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Prevymis

Prevymis

letermovir

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Letermovir
Indications/Uses
Prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
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Dosage/Direction for Use
Adult FC tab Recommended dose: 480 mg once daily. Co-administration w/ cyclosporine Decreased dose to 240 mg once daily. If cyclosporine is discontinued, the next dose should be increased to 480 mg once daily. Inj Administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter by IV infusion via peripheral catheter or central venous line over approx 60 min.
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Overdosage
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Administration
FC Tab: May be taken with or without food. Swallow whole, do not divide/crush/chew.
Contraindications
Hypersensitivity. Concomitant administration w/ pimozide, ergot alkaloids, cyclosporine w/ pitavastatin or simvastatin.
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Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Prevymis detailed prescribing information
Special Precautions
Not to be administered as IV bolus inj. Possible clinically significant adverse reactions from greater exposure of concomitant drugs. Significant decrease of concomitant drug plasma conc leading to reduced therapeutic effect. CYP3A substrates w/ narrow therapeutic ranges (eg, alfentanil, fentanyl, & quinidine). Closely monitor serum creatinine levels in patients w/ moderate or severe renal impairment (CrCl <50 mL/min). ESRD (CrCl <10 mL/min), including patients on dialysis. Not recommended in patients w/ moderate hepatic impairment combined w/ moderate or severe renal impairment. Pregnancy & lactation. Ped <18 yr.
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Adverse Reactions
Nausea, diarrhea, & vomiting.
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Drug Interactions
Increased plasma conc w/ OATP1B1/3 transporters inhibitors, rifampin. Decreased plasma conc w/ strong & moderate inducers of transporters (eg, P-gp) &/or enzymes (eg, UGTs). Increased plasma conc of amiodarone, glyburide, CYP2C8 substrates eg, repaglinide, rosiglitazone, CYP3A substrates eg, alfentanil, fentanyl, midazolam, quinidine. Decreased plasma conc w/ nafcillin, carbamazepine, phenobarb, phenytoin, voriconazole, efavirenz, etravirine, nevirapine. Decreased plasma conc of warfarin, rifabutin, rifampin, thioridazine, bosentan, St. John's wort. Not recommended in co-administration w/ pitavastatin, simvastatin. Increased statin plasma conc. Increased conc of both letermovir & cyclosporine. Increased conc of sirolimus. Decreased conc of PPIs eg, omeprazole, pantoprazole.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Prevymis detailed prescribing information
Storage
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Description
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Action
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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.
Presentation/Packing
Form
Prevymis FC tab 240 mg
Packing/Price
4 × 7's
Form
Prevymis inj soln 240 mg/12 mL
Packing/Price
((single-dose)) 1's
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