Sugammadex Sodium

Sugammadex Sodium is a prescription medication used for reversing the effects of Neuromuscular Blockers. 

• Sugammadex Sodium is available under the following different brand names: Bridion.

Adult and pediatric dosage

Injection (single dose vials)

• 200mg/2mL (100mg/mL)
• 500mg/5mL (100mg/mL)

Reversal of Neuromuscular Blockers

Adult dosage

• 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

For rocuronium and vecuronium

Adult dosage

• 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 recuronium- 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

Pediatric dosage

• Children younger than 2 years of age: Not established
• Children 2 years of age or older: 
• A dose of 4 mg/kg recommended if spontaneous recover 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 that reappearance of the second twitch (T2) in response to TOF stimulation following recuronium- or vecuronium-induced neuromuscular blockade

For rocuronium only

Adult dosage

• 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 or rocuronium 

Pediatric dosage

The immediate reversal in pediatric patients has not been studied

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Sugammadex Sodium include:

• slow heartbeats, 
• nausea, 
• vomiting, 
• pain, 
• headache, and
• lightheadedness

Serious side effects of Sugammadex Sodium include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• flushing (warmth, redness, or tingly feeling), 
• itching, 
• eye pain, itching or discomfort, 
• extreme weakness, and
• weak or shallow breathing

Rare side effects of Sugammadex Sodium include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Sugammadex Sodium has severe interactions with no other drugs.
• Sugammadex Sodium has serious interactions with the following drugs:
  • dienogest/estradiol valerate
  • ethinylestradiol
  • etonogestrel
  • levonorgestrel intrauterine
  • levonorgestrel oral
  • medroxyprogesterone
  • norethindrone
• Sugammadex Sodium has moderate interactions with the following drug:
  • toremifene
• Sugammadex Sodium has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

 

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 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sugammadex Sodium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sugammadex Sodium?”

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 (e.g., 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 (i.e., aPPT, INR) of up to 25% for up to 1 hour 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 (CrCl less than 30 mL/min) and 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)
• Risk of adverse reactions may be greater in patients with impaired renal function; care should be taken in the elderly when selecting dose, may be useful to monitor renal function
• 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 hours; 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 hours
  • Rocuronium readministration or vecuronium administration after reversal of rocuronium with sugammadex 16 mg/kg
  • Waiting time of 24 hours 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, non hormonal 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 and Lactation

• 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.