Multrys Drug Information
Generic name: TRACE ELEMENTS INJECTION 4
Uses of Multrys
Multrys is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Multrys is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Dosage & Administration of Multrys
Side Effects of Multrys
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 Vein damage and thrombosis Aluminum toxicity Adverse reactions with the use of trace elements administered parenterally or by other routes of administration: Neurologic toxicity with manganese Hepatic accumulation of copper and manganese Hypersensitivity reactions with zinc and copper This section intentionally left blank.
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.
Warnings & Cautions for Multrys
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. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred.
If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation. In addition to inspection of the solution , the infusion set and catheter should also periodically be checked for precipitates.
Vein Damage and Thrombosis Multrys must be prepared and used as an
admixture in parenteral nutrition solution. It is not for direct intravenous infusion. In addition, consider the osmolarity of the final parenteral nutrition solution in determining peripheral versus central administration.
Solution with an osmolarity of 900 mOsmol/L or greater must be infused through a central catheter . The infusion of hypertonic nutrient solution into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.
Neurologic Toxicity with Manganese Pediatric patients on long-term parenteral nutrition receiving manganese
at higher than recommended dosages and pediatric patients with cholestatic liver disease have experienced manganese accumulation in the basal ganglia. Some adult patients with brain MRI findings reportedly experienced neuropsychiatric symptoms, including changes in mood or memory, seizures and/or parkinsonian-like tremors, dysarthria, mask-face, and halting gait. Some pediatric patients experienced dystonic movements or seizures.
Brain MRI findings and clinical symptoms have also been observed in patients who received manganese at or below the recommended dosage and with normal blood manganese concentrations. Regression of symptoms and brain MRI findings have occurred over weeks to months following discontinuation of manganese in most patients but have not always completely resolved. Monitor patients receiving long-term parenteral nutrition solutions containing Multrys for neurologic signs and symptoms and routinely monitor whole blood manganese concentrations and liver function tests.
In case of suspected manganese toxicity or new neuro-psychiatric manifestations, temporarily discontinue Multrys, check manganese whole blood concentrations, and consider brain MRI evaluation. Monitor patients receiving Multrys for cholestasis or other biliary liver disease. Consider individual trace element products as an alternative to Multrys in patients with hepatobiliary disease .
Hepatic Accumulation of Copper and Manganese Copper is primarily eliminated in the
bile and excretion is decreased in patients with cholestasis and/or cirrhosis. Hepatic accumulation of copper and manganese have been reported in autopsies of patients receiving long-term parenteral nutrition containing copper and manganese at dosages higher than recommended. Patients with cholestasis and/or cirrhosis receiving parenteral nutrition are at increased risk of manganese brain deposition and neurotoxicity.
Administration of copper to patients with cholestasis and/or cirrhosis may cause hepatic accumulation of copper. Administration of copper to patients with Wilson disease, an inborn error of copper metabolism with a defect in hepatocellular copper transport, may cause both increased hepatic accumulation of copper and aggravation of the underlying hepatocellular degeneration. If a patient develops signs or symptoms of hepatobiliary disease during the use of Multrys, obtain serum concentrations of copper and ceruloplasmin as well as manganese whole blood concentrations; consider using individual trace element products in these patients .
Aluminum Toxicity Multrys contains aluminum that may be toxic. Aluminum may reach
toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm infants, including preterm neonates, are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including preterm infants and premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration or lower daily amounts. Exposure to aluminum from Multrys is not more than 0.45 mcg/kg/day. When prescribing Multrys for use in parenteral nutrition containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day.
Monitoring and Laboratory Tests
Monitor zinc, copper, and selenium serum concentrations, manganese whole blood concentration, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count, and coagulation parameters during use of parenteral nutrition containing Multrys .
Hypersensitivity Reactions with Zinc and Copper Postmarket safety reporting has identified zinc
hypersensitivity in patients receiving zinc-containing insulin products and copper hypersensitivity in women receiving copper-containing intrauterine devices, providing evidence that patients may experience hypersensitivity reactions when exposed to these metals. If hypersensitivity reactions (e.g., pruritis, angioedema, dyspnea, rash, urticaria) occur in patients receiving Multrys in parenteral nutrition, discontinue Multrys, and initiate appropriate medical treatment .
Pediatric Use of Multrys
Pediatric Use Multrys is approved for use in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients less than 10 kg are based on published literature describing controlled studies of products containing zinc, copper, manganese, and selenium .
Contraindications for Multrys
Multrys is contraindicated in patients with hypersensitivity to zinc or copper. Hypersensitivity to zinc or copper
Overdosage Information for Multrys
There is no information on overdose-related toxicity with a fixed-combination trace element product. However, there are reports on overdosage in the literature for the individual trace elements. Management of overdosage is supportive care based on presenting signs and symptoms.
Obtain blood samples for laboratory testing of the individual trace elements and ceruloplasmin for copper. Zinc Acute zinc toxicity was reported in an infant who received an inadvertent 1,000-fold overdose of zinc in parenteral nutrition that led to cardiac failure and death. Zinc toxicity in adult patients receiving 17 to 400-fold the recommended dosage in parenteral nutrition for 2.5 to 60 days reported signs and symptoms including vomiting, diarrhea, hyperamylasemia, thrombocytopenia, and anemia.
The zinc serum concentration was 2 to 30-fold the upper end of the reported range in healthy subjects in these cases. Copper Acute copper toxicity was reported in patients with oral, intravenous, or subcutaneous administration. Clinical manifestations included metallic taste, nausea, vomiting, abdominal pain, and multi-organ failure involving kidney, liver, blood, and cardiovascular systems.
Chelating agents can be used for treatment of acute toxicity. Long-term administration of parenteral copper above recommended dosage may result in significant accumulation of copper in the liver, brain, and other tissues with possible organ damage . Manganese Acute manganese toxicity was reported in adult patients following infusion of manganese more than 10,000-fold the recommended dosage and after use of dialysis fluid contaminated with manganese. Signs and symptoms included skin flushing, acute pancreatitis, elevated whole blood manganese concentrations, and MRI evidence of brain accumulation of manganese.
Chronic infusion and oral intake of manganese above recommended dosage have resulted in neuropsychiatric symptoms and MRI evidence of brain accumulation of manganese . Selenium Acute selenium toxicity was reported with oral overdosage of greater than 1 g/day. Symptoms included nausea, vomiting, diarrhea, abdominal pain, garlic breath odor, and altered mental status. Death from circulatory collapse was reported after oral ingestion of 5 to 10 g of selenium with blood concentrations ranging 10 to 50-fold the upper end of the reported range in healthy subjects.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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