Prevymis

— THERAPEUTIC CATEGORIES —
  • Viral infections

Prevymis Generic Name & Formulations

General Description

Letermovir 240mg, 480mg; tabs.

Pharmacological Class

CMV DNA terminase complex inhibitor.

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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