NOURISH

Indications and Important Risk Information

CLINOLIPID 20% (Lipid Injectable Emulsion) for intravenous use

Indication
CLINOLIPID injection is indicated in adults for providing a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Limitations of Use

CLINOLIPID injection is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID injection provides sufficient amounts of essential fatty acids in this population.

The omega-3: omega-6 fatty acid ratio in CLINOLIPID injection has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.

Important Risk Information

• The use of CLINOLIPID injection is contraindicated in patients with the following:

  • Known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients.

  • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL).

• Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.

• Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.

• Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.

• Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, Hypertriglyceridemia, and Essential Fatty Acid Deficiency (EFAD): Monitor for signs and symptoms; monitor laboratory parameters.

  • Ensure aseptic techniques are used for catheter placement, catheter maintenance, and preparation and administration of CLINOLIPID.

  • If signs or symptoms of fat overload syndrome occur, stop CLINOLIPID.

  • To prevent complications from Refeeding Syndrome, closely monitor severely malnourished patients and slowly increase their nutrient intake.

  • Measure serum triglycerides before the start of infusion and regularly throughout treatment. If triglyceride levels are above 400 mg/dL in adults, stop the CLINOLIPID infusion and monitor serum triglyceride levels to avoid clinical consequences of hypertriglyceridemia.

• Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates. CLINOLIPID injection contains no more than 25 mcg/L of aluminum.

• Frequent clinical and laboratory determinations are necessary throughout treatment. Monitor fluid status closely in patients with pulmonary edema or heart failure.

• Content of Vitamin K may counteract anticoagulant activity coumarin derivatives, including warfarin.

• The most common (5%) adverse drug reactions reported from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests.

• For infusion into a central or peripheral vein. When administered with dextrose and amino acids, choice of central or peripheral venous route is dependent on the osmolarity of the final infusate.

• When admixing CLINOLIPID, protect the admixed parenteral nutrition solution from light.

• Use only a 1.2 micron in-line filter during administration of CLINOLIPID alone and or as part of an admixture.

• CLINOLIPID 1,000mL Pharmacy Bulk Package is only indicated for use in pharmacy admixture programs for the preparation of three-in-one or total nutrition admixtures.

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CLINIMIX AND CLINIMIX E Indications and Important Risk Information

Indications

CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E (amino acids with electrolytes in dextrose with calcium) Injections are indicated as a source of calories and protein (and electrolytes for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E may be used to treat negative nitrogen balance in patients.

Important Risk Information

• CLINIMIX and CLINIMIX E Injections are contraindicated in patients with known hypersensitivity to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications; and in patients with pulmonary edema or acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated in neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
• Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. Excess addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. The solution should be inspected for precipitates before admixing, after admixing, and again before administration. Protect the activated parenteral nutrition solution from light. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
• Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.
• Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop.
• Monitor for signs and symptoms of early infections.
• Refeeding severely undernourished patients may result in refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely undernourished patients and slowly increase nutrient intakes.
• CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused through a central catheter.
• CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum which may reach toxic levels with prolonged administration in patients with impaired kidney function. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Patients with impaired kidney function, including preterm infants, 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.
• Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. If CLINIMIX and CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.
• Use CLINIMIX and CLINIMIX E with caution in patients with cardiac insufficiency or kidney disease due to increased risk of electrolyte and fluid volume imbalance.
• Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have been corrected.
• Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma.

Please click here for full Prescribing Information for Clinimix.
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INFUVITE Pediatric Multiple Vitamins for Infusion Indications and Important Risk Information

Indications

INFUVITE Pediatric is indicated as a daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.

INFUVITE Pediatric is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients. 

Important Risk Information

• INFUVITE Pediatric is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.
• INFUVITE Pediatric is administered in intravenous solutions, which may contain aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solution, which contain aluminum.
• Caution should be exercised when administering INFUVITE Pediatric to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy.
• If this formulation is the only source of vitamins for a long period of time, blood concentrations of each of the vitamins should be monitored to determine if deficiencies or excesses are occurring.
• Caution should be exercised when administering INFUVITE Pediatric due to possible physical incompatibilities and clinical interactions. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion and specific vitamin-drug interactions.
• Ascorbic acid in the urine may cause false negative urine glucose determinations
• There have been rare reports of anaphylactic reactions following parenteral multivitamin administration.

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INFUVITE^® Adult Multiple Vitamins for Infusion Indications and Important Risk Information

Indications

INFUVITE Adult is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition.

INFUVITE Adult is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body’s metabolic demands and consequent tissue depletion of nutrients.

Important Risk Information

• INFUVITE Adult is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product. Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.
• INFUVITE Adult contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
• Caution should be exercised when administering INFUVITE Adult to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. In such patients, periodic monitoring of prothrombin time/INR response is essential in determining the appropriate dosage of anticoagulant therapy.
• If this formulation is the only source of vitamins for a long period of time, blood concentrations of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring.
• Caution should be exercised when administering INFUVITE Adult due to possible physical incompatibilities and clinical interactions. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion and for specific vitamin-drug interactions.
• Ascorbic acid in the urine may cause false negative urine glucose determinations
• Safety and effectiveness in children below the age of 11 years have not been established
• There have been rare reports of anaphylactic reactions following parenteral multivitamin administration.

Please click here for full prescribing information for INFUVITE Adult.