Details of the Drug

General Information of Drug (ID: DMIWFRL)

• Drug Name: Tolvaptan
• Synonyms: Samsca; OPC 41061; Benzazepine derivative, 32; OPC-41061; Samsca (TN); N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide; (-)-4'-((7-Chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl)-o-tolu-m-toluidide; 7-Chloro-5-hydroxy-1-(2-methyl-4-(2-methylbenzoylamino)benzoyl)2,3,4,5-tetrahydro-1H-1-benzazepine

Indication

Disease Entry	ICD 11	Status	REF
Autosomal dominant polycystic kidney disease	GB81	Approved	[1]
Hyponatraemia	5C72	Approved	[2]
Heart failure	BD10-BD13	Phase 3	[2]
Hypernatremia	5C71	Investigative	[1]

• Drug Type: Small molecular drug
• #Ro5 Violations (Lipinski): 0:
  Molecular Weight (mw); 448.9
  Logarithm of the Partition Coefficient (xlogp); 4.8
  Rotatable Bond Count (rotbonds); 3
  Hydrogen Bond Donor Count (hbonddonor); 2
  Hydrogen Bond Acceptor Count (hbondacc); 3
• ADMET Property:
  BDDCS Class: Biopharmaceutics Drug Disposition Classification System (BDDCS) Class 2: low solubility and high permeability [3]
  Clearance: The clearance of drug is 4 mL/min/kg []
  Elimination: 0% of drug is excreted from urine in the unchanged form [3]
  Half-life: The concentration or amount of drug in body reduced by one-half in 12 hours [4]
  Metabolism: The drug is metabolized via the CYP3A4 enzyme in the liver []
  MRTD: The Maximum Recommended Therapeutic Dose (MRTD) of drug that ensured maximising efficacy and moderate side effect is 1.9092 micromolar/kg/day [5]
  Unbound Fraction: The unbound fraction of drug in plasma is 0.01% [4]
  Vd: The volume of distribution (Vd) of drug is 3 L/kg []
  Water Solubility: The ability of drug to dissolve in water is measured as 0.0005 mg/mL [3]
• Chemical Identifiers:
  Formula: C26H25ClN2O3
  IUPAC Name: N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide
  Canonical SMILES: CC1=CC=CC=C1C(=O)NC2=CC(=C(C=C2)C(=O)N3CCCC(C4=C3C=CC(=C4)Cl)O)C
  InChI: InChI=1S/C26H25ClN2O3/c1-16-6-3-4-7-20(16)25(31)28-19-10-11-21(17(2)14-19)26(32)29-13-5-8-24(30)22-15-18(27)9-12-23(22)29/h3-4,6-7,9-12,14-15,24,30H,5,8,13H2,1-2H3,(H,28,31)
  InChIKey: GYHCTFXIZSNGJT-UHFFFAOYSA-N
• Cross-matching ID:
  PubChem CID: 216237
  ChEBI ID: CHEBI:32246
  CAS Number: 150683-30-0
  DrugBank ID: DB06212
  TTD ID: D03KZM
  VARIDT ID: DR00059
  INTEDE ID: DR1617
  ACDINA ID: D00688
• Repurposed Drugs (RPD): Click to Jump to the Detailed RPD Information of This Drug

Molecular Interaction Atlas of This Drug

Drug Therapeutic Target (DTT)

DTT Name	DTT ID	UniProt ID	MOA	REF
Vasopressin V2 receptor (V2R)	TTK8R02	V2R_HUMAN	Antagonist	[6]

Drug Transporter (DTP)

DTP Name	DTP ID	UniProt ID	MOA	REF
P-glycoprotein 1 (ABCB1)	DTUGYRD	MDR1_HUMAN	Substrate	[7]

Drug-Metabolizing Enzyme (DME)

DME Name	DME ID	UniProt ID	MOA	REF
Cytochrome P450 3A4 (CYP3A4) Main DME	DE4LYSA	CP3A4_HUMAN	Substrate	[8]

Drug Off-Target (DOT)

