Bridion (sugammadex)

Common side effects of Bridion include:

• vomiting,
• pain,
• nausea,
• low blood pressure (hypotension),
• headache,
• abdominal pain,
• gas,
• dry mouth,
• fever,
• chills,
• dizziness,
• mouth or throat pain,
• cough,
• pain in extremities,
• muscle pain,
• insomnia,
• anxiety,
• reduced sense of touch,
• restlessness,
• depression,
• decreased red blood cell count,
• high blood pressure (hypertension),
• itching,
• skin redness,
• low blood calcium,
• heart disorders, or
• fast or slow heart rate.

Important Dosing And Administration Information

• Bridion dosing is based on actual body weight.
• Bridion (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
• Doses and timing of Bridion administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.
• 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.
• From the time of Bridion administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.
• The recommended dose of Bridion does not depend on the anesthetic regimen.

Recommended Dosing

• Bridion can be used to reverse different levels of rocuronium- or vecuronium-induced neuromuscular blockade.

For Rocuronium And Vecuronium

• A dose of 4 mg/kg Bridion is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade.
• A dose of 2 mg/kg Bridion is recommended if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade.

For Rocuronium Only

• A dose of 16 mg/kg Bridion is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. The efficacy of the 16 mg/kg dose of Bridion following administration of vecuronium has not been studied.

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
• 5% dextrose in 0.9% sodium chloride
• isolyte P with 5% dextrose
• Ringer's lactate solution
• Ringer's solution

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.

Based on binding affinity between Bridion and other drugs, preclinical experiments, clinical studies and simulations of a pharmacokinetic-pharmacodynamic (PK-PD) model, no clinically significant pharmacodynamic interactions with other drugs are expected, with the exception of toremifene and hormonal contraceptives.

Interactions Potentially Affecting The Efficacy Of Bridion

Toremifene

• For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with Bridion could occur.
• The recovery to TOF ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of surgery.

Interaction Potentially Affecting The Efficacy Of Hormonal Contraceptives

• In vitro binding studies indicate that Bridion may bind to progestogen, thereby decreasing progestogen exposure.
• Therefore, the administration of a bolus dose of Bridion is considered to be equivalent to missing dose(s) of oral contraceptives containing an estrogen or progestogen.
• 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.

Interference With Laboratory Tests

• Bridion may interfere with the serum progesterone assay. Interference with this test was observed at sugammadex plasma concentrations of 100 mcg/mL, which may be observed for up to 30 minutes after a 16 mg/kg dose.

• There are no clinical trial data on Bridion use in pregnant women to inform any drug-associated risks.
• The available data from the pharmacovigilance safety database and published literature on Bridion use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• No data are available regarding the presence of sugammadex in human milk, the effects of sugammadex on the breast fed infant, or the effects of sugammadex on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Bridion and any potential adverse effects on the breastfed infant from Bridion or from the underlying maternal condition.