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sugammadex 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4233 | 343306-71-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
|
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.18 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.28 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 2.53 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 15, 2015 | FDA | ORGANON USA INC | |
| July 25, 2008 | EMA | MERCK SHARP & DOHME LIMITED |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Recurrence of neuromuscular blockade | 391.63 | 44.41 | 48 | 2266 | 152 | 90625981 |
| Anaphylactic reaction | 351.22 | 44.41 | 117 | 2197 | 87407 | 90538726 |
| Anaphylactic shock | 303.82 | 44.41 | 83 | 2231 | 31534 | 90594599 |
| Bronchospasm | 244.36 | 44.41 | 64 | 2250 | 20645 | 90605488 |
| Bradycardia | 235.29 | 44.41 | 86 | 2228 | 83761 | 90542372 |
| Neuromuscular block prolonged | 114.85 | 44.41 | 19 | 2295 | 633 | 90625500 |
| Cardiac arrest | 114.47 | 44.41 | 55 | 2259 | 104880 | 90521253 |
| Hypotension | 75.65 | 44.41 | 64 | 2250 | 325333 | 90300800 |
| Vocal cord dysfunction | 69.25 | 44.41 | 13 | 2301 | 901 | 90625232 |
| Drug reaction with eosinophilia and systemic symptoms | 67.37 | 44.41 | 29 | 2285 | 42729 | 90583404 |
| Hypoventilation | 60.57 | 44.41 | 16 | 2298 | 5280 | 90620853 |
| Clonus | 59.26 | 44.41 | 16 | 2298 | 5734 | 90620399 |
| Oxygen saturation decreased | 54.53 | 44.41 | 34 | 2280 | 107449 | 90518684 |
| Muscle twitching | 53.75 | 44.41 | 21 | 2293 | 24181 | 90601952 |
| Hyperreflexia | 52.42 | 44.41 | 15 | 2299 | 6642 | 90619491 |
| Maternal exposure during pregnancy | 51.24 | 44.41 | 54 | 2260 | 360009 | 90266124 |
| Delayed recovery from anaesthesia | 49.46 | 44.41 | 10 | 2304 | 1020 | 90625113 |
| Fanconi syndrome | 48.49 | 44.41 | 11 | 2303 | 1932 | 90624201 |
| Angioedema | 47.37 | 44.41 | 26 | 2288 | 64850 | 90561283 |
| Anaesthetic complication neurological | 46.52 | 44.41 | 9 | 2305 | 732 | 90625401 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Anaphylactic reaction | 460.78 | 52.82 | 141 | 1927 | 42602 | 42576665 |
| Recurrence of neuromuscular blockade | 361.52 | 52.82 | 50 | 2018 | 228 | 42619039 |
| Anaphylactic shock | 323.93 | 52.82 | 94 | 1974 | 23423 | 42595844 |
| Negative pressure pulmonary oedema | 226.31 | 52.82 | 37 | 2031 | 588 | 42618679 |
| Bronchospasm | 197.10 | 52.82 | 56 | 2012 | 12829 | 42606438 |
| Cardiac arrest | 195.23 | 52.82 | 98 | 1970 | 109222 | 42510045 |
| Bradycardia | 177.46 | 52.82 | 85 | 1983 | 85399 | 42533868 |
| Neuromuscular block prolonged | 129.90 | 52.82 | 23 | 2045 | 596 | 42618671 |
| Laryngospasm | 92.25 | 52.82 | 21 | 2047 | 1967 | 42617300 |
| Kounis syndrome | 81.24 | 52.82 | 21 | 2047 | 3347 | 42615920 |
| Oxygen saturation decreased | 78.40 | 52.82 | 45 | 2023 | 64642 | 42554625 |
| Delayed recovery from anaesthesia | 74.39 | 52.82 | 16 | 2052 | 1153 | 42618114 |
| Hypotension | 65.66 | 52.82 | 71 | 1997 | 257560 | 42361707 |
| Hypoventilation | 55.65 | 52.82 | 16 | 2052 | 3786 | 42615481 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Anaphylactic reaction | 693.25 | 36.68 | 231 | 4049 | 114069 | 110470950 |
| Anaphylactic shock | 586.54 | 36.68 | 169 | 4111 | 51377 | 110533642 |
| Recurrence of neuromuscular blockade | 581.85 | 36.68 | 78 | 4202 | 353 | 110584666 |
| Bradycardia | 327.89 | 36.68 | 146 | 4134 | 155371 | 110429648 |
| Bronchospasm | 311.68 | 36.68 | 92 | 4188 | 30147 | 110554872 |
| Cardiac arrest | 256.89 | 36.68 | 133 | 4147 | 196620 | 110388399 |
| Negative pressure pulmonary oedema | 230.36 | 36.68 | 37 | 4243 | 662 | 110584357 |
| Neuromuscular block prolonged | 215.63 | 36.68 | 38 | 4242 | 1209 | 110583810 |
| Delayed recovery from anaesthesia | 128.49 | 36.68 | 27 | 4253 | 2188 | 110582831 |
| Laryngospasm | 118.55 | 36.68 | 29 | 4251 | 4639 | 110580380 |
| Oxygen saturation decreased | 117.60 | 36.68 | 74 | 4206 | 156908 | 110428111 |
| Hypotension | 114.83 | 36.68 | 120 | 4160 | 523729 | 110061290 |
| Kounis syndrome | 111.69 | 36.68 | 29 | 4251 | 5896 | 110579123 |
| Hypoventilation | 98.25 | 36.68 | 28 | 4252 | 8053 | 110576966 |
| Respiratory arrest | 68.89 | 36.68 | 37 | 4243 | 58262 | 110526757 |
| Blood pressure decreased | 63.72 | 36.68 | 45 | 4235 | 115046 | 110469973 |
| Vocal cord dysfunction | 63.34 | 36.68 | 13 | 4267 | 937 | 110584082 |
| Hypoxia | 58.96 | 36.68 | 45 | 4235 | 129470 | 110455549 |
| Haemodynamic instability | 56.13 | 36.68 | 24 | 4256 | 22864 | 110562155 |
| Pulseless electrical activity | 52.73 | 36.68 | 21 | 4259 | 16736 | 110568283 |
| Muscle twitching | 49.96 | 36.68 | 24 | 4256 | 29911 | 110555108 |
| Clonus | 46.12 | 36.68 | 16 | 4264 | 8700 | 110576319 |
| Drug interaction | 43.59 | 36.68 | 73 | 4207 | 500110 | 110084909 |
| Airway complication of anaesthesia | 43.50 | 36.68 | 9 | 4271 | 675 | 110584344 |
| Respiratory failure | 42.81 | 36.68 | 47 | 4233 | 215285 | 110369734 |
| Hyperreflexia | 41.05 | 36.68 | 15 | 4265 | 9470 | 110575549 |
| Anaesthetic complication neurological | 39.80 | 36.68 | 9 | 4271 | 1024 | 110583995 |
| Respiratory acidosis | 38.93 | 36.68 | 16 | 4264 | 13810 | 110571209 |
| Drug reaction with eosinophilia and systemic symptoms | 38.38 | 36.68 | 29 | 4251 | 82066 | 110502953 |
| Angioedema | 37.87 | 36.68 | 31 | 4249 | 98469 | 110486550 |
| Fanconi syndrome | 37.46 | 36.68 | 11 | 4269 | 3508 | 110581511 |
| Ventricular fibrillation | 37.33 | 36.68 | 22 | 4258 | 41291 | 110543728 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V03AB35 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes |
| FDA CS | M0081434 | gamma-Cyclodextrins |
| CHEBI has role | CHEBI:51372 | neuromuscular agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
| CHEBI has role | CHEBI:90753 | antidote to organophosphate poisoning |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
V03AB Antidotes 28 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Reversal of neuromuscular blockade | indication | 241703000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.58 | acidic |
| pKa2 | 7.94 | acidic |
| pKa3 | 8.0 | acidic |
| pKa4 | 8.0 | acidic |
| pKa5 | 8.0 | acidic |
| pKa6 | 8.0 | acidic |
| pKa7 | 8.0 | acidic |
| pKa8 | 8.0 | acidic |
| pKa9 | 13.29 | acidic |
| pKa10 | 13.65 | acidic |
| pKa11 | 13.89 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | RE44733 | Jan. 27, 2026 | REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK |
| EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | RE44733 | Jan. 27, 2026 | REVERSAL OF DRUG-INDUCED NEUROMUSCULAR BLOCK |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | Dec. 12, 2027 | NEW PATIENT POPULATION |
| EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | Dec. 12, 2027 | NEW PATIENT POPULATION |
| EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | June 12, 2028 | PEDIATRIC EXCLUSIVITY |
| EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | BRIDION | MSD SUB MERCK | N022225 | Dec. 15, 2015 | RX | SOLUTION | INTRAVENOUS | June 12, 2028 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D05940 | KEGG_DRUG |
| 4035288 | VANDF |
| C1700695 | UMLSCUI |
| CHEBI:90953 | CHEBI |
| CHEMBL2111107 | ChEMBL_ID |
| CHEMBL2107374 | ChEMBL_ID |
| D000077122 | MESH_DESCRIPTOR_UI |
| DB06206 | DRUGBANK_ID |
| 8528 | INN_ID |
| 343306-79-6 | SECONDARY_CAS_RN |
| 361LPM2T56 | UNII |
| 6918585 | PUBCHEM_CID |
| 1726987 | RXNORM |
| 159483 | MMSL |
| 26064 | MMSL |
| 31376 | MMSL |
| 31381 | MMSL |
| 350855 | MMSL |
| d07361 | MMSL |
| 012914 | NDDF |
| 012915 | NDDF |
| 1172425006 | SNOMEDCT_US |
| 442340006 | SNOMEDCT_US |
| 442379000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5423 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0006-5425 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0264-8200 | INJECTION | 200 mg | INTRAVENOUS | ANDA | 30 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3468 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 27 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3469 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 27 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-619 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 31 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-254 | INJECTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-255 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 27 sections |
| SUGAMMADEX SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-830 | SOLUTION | 200 mg | INTRAVENOUS | ANDA | 18 sections |
| SUGAMMADEX SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-935 | SOLUTION | 500 mg | INTRAVENOUS | ANDA | 18 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-924 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 27 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-925 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 27 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66794-256 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | unapproved drug other | 29 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66794-257 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | unapproved drug other | 29 sections |
| sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70069-892 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70069-893 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1650 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 24 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1651 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 24 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1856 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 1 sections |
| Sugammadex | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1857 | INJECTION, SOLUTION | 500 mg | INTRAVENOUS | ANDA | 1 sections |
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71872-7187 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
| SUGAMMADEX SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82449-241 | SOLUTION | 200 mg | INTRAVENOUS | ANDA | 18 sections |
| SUGAMMADEX SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82449-242 | SOLUTION | 500 mg | INTRAVENOUS | ANDA | 18 sections |
| BRIDION | HUMAN PRESCRIPTION DRUG LABEL | 1 | 84549-423 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 29 sections |