Bridion

Last reviewed on RxList: 3/8/2021
Bridion Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Bridion?

Bridion (sugammadex) Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

What Are Side Effects of Bridion?

Common side effects of Bridion include:

Dosage for Bridion

The dose of Bridion is based on the patient's body weight.

What Drugs, Substances, or Supplements Interact with Bridion?

Bridion may interact with toremifene or oral contraceptives. Patients using hormonal contraceptives must use an additional, non-hormonal method of contraception for the next 7 days following Bridion administration. Tell your doctor all medications and supplements you use.

Bridion During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before receiving Bridion. It is unknown if Bridion passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Bridion (sugammadex) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Bridion Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, skin rash or redness; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

  • flushing (warmth, redness, or tingly feeling);
  • itching;
  • eye pain, itching, or discomfort; or
  • extreme weakness, weak or shallow breathing.

Common side effects may include:

  • slow heartbeats;
  • nausea, vomiting;
  • pain;
  • headache; or
  • a light-headed feeling, like you might pass out.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bridion (Sugammadex Injection)

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Bridion Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Anaphylaxis and Hypersensitivity [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
  • Marked Bradycardia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect 2914 subjects exposed to 2, 4, or 16 mg/kg BRIDION and 544 to placebo in pooled Phase 1-3 studies. The population was 18 to 92 years old, 47% male and 53% female, 34% ASA (American Society of Anesthesiologists) Class 1, 51% ASA Class 2, and 14% ASA Class 3, and 82% Caucasian. Most subjects received a single dose of BRIDION 2 mg/kg or 4 mg/kg.

Adverse reactions reported in ≥10% of patients at a 2, 4, or 16 mg/kg BRIDION dose with a rate higher than the placebo rate are: vomiting, pain, nausea, hypotension, and headache.

All adverse reactions occurring in ≥2% of subjects treated with BRIDION and more often than placebo for adult subjects who received anesthesia and/or neuromuscular blocking agent in pooled Phase 1 to 3 studies are presented in Table 2.

Table 2: Percent of Subject Exposures in Pooled Phase 1 to 3 Studies with Adverse Reactions Incidence ≥2%

Body System Preferred Term Sugammadex Placebo
(N=544) n (%)
2 mg/kg
(N=895) n (%)
4 mg/kg
(N=1921) n (%)
16 mg/kg
(N=98) n (%)
Injury, poisoning and procedural complications
Incision site pain 58 (6) 106 (6) 4 (4) 6 (1)
Procedural complication 13 (1) 27 (1) 8 (8) 3 (1)
Airway complication of anesthesia 11 (1) 13 (1) 9 (9) 0
Anesthetic complication 8 (1) 14 (1) 9 (9) 1 (<1)
Wound hemorrhage 5 (1) 38 (2) 0 8 (1)
Recurrence of neuromuscular blockade 0 1 (<1) 2 (2) 0
Gastrointestinal disorders
Nausea* 208 (23) 503 (26) 23 (23) 127 (23)
Vomiting* 98 (11) 236 (12) 15 (15) 57 (10)
Abdominal pain* 48 (5) 68 (4) 6 (6) 17 (3)
Flatulence 17 (2) 51 (3) 1 (1) 10 (2)
Dry mouth 9 (1) 5 (<1) 2 (2) 0
General disorders and administration site conditions
Pain* 434 (48) 993 (52) 35 (36) 207 (38)
Pyrexia 77 (9) 109 (6) 5 (5) 17 (3)
Chills 30 (3) 61 (3) 7 (7) 27 (5)
Nervous system disorders
Headache 61 (7) 99 (5) 10 (10) 42 (8)
Dizziness 44 (5) 67 (3) 6 (6) 13 (2)
Hypoesthesia 12 (1) 24 (1) 3 (3) 9 (2)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 42 (5) 66 (3) 5 (5) 27 (5)
Cough 13 (1) 49 (3) 8 (8) 11 (2)
Musculoskeletal and connective tissue disorders
Pain in extremity 13 (1) 35 (2) 6 (6) 15 (3)
Musculoskeletal pain 16 (2) 33 (2) 1 (1) 6 (1)
Myalgia 5 (1) 17 (1) 2 (2) 3 (1)
Psychiatric disorders
Insomnia 20 (2) 103 (5) 5 (5) 22 (4)
Anxiety 14 (2) 19 (1) 3 (3) 1 (<1)
Restlessness 3 (<1) 17 (1) 2 (2) 2 (<1)
Depression 2 (<1) 5 (<1) 2 (2) 0
Investigations
Red blood cell count decreased* 13 (1) 34 (2) 1 (1) 2 (<1)
Electrocardiogram QT interval abnormal* 13 (1) 7 (<1) 6 (6) 4 (1)
Blood creatine phosphokinase increased 9 (1) 14 (1) 2 (2) 1 (<1)
Vascular disorders
Hypertension* 48 (5) 96 (5) 9 (9) 38 (7)
Hypotension* 33 (4) 102 (5) 13 (13) 20 (4)
Skin and subcutaneous tissue disorders
Pruritus 17 (2) 50 (3) 2 (2) 9 (2)
Erythema 5 (1) 31 (2) 0 6 (1)
Metabolism and nutrition disorders
Hypocalcemia 15 (2) 12 (1) 0 4 (1)
Cardiac disorders
Tachycardia* 17 (2) 29 (2) 5 (5) 4 (1)
Bradycardia* 9 (1) 21 (1) 5 (5) 6 (1)
Surgical and medical procedures
Hysterectomy 0 0 2 (2) 0
* Combinations of preferred terms are as follows:
Nausea includes preferred terms nausea and procedural nausea
Vomiting includes preferred terms vomiting and procedural vomiting
Abdominal pain includes preferred terms abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, and epigastric discomfort
Pain includes preferred terms pain and procedural pain

