Prevymis

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 30 kg Who Are HSCT Recipients or Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 40 kg Who Are Kidney Transplant Recipients:
• HSCT :
• 480 mg administered once daily orally or as an intravenous (IV) infusion over 1 hour through 100 days post-HSCT.
• In patients at risk for late CMV infection and disease, PREVYMIS may be continued through 200 days post-HSCT.
• ( 2.1 , 2.3 ) Kidney Transplant :
• 480 mg administered once daily orally or as an IV infusion over 1 hour through 200 days post-transplant.
• ( 2.1 , 2.3 ) Pediatric Patients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Who Are HSCT Recipients:
• HSCT :
• Dosing based on weight administered once daily orally or as an IV infusion over 1 hour through 100 days post-HSCT.
• In patients at risk for late CMV infection and disease, PREVYMIS may be continued through 200 days post-HSCT.
• ( 2.1 , 2.5 ) PREVYMIS injection must be diluted prior to administration.
• ( 2.1 ) PREVYMIS injection must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter.
• ( 2.1 , 2.10 ) Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended.
• ( 2.2 ) Dosage Adjustment:
• If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily in adult and pediatric patients 12 years of age and older.
• ( 2.4 ) If PREVYMIS is co-administered with cyclosporine in pediatric patients less than 12 years of age, dose adjustment may be required.
• ( 2.6 ) Instructions for Use should be followed for preparation and administration of PREVYMIS oral pellets.
• ( 2.9 )
• Do not use PREVYMIS injection with IV bags and infusion set materials containing the plasticizer diethylhexyl phthalate (DEHP).
• ( 2.10 , 2.13 )
• 2.1 Important Dosing and Administration Information PREVYMIS is available in 3 dosage forms:
• PREVYMIS Tablets - Administer orally with or without food. - Swallow tablets whole.
• PREVYMIS Oral Pellets - Administer orally mixed with soft food or via nasogastric tube (NG tube) or gastric tube (G tube) [see Dosage and Administration (2.9) ] . - Do not crush or chew.
• PREVYMIS Injection - PREVYMIS injection must be diluted prior to administration. - Administer PREVYMIS through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter. - Administer by intravenous infusion via a peripheral catheter or central venous line at a constant rate over 1 hour. - Do not administer as an intravenous bolus injection. - PREVYMIS injection, which contains hydroxypropyl betadex, should be used only in patients unable to take oral therapy.
• Patients should be switched to oral PREVYMIS as soon as they are able to take oral medications.
• If possible, intravenous administration should not exceed 4 weeks [see Warnings and Precautions (5.2) ] .
• No dosage adjustment is necessary when switching formulations in adult and pediatric patients 12 years of age and older [see Dosage and Administration (2.3) ] .
• Dosage adjustment may be necessary for pediatric patients less than 12 years of age when switching between oral and intravenous formulations (see Table 1 and Table 2 ) [see Dosage and Administration (2.5) ] .
• 2.2 Patient Monitoring Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended [see Clinical Studies (14.2) ] .
• 2.3 Recommended Dosage for Adult and Pediatric Patients 12 Years of Age and Older Who Are HSCT or Kidney Transplant Recipients HSCT:
• Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 30 kg The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.
• When PREVYMIS is administered orally, the recommended dosage is one 480 mg tablet once daily or two 240 mg tablets once daily.
• Four 120 mg packets of oral pellets once daily can be used for patients who cannot swallow tablets [see Dosage and Administration (2.9) ] .
• For preparation and administration instructions of intravenous dosing refer to instructions in subsection 2.10 [see Dosage and Administration (2.10) ].
• For pediatric patients less than 12 years of age or weighing less than 30 kg, refer to weight-based dosing in Table 1 and Table 2 [see Dosage and Administration (2.5) ] .
• Initiate PREVYMIS between Day 0 and Day 28 post-HSCT (before or after engraftment) and continue through Day 100 post-HSCT.
• In patients at risk for late CMV infection and disease, PREVYMIS may be continued through Day 200 post-HSCT [see Clinical Studies (14.2) ] .
• Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine [see Dosage and Administration (2.4) ] .
• Kidney Transplant:
• Adult and Pediatric Patients 12 Years of Age and Older and Weighing at least 40 kg The recommended dosage of PREVYMIS is 480 mg administered orally or intravenously once daily.
