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 Constipation was reported in 10 (24%) of 42 patients treated with Radiogardase.
Severity of constipation was mild in 7 patients and moderate in 3 patients [see Warnings and Precautions (5.2) ].
Most common adverse reaction (incidence >24%) was constipation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact info@heyl-berlin.de, Fax +49 30 817 4049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Increased radiation absorbed dose to gastrointestinal mucosa : Monitor for decreased gastrointestinal motility ( 5.1 ) Constipation : Monitor and treat ( 5.2 ) Electrolyte abnormalities : Monitor serum electrolytes during treatment ( 5.3 ) Blue discoloration of stool, oral mucosa and dentition ( 5.4 ) 5.1 Increased Radiation Absorbed Dose to Gastrointestinal Mucosa Radiogardase can decrease gastrointestinal motility, thus slowing the transit time of radioactivity in the gastrointestinal tract.
The slowed transit time can increase the radiation absorbed dose to the gastrointestinal mucosa.
5.2 Constipation Radiogardase can cause constipation.
Monitor and treat for signs and symptoms of constipation.
Patients with disorders associated with decreased gastrointestinal motility are at higher risk.
Like all medications, Radiogardase 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: