Bridion

Antidotes, Systemic

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Sugammadex is a clear, colorless to slightly yellow-brown solution.
Sugammadex should be administered by health care providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents and drugs that reverse neuromuscular blockade.
Do not mix sugammadex with any other medications.
Sugammadex is physically incompatible with verapamil, ondansetron, and ranitidine.

Preparation in Adult patients
May administer undiluted solution; no further dilution is necessary.
 
Preparation in Pediatric patients
To increase the accuracy of dosing in the pediatric population, sugammadex 100 mg/mL may be diluted to a concentration of 10 mg/mL using 0.9% Sodium Chloride Injection.
To prepare the required dose, aseptically transfer all the contents of the 2 mL single-dose vial containing 200 mg sugammadex (100 mg/mL) to a bottle (or IV bag) containing 18 mL of 0.9% Sodium Chloride Injection to achieve a final concentration of 10 mg/mL sugammadex.
Sugammadex injection is a single-dose sterile solution without preservatives; discard any unused portion from the vial.
Storage: Use diluted solution immediately.
 
IV Push
Infuse over 10 seconds as a single bolus injection into an existing intravenous line.
Sugammadex may be injected into intravenous lines of a running infusion of 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 0.45% Sodium Chloride and 2.5% Dextrose Injection, 5% Dextrose in 0.9% Sodium Chloride Injection, Isolyte P with 5% Dextrose Injection, Lactated Ringer's Injection, or Ringer's Injection.
Flush the infusion line between administration of sugammadex and other drugs.
Monitor the patient to assure adequate ventilation and maintenance of patent airway from time of sugammadex administration until complete recovery of neuromuscular function. Satisfactory recovery should be determined by response to peripheral nerve stimulation and assessment of skeletal muscle tone and respiratory measurements.

Bridion

Rx

Modified gamma cyclodextrin
Used for reversal of neuromuscular blockade effects of rocuronium and vecuronium in adults and pediatric patients 2 years and older undergoing surgery
Cases of severe bradycardia, some resulting in cardiac arrest, reported

2, 4, or 16 mg/kg/dose IV to reverse different levels of rocuronium-induced neuromuscular blockade. 2 mg/kg/dose IV if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to train-of-four (TOF) stimulation. 4 mg/kg/dose IV if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to TOF stimulation. 16 mg/kg/dose IV if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single rocuronium dose of 1.2 mg/kg. For re-use of rocuronium after sugammadex (up to 4 mg/kg/dose) administration, wait at least 5 minutes before readministration of rocuronium 1.2 mg/kg/dose and 4 hours before readministration of rocuronium 0.6 mg/kg/dose. The onset of neuromuscular blockade may be delayed up to 4 minutes, and the duration of blockade may be shortened up to 15 minutes after the readministration of rocuronium 1.2 mg/kg/dose within 30 minutes of sugammadex use. If a dose of sugammadex 16 mg/kg/dose was used for reversal, wait at least 24 hours before readministration of rocuronium. If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocker. The onset of a depolarizing neuromuscular blocker might be slower than expected, as postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.

2 or 4 mg/kg/dose IV to reverse different levels of rocuronium-induced neuromuscular blockade. 2 mg/kg/dose IV if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to train-of-four (TOF) stimulation. 4 mg/kg/dose IV if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to TOF stimulation. For re-use of rocuronium after sugammadex (up to 4 mg/kg/dose) administration, wait at least 5 minutes before readministration of rocuronium 1.2 mg/kg/dose and 4 hours before readministration of rocuronium 0.6 mg/kg/dose. The onset of neuromuscular blockade may be delayed up to 4 minutes, and the duration of blockade may be shortened up to 15 minutes after the readministration of rocuronium 1.2 mg/kg/dose within 30 minutes of sugammadex use. If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocker. The onset of a depolarizing neuromuscular blocker might be slower than expected, as postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.

2 or 4 mg/kg/dose IV to reverse different levels of vecuronium-induced neuromuscular blockade. 2 mg/kg/dose IV if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to train-of-four (TOF) stimulation. 4 mg/kg/dose IV if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to TOF stimulation. For re-use of vecuronium after sugammadex (up to 4 mg/kg/dose) administration, wait at least 4 hours before readministration of vecuronium 0.1 mg/kg/dose. If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocker. The onset of a depolarizing neuromuscular blocker might be slower than expected, as postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.