• When PREVYMIS is administered orally, the recommended dosage is one 480 mg tablet once daily or two 240 mg tablets once daily.
• Four 120 mg packets of oral pellets once daily can be used for patients who cannot swallow tablets [see Dosage and Administration (2.9) ] .
• For preparation and administration instructions of intravenous dosing refer to instructions in subsection 2.10 [see Dosage and Administration (2.10) ].
• Initiate PREVYMIS between Day 0 and Day 7 post-transplant and continue through Day 200 post-transplant.
• Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine [see Dosage and Administration (2.4) ] .
• 2.4 Dosage Adjustment When Co-administered with Cyclosporine for Adult and Pediatric Patients 12 Years of Age and Older Who Are HSCT or Kidney Transplant Recipients If oral or intravenous PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily in the following populations [see Drug Interactions (7.1 , 7.2 , 7.3) and Clinical Pharmacology (12.3) ] :
• HSCT:
• adult and pediatric patients 12 years of age and older and weighing at least 30 kg or Kidney transplant:
• adult and pediatric patients 12 years of age and older and weighing at least 40 kg.
• If cyclosporine is initiated after starting PREVYMIS, the next dose of PREVYMIS should be decreased to 240 mg once daily.
• If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be increased to 480 mg once daily.
• If cyclosporine dosing is interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
• 2.5 Recommended Dosage for Pediatric Patients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Who Are HSCT Recipients The recommended dosages of PREVYMIS for pediatric HSCT recipients 6 months to less than 12 years of age are based on weight and shown in Table 1 (tablets or oral pellets) and Table 2 (injection) [see Clinical Pharmacology (12.3) ] .
• PREVYMIS can be administered orally (tablet or pellet) or intravenously once daily.
• Dosage adjustment may be necessary for pediatric patients less than 12 years of age when switching between oral and intravenous formulations (see Table 1 and Table 2 ) .
• Initiate PREVYMIS between Day 0 and Day 28 post-HSCT (before or after engraftment) and continue through Day 100 post-HSCT.
• In patients at risk for late CMV infection and disease, PREVYMIS may be continued through Day 200 post-HSCT [see Clinical Studies (14.2) ] .
• Table 1:
• Recommended Daily Oral Dosage of PREVYMIS in Pediatric HSCT Recipients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Body Weight Daily Oral Dose Tablets Oral Pellets 30 kg and above 480 mg One 480 mg tablet or Two 240 mg tablets Four 120 mg packets of oral pellets 15 kg to less than 30 kg 240 mg One 240 mg tablet Two 120 mg packets of oral pellets 7.5 kg to less than 15 kg 120 mg Not recommended One 120 mg packet of oral pellets 6 kg to less than 7.5 kg 80 mg Not recommended Four 20 mg packets of oral pellets Table 2:
• Recommended Daily IV Dosage of PREVYMIS in Pediatric HSCT Recipients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Body Weight Daily IV Refer to Subsection 2.10 for intravenous preparation and administration dosing instructions Dose 30 kg and above 480 mg 15 kg to less than 30 kg 120 mg 7.5 kg to less than 15 kg 60 mg 6 kg to less than 7.5 kg 40 mg
• 2.6 Dosage Adjustment When Co-administered with Cyclosporine for Pediatric Patients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Who Are HSCT Recipients If oral or intravenous PREVYMIS is co-administered with cyclosporine in pediatric HSCT recipients 6 months to less than 12 years of age, the dosage of PREVYMIS may require adjustment as shown in Table 3 [see Drug Interactions (7.1 , 7.2 , 7.3) and Clinical Pharmacology (12.3) ] .
• If cyclosporine is initiated after starting PREVYMIS, the next dose of PREVYMIS should be the daily oral or intravenous dose co-administered with cyclosporine (Table 3) If cyclosporine is discontinued after starting PREVYMIS, the next dose of PREVYMIS should be the daily oral or intravenous dose administered without cyclosporine (Table 1 or Table 2) If cyclosporine dosing is interrupted due to high cyclosporine levels, no dose adjustment of PREVYMIS is needed.
• Table 3:
• Recommended Dosage of PREVYMIS when Co-administered with Cyclosporine in Pediatric HSCT Recipients 6 Months to Less than 12 Years of Age or 12 Years of Age and Older and Weighing Less than 30 kg Body Weight Daily Oral Dose Tablets Oral Pellets Daily IV Refer to Subsection 2.10 for intravenous preparation and administration dosing instructions Dose 30 kg and above 240 mg One 240 mg tablet Two 120 mg packets of oral pellets 240 mg 15 kg to less than 30 kg 120 mg Not recommended One 120 mg packet of oral pellets 120 mg 7.5 kg to less than 15 kg 60 mg Not recommended Three 20 mg packets of oral pellets 60 mg 6 kg to less than 7.5 kg 40 mg Not recommended Two 20 mg packets of oral pellets 40 mg
• 2.7 Use in Patients with Renal Impairment For adult patients with creatinine clearance (CLcr) greater than 10 mL/min and pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function), no dosage adjustment of PREVYMIS is required based on renal impairment [see Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] .
• There are insufficient data in adult patients with CLcr 10 mL/min or less or in patients on dialysis or in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) to make PREVYMIS dosing recommendations.
• In adult patients with CLcr less than 50 mL/min and in pediatric patients with a similar degree of renal impairment (based on age-appropriate assessment of renal function) receiving PREVYMIS injection, accumulation of the intravenous vehicle, hydroxypropyl betadex, may occur.
• Closely monitor serum creatinine levels in these patients [see Warnings and Precautions (5.2) ] .
• 2.8 Use in Patients with Hepatic Impairment No dosage adjustment of PREVYMIS is required for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
• PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment [see Use in Specific Populations (8.7) ] .
• 2.9 Preparation and Administration of Oral Pellets PREVYMIS oral pellets can be administered:
• orally after mixing with soft food or via NG tube or G tube.
• Preparation and Administration Mixed with Soft Food See Instructions for Use for details on the preparation and administration of PREVYMIS oral pellets mixed with soft food.
• Do not crush or chew PREVYMIS oral pellets.
• Mix PREVYMIS oral pellets with 1 to 3 teaspoons of soft food (such as applesauce, yogurt, or pudding) that is at or below room temperature.
• Do not use hot food.
• Administer entire mixture within 10 minutes of mixing PREVYMIS oral pellets with the soft food.
• Preparation and Administration via NG Tube or G Tube See Instructions for Use , Table 4 (NG tube) and Table 5 (G tube) for details on the preparation and administration of PREVYMIS oral pellets via NG tube or G tube.
• Pour PREVYMIS oral pellets into a medicine cup containing room temperature water (see Initial Volume in Table 4 and Table 5).
• Do not mix PREVYMIS oral pellets with hot or cold (refrigerated) water.
• Wait 10 minutes.
• Do not shake or swirl the medicine cup.
• PREVYMIS oral pellets will not dissolve but will become loose or broken up.
• The entire mixture should be administered (see steps 3 and 4) within 2 hours.
• Stir the mixture with the syringe and administer entire mixture right away using the syringe and NG tube or G tube.
• Add room temperature water (see Rinse Volume in Table 4 and Table 5) to the medicine cup for rinsing, stir with a syringe and administer the entire rinse mixture using the syringe and NG tube or G tube.
• Flush the NG tube or G tube with the volume of water recommended by the NG or G tube manufacturer.
• Table 4:
• Recommendations for Administration of PREVYMIS Oral Pellets Via NG Tube Dosage NG Tube Fr = French;
• PUR = polyurethane Syringe Type With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
• Mixing Container Initial Volume (mL) Rinse Volume (mL) 120 mg to 480 mg Any ≥ 8 Fr NG tube Appropriately sized ENFit or catheter-tipped syringe Medicine Cup 15 15 40 mg to 80 mg 5 Fr PUR NG tube or Any ≥ 6 Fr NG tube 3 2 Table 5:
• Recommendations for Administration of PREVYMIS Oral Pellets Via G Tube Dosage G Tube Fr = French;
• PUR = polyurethane Syringe Type With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
• Mixing Container Initial Volume (mL) Rinse Volume (mL) 120 mg to 480 mg Any G tube Appropriately sized ENFit or catheter-tipped syringe Medicine Cup 15 15 40 mg to 80 mg Any 12 Fr G tube 3 2
• 2.10 Preparation and Administration of Intravenous Solution PREVYMIS injection is supplied in 30 mL single-dose vials containing either 240 mg/12 mL per vial (20 mg/mL) or 480 mg/24 mL per vial (20 mg/mL).
• PREVYMIS vials are for single use only.
• Discard any unused portion.
• Preparation Instructions PREVYMIS must be diluted prior to intravenous (IV) use.
• Only 0.9% Sodium Chloride and 5% Dextrose are chemically and physically compatible with PREVYMIS injection.
• Do not shake PREVYMIS vial.
• Inspect vial contents for discoloration and particulate matter prior to dilution.
• PREVYMIS injection is a clear colorless solution and may contain a few product-related small translucent or white particles.
• Do not use the vial if the solution is cloudy, discolored, or contains matter other than a few small translucent or white particles.
• Once diluted, the solution of PREVYMIS is clear, and ranges from colorless to yellow.
• Variations of color within this range do not affect the quality of the product.
• Do not use PREVYMIS injection with IV bags and infusion set materials containing the plasticizer diethylhexyl phthalate (DEHP).
• Use only with IV bags and infusion set materials that are DEHP-free.
• Materials that are phthalate-free are also DEHP-free.
• Use compatible IV bags and infusion set materials.
• PREVYMIS injection is compatible with the following IV bags and infusion set materials.
• PREVYMIS injection is not recommended with any IV bags or infusion set materials not listed below (note that PREVYMIS injection is not recommended for use with polyurethane-containing IV administration set tubing).
• IV Bags Materials:
• Polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and polyolefin (polypropylene and polyethylene) Infusion Sets Materials:
• PVC, polyethylene (PE), polybutadiene (PBD), silicone rubber (SR), styrene–butadiene copolymer (SBC), styrene-butadiene-styrene copolymer (SBS), polystyrene (PS) Plasticizers:
• Tris (2-ethylhexyl) trimellitate (TOTM), benzyl butyl phthalate (BBP) Catheters:
• Radiopaque polyurethane For the 480 mg or 240 mg dose , add PREVYMIS injection (see Table 6 ) into a 250 mL pre-filled IV bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and mix bag gently.
• Do not shake.
• For the 120 mg or 60 mg dose , add PREVYMIS injection into a pre-filled IV bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP (see Table 6 ) and mix bag gently.
• Do not shake.
• Table 6:
• Preparation of PREVYMIS Intravenous Solution for Doses of 60 mg or Greater PREVYMIS Dose Volume of PREVYMIS 20 mg/mL to be Withdrawn from Vial Volume of Diluent 480 mg 24 mL 250 mL 240 mg 12 mL 250 mL 120 mg 6 mL 100 mL 60 mg 3 mL 50 mL For the 40 mg dose , prepare a dilution of PREVYMIS injection according to Table 7 in either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and mix bag gently.
• Transfer 20 mL from the prepared dilution into an appropriately sized IV bag or syringe.
• Do not shake.
• Table 7:
• Preparation of PREVYMIS Intravenous Solution for Doses of 40 mg PREVYMIS Dose Preparation of 2 mg/mL PREVYMIS Dilution Final Infusion Volume of the Prepared 2 mg/mL PREVYMIS Dilution 40 mg Add 5 mL of 20 mg/mL PREVYMIS to 45 mL of diluent (0.9% Sodium Chloride Injection or 5% Dextrose Injection) and mix gently 20 mL Administration Instructions Administer the entire contents of the intravenous bag or syringe by intravenous infusion via a peripheral catheter or central venous line at a constant rate over 1 hour [see Dosage and Administration (2.1) ] .
• The diluted solution must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter.
• Do not administer through a filter other than a sterile 0.2 micron or 0.22 micron PES in-line filter.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
• Discard if the diluted solution is cloudy, discolored, or contains matter other than a few small translucent or white particles.
• 2.11 Storage of the Diluted Solution The diluted solutions (as prepared in Table 6 or Table 7) are stable for up to 24 hours at room temperature or up to 48 hours under refrigeration at 2°C to 8°C (36°F to 46°F) (this time includes storage of the diluted solution in the intravenous bag through the duration of infusion).
• 2.12 Compatible Drug Products Used for Intravenous Administration Compatible Drug Products The physical compatibility of PREVYMIS injection with selected injectable drug products was evaluated in two commonly available diluents.
• PREVYMIS should not be co-administered through the same intravenous line (or cannula) with other drug products and diluent combinations except those listed below.
• Refer to the respective prescribing information of the co-administered drug(s) to confirm compatibility of simultaneous co-administration.
