SMOFLIPID Dosage & Rx Info | Uses, Side Effects

Smoflipid Generic Name & Formulations

Legal Class

General Description

Lipid content 0.2g/mL (mixture of soybean oil, medium-chain triglycerides, olive- and fish-oil); emulsion for IV infusion; contains aluminum.

Pharmacological Class

Fatty acids.

How Supplied

Emulsion (100mL)—10, 20; (250mL)—10; (500mL)—12

Manufacturer

Fresenius Kabi USA

Generic Availability

Mechanism of Action

Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.

Smoflipid provides a biologically utilizable source of calories and essential fatty acids.

Smoflipid Indications

Indications

To provide a source of calories and essential fatty acids in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Smoflipid Dosage and Administration

Adult

Individualize. Dose based on patient’s energy requirements, age, clinical status, body wt, tolerance, ability to eliminate and metabolize lipids, and additional energy given orally/enterally. Administer by IV infusion via a peripheral or central vein. Usual dose: 1–2g/kg/day; max 2.5g/kg/day. Initiate rate at 0.2mL/kg/hr for the first 15–30mins; increase gradually to required rate after 30mins; max 0.5mL/kg/hr. Max daily dose: 60% of total energy requirements. Duration of infusion: based on clinical status. If serum triglycerides (>400mg/dL): initiate at a lower dose and increase in smaller increments; check levels before each adjustment.

Children

Individualize. Dose and duration of infusion: based on patient’s clinical status. Administer by IV infusion via a peripheral or central vein. Max infusion rate at 0.75mL/kg/hr. Birth–2yrs (including preterm and term neonates): initially 0.5–1g/kg/day; max 3g/kg/day; 2–<2yrs: initially 1–2g/kg/day; max 3g/kg/day; 12–17yrs: initially 1g/kg/day; max 2.5g/kg/day.

Smoflipid Contraindications

Contraindications

Fish, egg, soybean, or peanut allergy. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1000mg/dL).

Smoflipid Boxed Warnings

Not Applicable

Smoflipid Warnings/Precautions

Warnings/Precautions

Clinical decompensation with rapid IV infusion in neonates/infants. Risk of parenteral nutrition-associated liver disease (PNALD)(eg, cholestasis or hepatic steatosis), other hepatobiliary disorders (eg, cholecystitis and cholelithiasis). Correct severe fluid and electrolyte disorders prior to initiation. Increased risk of hypertriglyceridemia esp. in those with inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes. Measure serum triglycerides at baseline and during therapy; if serum triglyceride >400mg/dL, discontinue and monitor levels. Assess high-risk patients for overall energy intake to minimize risk of new or worsening of hypertriglyceridemia. Discontinue if signs/symptoms of fat overload syndrome or hypersensitivity reactions occur; treat appropriately. Monitor for signs/symptoms of infection, essential fatty acid deficiency (EFAD). Severely undernourished: avoid overfeeding. Monitor fluids, electrolytes, blood glucose, liver (consider discontinuation or dose reduction if abnormal LFTs occur) and kidney function, CBCs, platelets, coagulation parameters throughout treatment. Hepatic impairment. Pregnancy. Nursing mothers.

Smoflipid Pharmacokinetics

Metabolism

Hydrolysis.

Smoflipid Interactions

Interactions

Vitamin K content may antagonize anticoagulants (eg, coumarin, warfarin); monitor. High lipid levels in plasma may interfere with blood tests (eg, hemoglobin, triglycerides, bilirubin, LDH, oxygen saturation).

Smoflipid Adverse Reactions

Adverse Reactions

Nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, hypertriglyceridemia, hypertension, sepsis, dyspepsia, UTI, anemia, device-related infections; refeeding syndrome, PNALD, aluminum toxicity (esp. preterm infants, renal impairment).

Smoflipid Clinical Trials

See Literature

Smoflipid Note