difelikefalin (Rx)

Brand and Other Names:Korsuva
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 65mcg/1.3mL

Pruritus

Indicated for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis (HD)

0.5 mcg/kg IV push into venous line of dialysis circuit at the end of each HD treatment

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment needed
  • Severe: Pharmacokinetics not evaluated; use not recommended

Dosing Considerations

Limitation of use

  • Not studied in patients on peritoneal dialysis; use not recommended

Safety and efficacy not established

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Interactions

Interaction Checker

and difelikefalin

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            Adverse Effects

            1-10%

            Diarrhea (9%)

            Dizziness (6.8%)

            Nausea (6.6%)

            Gait disturbances (6.6%)

            Hyperkalemia (4.7%)

            Headache (4.5%)

            Somnolence (4.2%)

            Mental status change (3.3%)

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            Warnings

            Contraindications

            None

            Cautions

            Dizziness, somnolence, mental status changes, and gait disturbances (eg, falls) have occurred; may subside over time with continued treatment

            May impair mental or physical abilities; advise patients not to drive or operate dangerous machinery until effect on a patient’s ability to drive or operate machinery is known

            Drug interaction overview

            • Centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the adverse reactions of difelikefalin; use with caution
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            Pregnancy & Lactation

            Pregnancy

            Limited human data are insufficient on use in pregnant females to evaluate drug-associated risks for major birth defects or miscarriage

            Lactation

            There are no data regarding drug presence in human milk, effects on breastfed infants, or effects on milk production

            Studies showed difelikefalin was transferred into milk in lactating rats

            When a drug is present in animal milk, it is likely that the drug will be present in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Kappa opioid receptor (KOR) agonist

            Relevance of KOR activation to therapeutic effectiveness is unknown

            Absorption

            Steady-state was reached after second dose

            Mean accumulation ratio: 1.6

            Distribution

            Vd: 238 mL/kg

            Protein bound: 23-28%

            Elimination

            Half-life (before dialysis): 23-31 hr

            Excretion: Urine (11%); feces (59%); dialysate fluid (20%)

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            Administration

            IV Preparation

            Do not mix or dilute before administration

            Visually inspect vials for particulate matter and discoloration before administering; solution should be clear and colorless; discard vials if particulate matter or discoloration is observed

            Vials are for single-dose use; discard any unused product

            May use the following formula to determine total injection volume on target body weight or may refer to prescribing information

            Total injection volume (mL) = Patient target dry body weight (kg) x 0.01, rounded to the nearest tenth (0.1 mL)

            IV Administration

            Administer after blood is no longer circulating through the dialyzer; dialyzer membrane removes difelikefalin

            Administer IV push into venous line of the dialysis circuit at the end of each HD session

            May be given either during or after rinse back of dialysis circuit

            Dose given after rinse back: Administer into venous line followed by ≥10 mL of 0.9% NaCl flush

            Dose given during rinse back: No additional 0.9% NaCl is needed to flush line

            Administer within 60 minutes of syringe preparation; discard any unused product

            Missed regularly scheduled HD treatment: Resume at the end of next HD treatment

            Storage

            Unopened vials

            • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Do not freeze

            Prepared syringe

            • Store at 20-25ºC (68-77ºF); discard after 60 minutes of syringe preparation
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            Images

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.