Data from FDA - Curated by EPG Health - Last updated 04 November 2017

Indication(s)

1 INDICATIONS AND USAGE CLINOLIPID 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 is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population. [See Use in Specific Populations (8.4)] The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions. [See Clinical Studies (14)] CLINOLIPID is indicated in adults for parenteral nutrition providing a source of calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated. (1) Limitations of Use: •CLINOLIPID is not indicated for use in pediatric patients because there is insufficient data to demonstrate that CLINOLIPID provides sufficient amounts of essential fatty acids in this population (1, 8.4) •The omega-3: omega-6 fatty acid ratio in CLINOLIPID has not been shown to improve clinical outcomes compared to other intravenous lipid emulsions (1)

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS The use of CLINOLIPID is contraindicated in patients with the following: •Known hypersensitivity to egg or soybean proteins or to any of the ingredients, including excipients. •Severe hyperlipidemia (serum triglyceride concentrations above 1000 mg/dL) or severe disorders of lipid metabolism characterized by hypertriglyceridemia. •Known hypersensitivity to egg and soybean proteins, the lipid emulsion and/or excipients. (4) •Severe hyperlipidemia or severe disorders of lipid metabolism. (4)
Adverse reactions
6 ADVERSE REACTIONS The most common (5%) adverse drug reactions from clinical trials were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The CLINOLIPID trials had small sample sizes and patients had a variety of underlying medical conditions both between different trials and within the individual trials. Patients had gastrointestinal diseases/dysfunction or were recovering from gastrointestinal or other surgeries, trauma, burns, or were afflicted by other chronic illness. The largest trial (Study 1, 48 subjects) enrolled patients with many different underlying diagnoses. The rates of treatment emergent adverse reactions can therefore not be directly compared to rates observed in the clinical trials of other related products and may not reflect the rates observed in clinical practice. Commonly observed adverse reactions in 261 adult patients who received CLINOLIPID were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests and occurred in 2 to 10 % of patients. In Study 1 the most common adverse reactions were infectious complications (urinary tract infection, septicemia, and fever of unknown origin), treatment emergent abnormalities on liver/gallbladder ultrasound and abnormalities of serum chemistries, principally, hepatic function tests. Adverse reactions in Study 2 were similar. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia. Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock). 6.2 Post-marketing Experience The following adverse reactions have been identified during use of CLINOLIPID, and listed by MedDRA System Organ Class, then by Preferred Term in order of severity. Because these reactions are 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. Gastrointestinal Disorders: Diarrhea Skin and Subcutaneous Tissue Disorders: Pruritus Immune System Disorders: Hypersensitivity with the manifestations of rash and dyspnea Investigations: International normalized ratio (INR) decreased in anticoagulated patients [see Drug Interactions (7)]

