Perikabiven
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Amino Acid, Lipid Emulsion
Dosing in kidney impairment
See full prescribing information regarding preparation, administration, instructions for use, the recommended dosage in adults, and dosage modifications for patients with renal impairment. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Administration Dosing in Renal Impairment In patients with renal impairment, the dosage of PERIKABIVEN should be the recommended adult dosage (see above).
Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of PERIKABIVEN administered as required [see Warnings and Precautions] . Renal patients not needing dialysis require 0.6 to 0.8 g of protein/kg/day. Patients on dialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses.
The PERIKABIVEN dosage can be adjusted based on the treatment for the renal impairment, supplementing protein as indicated.
Preparation and administration
Prepare this dose
Your numbers for perikabiven. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Administration
PERIKABIVEN is for intravenous infusion into a peripheral or central vein [see Warnings and Precautions].
Use a 1.2 micron in-line filter.
Use of a vented intravenous administration set with the vent in the open position could result in air embolism.
Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.
Do not exceed the recommended maximum infusion rate of 3.7 mL/kg/hour [see Dosage and Administration and Warnings and Precautions].
Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as PERIKABIVEN via a Y-site due to precipitation. However, in patients other than neonates, ceftriaxone and PERIKABIVEN may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Contraindications, Warnings and Precautions] .
Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
Important Preparation Instructions
Inspect the bag prior to activation. Discard the bag in the following situations: ͦ Evidence of damage to the bag ͦ More than one chamber is white ͦ Solution is yellow ͦ Any seal is already broken
Activate the bag [ s ee Dosage and Administration] .
Once the bag is activated, ensure the vertical seals between chambers are broken at least from the bend in the seals and down to the ports. The upper sections of the vertical seals above the bend and the horizontal seal may remain closed.
It is recommended to mix the contents thoroughly by inverting the bag upside down to ensure a homogenous admixture.
Ensure the vertical seals between chambers are broken and the contents of all three chambers are mixed together prior to infusion [ s ee Dosage and Administration].
Use PERIKABIVEN immediately after mixing and the introduction of additives. If not used immediately, the storage time and conditions prior to use should not be longer than 24 hours at 2° to 8°C (36° to 46°F). After removal from storage at 2° to 8°C (36° to 46°F), the admixture should be infused within 24 hours. Any mixture remaining must be discarded.
For total parenteral nutrition add multivitamins and trace elements via the additive port. Any other additions to the bag should be evaluated by a pharmacist for compatibility. Questions about compatibility may be directed to Fresenius Kabi USA, LLC.
When introducing additives, it is recommended to use 18 to 23 gauge needles with a maximum length of 1.5 inches (40 mm) and to mix thoroughly after each addition, use aseptic technique and add after the vertical seals have been broken (i.e., bag has been activated) and the three components are mixed [see Dosage and Administration].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Inspect PERIKABIVEN to ensure: ͦ Precipitates have not formed during the mixing or addition of additives. ͦ The emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion.
Discard the admixture if any of the above are observed.
| 1. INSPECT BAG PRIOR TO ACTIVATION. | |
| 3. ACTIVATE BAG. | |
| 6. MAKE ADDITIONS (if prescribed). WARNING: Ensure additives are compatible. | |
| 7. SPIKE AND HANG BAG. |
Drug interactions
Check perikabiven against a medication listLabel text (4 paragraphs)
Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters. ( 7.1 )
7.1 Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as PERIKABIVEN, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with PERIKABIVEN, via a Y-site. However, ceftriaxone and PERIKABIVEN, may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Dosage and Administration ( 2.1 )].
Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used [see Contraindications ( 4 ), Use in Specific Populations ( 8.4 )].
7.2 Coumarin and Coumarin Derivatives The soybean oil present in PERIKABIVEN has vitamin K 1 . Vitamin K 1 can reverse the anticoagulant activity of coumarin or coumarin derivatives, which work by blocking recycling of vitamin K 1 . Monitoring for anticoagulant activity is recommended in patients who are on both PERIKABIVEN and coumarin or coumarin derivatives.
Contraindications
The use of PERIKABIVEN is contraindicated in: • Neonates (28 days of age or younger) 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 [see Limitations of Use ( 1 ), Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.4 )].
• Patients with known hypersensitivity to egg, soybean, peanut or any of the active or inactive ingredients in PERIKABIVEN [see Warnings and Precautions ( 5.4 )] ; • Patients with severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration >1,000 mg/dL) [see Warnings and Precautions ( 5.10 )].
• Patients with inborn errors of amino acid metabolism • Patients with cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support) • Patients with hemophagocytic syndrome • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Known hypersensitivity to egg, soybean, peanut or any of the active ingredients or excipients. ( 4 ) • Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL). ( 4 , 5.10 ) • Inborn errors of amino acid metabolism. ( 4 ) • Cardiopulmonary instability.
( 4 ) • Hemophagocytic syndrome. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary The limited available data on the use of PERIKABIVEN in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if PERIKABIVEN is used in pregnant women [see Clinical Considerations ]. Animal reproduction studies have not been conducted with PERIKABIVEN. 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% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryofetal 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.