LYSAKARE SOLUTION FOR INFUSION 25G / 25G

3 Indications

LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.

5 Contraindications

None.

4 Dosage regimen and administration

Since LysaKare is indicated for administration during PRRT with lutetium (177Lu) oxodotreotide, it should only be administered by a healthcare provider experienced in the use of PRRT.

Please refer to full prescribing information of lutetium (177Lu) oxodotreotide.

Dosage regimen

General target population

Adults

The recommended treatment regimen in adults consists of infusion of a full bag of LysaKare concomitantly with lutetium (177Lu) oxodotreotide. The dose of LysaKare should not be decreased even if the dose of lutetium (177Lu) oxodotreotide is reduced.

Pre-treatment with an antiemetic is recommended to prevent nausea and vomiting. Antiemetics should be administered with sufficient lead time prior to the start of LysaKare. Please refer to the full prescribing information of the antiemetic for administration instructions.

Special populations

Renal impairment

Due to the potential for clinical complications related to volume overload and an increase of potassium in blood associated with the use of LysaKare, this product should not be administered in patients with creatinine clearance <30 mL/min. Care should be taken with LysaKare use in patients with creatinine clearance between 30 and 50 mL/min, due to a potential increased risk of transient hyperkalemia in these patients (see section Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

The use of arginine and lysine has not been specifically studied in patients with hepatic impairment (see section Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

The safety and efficacy of LysaKare in pediatric patients (below 18 years) has not been established. No data are available.

Geriatric patients (65 years or above)

No studies have been performed in patients 65 years of age or above.

Because elderly patients are more likely to have decreased renal function, care should be taken in determining eligibility based on creatinine clearance (see section Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

For intravenous (IV) use only.

LysaKare should be administered as a 4-hour IV infusion (250 mL/hour). The infusion must be initiated 30 minutes prior to administration of lutetium (177Lu) oxodotreotide to achieve optimal renal protection.

LysaKare and lutetium (177Lu) oxodotreotide must be administered through separate infusion lines.