• List of Compatible Drug Products when PREVYMIS and Drug Products are Prepared in 0.9% Sodium Chloride Injection, USP:
• Ampicillin sodium, ampicillin sodium/sulbactam sodium, anti-thymocyte globulin, caspofungin, daptomycin, fentanyl citrate, fluconazole, furosemide, human insulin, magnesium sulfate, methotrexate, micafungin.
• List of Compatible Drug Products when PREVYMIS and Drug Products are Prepared in 5% Dextrose Injection, USP:
• Amphotericin B (lipid complex) Amphotericin B (lipid complex) is compatible with PREVYMIS.
• However, Amphotericin B (liposomal) is incompatible [see Dosage and Administration (2.13) ] . , anidulafungin, cefazolin sodium, ceftaroline, ceftriaxone sodium, doripenem, famotidine, folic acid, ganciclovir sodium, hydrocortisone sodium succinate, morphine sulfate, norepinephrine bitartrate, pantoprazole sodium, potassium chloride, potassium phosphate, tacrolimus, telavancin, tigecycline.
• 2.13 Incompatible Drug Products and Other Materials Used for Intravenous Administration Incompatible Drug Products PREVYMIS injection is physically incompatible with amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
• Incompatible IV Bags and Infusion Set Materials PREVYMIS injection is incompatible with diethylhexyl phthalate (DEHP) plasticizers and polyurethane-containing IV administration set tubing.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of PREVYMIS have been established for:
• Prophylaxis of CMV infection and disease in pediatric CMV-seropositive recipients of an allogeneic HSCT 6 months of age and older and weighing at least 6 kg, and Prophylaxis of CMV disease in pediatric kidney transplant recipients 12 years of age and older and weighing at least 40 kg who are at high risk [D+/R-].
• HSCT Recipients:
• The use of PREVYMIS for prophylaxis of CMV infection and disease in pediatric recipients of an allogeneic HSCT is supported by evidence from adequate and well-controlled studies in
• adults with additional pharmacokinetic and safety data from pediatric patients in Trial P030.
• The safety and pharmacokinetic results were similar to those in
• adults [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical studies (14.2 , 14.4) ].
• Kidney Transplant Recipients:
• The use of PREVYMIS for prophylaxis of CMV disease in high-risk [D+/R-] kidney transplant recipients 12 years of age and older and weighing at least 40 kg is supported by evidence from an adequate and well-controlled study in
• adults and safety data from pediatric HSCT recipients (Trial P030).
• Letermovir exposures are expected to be similar between adult and pediatric patients 12 years of age and older and weighing at least 40 kg [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical studies (14.3 , 14.4) ].
• The safety and effectiveness of PREVYMIS have not been established for:
• HSCT recipients less than 6 months of age or weighing less than 6 kg, or Kidney transplant recipients less than 12 years of age or weighing less than 40 kg.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the 373 subjects treated with PREVYMIS in Trial P001, 56 (15%) subjects were 65 years of age or older.
• Of the 144 subjects treated with PREVYMIS in Trial P040, 32 (22%) subjects were 65 years of age or older.
• Of the 292 subjects treated with PREVYMIS in Trial P002, 48 (16%) subjects were 65 years of age or older.
• Safety and efficacy were similar across older and younger subjects in each trial.
• No dosage adjustment of PREVYMIS is required based on age [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• Adult HSCT Patients:
• Most common adverse events (occurring in at least 10% of subjects in the PREVYMIS group and at a frequency at least 2% greater than placebo) are nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.
• ( 6.1 ) Adult Kidney Transplant Patients:
• Most common adverse event (occurring in at least 10% of subjects in the PREVYMIS group and at a frequency greater than valganciclovir) is diarrhea.
• ( 6.1 ) Pediatric Patients: Adverse events in pediatric patients are similar to adults.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Adult CMV-seropositive Recipients [R+] of an Allogeneic HSCT Prophylaxis Through Week 14 (~100 days) Post-HSCT The safety of PREVYMIS was evaluated in a Phase 3 randomized, double-blind, placebo-controlled trial (P001) in which 565 subjects were randomized and treated with PREVYMIS (N=373) or placebo (N=192) through Week 14 post-HSCT.
• Adverse events were those reported while subjects were on study medication or within two weeks of study medication completion/discontinuation.
