade 3 to 4 elevations in creatine kinase were reported in up to 3% and up to 4% of therapy-naive patients, respectively.

Common (1% to 10%): Elevated creatine kinase, myositis

Hematologic

Common (1% to 10%): Decreased total neutrophils, hematology laboratory abnormality

Grade 2 and Grade 3 to 4 reductions in total neutrophils were reported in up to 3% and 2% of therapy-naive patients, respectively. 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

Very common (10% or more): Headache (up to 14%)
Common (1% to 10%): Dizziness

Dermatologic

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

Renal

Common (1% to 10%): Renal impairment
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

Hypersensitivity

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

Immunologic

Uncommon (0.1% to 1%): Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

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