Letermovir
PREVYMIS
What it isCMV terminase complex inhibitor; CMV prophylaxis after stem cell transplant.
Why this oneIt has no myelosuppression, unlike ganciclovir, which matters in a marrow already recovering.
What limits itProphylaxis only; it does not treat established CMV disease. It inhibits CYP3A4 and raises cyclosporine and tacrolimus.
FDA-approved for
- CMV prophylaxis after transplant (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| CMV prophylaxis (HSCT) | Adults & peds ≥12 yr, ≥30 kg | 480 mg QD | 480 mg QD | 480 mg QD |
| CMV prophylaxis (kidney transplant) | Adults & peds ≥12 yr, ≥40 kg | 480 mg QD | 480 mg QD | 480 mg QD |
| CMV prophylaxis (HSCT) | Peds 6 mo–<12 yr (weight-based) | weight-based QD | 40–480 mg QD by weight (6 kg–≥30 kg) | 480 mg QD |
Renal No adjustment for CLcr >10 mL/min; insufficient data if CLcr ≤10 mL/min or on dialysis. With IV formulation and CLcr <50 mL/min, monitor serum creatinine (hydroxypropyl betadex accumulation).
Hepatic No adjustment for mild–moderate (Child-Pugh A/B); not recommended in severe (Child-Pugh C).
With cyclosporine, reduce to 240 mg QD in patients ≥12 yr.
Instructions
- Tablets: swallow whole, with or without food.
- Oral pellets: mix with soft food (≤ room temp) or give via NG/G tube; do not crush or chew.
- Injection: dilute before use; infuse over 1 hr through 0.2/0.22 micron PES in-line filter; use only if unable to take oral, do not exceed 4 weeks; not as IV bolus; avoid DEHP-containing IV bags/sets.
- HSCT: start Day 0–28, continue to Day 100 (or 200 if late-CMV risk). Kidney: start Day 0–7, continue to Day 200.
Contraindications
- Pimozide (CYP3A inhibition → ↑pimozide, QT prolongation/torsades)
- Ergot alkaloids (ergotamine, dihydroergotamine) — risk of ergotism
- Pitavastatin or simvastatin when co-administered with cyclosporine (myopathy/rhabdomyolysis)
Cautions
- Significant CYP3A drug interactions — review concomitant meds
- IV formulation contains hydroxypropyl betadex: accumulation in renal impairment, potential ototoxicity (animal); limit IV to ≤4 weeks
Adverse reactions
- Nausea, diarrhea, vomiting
- Peripheral edema, cough, headache, fatigue, abdominal pain
- Cardiac events (tachycardia, atrial fibrillation)
Pregnancy No adequate human data; animal embryo-fetal toxicity/malformations at ~11x human exposure.
Lactation Unknown in human milk; present in milk of lactating rats.
NO BOXED WARNINGS
Principal riskProphylaxis only; it raises tacrolimus and cyclosporine
Cost, est. cash$300–$2,000/month
Generic entry2033 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityAgent-specific renal, hepatic, hematologic, metabolic and drug-interaction toxicity.
Mechanism of action: Letermovir ballicule