• The mean time for reporting adverse events and laboratory abnormalities was approximately 22% longer in the PREVYMIS arm compared to the placebo arm.
• Cardiac Adverse Events The cardiac adverse event rate was higher in subjects receiving PREVYMIS (13%) compared to subjects receiving placebo (6%).
• The most common cardiac adverse events 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 one or more cardiac adverse events, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.
• Common Adverse Events The rate of adverse events occurring in at least 10% of subjects in the PREVYMIS group and at a frequency at least 2% greater than placebo are outlined in Table 8.
• Table 8:
• Trial P001 All Grade Adverse Events Reported in ≥ 10% of PREVYMIS-Treated HSCT Recipients at a Frequency at least 2% Greater than Placebo Adverse Events PREVYMIS (N=373) Placebo (N=192) nausea 27% 23% diarrhea 26% 24% vomiting 19% 14% peripheral edema 14% 9% cough 14% 10% headache 14% 9% fatigue 13% 11% abdominal pain 12% 9% Overall, similar proportions of subjects in each group discontinued study medication due to an adverse event (13% of PREVYMIS subjects vs. 12% of placebo subjects).
• The most frequently reported adverse event that led to study drug discontinuation was nausea, occurring in 2% of PREVYMIS subjects and 1% of placebo subjects.
• Hypersensitivity reaction, with associated moderate dyspnea, occurred in one subject following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.
• Laboratory Abnormalities Selected laboratory abnormalities reported during treatment or within 2 weeks of stopping treatment are presented in Table 9.
• Table 9:
• Trial P001 Selected Laboratory Abnormalities PREVYMIS N=373 Placebo N=192 Absolute neutrophil count (cells/μL) < 500 19% 19% 500 – < 750 4% 7% 750 – < 1000 8% 9% Hemoglobin (g/dL) < 6.5 2% 1% 6.5 – < 8.0 14% 15% 8.0 – < 9.5 41% 43% Platelets (cells/μL) < 25000 27% 21% 25000 – < 50000 17% 18% 50000 – < 100000 20% 30% Serum creatinine (mg/dL) > 2.5 2% 3% > 1.5 – 2.5 17% 20% The median time to engraftment (defined as absolute neutrophil count ≥ 500/mm 3 on 3 consecutive days after transplantation) was 19 days in the PREVYMIS group and 18 days in the placebo group.
• Prophylaxis From Week 14 (~100 days) Through Week 28 (~200 days) Post-HSCT The safety of PREVYMIS was evaluated in a Phase 3 randomized, double-blind, placebo-controlled trial (P040) in which 218 subjects who completed PREVYMIS prophylaxis through ~100 days post-HSCT were randomized to treatment with PREVYMIS (N=144) or placebo (N=74) through Week 28 (~200 days) post-HSCT.
• Adverse events were those reported while subjects were on study drug or within two weeks of study drug completion/discontinuation.
• The most commonly reported adverse events in P040 were similar to those reported in P001.
• Study drug was discontinued due to an adverse event in 5% of PREVYMIS subjects and 1% of placebo subjects.
• The cardiac adverse event rate was 4% in the PREVYMIS and placebo groups.
• The rates of hematologic laboratory abnormalities were comparable in the PREVYMIS and placebo groups.
• Serum creatinine abnormalities > 1.5 mg/dL occurred in 15% of PREVYMIS and 8% of placebo subjects.
• Adult Kidney Transplant Recipients [D+/R-] The safety of PREVYMIS was evaluated in a Phase 3 randomized, double-blind, active comparator-controlled trial (P002) in which 589 subjects were treated with PREVYMIS (N=292) or valganciclovir (N=297) through Week 28 post-transplant.
• Adverse events were those reported while subjects were on study medication or within two weeks of study medication completion/discontinuation.
• In these subjects, diarrhea was reported in at least 10% of subjects in the PREVYMIS group and at a frequency greater than valganciclovir (PREVYMIS, 32%; valganciclovir, 29%).
• Study drug was discontinued due to an adverse event in 4% of PREVYMIS subjects and 14% of valganciclovir subjects.
• The most frequently reported adverse events that led to study drug discontinuation were neutropenia (PREVYMIS, 1%; valganciclovir, 2%) and leukopenia (PREVYMIS, 1%; valganciclovir, 5%).
