Dosing and uses of Bridion (sugammadex sodium)
Adult dosage forms and strengths
injection
- 200mg/2mL (100mg/mL)
- 500mg/5mL (100mg/mL)
- Available as single-dose vials
Reversal of Neuromuscular Blockers
Selective relaxant binding agent for reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adults undergoing surgery
Doses and timing of administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred
Administer as single IV bolus injection infused over 10 seconds into existing IV line
Dose on actual body weight
For rocuronium and vecuronium
- A dose of 4 mg/kg is recommended if spontaneous recovery of the twitch response has reached 1-2 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 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 is recommended if there is a clinical need to reverse neuromuscular blockade soon (~3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium
- The efficacy of the 16-mg/kg dose following administration of vecuronium has not been studied
Dosing Considerations
Should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents and neuromuscular block reversal agents
Pediatric dosage forms and strengths
Safety and efficacy not established
Bridion (sugammadex sodium) adverse (side) effects
>10%
Pain (36-52%)
Nausea (23-26%)
Vomiting (11-15%)
Hypotension (4-13%)
1-10%
Headache (5-10%)
Pyrexia (5-9%)
Hypertension (5-9%)
Airway complication of anesthesia (1-9%)
Anesthetic complication (1-9%)
Procedural complication (1-8%)
Cough (1-8%)
Chills (3-7%)
Incision site pain (4-6%)
Abdominal pain (4-6%)
Dizziness (3-6%)
Pain in extremity (1-6%)
QT interval abnormal (1-6%)
Oropharyngeal pain (3-5%)
Insomnia (2-5%)
Tachycardia (2-5%)
Bradycardia (1-5%)
Pruritus (2-3%)
Flatulence (1-3%)
Hypoesthesia (1-3%)
Anxiety (1-3%)
Wound hemorrhage (1-2%)
Dry mouth (1-2%)
Restlessness (1-2%)
Depression (1-2%)
Decreased RBCs (1-2%)
Increased CPK (1-2%)
Musculoskeletal pain (1-2%)
Myalgia (1-2%)
Erythema (1-2%)
Hypocalcemia (1-2%)
Warnings
Contraindications
Known hypersensitivity to sugammadex or any of its components
Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (ie, anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex
Cautions
Anaphylaxis and hypersensitivity: Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions
Marked bradycardia reported, some resulting in cardiac arrest, within minutes following sugammadex administration
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured
A small number of patients experienced a delayed or minimal response to sugammadex; it is important to monitor ventilation until recovery occurs
Lower than recommended sugammadex doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended
Drugs that potentiate neuromuscular blockade (eg, aminoglycosides, opioids) are used in the postoperative phase, so special attention should be paid to the possibility of recurrence of neuromuscular blockade
Doses up to 16 mg/kg were associated with increased coagulation parameters (ie, aPPT, INR) of up to 25% for up to 1 hr in healthy volunteers; in patients undergoing major orthopedic surgery of the lower extremity who were concomitantly treated with heparin or LMWH for thromboprophylaxis, increases in aPTT and PT (INR) of 5.5% and 3%, respectively, were observed in the hour following sugammadex 4 mg/kg
Not recommended for patients with severe renal impairment, including those on dialysis
In clinical trials when neuromuscular blockade was intentionally reversed in the middle of anesthesia, the following signs of light anesthesia were observed: movement, coughing, grimacing, and suckling of the tracheal tube
Has not been studied for reversal following rocuronium or vecuronium administration in the ICU setting
Do not use to reverse blockade induced by nonsteroidal neuromuscular blocking agents (eg, succinylcholine, benzylisoquinolinium compounds)
Do not use to reverse neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium
Waiting times for readministration of NBA following reversal with sugammadex
- Minimum waiting time for 1.2 mg/kg rocuronium: 5 minutes
- When rocuronium 1.2 mg/kg is administered within 30 minutes after reversal with sugammadex, the onset of neuromuscular blockade may be delayed up to ~4 minutes and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes
- Minimum waiting time for 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium (normal renal function): 4 hr; if a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg
- Minimum waiting time for 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium (mild-to-moderate renal impairment): 24 hr
- Rocuronium readministration or vecuronium administration after reversal of rocuronium with sugammadex 16 mg/kg
- Waiting time of 24 hr is suggested
- If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent
- The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent
Drug interaction overview
- Toremifene has a relatively high binding affinity for sugammadex, and therefore, some displacement of vecuronium or rocuronium from the sugammadex binding complex could occur and result in recurrence of neuromuscular blockade
- Hormonal contraceptives
- May bind to progestogen, thereby decreasing progestogen exposure
- Administration of a bolus dose of sugammadex 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 sugammadex is administered, the patient must use an additional, nonhormonal contraceptive method or backup method of contraception (eg, condoms and spermicides) for the next 7 days
- In the case of hormonal hormonal contraceptives not taken orally, the patient must use an additional, hormonal contraceptive method or backup method of contraception (eg, condoms and spermicides) for the next 7 days
- Sugammadex may also interfere with serum progesterone assay
Pregnancy
Pregnancy
There are no data on use in pregnant women to inform any drug-associated risks
In animal reproduction studies, there was no evidence of teratogenicity following daily IV administration 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 rabbits
Lactation
Unknown if distributed in human breast milk
Present in rat milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Bridion (sugammadex sodium)
Mechanism of action
Selective relaxant binding agent; forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction
Distribution
Vd: 11-14 L
Metabolism
No metabolites of sugammadex have been observe
Elimination
Clearance: 88 mL/min
Excretion: 96% urine; <0.02% feces or expired air
Half-life
- Normal renal function: 2 hr
- Mild renal impairment: 4 hr
- Moderate renal impairment: 6 hr
- Severe renal impairment: 19 hr
Administration
IV Compatibilities
0.9% NaCL
5% dextrose
0.45% NaCl/2.5% dextrose
5% dextrose/0.9% NaCL
Isolyte P with 5% dextrose
Ringer lactate solution
Ringer solution
IV Incompatibilities
VerapamiL
Ondansetron
Ranitidine
IV Administration
Administer by IV bolus into existing running IV line (see IV compatibilities)
Ensure the infusion line is adequately flushed (eg, with 0.9% NaCl) between sugammadex sodium and administration of other drugs
Storage
Packaging does not contain natural rubber latex
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Protect from light
When not protected from light, the vial should be used within 5 days
