Prevymis Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Letermovir

Indications/Uses

Prophylaxis of cytomegalovirus (CMV) infection & disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

Click to view Prevymis detailed prescribing information

Dosage/Direction for Use

480 mg once daily started on transplant day & no later than 28 days post-transplant. Co-administration w/ cyclosporine Decreased to 240 mg once daily. Infusion conc: Administer by IV infusion over approx 60 min.

Click to view Prevymis detailed prescribing information

Overdosage

View Prevymis overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: Swallow whole, do not chew/crush/divide.

Contraindications

Hypersensitivity. Concomitant use w/ pimozide, ergot alkaloids; cyclosporine w/ pitavastatin o simvastatin.

Click to view Prevymis detailed prescribing information

Special Precautions

Monitor CVM DNA on wkly basis. Concomitant use w/ CYP3A substrates w/ narrow therapeutic ranges eg, alfentanil, fentanyl, quinidine. Not recommended in severe hepatic impairment; moderate hepatic impairment w/ moderate or severe renal impairment. ESRD w/ or w/o dialysis. Not recommended in women of childbearing potential & during pregnancy. Lactation. Childn <18 yr. Infusion conc: Not to be administered as IV bolus inj.

Click to view Prevymis detailed prescribing information

Use In Pregnancy & Lactation

Click to view Prevymis detailed prescribing information

Adverse Reactions

Nausea, diarrhoea, vomiting.

Click to view Prevymis detailed prescribing information

Drug Interactions

Decreased plasma conc by nafcillin, carbamazepine, phenobarb, phenytoin, rifabutin, rifampin, thioridazine, bosentan, St. John's wort, efavirenz, etravirine, nevirapine, modafinil. Decreased plasma conc of warfarin, voriconazole, PPIs. Increased plasma conc of amiodarone, glyburide, statins, HMG-CoA reductase inhibitors, cyclosporine, sirolimus, tacrolimus, CYP2C8 & CYP3A substrates.

Click to view Prevymis detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Prevymis detailed prescribing information

Storage

View Prevymis storage conditions for details to ensure optimal shelf-life.

Description

View Prevymis description for details of the chemical structure and excipients (inactive components).

Action

View Prevymis mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Antivirals

ATC Classification

J05AX18 - letermovir ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.

Regulatory Classification

Presentation/Packing

Form

Prevymis FC tab 240 mg

Packing/Price

28's

Form

Prevymis infusion conc (vial) 240 mg/12 mL

Packing/Price

1's

Form

Prevymis infusion conc (vial) 480 mg/24 mL

Packing/Price

1's

Prevymis

letermovir

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma