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BRIDION®

(sugammadex) injection 100mg/ml (equivalent to 108.8 mg/ml sugammadex sodium),
for intravenous use

BRIDION®(sugammadex) injection 100mg/ml (equivalent to 108.8 mg/ml sugammadex
sodium), for intravenous use
 * Prescribing Information

View More
 * Dosing
 * Selected Safety Information
 * Clinical Data
   
   
   CLINICAL DATA
   
   Close Menu
   
   
   EFFICACY
   
    * Moderate and Deep Block Efficacy
    * Recovery in Specific Populations
   
   
   

 * Mechanism of Action
 * Frequently Asked Questions

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Mechanism of Action


BRIDION WORKS DIFFERENTLY THAN NEOSTIGMINE BY DIRECTLY ENCAPSULATING, BINDING,
AND THUS INACTIVATING ROCURONIUM OR VECURONIUM.1-3



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See the mechanism of BRIDION in action
See the BRIDION encapsulation in action

After intravenous injection, BRIDION distributes through the plasma and binds to
the neuromuscular blocking agents rocuronium or vecuronium to form a complex.3
BRIDION does not affect the release or breakdown of acetylcholine.2

 * The reduction of free rocuronium available in the blood plasma creates a
   concentration gradient with the neuromuscular junction.2
 * As a result, there is a shift of rocuronium into the plasma, where it is
   encapsulated by BRIDION.2
 * This process reduces the amount of neuromuscular blocking agent available to
   bind to nicotinic cholinergic receptors in the neuromuscular junction,
   resulting in the reversal of neuromuscular blockade.
 * The process is similar for vecuronium.
 * The elimination half-life of BRIDION for adults with normal renal function is
   approximately 2 hours, with over 90% excreted within 24 hours, primarily in
   urine.


INDICATION

 * BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade
   induced by rocuronium bromide and vecuronium bromide in adults undergoing
   surgery.

Read More


SELECTED SAFETY INFORMATION

 * BRIDION is contraindicated in patients with known hypersensitivity to
   sugammadex or any of its components. Hypersensitivity reactions that occurred
   varied from isolated skin reactions to serious systemic reactions (i.e.,
   anaphylaxis, anaphylactic shock) and have occurred in patients with no prior
   exposure to sugammadex.
 * Potentially serious hypersensitivity reactions, including anaphylaxis, have
   occurred in patients treated with BRIDION. In a clinical study, anaphylaxis
   occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The
   most common hypersensitivity adverse reactions reported were nausea, pruritus
   and urticaria and showed a dose response relationship, occurring more
   frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups.
   Observe patients for an appropriate period of time after administration and
   take the necessary precautions. Anaphylaxis has also been reported in the
   post-marketing setting. Clinical features in anaphylaxis reports have
   included dermatologic symptoms; hypotension often requiring the use of
   vasopressors; and prolonged hospitalization and/or the use of additional
   respiratory support until full recovery.
 * Cases of marked bradycardia, some of which have resulted in cardiac arrest,
   have been observed within minutes after the administration of BRIDION.
   Monitor for hemodynamic changes and treat with anticholinergic agents, such
   as atropine, if clinically significant bradycardia is observed.
 * Ventilatory support is mandatory for patients until adequate spontaneous
   respiration is restored and the ability to maintain a patent airway is
   assured. Should neuromuscular blockade persist after BRIDION or recur
   following extubation, take appropriate steps to provide adequate ventilation.
 * In clinical trials, a small number of patients experienced a delayed or
   minimal response to BRIDION. Monitor ventilation until recovery occurs.
 * A minimum waiting time is necessary before re-administration of a steroidal
   neuromuscular blocking agent after administration of BRIDION.

RE-ADMINISTRATION OF ROCURONIUM OR VECURONIUM AFTER REVERSAL (UP TO 4 MG/KG
BRIDION)

View More

Minimum Waiting Time NMBA and Dose to be Administered 5 minutes 1.2 mg/kg
rocuronium 4 hours 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

View More

If neuromuscular blockade is required before the recommended waiting time has
elapsed, use a nonsteroidal neuromuscular blocking agent.