Anaphylaxis And Hypersensitivity

Hypersensitivity reactions, including anaphylaxis, have occurred in both premarketing clinical trials and in post-marketing spontaneous reports. In a dedicated hypersensitivity study in healthy volunteers, the frequency of anaphylaxis was 0.3% [see WARNINGS AND PRECAUTIONS]. These reactions 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.

Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal.

A randomized, double-blind study examined the incidence of drug hypersensitivity reactions in healthy volunteers given up to 3 doses of placebo (N=76), sugammadex 4 mg/kg (N=151) or sugammadex 16 mg/kg (N=148). Reports of suspected hypersensitivity were adjudicated by a blinded committee. The incidence of adjudicated hypersensitivity was 1%, 7% and 9% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively. There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg. There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg. The frequency of anaphylaxis for the 299 healthy volunteers treated with intravenous sugammadex was 0.3%. There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing.

In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 1% in the 298 healthy volunteers treated with sugammadex).

Recurrence Of Neuromuscular Blockade

In clinical studies with subjects treated with rocuronium or vecuronium, where BRIDION was administered using a dose labeled for the depth of neuromuscular blockade (N=2022), an incidence of <1% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence [see WARNINGS AND PRECAUTIONS].

Bronchospasm

In one dedicated clinical trial and in post-marketing data, in patients with a history of pulmonary complications [see Use In Specific Populations], bronchospasm was reported as a possibly related adverse event.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of BRIDION. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders

Cases of marked bradycardia and bradycardia with cardiac arrest have been observed within minutes after administration of sugammadex [see WARNINGS AND PRECAUTIONS]. Other cardiac rhythm abnormalities have included atrial fibrillation, atrioventricular block, cardiac/cardiorespiratory arrest, electrocardiographic (ECG) ST segment changes, supraventricular tachycardia/extrasystoles, tachycardia, ventricular fibrillation, and ventricular tachycardia. Anaphylaxis associated with ECG ST segment changes (elevation or depression) consistent with myocardial ischemia or coronary spasm has also been reported.

General Disorders And Administration Site Conditions

Cases of BRIDION not having the intended effect.

Immune System Disorders

Hypersensitivity events including anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, and Type 1 hypersensitivity have been reported [see WARNINGS AND PRECAUTIONS].

Respiratory, Thoracic, And Mediastinal Disorders

Events of laryngospasm, dyspnea, wheezing, pulmonary edema, and respiratory arrest have been reported.

DRUG INTERACTIONS

Summary

The information reported in sections 7.2 - 7.4 is based on binding affinity between BRIDION and other drugs, preclinical experiments, clinical studies and simulations of a pharmacokinetic-pharmacodynamic (PK-PD) model. Based on these considerations, 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.

Read the entire FDA prescribing information for Bridion (Sugammadex Injection)

© Bridion Patient Information is supplied by Cerner Multum, Inc. and Bridion Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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