LYSAKARE SOLUTION FOR INFUSION 25G / 25G [SIN16003P]

Product Info

LYSAKARE SOLUTION FOR INFUSION 25G / 25G

[SIN16003P]

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

4 Dosage regimen and administration
LysaKare is indicated for administration during PRRT with lutetium (¹⁷⁷Lu) oxodotreotide. It should therefore 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.

Antiemetics

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. In case of severe nausea or vomiting during the infusion of LysaKare despite administration of a preventive antiemetic, an antiemetic of a different pharmacological class can be administered. 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 in serum potassium associated with the use of LysaKare, this medicinal 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 6 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 severe hepatic impairment (see section 6 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) have not been established. No data are available.

Geriatric patients (65 years or above)
There are limited data on the use of LysaKare in patients 65 years of age or above.
Elderly patients are more likely to have decreased renal function, and care should therefore be taken in determining eligibility based on creatinine clearance (see section 6 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.
To achieve optimal renal protection, LysaKare should be administered as a 4-hour infusion (250 mL/hour) and must be initiated 30 minutes prior to administration of lutetium (¹⁷⁷Lu) oxodotreotide.
Infusion of LysaKare and lutetium (¹⁷⁷Lu) oxodotreotide through a separate venous access in each of the patient’s arms is the preferred method. However, if two intravenous lines are not possible due to poor venous access or institutional/clinical preference, LysaKare and lutetium (¹⁷⁷Lu) oxodotreotide may be infused through the same line via a three-way valve, taking into consideration flow rate and maintenance of venous access.

5 Contraindications
None.