PREVYMIS^® (letermovir) 240mg, 480mg tablets / Injection 20mg/mL

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FDA Approves New Indication for Merck’s PREVYMIS® (letermovir)

Dosing for PREVYMIS^® (letermovir) in CMV R+ allogeneic HSCT patients

Once-daily dosing with PREVYMIS as early as the day of transplant

Timeline for Dosing of PREVYMIS® (letermovir) Post-Transplant

Start PREVYMIS as early as day 0 and no later than day 28 post-transplant.
PREVYMIS can be initiated before or after engraftment.
Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation is recommended.

Oral or IV dosing

Once-daily dosing

The Recommended Dosage of PREVYMIS® is 480 mg Administered Orally or Intravenously Once Daily

480 mg tablet

PREVYMIS® (letermovir) 480 mg IV Infusion Vial

480 mg/24 mL vial

If Co-administered With Cyclosporine, the Recommended Dose of PREVYMIS is 240 mg Once Daily

240 mg tablet

PREVYMIS® (letermovir) 240 mg IV Infusion Vial

240 mg/12 mL vial

Tablets and vials not actual size.

The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.

Please see full Prescribing Information for proper preparation and administration of PREVYMIS IV infusion.
If coadministered with cyclosporine, the recommended dose of PREVYMIS is 240 mg once daily.

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Indication

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

Selected Safety Information

PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids.
- - Increased pimozide concentrations may lead to QT prolongation and torsades de pointes.
  - Increased ergot alkaloids concentrations may lead to ergotism.
PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.
The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.
The rate of adverse events occurring in at least 10% of HSCT recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).
Hypersensitivity reaction, with associated moderate dyspnea, occurred in one HSCT recipient following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.
If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.
Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions.
Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection.
PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.
The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.

Before prescribing PREVYMIS^® (letermovir), please read the accompanying Prescribing information. The Patient information also is available.

Indication Indication

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV)

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)

Selected Safety Information Selected Safety Information

PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids.
- - Increased pimozide concentrations may lead to QT prolongation and torsades de pointes.
  - Increased ergot alkaloids concentrations may lead to ergotism.
PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.
The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug.
The rate of adverse events occurring in at least 10% of HSCT recipients treated with PREVYMIS and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).
Hypersensitivity reaction, with associated moderate dyspnea, occurred in one HSCT recipient following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.
If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily.
Co-administration of PREVYMIS may alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PREVYMIS. Consult the full Prescribing Information prior to and during treatment for potential drug interactions.
Closely monitor serum creatinine levels in patients with CLcr less than 50 mL/min using PREVYMIS injection.
PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.
The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.
For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.