DOT Name	DOT ID	UniProt ID	Interaction	REF
ATP-binding cassette sub-family C member 2 (ABCC2)	OTJSIGV5	MRP2_HUMAN	Gene/Protein Processing	[9]
ATP-binding cassette sub-family C member 3 (ABCC3)	OTC3IJV4	MRP3_HUMAN	Gene/Protein Processing	[9]
ATP-binding cassette sub-family C member 4 (ABCC4)	OTO27PAL	MRP4_HUMAN	Gene/Protein Processing	[9]
Bile salt export pump (ABCB11)	OTRU7THO	ABCBB_HUMAN	Gene/Protein Processing	[9]
Cytochrome P450 1A1 (CYP1A1)	OTE4EFH8	CP1A1_HUMAN	Gene/Protein Processing	[10]
Cytochrome P450 1B1 (CYP1B1)	OTYXFLSD	CP1B1_HUMAN	Gene/Protein Processing	[10]
Hepatic sodium/bile acid cotransporter (SLC10A1)	OTUJVMCL	NTCP_HUMAN	Gene/Protein Processing	[9]

Drug-Drug Interaction (DDI) Information of This Drug

Coadministration of a Drug Treating the Disease Different from Tolvaptan (Comorbidity)

DDI Drug Name	DDI Drug ID	Severity	Mechanism	Comorbidity	REF
Remdesivir	DMBFZ6L	Moderate	Increased risk of hepatotoxicity by the combination of Tolvaptan and Remdesivir.	1D6YCoronavirus Disease 2019 [1D6YCoronavirus Disease 2019]	[11]
Sarecycline	DMLZNIQ	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Sarecycline .	Acne vulgaris [ED80]	[12]
Metreleptin	DM1NOEK	Moderate	Increased metabolism of Tolvaptan caused by Metreleptin mediated induction of CYP450 enzyme.	Acute diabete complication [5A2Y]	[13]
Ivosidenib	DM8S6T7	Moderate	Increased metabolism of Tolvaptan caused by Ivosidenib mediated induction of CYP450 enzyme.	Acute myeloid leukaemia [2A60]	[13]
Midostaurin	DMI6E0R	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Midostaurin.	Acute myeloid leukaemia [2A60]	[12]
Arn-509	DMT81LZ	Major	Increased metabolism of Tolvaptan caused by Arn-509 mediated induction of CYP450 enzyme.	Acute myeloid leukaemia [2A60]	[13]
Gilteritinib	DMTI0ZO	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Gilteritinib.	Acute myeloid leukaemia [2A60]	[13]
Bedaquiline	DM3906J	Moderate	Increased risk of hepatotoxicity by the combination of Tolvaptan and Bedaquiline.	Antimicrobial drug resistance [MG50-MG52]	[14]
ABT-492	DMJFD2I	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by ABT-492.	Bacterial infection [1A00-1C4Z]	[11]
Troleandomycin	DMUZNIG	Major	Decreased metabolism of Tolvaptan caused by Troleandomycin mediated inhibition of CYP450 enzyme.	Bacterial infection [1A00-1C4Z]	[11]
Erdafitinib	DMI782S	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Erdafitinib.	Bladder cancer [2C94]	[12]
Pexidartinib	DMS2J0Z	Major	Increased risk of hepatotoxicity by the combination of Tolvaptan and Pexidartinib.	Bone/articular cartilage neoplasm [2F7B]	[15]
Talazoparib	DM1KS78	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Talazoparib.	Breast cancer [2C60-2C6Y]	[16]
Tucatinib	DMBESUA	Major	Decreased metabolism of Tolvaptan caused by Tucatinib mediated inhibition of CYP450 enzyme.	Breast cancer [2C60-2C6Y]	[11]
Alpelisib	DMEXMYK	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Alpelisib.	Breast cancer [2C60-2C6Y]	[12]
Bosutinib	DMTI8YE	Moderate	Decreased metabolism of Tolvaptan caused by Bosutinib mediated inhibition of CYP450 enzyme.	Breast cancer [2C60-2C6Y]	[13]
PF-04449913	DMSB068	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by PF-04449913.	Chronic myelomonocytic leukaemia [2A40]	[12]
Fidaxomicin	DMFP6MV	Minor	Decreased clearance of Tolvaptan due to the transporter inhibition by Fidaxomicin.	Clostridium difficile enterocolitis [1A04]	[11]
Ulipristal	DMBNI20	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ulipristal.	Contraceptive management [QA21]	[12]
Lumacaftor	DMCLWDJ	Major	Increased metabolism of Tolvaptan caused by Lumacaftor mediated induction of CYP450 enzyme.	Cystic fibrosis [CA25]	[13]
Ivacaftor	DMZC1HS	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ivacaftor.	Cystic fibrosis [CA25]	[12]
MK-8228	DMOB58Q	Moderate	Decreased metabolism of Tolvaptan caused by MK-8228 mediated inhibition of CYP450 enzyme.	Cytomegaloviral disease [1D82]	[12]
Rivaroxaban	DMQMBZ1	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Rivaroxaban.	Deep vein thrombosis [BD71]	[17]
Empagliflozin	DMRF9YK	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Empagliflozin.	Diabetes mellitus [5A10]	[11]
