letermovir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antivirals 5262 917389-32-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • letermovir
  • prevymis
  • AIC246
Letermovir inhibits the CMV DNA terminase complex (pUL51, pUL56, and pUL89) which is required for viral DNA processing and packaging. Biochemical characterization and electron microscopy demonstrated that letermovir affects the production of proper unit length genomes and interferes with virion maturation. Genotypic characterization of virus resistant to letermovir confirmed that letermovir targets the terminase complex.
  • Molecular weight: 572.56
  • Formula: C29H28F4N4O4
  • CLOGP: 6.92
  • LIPINSKI: 2
  • HAC: 8
  • HDO: 1
  • TPSA: 77.84
  • ALOGS: -4.76
  • ROTB: 7
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.48 g O
0.48 g P

ADMET properties:

PropertyValueReference
S (Water solubility) 0.35 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 0.94 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,BRAF,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4,PIK3CG,PRKDC 13
kinase-selectivity-class AXL,GRK2 2
pfas-class PFAS structural alert (1 = True, 0 = False) 1

Approvals:

DateAgencyCompanyOrphan
Jan. 8, 2018 EMA Merck Sharp & Dohme Limited
March 23, 2018 PMDA MSD KK
Nov. 8, 2017 FDA MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytomegalovirus infection reactivation 282.27 48.18 60 2300 7740 90618347
Off label use 197.66 48.18 187 2173 1102065 89524022
Cytomegalovirus infection 148.14 48.18 46 2314 26556 90599531
Post transplant lymphoproliferative disorder 144.44 48.18 34 2326 6915 90619172
Cytomegalovirus viraemia 116.06 48.18 29 2331 7557 90618530
Pathogen resistance 99.48 48.18 26 2334 8089 90617998
Drug resistance 98.60 48.18 35 2325 30414 90595673
Graft versus host disease 85.11 48.18 23 2337 8121 90617966
Retinitis viral 83.68 48.18 13 2347 282 90625805
Cytomegalovirus test positive 61.31 48.18 15 2345 3576 90622511
Graft versus host disease in gastrointestinal tract 58.32 48.18 15 2345 4373 90621714
Viral load increased 56.36 48.18 12 2348 1544 90624543
Immunosuppressant drug level increased 52.58 48.18 14 2346 4666 90621421
Cytomegalovirus colitis 52.04 48.18 13 2347 3373 90622714
Product use in unapproved indication 49.80 48.18 52 2308 336184 90289903

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytomegalovirus infection reactivation 455.93 45.23 117 3299 11061 42606858
Encephalitis cytomegalovirus 337.74 45.23 62 3354 1177 42616742
Epstein-Barr viraemia 259.30 45.23 55 3361 2234 42615685
BK virus infection 244.16 45.23 68 3348 8716 42609203
Cystitis haemorrhagic 223.34 45.23 61 3355 7268 42610651
Off label use 208.74 45.23 253 3163 638082 41979837
Generalised oedema 163.38 45.23 57 3359 15279 42602640
Nephropathy toxic 150.69 45.23 55 3361 16783 42601136
Respiratory distress 125.70 45.23 63 3353 41757 42576162
Pancytopenia 125.65 45.23 91 3325 117652 42500267
Myelosuppression 118.79 45.23 60 3356 40401 42577518
Lung disorder 92.95 45.23 54 3362 47869 42570050
Pathogen resistance 89.90 45.23 34 3382 11416 42606503
Acute kidney injury 85.07 45.23 124 3292 367213 42250706
Drug resistance 81.07 45.23 44 3372 34204 42583715
Cytomegalovirus infection 80.65 45.23 43 3373 32263 42585656
Oesophagitis 70.59 45.23 31 3385 15216 42602703
Cytomegalovirus viraemia 67.90 45.23 27 3389 10350 42607569
Gingivitis ulcerative 58.69 45.23 11 3405 233 42617686
Cytomegalovirus test positive 53.51 45.23 18 3398 4301 42613618
Product use in unapproved indication 47.92 45.23 66 3350 184390 42433529
Thrombotic microangiopathy 46.47 45.23 23 3393 14759 42603160

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cytomegalovirus infection reactivation 722.29 38.68 172 5673 18161 110565293
Off label use 392.44 38.68 433 5412 1499752 109083702
Encephalitis cytomegalovirus 349.38 38.68 64 5781 1846 110581608
Epstein-Barr viraemia 274.56 38.68 58 5787 3521 110579933
Cystitis haemorrhagic 268.54 38.68 72 5773 12137 110571317
BK virus infection 258.84 38.68 71 5774 13035 110570419
Nephropathy toxic 203.13 38.68 70 5775 27408 110556046
Cytomegalovirus infection 202.85 38.68 84 5761 54360 110529094
Cytomegalovirus viraemia 186.52 38.68 59 5786 17705 110565749
Pathogen resistance 174.44 38.68 56 5789 17616 110565838
Pancytopenia 173.21 38.68 118 5727 209495 110373959
Drug resistance 160.70 38.68 72 5773 56302 110527152
Generalised oedema 158.53 38.68 60 5785 30644 110552810
Post transplant lymphoproliferative disorder 139.96 38.68 46 5799 15567 110567887
Myelosuppression 128.30 38.68 73 5772 94267 110489187
Respiratory distress 123.43 38.68 64 5781 68810 110514644
Cytomegalovirus test positive 111.02 38.68 32 5813 7004 110576450
Acute kidney injury 101.75 38.68 145 5700 635285 109948169
Immunosuppressant drug level increased 90.99 38.68 31 5814 11693 110571761
Graft versus host disease 90.74 38.68 35 5810 18771 110564683
Product use in unapproved indication 84.95 38.68 111 5734 447266 110136188
Cytomegalovirus colitis 84.77 38.68 26 5819 7035 110576419
Drug ineffective 81.57 38.68 218 5627 1520322 109063132
Mucosal inflammation 76.55 38.68 53 5792 96088 110487366
Aplastic anaemia 75.49 38.68 33 5812 24275 110559179
Drug interaction 75.32 38.68 111 5734 500072 110083382
Oesophagitis 73.32 38.68 34 5811 28681 110554773
Acute graft versus host disease in skin 70.25 38.68 25 5820 10715 110572739
Retinitis viral 68.73 38.68 13 5832 446 110583008
Graft versus host disease in gastrointestinal tract 62.94 38.68 22 5823 8946 110574508
Thrombotic microangiopathy 60.68 38.68 30 5815 29119 110554335
Acute graft versus host disease 58.68 38.68 23 5822 12858 110570596
Lung disorder 56.55 38.68 58 5787 179989 110403465
Gingivitis ulcerative 54.95 38.68 11 5834 509 110582945
Drug level increased 54.46 38.68 33 5812 47686 110535768
Viral load increased 47.21 38.68 14 5831 3376 110580078
Cystitis viral 43.55 38.68 11 5834 1462 110581992
Parenteral nutrition 43.54 38.68 10 5835 890 110582564
Septic shock 42.80 38.68 47 5798 157481 110425973
Pneumonia cytomegaloviral 41.02 38.68 15 5830 6939 110576515
Febrile neutropenia 38.76 38.68 64 5781 316703 110266751

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AX18 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Other antivirals
MeSH PA D000067856 Poly(ADP-ribose) Polymerase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
FDA MoA N0000185507 Cytochrome P450 2C9 Inducers
FDA MoA N0000185607 Cytochrome P450 2C19 Inducers
FDA MoA N0000187062 Cytochrome P450 2C8 Inhibitors
FDA MoA N0000190107 Organic Anion Transporting Polypeptide 1B1 Inhibitors
FDA MoA N0000190108 Organic Anion Transporting Polypeptide 1B3 Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
FDA EPC N0000193800 Cytomegalovirus DNA Terminase Complex Inhibitor
FDA MoA N0000193801 DNA Terminase Complex Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent

Related Drugs by ATC class:

J05AX Other antivirals 15 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Cytomegalovirus infection indication 28944009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.4 acidic
pKa2 6.77 Basic
pKa3 4.76 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL June 5, 2026 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL June 5, 2026 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS June 5, 2026 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS June 5, 2026 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 2, 2026 EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 2, 2026 EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 2, 2026 EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 2, 2026 EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2027 NEW PATIENT POPULATION
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2027 NEW PATIENT POPULATION
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2027 NEW PATIENT POPULATION
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2027 NEW PATIENT POPULATION
120MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2027 NEW PRODUCT
20MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2027 NEW PRODUCT
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL June 5, 2030 FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL June 5, 2030 FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS June 5, 2030 FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS June 5, 2030 FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
120MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL June 5, 2030 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
20MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL June 5, 2030 FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
240MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG PREVYMIS MERCK SHARP DOHME N209939 Nov. 8, 2017 RX TABLET ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
240MG/12ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
480MG/24ML (20MG/ML) PREVYMIS MERCK SHARP DOHME N209940 Nov. 8, 2017 RX SOLUTION INTRAVENOUS Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
120MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
120MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
20MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
20MG/PACKET PREVYMIS MSD N219104 Aug. 30, 2024 RX PELLETS ORAL Aug. 30, 2031 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER AND WEIGHING AT LEAST 6 KG WHO ARE CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA terminase complex Enzyme INHIBITOR EC50 8.68 DRUG LABEL DRUG LABEL

External reference:

IDSource
1H09Y5WO1F UNII
4037136 VANDF
C3852938 UMLSCUI
CHEBI:749693 CHEBI
CHEMBL1241951 ChEMBL_ID
45138674 PUBCHEM_CID
DB12070 DRUGBANK_ID
D10801 KEGG_DRUG
9384 INN_ID
C000588473 MESH_SUPPLEMENTAL_RECORD_UI
763033005 SNOMEDCT_US
763568003 SNOMEDCT_US
265515 MMSL
33254 MMSL
d08676 MMSL
017399 NDDF
1988648 RXNORM
1H09Y5WO1F INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3075 TABLET, FILM COATED 240 mg ORAL NDA 31 sections
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3076 TABLET, FILM COATED 480 mg ORAL NDA 31 sections
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-5003 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-5004 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 31 sections
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-5085 PELLET 120 mg ORAL NDA 31 sections
PREVYMIS HUMAN PRESCRIPTION DRUG LABEL 1 0006-5086 PELLET 20 mg ORAL NDA 31 sections