Applies to maribavir: oral tablet.

Serious side effects of Maribavir

Along with its needed effects, maribavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects of Maribavir

Some side effects of maribavir 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:

More common

• Change of taste
• diarrhea
• loss of taste
• nausea
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to maribavir: oral tablet.

General

The most commonly reported adverse reactions in patients treated with this drug were taste disturbance, nausea, diarrhea, vomiting, and fatigue. The most commonly reported serious adverse reactions were diarrhea, nausea, decreased weight, fatigue, immunosuppressant drug level increased, and vomiting. More patients in the investigator-assigned treatment group (32%) discontinued therapy due to a side effect compared to those in the group using this drug (13%); the most common side effects leading to discontinuation of this drug were dysgeusia, diarrhea, nausea, and recurrence of underlying disease.^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Gastrointestinal

Very common (10% or more): Nausea (up to 21%), diarrhea (up to 19%), vomiting (up to 14%)

Common (1% to 10%): Upper abdominal pain

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 32%), decreased platelets (up to 18%)

Common (1% to 10%): Decreased neutrophils, neutropenia, leukopenia

Decreased hemoglobin (8 to less than 9.5 g/dL: 32%; 6.5 to less than 8 g/dL: 15%; less than 6.5 g/dL: 1%), platelets (50,000 to less than 100,000 cells/mcL: 18%; 25,000 to less than 50,000 cells/mcL: 12%; less than 25,000 cells/mcL: 5%), and neutrophils (750 to less than 1000 cells/mcL: 4%; 500 to less than 750 cells/mcL: 3%; less than 500 cells/mcL: 2%) have been reported.

Metabolic

Common (1% to 10%): Hypomagnesemia, hypokalemia, decreased appetite

Nervous system

Taste disturbance was reported in 46% of patients using this drug; this resolved in 37% of patients during therapy (median duration: 43 days; range: 7 to 59 days) and rarely resulted in discontinuation of this drug. For patients with ongoing taste disturbances after stopping this drug, resolution occurred in 89%; the median duration of symptoms off therapy was 6 days (range: 2 to 85 days).

Very common (10% or more): Taste disturbance (includes ageusia, dysgeusia, hypogeusia, taste disorder; up to 46%)

Common (1% to 10%): Headache

Other

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

Common (1% to 10%): Pyrexia, peripheral edema, immunosuppressant drug level increased (includes immunosuppressant drug level increased, drug level increased), decreased weight

Frequency not reported: CMV infection/disease, recurrence of underlying disease

Renal

Increased creatinine greater than 1.5 to 2.5 mg/dL was reported in 33% of patients; increased creatinine greater than 2.5 mg/dL was reported in 7% of patients.

Very common (10% or more): Increased creatinine (up to 33%)

Common (1% to 10%): Acute kidney injury