 * Due to the administration of BRIDION, certain drugs, including hormonal
   contraceptives, could become less effective due to a lowering of the (free)
   plasma concentrations. Consider re-administration of the other drug,
   administration of a therapeutic equivalent drug, and/or non-pharmacological
   interventions as appropriate. If an oral contraceptive is taken on the same
   day that BRIDION is administered, the patient must use an additional,
   non-hormonal contraceptive method or back-up method of contraception (such as
   condoms and spermicides) for the next 7 days. In the case of non-oral
   hormonal contraceptives, the patient must use an additional, non-hormonal
   contraceptive method or back-up method of contraception (such as condoms and
   spermicides) for the next 7 days.
 * Recurrence of neuromuscular blockade may occur due to displacement of
   rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation
   may be required. Stop the administration of the drug which caused
   displacement, if being administered by infusion.
 * The use of lower than recommended doses of BRIDION may lead to an increased
   risk of recurrence of neuromuscular blockade and is not recommended. Also,
   when drugs which potentiate neuromuscular blockade are used in the
   post-operative phase, recurrence of neuromuscular blockade is possible.
 * BRIDION doses of up to 16 mg/kg were associated with increases in activated
   partial thromboplastin time and prothrombin time/international normalized
   ratio. Carefully monitor coagulation parameters in patients with known
   coagulopathies; being treated with therapeutic anticoagulation; receiving
   thromboprophylaxis drugs other than heparin and low molecular weight heparin;
   or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg
   sugammadex.
 * BRIDION is not recommended for use in patients with severe renal impairment,
   including those requiring dialysis.
 * BRIDION has not been studied for reversal following rocuronium or vecuronium
   administration in the ICU.
 * Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or
   steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
 * The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4,
   or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%,
   12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at
   38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%,
   or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at
   8%).

Before administering BRIDION, please read the Prescribing Information.
Read More


BRIDION®

(sugammadex) injection 100mg/ml (equivalent to 108.8 mg/ml sugammadex sodium),
for intravenous use Close


INDICATION

 * BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade
   induced by rocuronium bromide and vecuronium bromide in adults undergoing
   surgery.


SELECTED SAFETY INFORMATION

 * BRIDION is contraindicated in patients with known hypersensitivity to
   sugammadex or any of its components. Hypersensitivity reactions that occurred
   varied from isolated skin reactions to serious systemic reactions (i.e.,
   anaphylaxis, anaphylactic shock) and have occurred in patients with no prior
   exposure to sugammadex.
 * Potentially serious hypersensitivity reactions, including anaphylaxis, have
   occurred in patients treated with BRIDION. In a clinical study, anaphylaxis
   occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The
   most common hypersensitivity adverse reactions reported were nausea, pruritus
   and urticaria and showed a dose response relationship, occurring more
   frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups.
   Observe patients for an appropriate period of time after administration and
   take the necessary precautions. Anaphylaxis has also been reported in the
   post-marketing setting. Clinical features in anaphylaxis reports have
   included dermatologic symptoms; hypotension often requiring the use of
   vasopressors; and prolonged hospitalization and/or the use of additional
   respiratory support until full recovery.
 * Cases of marked bradycardia, some of which have resulted in cardiac arrest,
   have been observed within minutes after the administration of BRIDION.
   Monitor for hemodynamic changes and treat with anticholinergic agents, such
   as atropine, if clinically significant bradycardia is observed.
 * Ventilatory support is mandatory for patients until adequate spontaneous
   respiration is restored and the ability to maintain a patent airway is
   assured. Should neuromuscular blockade persist after BRIDION or recur
   following extubation, take appropriate steps to provide adequate ventilation.
 * In clinical trials, a small number of patients experienced a delayed or
   minimal response to BRIDION. Monitor ventilation until recovery occurs.
 * A minimum waiting time is necessary before re-administration of a steroidal
   neuromuscular blocking agent after administration of BRIDION.

