sugammadex sodium (Rx)Brand and Other Names:Bridion

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & 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

Safety and efficacy not established

Next

Interactions

Interaction Checker

sugammadex sodium and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
            Previous
            Next

            Adverse 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%)

            Previous
            Next

            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
            Previous
            Next

            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.

            more...
            Previous
            Next

            Pharmacology

            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
            Previous
            Next

            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

            Previous
            Next

            Images

            Previous
            Next

            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Add or Remove Plans
            Plans for
            Select State:
            Non-Medicare PlansMedicare Plans

            Select a box to add or remove a plan.

            Select a class to view formulary status for similar drugs

            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
             
             
             
            All material on this website is protected by copyright, Copyright © 1994-2016 by WebMD LLC. This website also contains material copyrighted by 3rd parties.