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
