Frequently asked questions about PREVYMIS® (letermovir)
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What is the indication and usage for PREVYMIS® (letermovir)?
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).
What is the recommended dosing for PREVYMIS® (letermovir)?
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.
Start PREVYMIS as early as day 0 and no later than day 28 post-transplant and continue through day 100 post-transplant.
PREVYMIS can be initiated before or after engraftment.
Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation is recommended.
What is the Selected Safety Information for PREVYMIS® (letermovir)?
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.
What is PREVYMIS® (letermovir)?
PREVYMIS is an antiviral approved for CMV prophylaxis in adult CMV-seropositive recipients of allogeneic HSCT. A novel CMV DNA terminase complex inhibitor, PREVYMIS targets a component of the terminase complex involved in viral DNA cleavage and packaging, restricting drug activity to the virus alone.1
Reference
Griffiths PD, Emery VC. Taming the transplantation troll by targeting terminase. N Engl J Med. 2014;370(19):1844–1846.
Is there additional information to help me understand my patients’ coverage for PREVYMIS® (letermovir)?
Yes. The Merck Access Program for PREVYMIS may be able to help answer questions about insurance coverage for patients, benefit investigations, and the prior authorization and appeals process.
Is there a coupon available for PREVYMIS® (letermovir)?
Yes. Eligible, privately insured patients may pay as little as $15 per prescription on each of up to 8 qualifying prescriptions for up to a one-month’s supply per prescription. Maximum savings is $2,500 per prescription.
Your patients can visit PREVYMIS.com to request a coupon, and if eligible, activate and bring to their pharmacy along with their prescription.
Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Tell your eligible, privately insured patients to visit PREVYMIS.com to review the Terms and Conditions.
Also, eligible health care professionals may request coupons for PREVYMIS for use with their appropriate patients.
George B, Pati N, Gilroy N, et al. Pre-transplant cytomegalovirus (CMV) serostatus remains the most important determinant of CMV reactivation after allogeneic hematopoietic stem cell transplantation in the era of surveillance and preemptive therapy. Transpl Infect Dis. 2010;12(4):322–329.
Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant recipients. Hematol Oncol Clin North Am. 2011;25(1):151–169.
Sousa H, Boutolleau D, Ribeiro J, et al. Cytomegalovirus infection in patients who underwent allogeneic hematopoietic stem cell transplantation in Portugal: a five-year retrospective review. Biol Blood Marrow Transplant. 2014;20(12):1958–1967.
Green ML, Leisenring W, Xie H, et al. Cytomegalovirus viral load and mortality after haematopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective cohort study. Lancet Haematol. 2016;3(3):e119–e127.
Teira P, Battiwalla M, Ramanathan M, et al. Early cytomegalovirus reactivation remains associated with increased transplant-related mortality in the current era: a CIBMTR analysis. Blood. 2016; 127(20)2427-2438. doi:10.1182/blood-2015-11-679639
Did PREVYMIS® (letermovir) demonstrate significant efficacy vs placebo in CMV seropositive HSCT patients?
Yes. PREVYMIS demonstrated significant efficacy vs placebo in the primary endpoint: Clinically significant CMV infectiona at week 24 (NC=F approach)b. See full clinical data and end points at the link below.
(a) Clinically significant CMV infection was defined as either the occurrence of CMV end-organ disease or initiation of anti-CMV PET, based on documented CMV viremia and the clinical condition of the patient. Viremia was determined using the Roche COBAS® AmpliPrep/COBAS TaqMan® assay; lower limit of quantification was 137 IU/mL, which is approximately 150 copies/mL.
(b) The Noncompleter=Failure (NC=F) approach was used in which patients who discontinued from the study prior to week 24 post-transplant or had a missing outcome at week 24 post-transplant were counted as failures.
What is the adverse events profile for PREVYMIS® (letermovir)?
Adverse events (AE) profile
Cardiac AEs The cardiac AE rate was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%). The most common cardiac AEs were tachycardia (reported in 4% of PREVYMIS subjects and in 2% of placebo subjects) and atrial fibrillation (reported in 3% of PREVYMIS subjects and in 1% of placebo subjects). Among those subjects who experienced 1 or more cardiac AEs, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.
All grade AEs reported in ≥10% of patients treated with PREVYMIS at a frequency at least 2% greater than placebo
Drug-related renal and hepatic AEs1
Rates of discontinuation due to AEs were comparable between PREVYMIS and placebo (13% vs 12%, respectively)
No differences in incidence of or time to engraftmenta between PREVYMIS and placebo2
(a) Engraftment was defined as an absolute neutrophil count ≥500/mm3 on 3 consecutive days after transplantation.
References
Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-CYT-01362.
Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. N Engl J Med. 2017;377(25)(suppl):1-54. Accessed September 6, 2023. http://www.nejm.org/doi/suppl/10.1056/NEJMoa1706640/suppl_file/nejmoa1706640_appendix.pdf
Are there additional resources for PREVYMIS® (letermovir)?
Yes. Please see additional professional resources and medical education videos on the Professional Resources page, at the link below. There you can learn and understand about early CMV reactivation, identify appropriate patients for prophylaxis with PREVYMIS, and view clinical data for PREVYMIS.
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.
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TERMS AND CONDITIONS
no
no
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.
