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BRIDION®

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

BRIDION®(sugammadex) injection 100 mg/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
    * Pediatric
   
   
   RECOVERY IN SPECIAL PATIENT POPULATIONS
   
    * View all
    * Geriatric
    * Cardiac
    * Pulmonary
    * Obese

 * Mechanism of Action
 * Frequently Asked Questions

View More


DOSING FOR BRIDION® (SUGAMMADEX)


DOSING BASED ON ACTUAL BODY WEIGHT AND DEPTH OF BLOCK


ROUTINE CO-ADMINISTRATION OF AN ANTICHOLINERGIC AGENT IS NOT REQUIRED.


Treatment with anticholinergic agents, such as atropine, should be administered
if clinically significant bradycardia is observed.

If spontaneous recovery of the twitch response has reached 1-2 PTCs, no twitch
responses to TOF Moderate Block 2 mg/kg dose Deep Block 4 mg/kg dose

View dosing information for BRIDION
 * The recommended dose of BRIDION does not depend on the anesthetic regimen.
 * Administer BRIDION intravenously as a single bolus injection. The bolus
   injection may be given over 10 seconds into an existing intravenous line.
   BRIDION has only been administered as a single bolus injection in clinical
   trials.
 * BRIDION 100 mg/mL may be diluted to a concentration of 10 mg/mL, using 0.9%
   sodium chloride injection, USP, to increase the accuracy of dosing in the
   pediatric population. Review the PI for additional instructions on how to
   dilute BRIDION for pediatric use.


NO DOSE ADJUSTMENTS OF BRIDION REQUIRED IN THESE SPECIAL PATIENT POPULATIONS


 * Geriatric patients with normal organ function
 * Patients diagnosed with or who have a history of pulmonary complications
 * Patients diagnosed with or who have a history of cardiac disease (e.g.,
   patients with ischemic heart disease, chronic heart failure, or arrhythmia)
 * Patients with mild to moderate renal impairment
   * BRIDION is not recommended for use in patients with severe renal
     impairment, including those requiring dialysis.
 * Obese patients with a BMI ≥40kg/m2

2-mL Single-Dose Vial With 200 mg of BRIDION® (sugammadex) 5-mL Single-Dose Vial
With 500 mg of BRIDION® (sugammadex) Convenient single-dose vials 2-mL vial 200
mg BRIDION (sugammadex) 5-mL vial 500 mg BRIDION (sugammadex) Vials not shown at
actual size. Each single-use vial contains a concentration of 100 mg/mL of
sugammadex, which is equivalent to 108.8 mg/mL sugammadex sodium. Vials include
a peel-off label that can be applied to the syringe.

Drug compatibility


 * May inject BRIDION into the intravenous line of a running infusion with the
   following intravenous solutions:
   * 0.9% sodium chloride
   * 5% dextrose
   * 0.45% sodium chloride and 2.5% dextrose
   * Ringer’s solution
   * Isolyte P with 5% dextrose
   * Ringer’s lactate solution
   * 5% dextrose in 0.9% sodium chloride
 * Ensure the infusion line is adequately flushed (e.g., with 0.9% sodium
   chloride) between administration of BRIDION and other drugs.
 * Do not mix BRIDION with other products except those listed above.
 * BRIDION is physically incompatible with verapamil, ondansetron, and
   ranitidine.
 * Visually inspect parenteral drug products for particulate matter and
   discoloration prior to administration, whenever the solution and container
   permit.


ABBREVIATIONS

 * BMI = body mass index
 * T2 = second twitch
 * TOF = train-of-four
 * PTC = post-tetanic count

--------------------------------------------------------------------------------

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Clinical Data: Moderate and Deep Block Efficacy

--------------------------------------------------------------------------------


BRIDION® (SUGAMMADEX)


THANK YOU FOR YOUR RESPONSE!

Close


INDICATION

 * BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade
   induced by rocuronium bromide and vecuronium bromide in adults and pediatric
   patients aged 2 years and older undergoing surgery.

Read More


SELECTED SAFETY INFORMATION FOR BRIDION® (SUGAMMADEX)

 * 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.
 * Safety and effectiveness in patients younger than 2 years of age have not
   been established.
 * The most common adverse reactions (reported in ≥ 10% of adult 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%). The most common adverse reactions (reported in ≥ 10% of
   pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg)
   were pain (65% and 61%), vomiting (14% and 13%), and nausea (10% and 11%).

Before administering BRIDION® (sugammadex), please read the Prescribing
Information.
Read More


BRIDION®

(sugammadex) injection 100 mg/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 and pediatric
   patients aged 2 years and older undergoing surgery.


SELECTED SAFETY INFORMATION FOR BRIDION® (SUGAMMADEX)

 * 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.
 * Safety and effectiveness in patients younger than 2 years of age have not
   been established.
 * The most common adverse reactions (reported in ≥ 10% of adult 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%). The most common adverse reactions (reported in ≥ 10% of
   pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg)
   were pain (65% and 61%), vomiting (14% and 13%), and nausea (10% and 11%).

Before administering BRIDION® (sugammadex), please read the Prescribing
Information.
Indication Selected Safety Information for BRIDION® (sugammadex)
View More


INDICATION

 * BRIDION® (sugammadex) is indicated for the reversal of neuromuscular blockade
   induced by rocuronium bromide and vecuronium bromide in adults and pediatric
   patients aged 2 years and older undergoing surgery.


SELECTED SAFETY INFORMATION FOR BRIDION® (SUGAMMADEX)

 * 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.
 * Safety and effectiveness in patients younger than 2 years of age have not
   been established.
 * The most common adverse reactions (reported in ≥ 10% of adult 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%). The most common adverse reactions (reported in ≥ 10% of
   pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg)
   were pain (65% and 61%), vomiting (14% and 13%), and nausea (10% and 11%).

Before administering BRIDION® (sugammadex), please read the Prescribing
Information.
US-XBR-0160202/23

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