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 No selenium-related adverse reactions have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range.
The following adverse reactions associated with use of other components of parenteral nutrition solutions were identified in clinical studies or postmarketing reports.
Because some of these reactions were 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: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] No selenium-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing selenious acid within the recommended dosage range.
To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
( 5.1 ) • Vein Damage and Thrombosi s: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central venous catheter.
( 2.1 , 5.2 ) • Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants.
( 5.3 , 5.4 ) • Monitoring and Laboratory Tests : Monitor selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.
( 5.4 , 2.5 ) 5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition.
Like all medications, Selenious Acid 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: