Active Ingredient: Difelikefalin
Difelikefalin is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.5 - 0.5 ug per kg of body weight
From 0.5 To 0.5 ug per kg of body weight once every 2 day(s)
Difelikefalin is administered 3 times per week by intravenous bolus injection into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or after rinse-back.
The recommended dose of difelikefalin is 0.5 micrograms/kg dry body weight (i.e., the target postdialysis weight). The total dose volume (mL) required from the vial should be calculated as follows: 0.01 × dry body weight (kg), rounded to the nearest tenth (0.1 mL). For patients with a dry body weight equal to or above 195 kg the recommended dose is 100 micrograms (2 mL).
An effect of difelikefalin in reducing pruritus is expected after 2-3 weeks of treatment.
If a regularly scheduled haemodialysis treatment is missed, difelikefalin should be administered at the next haemodialysis treatment at the same dose.
If a 4th haemodialysis treatment is performed in a week, difelikefalin should be administered at the end of the haemodialysis per the recommended dose. No more than 4 doses per week should be administered even if the number of haemodialysis treatments in a week exceeds 4. A 4th dose of difelikefalin is unlikely to lead to accumulation of difelikefalin that would be of concern for safety, as the majority of remaining difelikefalin from the previous treatment will be cleared by haemodialysis. However, safety and efficacy of a 4th dose has not been fully established due to insufficient data.
For haemodialysis treatments less than 1 hour, administration of difelikefalin should be withheld until the next haemodialysis session.
Following administration of difelikefalin in haemodialysis subjects, up to 70% is eliminated from the body prior to the next haemodialysis session. Difelikefalin plasma level remaining at the time of the next haemodialysis is reduced by about 40-50% within one hour of haemodialysis.
Difelikefalin should not be mixed with other medicinal products.
Difelikefalin is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer. Difelikefalin is administered 3 times per week by intravenous bolus injection into the venous line of the dialysis circuit at the end of the haemodialysis treatment during rinse-back or after rinse-back.
When given after rinse-back, at least 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection rinse-back volume should be administered after injection of difelikefalin. If the dose is given during rinse-back, no additional sodium chloride 9 mg/mL (0.9%) solution for injection is needed to flush the line.
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