BRIDION SIDE EFFECTS

  • Generic Name: sugammadex injection
  • Brand Name: Bridion
Last updated on MDtodate: 10/12/2022

SIDE EFFECTS

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

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 1.

Table 1: 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%. 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.

Bronchospasm

In one dedicated clinical trial and in post-marketing data, in patients with a history of pulmonary complications,  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. 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.

Respiratory, Thoracic, And Mediastinal Disorders

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

 

SRC: NLM .