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Note: This document contains side effect information about letermovir. Some of the dosage forms listed on this page may not apply to the brand name Prevymis.For the Consumer
Applies to letermovir: oral tablet
Other dosage forms:
Along with its needed effects, letermovir (the active ingredient contained in Prevymis) 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 letermovir:
Some side effects of letermovir 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:
For Healthcare Professionals
Applies to letermovir: intravenous solution, oral tabletGeneral
Side effects included those reported during treatment with study medication or within 2 weeks of study medication completion/discontinuation; the time for reporting side effects and laboratory abnormalities averaged about 22% longer with this drug compared to with placebo. The side effects most commonly reported included nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.Hematologic
Decreased hemoglobin (less than 6.5 g/dL: 2%; 6.5 to less than 8 g/dL: 14%; 8 to less than 9.5 g/dL: 41%), platelets (less than 25,000 cells/mcL: 27%; 25,000 to less than 50,000 cells/mcL: 17%; 50,000 to less than 100,000 cells/mcL: 20%), and absolute neutrophil count (less than 500 cells/mcL: 19%; 500 to less than 750 cells/mcL: 4%; 750 to less than 1000 cells/mcL: 8%) were reported during therapy or within 2 weeks of stopping therapy.
Very common (10% or more): Decreased hemoglobin (up to 41%), decreased platelets (up to 27%), decreased absolute neutrophil count (up to 19%)Gastrointestinal
Very common (10% or more): Nausea (27%), diarrhea (26%), vomiting (19%), abdominal pain (12%)Renal
Increased serum creatinine (greater than 2.5 mg/dL: 2%; greater than 1.5 to 2.5 mg/dL: 17%) was reported during therapy or within 2 weeks of stopping therapy.
Very common (10% or more): Increased serum creatinine (up to 17%)Other
Very common (10% or more): Peripheral edema (14%), fatigue (13%)Nervous system
Very common (10% or more): Headache (14%)
Uncommon (0.1% to 1%): Dysgeusia, vertigoRespiratory
Very common (10% or more): Cough (14%)
Frequency not reported: DyspneaCardiovascular
Common (1% to 10%): Tachycardia, atrial fibrillation
The cardiac side effect rate was higher in patients using this drug (13%) compared to those using placebo (6%). Tachycardia (4% [compared to 2% with placebo]) and atrial fibrillation (3% [compared to 1% with placebo]) were the most commonly reported cardiac side effects. Most cardiac side effects were reported as mild or moderate in severity.Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reaction
After switching from the oral formulation, hypersensitivity reaction (associated with moderate dyspnea) was reported in 1 patient after the first IV infusion; as a result, treatment was discontinued.Hepatic
Uncommon (0.1% to 1%): Increased ALT, increased ASTMetabolic
Uncommon (0.1% to 1%): Decreased appetiteMusculoskeletal
Uncommon (0.1% to 1%): Muscle spasms
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