ferric derisomaltose 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
5687 1345510-43-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • ferric derisomaltose
  • NS32
  • monover
  • monoferric
Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
  • Molecular weight:
  • Formula: C12H24FeO11(C6H10O5)n
  • CLOGP: -5.19
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS: -0.25
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 16, 2020 FDA PHARMACOSMOS AS
March 28, 2022 PMDA Nippon Shinyaku Co., Ltd

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
Fishbane reaction 116.66 54.80 12 928 6 63488076
Flushing 112.55 54.80 42 898 75045 63413037
Chest discomfort 110.39 54.80 46 894 109923 63378159
Dyspnoea 91.95 54.80 76 864 661237 62826845
Procedural anxiety 64.58 54.80 11 929 765 63487317

FDA Adverse Event Reporting System (Male)

None

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
Flushing 130.71 51.38 47 967 88221 79655153
Chest discomfort 117.01 51.38 49 965 137995 79605379
Fishbane reaction 95.36 51.38 10 1004 11 79743363
Dyspnoea 86.68 51.38 77 937 856948 78886426
Procedural anxiety 59.40 51.38 10 1004 756 79742618

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

None

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Iron deficiency anemia indication 87522002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 DISCN SOLUTION INTRAVENOUS 8815301 Aug. 14, 2029 METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
1GM/10ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 RX SOLUTION INTRAVENOUS 8815301 Aug. 14, 2029 METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
500MG/5ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 DISCN SOLUTION INTRAVENOUS 8815301 Aug. 14, 2029 METHOD OF TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
100MG/ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 DISCN SOLUTION INTRAVENOUS 11633489 June 22, 2036 TREATMENT OF IRON DEFICIENCY ANEMIA (DIA) IN ADULTS PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
1GM/10ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 RX SOLUTION INTRAVENOUS 11633489 June 22, 2036 TREATMENT OF IRON DEFICIENCY ANEMIA (DIA) IN ADULTS PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE
500MG/5ML (100MG/ML) MONOFERRIC PHARMACOSMOS AS N208171 Jan. 16, 2020 DISCN SOLUTION INTRAVENOUS 11633489 June 22, 2036 TREATMENT OF IRON DEFICIENCY ANEMIA (DIA) IN ADULTS PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON, WHO HAVE NON-HEMODIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE, BY ADMINISTERING FERRIC DERISOMALTOSE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Serotransferrin Enzyme UNKNOWN DRUG LABEL

External reference:

IDSource
CHEMBL4298187 ChEMBL_ID
C000718030 MESH_SUPPLEMENTAL_RECORD_UI
DB15617 DRUGBANK_ID
013537 NDDF
4039692 VANDF
C5233985 UMLSCUI
9712 INN_ID
1172494003 SNOMEDCT_US
1172497005 SNOMEDCT_US
D11808 KEGG_DRUG
86278348 PUBCHEM_CID
2274394 RXNORM
296635 MMSL
34025 MMSL
d07699 MMSL
AHU547PI9H UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9301 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 28 sections
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9301 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 28 sections
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9305 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 28 sections
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9305 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 28 sections
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9310 INJECTION, SOLUTION 1000 mg INTRAVENOUS NDA 28 sections
Monoferric HUMAN PRESCRIPTION DRUG LABEL 1 73594-9310 INJECTION, SOLUTION 1000 mg INTRAVENOUS NDA 28 sections