• Laboratory Abnormalities Selected laboratory abnormalities reported through Week 28 post-transplant are presented in Table 10.
• Table 10:
• Trial P002 Selected Laboratory Abnormalities PREVYMIS N=292 Valganciclovir N=297 Absolute neutrophil count (cells/μL) < 500 2% 7% 500 – < 750 1% 4% 750 – < 1000 1% 8% Total < 1000 5% 18% Hemoglobin (g/dL) < 6.5 2% 0% 6.5 – < 8.0 4% 5% 8.0 – < 9.5 29% 32% Total < 9.5 34% 37% Platelets (cells/μL) < 50000 0% 0% 50000 – < 100000 1% 3% Total < 100000 1% 3% Leukocytes (cells/μL) < 1000 1% 2% 1000 – < 2000 5% 19% 2000 – < 2500 4% 14% Total < 2500 10% 35% Serum creatinine (mg/dL) > 2.5 24% 22% > 1.5 – 2.5 49% 52% Total > 1.5 73% 73% Pediatric Recipients of an Allogeneic HSCT The safety of PREVYMIS was evaluated in 63 pediatric subjects aged 2 months to less than 18 years of age who received an allogeneic HSCT (P030).
• PREVYMIS was administered orally (tablet or pellet) or intravenously.
• The duration of PREVYMIS exposure ranged from 3 days to 102 days (median duration 84 days).
• The safety profile was consistent with the safety profile observed in clinical trials of PREVYMIS in
• adults [see Use in Specific Populations (8.4) and Clinical Studies (14.4) ].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ).
• Drug Interactions Inform patients that PREVYMIS may interact with some drugs; therefore, advise patients to report the use of any prescription, non-prescription medication, or herbal products to their healthcare provider [see Dosage and Administration (2.4 , 2.6) , Contraindications (4) , Warnings and Precautions (5.1) , and Drug Interactions (7) ] .
• Risks Associated with Hydroxypropyl Betadex Excipient in Intravenous Formulation Inform patients that the intravenous formulation of PREVYMIS contains hydroxypropyl betadex which is eliminated through glomerular filtration and may accumulate in patients with renal impairment.
• In animals, hydroxypropyl betadex has been shown to cause ototoxicity [see Warnings and Precautions (5.2) , Use in Specific Populations (8.6) and Nonclinical Toxicology (13.2) ].
• Administration Inform patients that it is important not to miss or skip doses and to take PREVYMIS for the duration that is recommended by the healthcare provider.
• Instruct patients that if they miss a dose of PREVYMIS, they should take it as soon as they remember.
• If they do not remember until it is time for the next dose, instruct them to skip the missed dose and go back to the regular schedule.
• Instruct patients not to double their next dose or take more than the prescribed dose.
• Advise patients that PREVYMIS injection should be used only in patients unable to take oral therapy and that patients should be switched to oral therapy as soon as they are able [see Dosage and Administration (2.1) ] .
• For PREVYMIS oral pellets, advise patients or caregivers to read and follow the Instructions for Use for preparing and taking the correct dose [see Dosage and Administration (2.3 , 2.4 , 2.5 , 2.6 , 2.9) ] .
• Storage Advise patients to store PREVYMIS tablets and oral pellets in the original package until use [see How Supplied/Storage and Handling (16) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Tablet:
• 240 mg; 480 mg ( 3 ) Oral Pellets:
• 20 mg or 120 mg per packet ( 3 ) Injection:
• 240 mg/12 mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) in a single-dose vial ( 3 ) Tablets PREVYMIS 240 mg tablet:
• yellow oval tablet with "591" on one side and corporate logo on the other side.
• PREVYMIS 480 mg tablet:
• pink oval, bi-convex tablet with "595" on one side and corporate logo on the other side.
• Oral Pellets PREVYMIS oral pellets: beige round pellets in packets.
• Each packet contains 20 mg letermovir.
• PREVYMIS oral pellets: beige round pellets in packets.
• Each packet contains 120 mg letermovir.
• Injection PREVYMIS 240 mg/12 mL (20 mg/mL) injection:
• clear and colorless solution in a single-dose vial.
• PREVYMIS 480 mg/24 mL (20 mg/mL) injection:
• clear and colorless solution in a single-dose vial.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Tablets:
• Each PREVYMIS 240 mg tablet is a yellow oval tablet; each tablet is debossed with "591" on one side and corporate logo on the other side.
