KORSUVA SOLUTION FOR INJECTION 50 MICROGRAMS/ ML [SIN16582P]

Product Info

KORSUVA SOLUTION FOR INJECTION 50 MICROGRAMS/ ML

[SIN16582P]

4.1 Therapeutic indications

KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

KORSUVA should only be used in a clinic that performs haemodialysis and by health care professionals trained in haemodialysis administration.

KORSUVA is intended for use by healthcare professionals experienced in the diagnosis and treatment of conditions for which difelikefalin is indicated. Causes of pruritus other than chronic kidney disease should be excluded before initiating treatment with difelikefalin.

Posology

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). Injection volumes are detailed in the table below:

Missed doses

If a regularly scheduled haemodialysis treatment is missed, KORSUVA should be administered at the next haemodialysis treatment at the same dose.

Extra treatment

If a 4th haemodialysis treatment is performed in a week, KORSUVA 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 KORSUVA 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 (see sections 4.9 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, safety and efficacy of a 4th dose has not been fully established due to insufficient data (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Patients with incomplete haemodialysis treatment

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 (see sections 4.9 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Difelikefalin plasma level remaining at the time of the next haemodialysis is reduced by about 40–50% within one hour of haemodialysis.

Patients with hepatic impairment

Metabolism by hepatic enzymes does not significantly contribute to elimination of difelikefalin. While faecal excretion contributes to elimination, it is not known whether hepatic impairment has a clinically relevant effect on overall difelikefalin clearance in haemodialysis patients. Evaluation of available population pharmacokinetic data in HD patients concluded that no adjustment of intravenous difelikefalin dosage is needed in patients with mild to moderate hepatic impairment; however, clinical data following IV dosing in patients with moderate hepatic impairment is currently limited (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Difelikefalin has not been studied in subjects with severe hepatic impairment (National Cancer Institute (NCI) Organ Dysfunction Working Group (ODWG)) and is therefore not recommended for use in this patient population.

Elderly population (≥ 65 years of age)

Dosing recommendations for elderly patients are the same as for adult patients.

Paediatric population

The safety and efficacy of difelikefalin in children aged 0-17 years has not yet been established. No data are available.

Method of administration

Inspect KORSUVA for particulate matter and discoloration prior to administration. The solution should be clear and colourless. Do not use KORSUVA vials if particulate matter or discolouration is observed.

KORSUVA should not be diluted and should not be mixed with other medicinal products.

The dose must be administered within 60 minutes of the completion of the syringe preparation.

Difelikefalin is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer. Difelikefalin is administered 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 KORSUVA. 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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.