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Dolutegravir Side Effects

For the Consumer

Applies to dolutegravir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by dolutegravir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • 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

Minor Side Effects

Some of the side effects that can occur with dolutegravir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.[Ref]

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[Ref]

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.[Ref]

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")[Ref]

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.[Ref]

Psychiatric

Common (1% to 10%): Insomnia, abnormal dreams[Ref]

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 therapy, especially when antihepatitis therapy was stopped.[Ref]

Common (1% to 10%): Elevated AST, elevated ALT, elevated total bilirubin, hepatitis
Frequency not reported: Liver chemistry elevations consistent with immune reconstitution syndrome[Ref]

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.[Ref]

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

Hematologic

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.[Ref]

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

Nervous system

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

Dermatologic

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

Renal

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.[Ref]

Common (1% to 10%): Renal impairment
Frequency not reported: Increased serum creatinine (due to inhibition of tubular secretion of creatinine)[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Hypersensitivity

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

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)[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Tivicay (dolutegravir)." ViiV Healthcare, Research Triangle Park, NC.

Not all side effects for dolutegravir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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