Difelikefalin Intravenous injection for adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

Unlicensed product 

  • Supplied on compassionate use by renal specialists
  • Patient must be informed of unlicensed status before it is administered to them

Available preparations

0.075mg per 1.5mL vial (0.05mg/ml)

A volume of 1.3mL is extractable from each vial

Methods of intravenous administration

Intravenous bolus injection

  • Do not mix or dilute the injection solution prior to administration
  • The drug is removed by the dialyser membrane and must be administered after blood is no longer circulating through the dialyser
  • Administer by intravenous bolus injection into the venous line of the dialysis circuit at the
    end of each HD session

    • The dose may be given either during or after rinse back of the dialysis circuit.
    • If the dose is given after rinse back, administer it into the venous line followed by at least 10 mL of Sodium chloride 0.9% flush
    • If the dose is given during rinse back, no additional Sodium chloride 0.9% is needed to flush the line
    • The dose must be administered within 60 minutes of the completion of the syringe preparation.  Discard any unused product

Dose in adults

Moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis

  • The recommended dose is 0.5 mcg/kg at the end of each HD session (see next point re weight to use)
  • The dose/kg is determined by patient's target dry body weight in kilograms See Table 1. 
  • If a regularly scheduled HD treatment is missed, resume administration of the drug at the end of the next HD treatment
Table 1: Injection volume based on Target Dry Weight
Target Dry Body Weight Range (kg) Injection volume (mL)
36-44 0.4
45-54 0.5
55-64 0.6
65-74 0.7
75-84 0.8
85-94 0.9
95-104 1
105-114 1.1
115-124 1.2
125-134 1.3
135-144 1.4
145-154 1.5
155-164 1.6
165-174 1.7
175-184 1.8
185-194 1.9
195-204 2

* Total Injection Volume (mL) = Patient Target Dry Body Weight (kg) x 0.01, rounded to the nearest tenth (0.1 mL).

Use this formula for patient target dry body weight outside of the ranges in above table

 

Further information

  • Difelikefalin has not been studied in patients on peritoneal dialysis and is not recommended for use in this population

Storage

Store below 250C

References

Korsuva SPC 08/2021

Therapeutic classification

Kappa opioid receptor agonist