Prevymis Generic Name & Formulations
Legal Class
Rx
General Description
Letermovir 240mg, 480mg; tabs.
Pharmacological Class
CMV DNA terminase complex inhibitor.
See Also
How Supplied
Tabs—14, 28; Single-dose vial—1
Manufacturer
Generic Availability
NO
Prevymis Indications
Indications
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).
Prevymis Dosage and Administration
Adult
Swallow whole. Start between Days 0 and 28 post-transplantation (before or after engraftment) and continue through Day 100 post-transplant. 480mg once daily. Concomitant cyclosporine: 240mg once daily.
Children
<18yrs: not established.
Prevymis Contraindications
Contraindications
Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.
Prevymis Boxed Warnings
Not Applicable
Prevymis Warnings/Precautions
Warnings/Precautions
Monitor for CMV reactivation after therapy completion. Renal impairment (CrCl <50mL/min): closely monitor serum creatinine (in IV use). Severe hepatic impairment (Child-Pugh C): not recommended. Pregnancy. Nursing mothers.
Prevymis Pharmacokinetics
See Literature
Prevymis Interactions
Interactions
See Contraindications. Specific interactions with cyclosporine: see full labeling. Concomitant inducers of P-gp and/or UGT, nafcillin, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, thioridazine, bosentan, St. John's wort, efavirenz, etravirine, nevirapine, pitavastatin, simvastatin, modafinil: not recommended. May be potentiated by OATP1B1/3 inhibitors. Potentiates CYP3A substrates (eg, midazolam, alfentanil, fentanyl, quinidine), OATP1B1/3 substrates: see full labeling for dose adjustment. Concomitant amiodarone, voriconazole, sirolimus, tacrolimus, omeprazole, pantoprazole: monitor frequently and adjust dose if necessary. Monitor INR with warfarin. Concomitant glyburide, repaglinide, rosiglitazone: monitor glucose levels; avoid repaglinide if co-administered with cyclosporine. Concomitant atorvastatin (max 20mg daily): monitor closely; avoid if co-administered with cyclosporine. Concomitant fluvastatin, lovastatin, pravastatin, rosuvastatin: monitor and reduce statin dose if necessary; avoid lovastatin if co-administered with cyclosporine.
Prevymis Adverse Reactions
Adverse Reactions
Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.
Prevymis Clinical Trials
See Literature
Prevymis Note
Not Applicable
Prevymis Patient Counseling
See Literature
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