Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1–800-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial.
A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously;
58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL.
The 2.5 mL dose is not approved [see Dosage and Administration ( 2.1 )].
The mean age of patients was 51 years and 35 (30%) patients were 65 years of age or older.
The majority of patients were White 105 (89%) and female 87 (74%).
The adverse reactions (≥1%) reported in the clinical trial are provided in Table 1 .
5 WARNINGS AND PRECAUTIONS Cardiovascular Reactions : Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported.
Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO injection.
Interrupt administration if reactions are observed.
( 5.1 ) Hypersensitivity Reactions : Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported.
Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available.
Like all medications, Bludigo can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: