Bridion SSI
BRIDION® (sugammadex) SELECTED SAFETY INFORMATION
(based on TGA Product Information last amended 18 November 2021)
Hypersensitivity reactions that have 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. The risk of drug hypersensitivity reactions appears to be dose dependent. Symptoms associated with these reactions can include flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia and swelling of tongue and pharynx. Severe hypersensitivity reactions can be fatal. Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions.
BRIDION® (sugammadex) SELECTED SAFETY INFORMATION
(based on TGA Product Information last amended 18 November 2021)
Hypersensitivity reactions that have 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. The risk of drug hypersensitivity reactions appears to be dose dependent. Symptoms associated with these reactions can include flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia and swelling of tongue and pharynx. Severe hypersensitivity reactions can be fatal. Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been seen within minutes after the administration of BRIDION. Monitor for haemodynamic 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 following reversal.
In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. 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 peri- and post-operative phase, recurrence of neuromuscular blockade is possible.
Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
BRIDION is not recommended to reverse blockade induced with pancuronium.
There is no data for immediate reversal following vecuronium blockade.
There is no experience with repeated exposure to BRIDION in patients.
BRIDION has not been investigated in the ICU setting.
BRIDION doses of up to 16 mg/kg has been associated with increases in activated partial thromboplastin time and prothrombin time/international normalised 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.
Conditions associated with prolonged circulation time such as cardiovascular disease, old age, or oedematous state may be associated with longer recovery times.
Pregnancy Category B2.
It is not known if BRIDION is excreted in human breast milk. Caution should be exercised when administering sugammadex to a breast-feeding woman.
If an oral contraceptive is taken on the same day that BRIDION is administered, follow missed dose advice. For non-oral hormonal contraceptives, use an additional non-hormonal contraception method for 7 days.
BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis
Caution should be exercised when considering the use of BRIDION in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy.
Due to the administration of certain drugs after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex. As a result, recurrence of neuromuscular blockade might be observed. In this situation the patient must be ventilated. Administration of the medicinal product which caused displacement should be stopped in case of an infusion.
Other adverse events include wound complication, airway complication of anaesthesia, anaesthetic complication, procedural hypotension, procedural complication, vomiting, pain at administration site, pyrexia, cough, investigations, hypotension, ear and labyrinth disorders, procedural pain, nausea, musculoskeletal and connective tissue disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders. Pulmonary patients the physician should be aware of the possible occurrence of bronchospasm. Anaesthetic complications: (e.g., movement, coughing, grimacing, or suckling on the endotracheal tube).
Morbidly obese patients (BMI≥40 kg/m2) In a post-marketing clinical trial in morbidly obese patients, the adverse reaction profiles were generally similar between the patients dosed with sugammadex according to Actual Body Weight (ABW) and the patients dosed according to Ideal Body Weight (IBW).
BRIDION should not be given to children aged less than 2 years.
Efficacy and safety of BRIDION for immediate reversal in children have not been assessed.
INDICATIONS
BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.
CONTRAINDICATIONS
BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components.
BRIDION® (sugammadex) SELECTED SAFETY INFORMATION
(based on TGA Product Information last amended 18 November 2021)
Hypersensitivity reactions that have 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. The risk of drug hypersensitivity reactions appears to be dose dependent. Symptoms associated with these reactions can include flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia and swelling of tongue and pharynx. Severe hypersensitivity reactions can be fatal. Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions.
Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been seen within minutes after the administration of BRIDION. Monitor for haemodynamic 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 following reversal.
In clinical trials, a small number of patients experienced a delayed or minimal response to BRIDION. 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 peri- and post-operative phase, recurrence of neuromuscular blockade is possible.
Do not use BRIDION to reverse nonsteroidal neuromuscular blocking agents or steroidal neuromuscular blocking agents other than rocuronium or vecuronium.
BRIDION is not recommended to reverse blockade induced with pancuronium.
There is no data for immediate reversal following vecuronium blockade.
There is no experience with repeated exposure to BRIDION in patients.
BRIDION has not been investigated in the ICU setting.
BRIDION doses of up to 16 mg/kg has been associated with increases in activated partial thromboplastin time and prothrombin time/international normalised 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.
Conditions associated with prolonged circulation time such as cardiovascular disease, old age, or oedematous state may be associated with longer recovery times.
Pregnancy Category B2.
It is not known if BRIDION is excreted in human breast milk. Caution should be exercised when administering sugammadex to a breast-feeding woman.
If an oral contraceptive is taken on the same day that BRIDION is administered, follow missed dose advice. For non-oral hormonal contraceptives, use an additional non-hormonal contraception method for 7 days.
BRIDION is not recommended for use in patients with severe renal impairment, including those requiring dialysis
Caution should be exercised when considering the use of BRIDION in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy.
Due to the administration of certain drugs after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex. As a result, recurrence of neuromuscular blockade might be observed. In this situation the patient must be ventilated. Administration of the medicinal product which caused displacement should be stopped in case of an infusion.
Other adverse events include wound complication, airway complication of anaesthesia, anaesthetic complication, procedural hypotension, procedural complication, vomiting, pain at administration site, pyrexia, cough, investigations, hypotension, ear and labyrinth disorders, procedural pain, nausea, musculoskeletal and connective tissue disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders. Pulmonary patients the physician should be aware of the possible occurrence of bronchospasm. Anaesthetic complications: (e.g., movement, coughing, grimacing, or suckling on the endotracheal tube).
Morbidly obese patients (BMI≥40 kg/m2) In a post-marketing clinical trial in morbidly obese patients, the adverse reaction profiles were generally similar between the patients dosed with sugammadex according to Actual Body Weight (ABW) and the patients dosed according to Ideal Body Weight (IBW).
BRIDION should not be given to children aged less than 2 years.
Efficacy and safety of BRIDION for immediate reversal in children have not been assessed.
INDICATIONS
BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.
CONTRAINDICATIONS
BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components.