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 The following adverse reactions were identified in clinical studies or post-marketing reports.
Given that 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.
Adverse reactions with other components of parenteral nutrition solutions: 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 ( 5.5 )] Adverse reactions with the use of trace elements administered parenterally or by other routes of administration: Neurologic toxicity with manganese [see Warnings and Precautions ( 5.3 )] Hepatic accumulation of copper and manganese [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions with zinc and copper [see Warnings and Precautions ( 5.7)] This section intentionally left blank.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc.
at 1-800-734-9236 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 Thrombosis :Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter.
( 2.1 , 5.2 ) Neurologic Toxicity with Manganese :Monitor for clinical signs and symptoms of neurotoxicity, whole blood manganese concentrations, and liver function tests in patients receiving long-term Multrys.Discontinue Multrys and consider brain magnetic resonance imaging (MRI) if toxicity is suspected.
( 5.3 ) Hepatic Accumulation of Copper and Manganese :Assess for development of hepatic accumulation.Monitor concentrations of copper and manganese in patients with cholestasis or cirrhosis receiving Multrys long-term.
( 5.4 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants.
Like all medications, Multrys 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: