Difelikefalin Intravenous injection for adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Available preparations

Kapruvia 50micrograms per 1mL 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

Dose in adults

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

• 0.5 micrograms/kg dry body weight (i.e. the target post-dialysis weight), administered at the end of each HD session
• The total dose volume (mL) required from the vial should be calculated as follows: 0.01 x dry body weight (kg), rounded to the nearest tenth (0.1 mL) (see table 1 below)
• For patients with a dry body weight equal to or above 195 kg the recommended dose is 100 micrograms (2 mL)
• If a regularly scheduled HD treatment is missed, resume administration of the drug at the end of the next HD treatment
• Patients with incomplete haemodialysis treatment: for haemodialysis treatments less than 1 hour, administration of difelikefalin should be withheld until the next haemodialysis session
• Maximum number of doses per week is four (even if the number of dialysis sessions exceeds this)

Table 1: Injection volume based on Target Dry Weight
Target Dry Body Weight Range (kg)	Injection volume (mL)
40-44	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)

Further information

• An effect of difelikefalin in reducing pruritus is expected after 2 to 3 weeks of treatment.
• 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 downloaded 15th October 2024

Therapeutic classification

Kappa opioid receptor agonist