RE-ADMINISTRATION OF ROCURONIUM OR VECURONIUM AFTER REVERSAL (UP TO 4 MG/KG
BRIDION)

View More

Minimum Waiting Time NMBA and Dose to be Administered 5 minutes 1.2 mg/kg
rocuronium 4 hours 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

View More

If neuromuscular blockade is required before the recommended waiting time has
elapsed, use a nonsteroidal neuromuscular blocking agent.

 * Due to the administration of BRIDION, certain drugs, including hormonal
   contraceptives, could become less effective due to a lowering of the (free)
   plasma concentrations. Consider re-administration of the other drug,
   administration of a therapeutic equivalent drug, and/or non-pharmacological
   interventions as appropriate. If an oral contraceptive is taken on the same
   day that BRIDION is administered, the patient must use an additional,
   non-hormonal contraceptive method or back-up method of contraception (such as
   condoms and spermicides) for the next 7 days. In the case of non-oral
   hormonal contraceptives, the patient must use an additional, non-hormonal
   contraceptive method or back-up method of contraception (such as condoms and
   spermicides) for the next 7 days.
 * Recurrence of neuromuscular blockade may occur due to displacement of
   rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation
   may be required. Stop the administration of the drug which caused
   displacement, if being administered by infusion.
 * The use of lower than recommended doses of BRIDION may lead to an increased
   risk of recurrence of neuromuscular blockade and is not recommended. Also,
   when drugs which potentiate neuromuscular blockade are used in the
   post-operative phase, recurrence of neuromuscular blockade is possible.
 * BRIDION doses of up to 16 mg/kg were associated with increases in activated
   partial thromboplastin time and prothrombin time/international normalized
   ratio. Carefully monitor coagulation parameters in patients with known
   coagulopathies; being treated with therapeutic anticoagulation; receiving
   thromboprophylaxis drugs other than heparin and low molecular weight heparin;
   or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg
   sugammadex.
 * BRIDION is not recommended for use in patients with severe renal impairment,
   including those requiring dialysis.
 * BRIDION has not been studied for reversal following rocuronium or vecuronium
   administration in the ICU.
 * Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or
   steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
 * The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4,
   or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%,
   12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at
   38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%,
   or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at
   8%).

Before administering BRIDION, please read the Prescribing Information.
Indication Selected Safety Information
View More


INDICATION

 * BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade
   induced by rocuronium bromide and vecuronium bromide in adults undergoing
   surgery.


SELECTED SAFETY INFORMATION

 * BRIDION is contraindicated in patients with known hypersensitivity to
   sugammadex or any of its components. Hypersensitivity reactions that occurred
   varied from isolated skin reactions to serious systemic reactions (i.e.,
   anaphylaxis, anaphylactic shock) and have occurred in patients with no prior
   exposure to sugammadex.
 * Potentially serious hypersensitivity reactions, including anaphylaxis, have
   occurred in patients treated with BRIDION. In a clinical study, anaphylaxis
   occurred in 0.3% (n=1/299) of healthy volunteers treated with BRIDION. The
   most common hypersensitivity adverse reactions reported were nausea, pruritus
   and urticaria and showed a dose response relationship, occurring more
   frequently in the 16 mg/kg group compared to the 4 mg/kg and placebo groups.
   Observe patients for an appropriate period of time after administration and
   take the necessary precautions. Anaphylaxis has also been reported in the
   post-marketing setting. Clinical features in anaphylaxis reports have
   included dermatologic symptoms; hypotension often requiring the use of
   vasopressors; and prolonged hospitalization and/or the use of additional
   respiratory support until full recovery.
 * Cases of marked bradycardia, some of which have resulted in cardiac arrest,
   have been observed within minutes after the administration of BRIDION.
   Monitor for hemodynamic changes and treat with anticholinergic agents, such
   as atropine, if clinically significant bradycardia is observed.
 * Ventilatory support is mandatory for patients until adequate spontaneous
   respiration is restored and the ability to maintain a patent airway is
   assured. Should neuromuscular blockade persist after BRIDION or recur
   following extubation, take appropriate steps to provide adequate ventilation.
 * In clinical trials, a small number of patients experienced a delayed or
   minimal response to BRIDION. Monitor ventilation until recovery occurs.
 * A minimum waiting time is necessary before re-administration of a steroidal
   neuromuscular blocking agent after administration of BRIDION.

