NOURISH

Indications and Important Risk Information

Clinolipid 20% (Lipid Injectable Emulsion) for intravenous use Indications and Important Risk Information

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 and soybean proteins, the lipid emulsion and/or excipients.

      • Severe hyperlipidemia or severe disorders of lipid metabolism.

  • Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity or allergic reaction develop.

  • Monitor for signs and symptoms of fat overload, essential fatty acid deficiency (EFAD) and infections including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device.

  • Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding, to prevent refeeding complications.

  • 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.

  • CLINOLIPID injection contains no more than 25 mcg/L of aluminum. There is an increased aluminum toxicity risk in patients with impaired kidney function, including preterm infants.

  • Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. Monitor liver function tests. If patients develop liver test abnormalities consider discontinuation or dose reduction.

  • Reduce dose of CLINOLIPID injection and monitor serum triglyceride levels in patients with serum triglyceride concentrations above 400 mg/dL to avoid clinical consequences associated with hypertriglyceridemia.

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

• When admixing CLINOLIPID, protect the admixed parenteral nutrition solution from light. Use only a 1.2 micron filter to administer CLINOLIPID and admixtures containing CLINOLIPID.

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CLINIMIX and CLINIMIX E Indications and Important Risk Information

Indications

CLINIMIX sulfite-free (Amino Acid in Dextrose) Injections and CLINIMIX E sulfite-free (Amino Acid 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 admixed 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 renal impairment.
• 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 renal impairment, 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 renal impairment 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.

Please click here for full prescribing information for INFUVITE Pediatric.

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.

INTRALIPID 20% (a 20% Intravenous Fat Emulsion) and INTRALIPID 20% and 30% Pharmacy Bulk Packages (a 20% and 30% Intravenous Fat Emulsion) Indications and Important Risk Information

Indications

INTRALIPID 20% (A 20% Intravenous Fat Emulsion) is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).

INTRALIPID 20% Pharmacy Bulk Package (A 20% Intravenous Fat Emulsion) and INTRALIPID 30% Pharmacy Bulk Package (A 30% Intravenous Fat Emulsion) are indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrient admixtures to provide a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of Essential Fatty Acid Deficiency (EFAD).

Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including Intralipid, have been associated with development of PNALD.

INTRALIPID 20% AND 30% PHARMACY BULK PACKAGE ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION AND INTRALIPID® 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID® 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION (FOR EXAMPLE, THROUGH A Y-CONNECTOR).

The administration of INTRALIPID 20% and INTRALIPID 30% are contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia. INTRALIPID 20% and INTRALIPID 30% are contraindicated in patients with known hypersensitivity to egg, soybean, or peanut protein, or to any of the active ingredients or excipients.

Exercise caution when administering INTRALIPID 20% and INTRALIPID 30% to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.

INTRALIPID 20% and INTRALIPID 30% contain no more than 25 mcg/L of aluminum. 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 solutions which contain aluminum. Research indicates that patients with impaired kidney function, including 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.

Monitor serum triglycerides to determine the patient’s capacity to eliminate the infused fat from the circulation. Overdosage must be avoided.

During administration with INTRALIPID 20% or INTRALIPID 30%, liver function tests should be performed to monitor for the potential risk of PNALD/IFALD. If patients develop liver test abnormalities, consider discontinuation of lipid emulsion or dose reduction. 

Frequent platelet counts should be done in neonatal patients receiving parenteral nutrition with INTRALIPID 20% or INTRALIPID 30%.

Frequent adverse events include sepsis due to contamination of the IV catheter or vein irritation may result in thrombophlebitis by concurrently infused hypertonic solutions. These adverse reactions are inseparable for the hyperalimentation procedure with or without INTRALIPID 20% or INTRALIPID 30%. Less frequent reactions more directly related to Intralipid reported <1% in clinical trials are: Immediate or early: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion and rarely thrombocytopenia in neonates.

Delayed: hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).

The deposition of a brown pigmentation in the reticuloendothelial system called “intravenous fat pigment” has been reported. The causes and significance are unknown.

In the event of fat overload during therapy, stop the infusion of INTRALIPID 20% until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures.

Protect the admixed PN solution from light.

To report SUSPECTED ADVERSE REACTIONS, contact Baxter at 866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for INTRALIPID 20%

Please click here for full Prescribing Information for INTRALIPID 20% Pharmacy Bulk Package

Please click here for full Prescribing Information for INTRALIPID 30% Pharmacy Bulk Package

Baxter, Clinolipid, Clinimix and Clinimix E are registered trademarks of Baxter International Inc. or its subsidiaries.

Intralipid is a registered trademark of Fresenius Kabi AG or its subsidiaries.

Q-NRG+ is a registered trademark of COSMED.

Infuvite is a registered trademark of Sandoz Canada Inc.