2 or 4 mg/kg/dose IV to reverse different levels of vecuronium-induced neuromuscular blockade. 2 mg/kg/dose IV if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to train-of-four (TOF) stimulation. 4 mg/kg/dose IV if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to TOF stimulation. For re-use of vecuronium after sugammadex (up to 4 mg/kg/dose) administration, wait at least 4 hours before readministration of vecuronium 0.1 mg/kg/dose. If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocker. The onset of a depolarizing neuromuscular blocker might be slower than expected, as postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

CrCl 30 to 80 mL/minute: No dosage adjustments needed. The recommended waiting time after neuromuscular blockade reversal with sugammadex (up to 4 mg/kg/dose) prior to readministration of rocuronium 0.6 mg/kg/dose or vecuronium 0.1 mg/kg/dose is 24 hours. If a shorter waiting time is required, the rocuronium dose for new neuromuscular blockade should be 1.2 mg/kg/dose.
CrCl less than 30 mL/minute: Not recommended for use due to lack of safety data and the prolonged and increased exposure in this patient population.

Conjugated Estrogens; Medroxyprogesterone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Desogestrel; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Dienogest; Estradiol valerate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Drospirenone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Drospirenone; Estetrol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Drospirenone; Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Drospirenone; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Drospirenone; Ethinyl Estradiol; Levomefolate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Elagolix; Estradiol; Norethindrone acetate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Estradiol; Levonorgestrel: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Estradiol; Norethindrone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Estradiol; Norgestimate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Ethinyl Estradiol; Norelgestromin: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Ethinyl Estradiol; Norethindrone Acetate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Ethinyl Estradiol; Norgestrel: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Ethynodiol Diacetate; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Etonogestrel: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Etonogestrel; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Leuprolide; Norethindrone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Levonorgestrel: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Levonorgestrel; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Medroxyprogesterone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norethindrone: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norethindrone; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norgestimate; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Norgestrel: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Oral Contraceptives: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Relugolix; Estradiol; Norethindrone acetate: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Segesterone Acetate; Ethinyl Estradiol: (Major) If an oral contraceptive is taken the same day sugammadex is administered, the patient must use an additional, non-hormonal contraceptive method or back-up method of contraception for the next 7 days. Sugammadex may bind to progestogen, resulting in a decrease in progestogen exposure. The administration of a bolus dose of sugammadex results in actions that are essentially equivalent to missing one or more doses of contraceptives containing estrogen or progestogen, including combination oral contraceptives, non-oral combination contraceptives, or progestins.
Toremifene: (Minor) Toremifene has a relatively high binding affinity for sugammadex and could displace vecuronium or rocuronium from the complex with sugammadex. The recovery to train of four (TOF) ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of surgery.

Bridion/Sugammadex Intravenous Sol: 1mL, 100mg

16 mg/kg/dose IV.

16 mg/kg/dose IV.

4 mg/kg/dose IV.

2 to 12 years: 4 mg/kg/dose IV.
younger than 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Sugammadex is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agents rocuronium and vecuronium. This results in a reduction in the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction, and the neuromuscular blockade induced by rocuronium or vecuronium is thereby reversed.

Sugammadex is administered intravenously. The observed steady-state volume of distribution in adult patients with normal renal function is 11 to 14 L. Sugammadex and the complex of sugammadex and rocuronium do not bind to plasma proteins or erythrocytes. Linear kinetics are observed when sugammadex is administered within the dosage range of 1 to 16 mg/kg as an IV bolus. The elimination half-life of sugammadex in adults is about 2 hours, and the estimated plasma clearance is about 88 mL/minute. Sugammadex is retained in sites of active mineralization, such as bone and teeth, with a mean half-life of 172 and 8 days, respectively. No sugammadex metabolites have been observed in clinical studies. Sugammadex is renally excreted as unchanged product, with more than 90% of the dose excreted within 24 hours.[60450]
 
Affected cytochrome P450 isoenzymes and drug transporters: none

There are no clinical trial data with sugammadex use during pregnancy to inform a drug-associated risk. Data from the pharmacovigilance safety database and published literature on sugammadex use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of malformations after daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg. However, there was an increase in the incidence of incomplete ossification of the sternebra and reduced fetal body weights in the rabbit study at 8 times the MRHD; maternal toxicity was also observed.[60450]

There are no data on the presence of sugammadex in human milk, the effects on the breast-fed infant, or the effects on milk production. However, sugammadex is present in rat milk. Consider the benefits of breast-feeding along with the mother's clinical need for sugammadex and any potential adverse effects on the breast-fed infant from sugammadex or the underlying maternal condition.