RE-ADMINISTRATION OF ROCURONIUM OR VECURONIUM AFTER REVERSAL (UP TO 4 MG/KG
BRIDION)

View More

Minimum Waiting Time NMBA and Dose to be Administered 5 minutes 1.2 mg/kg
rocuronium 4 hours 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium

View More

If neuromuscular blockade is required before the recommended waiting time has
elapsed, use a nonsteroidal neuromuscular blocking agent.

 * Due to the administration of BRIDION, certain drugs, including hormonal
   contraceptives, could become less effective due to a lowering of the (free)
   plasma concentrations. Consider re-administration of the other drug,
   administration of a therapeutic equivalent drug, and/or non-pharmacological
   interventions as appropriate. If an oral contraceptive is taken on the same
   day that BRIDION is administered, the patient must use an additional,
   non-hormonal contraceptive method or back-up method of contraception (such as
   condoms and spermicides) for the next 7 days. In the case of non-oral
   hormonal contraceptives, the patient must use an additional, non-hormonal
   contraceptive method or back-up method of contraception (such as condoms and
   spermicides) for the next 7 days.
 * Recurrence of neuromuscular blockade may occur due to displacement of
   rocuronium or vecuronium from BRIDION by other drugs. Mechanical ventilation
   may be required. Stop the administration of the drug which caused
   displacement, if being administered by infusion.
 * The use of lower than recommended doses of BRIDION may lead to an increased
   risk of recurrence of neuromuscular blockade and is not recommended. Also,
   when drugs which potentiate neuromuscular blockade are used in the
   post-operative phase, recurrence of neuromuscular blockade is possible.
 * BRIDION doses of up to 16 mg/kg were associated with increases in activated
   partial thromboplastin time and prothrombin time/international normalized
   ratio. Carefully monitor coagulation parameters in patients with known
   coagulopathies; being treated with therapeutic anticoagulation; receiving
   thromboprophylaxis drugs other than heparin and low molecular weight heparin;
   or receiving thromboprophylaxis drugs and who then receive a dose of 16 mg/kg
   sugammadex.
 * BRIDION is not recommended for use in patients with severe renal impairment,
   including those requiring dialysis.
 * BRIDION has not been studied for reversal following rocuronium or vecuronium
   administration in the ICU.
 * Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or
   steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
 * The most common adverse reactions (reported in ≥ 10% of patients at a 2, 4,
   or 16 mg/kg BRIDION dose and higher than placebo rate) were vomiting (11%,
   12%, or 15% versus placebo at 10%), pain (48%, 52%, or 36% versus placebo at
   38%), nausea (23%, 26%, or 23% versus placebo at 23%), hypotension (4%, 5%,
   or 13% versus placebo at 4%), and headache (7%, 5%, or 10% versus placebo at
   8%).

Before administering BRIDION, please read the Prescribing Information.


REFERENCES:

1. Claudius C et al. Neuromuscular monitoring. In: Gropper MA, ed. Miller's
Anesthesia. 9th ed. Philadelphia, PA: Elsevier; 2020: 1354-1372.

2. Bom A, Hope F, Rutherford S, et al. Preclinical pharmacology of sugammadex. J
Crit Care. 2009;24(1):29–35.

3. Gijsenbergh F, Ramael S, Houwing N, et al. First human exposure of Org 25969,
a novel agent to reverse the action of rocuronium bromide. Anesthesiology.
2005;103(4):695–703. 

4. Bom A, Bradley M, Cameron K, et al. A novel concept of reversing
neuromuscular block: chemical encapsulation of rocuronium bromide by a
cyclodextrin-based synthetic host. Angew Chem Int Ed Engl. 2002;41(2):266-270.

US-XBR-0106902/21

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