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PREVYMIS
Viral infections
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Drug Name:

PREVYMIS Rx

Generic Name and Formulations:
Letermovir 240mg, 480mg; tabs.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for PREVYMIS:

Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).

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.

Contraindications:

Concomitant pimozide, ergot alkaloids. Concomitant pitavastatin, simvastatin when co-administered with cyclosporine.

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.

See Also:

PREVYMIS INJECTION

Pharmacological Class:

CMV DNA terminase complex inhibitor.

Interactions:

See Contraindications. Specific interactions with cyclosporine: see full labeling. 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, phenytoin, 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 rifampin, pitavastatin, simvastatin: not recommended. 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.

Adverse Reactions:

Nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, abdominal pain, lab abnormalities.

Generic Availability:

NO

How Supplied:

Tabs—14, 28; Single-dose vial (30mL)—1

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