Stiripentol	DMMSDOY	Moderate	Decreased metabolism of Tolvaptan caused by Stiripentol mediated inhibition of CYP450 enzyme.	Epilepsy/seizure [8A61-8A6Z]	[12]
Cannabidiol	DM0659E	Moderate	Increased risk of hepatotoxicity by the combination of Tolvaptan and Cannabidiol.	Epileptic encephalopathy [8A62]	[13]
Ripretinib	DM958QB	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ripretinib.	Gastrointestinal stromal tumour [2B5B]	[11]
Boceprevir	DMBSHMF	Major	Decreased metabolism of Tolvaptan caused by Boceprevir mediated inhibition of CYP450 enzyme.	Hepatitis virus infection [1E50-1E51]	[11]
Daclatasvir	DMSFK9V	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Daclatasvir.	Hepatitis virus infection [1E50-1E51]	[12]
Brentuximab vedotin	DMWLC57	Moderate	Increased risk of hepatotoxicity by the combination of Tolvaptan and Brentuximab vedotin.	Hodgkin lymphoma [2B30]	[18]
Cobicistat	DM6L4H2	Major	Decreased metabolism of Tolvaptan caused by Cobicistat mediated inhibition of CYP450 enzyme.	Human immunodeficiency virus disease [1C60-1C62]	[11]
Teriflunomide	DMQ2FKJ	Major	Increased risk of hepatotoxicity by the combination of Tolvaptan and Teriflunomide.	Hyper-lipoproteinaemia [5C80]	[19]
BMS-201038	DMQTAGO	Major	Increased risk of hepatotoxicity by the combination of Tolvaptan and BMS-201038.	Hyper-lipoproteinaemia [5C80]	[20]
Aliskiren	DM1BV7W	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Aliskiren.	Hypertension [BA00-BA04]	[19]
TAK-491	DMCF6SX	Moderate	Increased risk of hyperkalemia by the combination of Tolvaptan and TAK-491.	Hypertension [BA00-BA04]	[12]
Berotralstat	DMWA2DZ	Major	Decreased clearance of Tolvaptan due to the transporter inhibition by Berotralstat.	Innate/adaptive immunodeficiency [4A00]	[21]
Suvorexant	DM0E6S3	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Suvorexant.	Insomnia [7A00-7A0Z]	[12]
Naloxegol	DML0B41	Minor	Decreased clearance of Tolvaptan due to the transporter inhibition by Naloxegol.	Large intestine motility disorder [DB32]	[22]
Crizotinib	DM4F29C	Moderate	Decreased metabolism of Tolvaptan caused by Crizotinib mediated inhibition of CYP450 enzyme.	Lung cancer [2C25]	[12]
Brigatinib	DM7W94S	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Brigatinib.	Lung cancer [2C25]	[12]
PF-06463922	DMKM7EW	Moderate	Increased metabolism of Tolvaptan caused by PF-06463922 mediated induction of CYP450 enzyme.	Lung cancer [2C25]	[13]
Pralsetinib	DMWU0I2	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Pralsetinib.	Lung cancer [2C25]	[11]
Capmatinib	DMYCXKL	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Capmatinib.	Lung cancer [2C25]	[12]
Selpercatinib	DMZR15V	Moderate	Decreased metabolism of Tolvaptan caused by Selpercatinib mediated inhibition of CYP450 enzyme.	Lung cancer [2C25]	[13]
Artesunate	DMR27C8	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Artesunate.	Malaria [1F40-1F45]	[11]
Calaspargase pegol	DMQZBXI	Moderate	Increased risk of hepatotoxicity by the combination of Tolvaptan and Calaspargase pegol.	Malignant haematopoietic neoplasm [2B33]	[23]
Idelalisib	DM602WT	Major	Decreased metabolism of Tolvaptan caused by Idelalisib mediated inhibition of CYP450 enzyme.	Mature B-cell leukaemia [2A82]	[11]
GDC-0199	DMH0QKA	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by GDC-0199.	Mature B-cell leukaemia [2A82]	[12]
IPI-145	DMWA24P	Moderate	Decreased metabolism of Tolvaptan caused by IPI-145 mediated inhibition of CYP450 enzyme.	Mature B-cell leukaemia [2A82]	[12]
Ibrutinib	DMHZCPO	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ibrutinib.	Mature B-cell lymphoma [2A85]	[13]
Ponatinib	DMYGJQO	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ponatinib.	Mature B-cell lymphoma [2A85]	[12]
Arry-162	DM1P6FR	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Arry-162.	Melanoma [2C30]	[11]
Vemurafenib	DM62UG5	Moderate	Increased metabolism of Tolvaptan caused by Vemurafenib mediated induction of CYP450 enzyme.	Melanoma [2C30]	[13]
LGX818	DMNQXV8	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by LGX818.	Melanoma [2C30]	[12]
Dabrafenib	DMX6OE3	Moderate	Increased metabolism of Tolvaptan caused by Dabrafenib mediated induction of CYP450 enzyme.	Melanoma [2C30]	[13]
