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Prevymis Dosage

Generic name: LETERMOVIR 240mg
Dosage form: tablet, film coated
Drug class: Miscellaneous antivirals

Medically reviewed by Drugs.com. Last updated on Aug 30, 2024.

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).
      -
      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.
  • ​No dosage adjustment is necessary when switching formulations in adult and pediatric patients 12 years of age and older.
  • ​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).

Patient Monitoring

Following the completion of PREVYMIS prophylaxis, monitoring for CMV reactivation in HSCT recipients is recommended.

​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. For preparation and administration instructions of intravenous dosing refer to instructions in subsection 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.

​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.

​Dosage of PREVYMIS should be adjusted when co-administered with cyclosporine.

​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. For preparation and administration instructions of intravenous dosing refer to instructions in subsection 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.

​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:
    • 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). 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.

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* Dose
*
Refer to Subsection 2.10 for intravenous preparation and administration dosing instructions
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.

  • ​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* Dose
*
Refer to Subsection 2.10 for intravenous preparation and administration dosing instructions
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.
  • ​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.

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.

​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.

  1. ​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.
  2. ​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.
  3. ​Stir the mixture with the syringe and administer entire mixture right away using the syringe and NG tube or G tube.
  4. ​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.
  5. ​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* ​Syringe Type† ​Mixing Container ​Initial Volume (mL) ​Rinse Volume (mL)
*
Fr = French; PUR = polyurethane
†
With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
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* ​Syringe Type† ​Mixing Container ​Initial Volume (mL) ​Rinse Volume (mL)
*
Fr = French; PUR = polyurethane
†
With ENFit syringe, a medicine straw (large bore) is needed to aid withdrawal of the mixture from the medicine cup.
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

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.
  • 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.

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).

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)1, 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.
1
Amphotericin B (lipid complex) is compatible with PREVYMIS. However, Amphotericin B (liposomal) is incompatible.

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.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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