LysaKare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.
LysaKare is indicated for administration with PRRT with lutetium (177Lu) oxodotreotide therefore, it should only be administered by a health care provider experienced in the use of PRRT.
The recommended treatment regimen in adults consists of infusion of full bag of LysaKare concomitantly with lutetium (177Lu) oxodotreotide infusion, even when patients require PRRT dose reduction.
Pre-treatment with an anti-emetic 30 minutes prior to start of LysaKare infusion is recommended to reduce the incidence of nausea and vomiting.
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. Treatment with lutetium (177Lu) oxodotreotide is not recommended for patients with renal function between 30 and 50 mL/min therefore, the benefit risk for these patients will always need to be weighed carefully, which should include consideration of an increased risk for transient hyperkalaemia in these patients (see section 4.4).
The safety and efficacy of LysaKare in children less than 18 years have not been established.
No data are available.
For intravenous use.
LysaKare should be administered as a 4-hour infusion (250 mL/hour) starting 30 minutes prior to administration of lutetium (177Lu) oxodotreotide to achieve optimal renal protection.
LysaKare and lutetium (177Lu) oxodotreotide must be given through a separate infusion line.
In the event of over-hydration or solute overload, the elimination should be promoted by frequent micturition or by forced diuresis and frequent bladder voiding.
2 years.
Store below 25°C.
Infusion bag made of polyvinyl chloride (PVC) containing 1,000 mL of solution, wrapped in a polyethylene polyamine/aluminium foil.
This medicinal product is for single use only.
Do not remove unit from overwrap until ready to use.
Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier.
Do not reconnect partially used bags.
LysaKare must not be diluted.
Do not use solutions which are cloudy or have deposits. This may indicate that the product is unstable or that the solution has become contaminated.
Once the container has been opened, the contents should be used immediately.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