Ubrogepant	DM749I3	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Ubrogepant.	Migraine [8A80]	[24]
Rimegepant	DMHOAUG	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Rimegepant.	Migraine [8A80]	[25]
Lasmiditan	DMXLVDT	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Lasmiditan.	Migraine [8A80]	[12]
Fedratinib	DM4ZBK6	Moderate	Decreased metabolism of Tolvaptan caused by Fedratinib mediated inhibition of CYP450 enzyme.	Myeloproliferative neoplasm [2A20]	[12]
Rolapitant	DM8XP26	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Rolapitant.	Nausea/vomiting [MD90]	[12]
Netupitant	DMEKAYI	Moderate	Decreased metabolism of Tolvaptan caused by Netupitant mediated inhibition of CYP450 enzyme.	Nausea/vomiting [MD90]	[12]
S-297995	DM26IH8	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by S-297995.	Opioid use disorder [6C43]	[11]
Rucaparib	DM9PVX8	Moderate	Decreased metabolism of Tolvaptan caused by Rucaparib mediated inhibition of CYP450 enzyme.	Ovarian cancer [2C73]	[26]
MK-4827	DMLYGH4	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by MK-4827.	Ovarian cancer [2C73]	[11]
Istradefylline	DM20VSK	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Istradefylline.	Parkinsonism [8A00]	[12]
Abametapir	DM2RX0I	Moderate	Decreased metabolism of Tolvaptan caused by Abametapir mediated inhibition of CYP450 enzyme.	Pediculosis [1G00]	[27]
Lefamulin	DME6G97	Moderate	Decreased metabolism of Tolvaptan caused by Lefamulin mediated inhibition of CYP450 enzyme.	Pneumonia [CA40]	[28]
Lonafarnib	DMGM2Z6	Major	Decreased metabolism of Tolvaptan caused by Lonafarnib mediated inhibition of CYP450 enzyme.	Premature ageing appearance [LD2B]	[11]
Enzalutamide	DMGL19D	Major	Increased metabolism of Tolvaptan caused by Enzalutamide mediated induction of CYP450 enzyme.	Prostate cancer [2C82]	[13]
Relugolix	DMK7IWL	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Relugolix.	Prostate cancer [2C82]	[11]
Darolutamide	DMV7YFT	Minor	Decreased metabolism of Tolvaptan caused by Darolutamide mediated inhibition of CYP450 enzyme.	Prostate cancer [2C82]	[29]
Selexipag	DMAHSU0	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Selexipag.	Pulmonary hypertension [BB01]	[11]
Riociguat	DMXBLMP	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Riociguat.	Pulmonary hypertension [BB01]	[11]
Voxelotor	DMCS6M5	Moderate	Decreased metabolism of Tolvaptan caused by Voxelotor mediated inhibition of CYP450 enzyme.	Sickle-cell disorder [3A51]	[12]
Sodium chloride	DMM3950	Moderate	Increased risk of hypernatremia by the combination of Tolvaptan and Sodium chloride.	Skin sensation disturbance [ME65]	[13]
Telotristat ethyl	DMDIYFZ	Moderate	Increased metabolism of Tolvaptan caused by Telotristat ethyl mediated induction of CYP450 enzyme.	Small intestine developmental anomaly [DA90]	[13]
Larotrectinib	DM26CQR	Moderate	Decreased metabolism of Tolvaptan caused by Larotrectinib mediated inhibition of CYP450 enzyme.	Solid tumour/cancer [2A00-2F9Z]	[11]
Armodafinil	DMGB035	Moderate	Increased metabolism of Tolvaptan caused by Armodafinil mediated induction of CYP450 enzyme.	Solid tumour/cancer [2A00-2F9Z]	[13]
LEE011	DMMX75K	Moderate	Decreased metabolism of Tolvaptan caused by LEE011 mediated inhibition of CYP450 enzyme.	Solid tumour/cancer [2A00-2F9Z]	[12]
Fostamatinib	DM6AUHV	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Fostamatinib.	Thrombocytopenia [3B64]	[12]
Lusutrombopag	DMH6IKO	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Lusutrombopag.	Thrombocytopenia [3B64]	[26]
Apixaban	DM89JLN	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Apixaban.	Thrombosis [DB61-GB90]	[13]
Brilinta	DMBR01X	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Brilinta.	Thrombosis [DB61-GB90]	[12]
Cabozantinib	DMIYDT4	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Cabozantinib.	Thyroid cancer [2D10]	[12]
Elagolix	DMB2C0E	Moderate	Increased metabolism of Tolvaptan caused by Elagolix mediated induction of CYP450 enzyme.	Uterine fibroid [2E86]	[13]
Betrixaban	DM2C4RF	Moderate	Decreased clearance of Tolvaptan due to the transporter inhibition by Betrixaban.	Venous thromboembolism [BD72]	[30]

Drug Inactive Ingredient(s) (DIG) and Formulation(s) of This Drug

DIG

DIG Name	DIG ID	PubChem CID	Functional Classification
FD&C blue no. 2	E00446	2723854	Colorant
Lactose monohydrate	E00393	104938	Binding agent; Diluent; Dry powder inhaler carrier; Lyophilization aid
Magnesium stearate	E00208	11177	lubricant

Pharmaceutical Formulation

Formulation Name	Drug Dosage	Dosage Form	Route
Tolvaptan 15 mg tablet	15 mg	Oral Tablet	Oral

Jump to Detail Pharmaceutical Formulation Page of This Drug

References

• [1] Tolvaptan FDA Label
• [2] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 2226).
• [3] BDDCS applied to over 900 drugs
• [4] Trend Analysis of a Database of Intravenous Pharmacokinetic Parameters in Humans for 1352 Drug Compounds
• [5] Estimating the safe starting dose in phase I clinical trials and no observed effect level based on QSAR modeling of the human maximum recommended daily dose
• [6] Antibody-mediated disruption of the interaction between PCSK9 and the low-density lipoprotein receptor. Biochem J. 2009 May 1;419(3):577-84.
• [7] In vitro P-glycoprotein interactions and steady-state pharmacokinetic interactions between tolvaptan and digoxin in healthy subjects. J Clin Pharmacol. 2011 May;51(5):761-9.
• [8] Tolvaptan: a new therapeutic agent. Rev Recent Clin Trials. 2011 May;6(2):177-88.
• [9] Inhibition of Human Hepatic Bile Acid Transporters by Tolvaptan and Metabolites: Contributing Factors to Drug-Induced Liver Injury?. Toxicol Sci. 2016 Jan;149(1):237-50. doi: 10.1093/toxsci/kfv231. Epub 2015 Oct 26.
• [10] Association of CYP1A1 and CYP1B1 inhibition in in vitro assays with drug-induced liver injury. J Toxicol Sci. 2021;46(4):167-176. doi: 10.2131/jts.46.167.
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• [17] Product Information. Xarelto (rivaroxaban). Bayer Inc, Toronto, IA.
• [18] Product Information. Adcetris (brentuximab vedotin). Seattle Genetics Inc, Bothell, WA.
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• [21] Product Information. Orladeyo (berotralstat). BioCryst Pharmaceuticals Inc, Durham, NC.
• [22] Product Information. Movantik (naloxegol). Astra-Zeneca Pharmaceuticals, Wilmington, DE.
• [23] Al-Nawakil C, Willems L, Mauprivez C, et.al "Successful treatment of l-asparaginase-induced severe acute hepatotoxicity using mitochondrial cofactors." Leuk Lymphoma 55 (2014): 1670-4. [PMID: 24090500]
• [24] Product Information. Ubrelvy (ubrogepant). Allergan Inc, Irvine, CA.
• [25] Product Information. Nurtec ODT (rimegepant). Biohaven Pharmaceuticals, New Haven, CT.
• [26] EMA. European Medicines Agency. European Union "EMA - List of medicines under additional monitoring.".
• [27] Product Information. Xeglyze (abametapir topical). Dr. Reddy's Laboratories Inc, Upper Saddle River, NJ.
• [28] Product Information. Xenleta (lefamulin). Nabriva Therapeutics US, Inc., King of Prussia, PA.
• [29] Product Information. Nubeqa (darolutamide). Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ.
• [30] Product Information. Bevyxxa (betrixaban). Portola Pharmaceuticals, South San Francisco, CA.