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Use a 1.2 micron in-line filter when administering to a patient (2.1) •See full prescribing information for administration and admixing instructions (2.2, 2.3) •CLINOLIPID is intended for intravenous infusion. (2.4) •The recommended dose depends on energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient. The usual daily lipid dosage in adults is 1 to 1.5 g/kg/day and should not exceed 2.5 g/kg/day. (2.4) 2.1 Use of an Inline Filter When Administering CLINOLIPID to a Patient Fragments of the administration port membrane could be dislodged into the bag after spiking. Use a 1.2 micron in-line filter during administration of CLINOLIPID (alone or as part of an admixture) to remove particulate matter or micro-precipitate contamination during administration of a lipid injection (alone or as part of an admixture). Particulate matter greater than 5 microns has the capability of obstructing blood flow through capillaries, which could lead to embolism and vascular occlusion. Do not use filters of less than 1.2 micron pore size with lipid emulsions. 2.2 Important Administration Instructions Before opening the overwrap, check the color of the oxygen indicator. Compare color of the indicator to the reference color printed next to the OK symbol depicted in the printed area of the indicator label. Do not use the product if the color of the oxygen absorber/indicator does not correspond to the reference color printed next to the OK symbol. After opening the bag, use the contents immediately and discard unused portion. Visually inspect that the emulsion is a homogeneous liquid with a milky appearance. Inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. When Administering CLINOLIPID to a Patient: Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. Do not use vented administration sets with the vent in the open position. This can result in air embolism. If CLINOLIPID is mixed with dextrose and/or amino acid solutions, check the compatibility before administration by inspecting the mixture closely for the presence of precipitates. Formation of precipitates could result in vascular occlusion. When infused alone, CLINOLIPID can be administered via central or peripheral vein. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depending on the osmolarity of the final infusate. Do not use administration sets and lines that contain di-2-ehtylhexyl phthalate (DEHP). Use only a 1.2 micron pore size in-line filter to administer CLINOLIPID. DO NOT use any size less than 1.2 micron pore size in-line filter [see Dosage and Administration (2.1)]. 2.3 Admixing Guidelines When Admixing CLINOLIPID in the Pharmacy: Prepare the admixture using strict aseptic techniques to avoid microbial contamination. Do not add additives directly to CLINOLIPID. Do not add CLINOLIPID to the total parenteral nutrition container first; destabilization of the lipid may occur from such an admixture. Do not use the EXACTAMIX Inlet REF 173 (H938173) with an EXACTAMIX compounder to transfer CLINOLIPID. This inlet spike has been associated with dislodgement of the administration port membrane into the CLINOLIPID bag. Use of EXACTAMIX Inlet REF 174 (H938174) is recommended. The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone: 1.Transfer Dextrose Injection to the Total Parenteral Nutrition Admixture Container 2.Transfer Amino Acid Injection 3.Transfer Lipid Emulsion Amino Acid Injection, Dextrose Injection and Lipid Emulsions may be simultaneously transferred to the admixture container. Use gentle agitation during admixing to minimize localized concentration effects; shake bags gently after each addition. The prime destabilizers of emulsions are excessive acidity (such as a pH below 5) and inappropriate electrolyte content. Give careful consideration to additions of divalent cations (Ca++ and Mg++), which have been shown to cause emulsion instability. Amino acid solutions exert buffering effects that protect the emulsion. Inspect the admixture closely for separation of the emulsion. This can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The admixture should also be examined for particulates. Discard the admixture if any of the above is observed. 2.4 Dosing Considerations The dosing of CLINOLIPID depends on energy expenditure, the patient’s clinical status, body weight, tolerance, and ability to metabolize CLINOLIPID, as well as additional energy given orally/enterally to the patient. For complete parenteral nutrition, concomitant supplementation with amino acids, carbohydrates, electrolytes, vitamins, and trace elements is necessary. Prior to administration of CLINOLIPID, correct severe water and electrolyte disorders, severe fluid overload states, and severe metabolic disorders. Before starting the infusion, obtain serum triglyceride levels to establish the baseline value. In patients with elevated triglyceride levels, initiate CLINOLIPID injection at a lower dose, and advance in smaller increments, checking the triglyceride levels prior to each adjustment. Adjust the administration flow rate by taking into account the dose being administered, the daily volume intake, and the duration of the infusion [see Overdosage (10)]. The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation. Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition. The maximum daily dose of CLINOLIPID should be based on individual total nutritional requirements and patient tolerance. The usual lipid dosage is 1 to 1.5 g/kg/day (equal to 5 to 7.5 mL/kg/day of CLINOLIPID 20%) 1. The daily dose should not exceed 2.5 g/kg/day. The initial infusion rate should not exceed 0.1 g (equal to 0.5 mL) per minute for the first 15 to 30 minutes. If tolerated, gradually increase until reaching the required rate after 30 minutes.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Hepatic Impaired: Use with caution in patients with preexisting liver disease or liver insufficiency. (8.5) 8.1 Pregnancy Risk Summary The limited available data on the use of CLINOLIPID in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if CLINOLIPID is used in pregnant women [see Clinical Considerations]. Animal reproduction studies have not been conducted with lipid injectable emulsion. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk: Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. It is not known whether the administration of CLINOLIPID to pregnant women provides adequate essential fatty acids to the developing fetus. 8.2 Lactation Risk Summary There are no data available to assess the presence of CLINOLIPID and/or its active metabolite(s) in human milk, the effects on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINOLIPID and any potential adverse effects on the breastfed child from CLINOLIPID or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of CLINOLIPID have not been established in pediatric patients. CLINOLIPID is not indicated for use in pediatric patients. Pediatric studies did not establish that CLINOLIPID provides sufficient amounts of essential fatty acids (EFA) in pediatric patients. Pediatric patients may be particularly vulnerable to neurologic complications due to EFA deficiency if adequate amounts of EFA are not provided. Deaths in preterm infants after infusion of intravenous lipid emulsion have been reported [see Warnings and Precautions (5.1)]. Patients, particularly preterm infants, are at risk for aluminum toxicity [see Warnings and Precautions (5.8)]. Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.9)]. In clinical trials of a pure soybean oil based intravenous lipid emulsion product, thrombocytopenia in neonates occurred (less than 1%). 8.5 Geriatric Use Of the total number of subjects in clinical studies of CLINOLIPID, 21% were 65 and over, while 10% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Hepatic Impairment Parenteral nutrition should be used with caution in patients with hepatic impairment. Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, including cholestasis, hepatic steatosis, fibrosis and cirrhosis (parenteral nutrition associated liver disease), possibly leading to hepatic failure. Cholecystitis and cholelithiasis have also been observed. The etiology of these disorders is thought to be multifactorial and may differ between patients. Monitor liver function parameters closely. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify causative and contributory factors, and possible therapeutic and prophylactic interventions.

Interactions

7 DRUG INTERACTIONS No drug interaction studies have been performed with CLINOLIPID. Olive and soybean oils have a natural content of Vitamin K1 that may counteract the anticoagulant activity of coumarin derivatives, including warfarin. The anticoagulant activity of coumarin derivatives, including warfarin, may be counteracted. (7)

More information

Category Value
Authorisation number NDA204508
Agency product number 6UYK2W1W1E
Orphan designation No
Product NDC 0338-9540
Date Last Revised 20-07-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1986378
Marketing authorisation holder Baxter Healthcare Corporation
Warnings WARNING: DEATH IN PRETERM INFANTS Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. [See Warnings and Precautions( 5.1 )and Use in Specific Populations( 8.4 )] WARNING: DEATH IN PRETERM INFANTS See full prescribing information for complete boxed warning • Deaths in preterm infants have been reported in literature. ( 5.1 , 8.4 ) • Autopsy findings included intravascular fat accumulation in the lungs. ( 5.1 , 8.4 ) • Preterm and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. ( 5.1 , 8.4 )