• Each PREVYMIS 480 mg tablet is a pink oval, bi-convex tablet debossed with "595" on one side and corporate logo on the other side.
• The 240 mg tablets are packaged into a carton (NDC 0006-3075-02) containing four (4) Child Resistant (CR) Dosepaks®, each containing a 7-count blister card for a total of 28 tablets, or into a carton (NDC 0006-3075-04) containing two (2) unit-dose 7-count blister cards for a total of 14 tablets.
• The 480 mg tablets are packaged into a carton (NDC 0006-3076-02) containing four (4) Child Resistant (CR) Dosepaks®, each containing a 7-count blister card for a total of 28 tablets, or into a carton (NDC 0006-3076-04) containing two (2) unit-dose 7-count blister cards for a total of 14 tablets.
• Store PREVYMIS tablets in the original package until use to protect from moisture.
• Store PREVYMIS tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Oral Pellets: PREVYMIS oral pellets are supplied as beige round pellets in packets.
• Each packet contains 20 mg of letermovir.
• PREVYMIS oral pellets are supplied as beige round pellets in packets.
• Each packet contains 120 mg of letermovir.
• The 20 mg packets of PREVYMIS oral pellets are packaged into a carton (NDC 0006-5086-01).
• Each carton contains 30 child resistant packets.
• The 120 mg packets of PREVYMIS oral pellets are packaged into a carton (NDC 0006-5085-01).
• Each carton contains 30 child resistant packets.
• Store PREVYMIS oral pellets in the original packet until use.
• Store PREVYMIS oral pellets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Injection:
• PREVYMIS is supplied as a sterile, clear and colorless solution for intravenous use of 240 mg/12 mL (20 mg/mL) or 480 mg/24 mL (20 mg/mL) that may contain a few product-related small translucent or white particles.
• The single-dose vials are supplied in cartons that contain a 240 mg single-dose vial (NDC 0006-5003-01) or a 480 mg single-dose vial (NDC 0006-5004-01).
• Store PREVYMIS injection vials at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Store in the original carton to protect from exposure to light.

Quoted from the official label, section “How Supplied”.

How to store it

• Store PREVYMIS tablets in the original package until use to protect from moisture. Store PREVYMIS tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Store PREVYMIS injection vials at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original carton to protect from exposure to light.

Quoted from the official label, section “Storage and Handling”.

What is in it

• PREVYMIS contains letermovir, an inhibitor of the CMV DNA terminase complex, and is administered orally or by intravenous infusion.
• Letermovir has a molecular formula of C 29 H 28 F 4 N 4 O 4 and a molecular weight of 572.55.
• The chemical name for letermovir is (4 S )-2-{8-Fluoro-2-[4-(3- methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5- (trifluoromethyl)phenyl]-3,4-dihydroquinazolin-4-yl}acetic acid.
• Letermovir is very slightly soluble in water.
• The chemical structure of letermovir is:
• PREVYMIS is available as 240 mg and 480 mg tablets.
• PREVYMIS tablets contain either 240 mg or 480 mg of letermovir and the following inactive ingredients:
• colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone 25, and film-coated with a coating material containing the following inactive ingredients:
• hypromellose 2910, iron oxide red (only for 480 mg tablets), iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
• Carnauba wax is added as a polishing agent.
• PREVYMIS is available as 20 mg and 120 mg packets of oral pellets.
• PREVYMIS packets of oral pellets contain either 20 mg or 120 mg of letermovir.
• PREVYMIS oral pellets contain the following inactive ingredients:
• colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone K-29/32, and are film-coated with a coating material containing the following inactive ingredients:
• hypromellose 2910, iron oxide red, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
• PREVYMIS is also available as 240 mg/12 mL (20 mg/mL) and 480 mg/24 mL (20 mg/mL) injection for intravenous infusion.
• PREVYMIS injection is a clear, preservative-free sterile solution and may contain a few small translucent or white particles in single-dose vials of either 240 mg or 480 mg per vial.
• Each 1 mL of solution contains 20 mg letermovir, hydroxypropyl betadex (150 mg), sodium chloride (3.1 mg), sodium hydroxide (1.2 mg), and Water for Injection.
• The amount of sodium hydroxide may be adjusted to achieve a pH of approximately 7.5.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Letermovir