PEDMARQSI Solution for infusion Ref.[50987] Active ingredients: Thiosulfate

Pedmarqsi is intended for hospital use only, under the supervision of an appropriately qualified physician.

Posology

The recommended dose of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity is weight based and normalised to body surface area according to the table below:

Pre-treatment with antiemetics is recommended to reduce the incidence of nausea and vomiting (see section 4.4).

Special populations

Preterm and term newborn infants from birth to less than 1 month of age

Sodium thiosulfate is contraindicated in preterm and term newborn infants from birth to less than 1 month of age (see sections 4.3 and 4.4).

Renal impairment

No dose adjustment is recommended for patients with renal impairment (see section 5.2). Due to the sodium content of sodium thiosulfate, there is an increased risk of adverse reactions in patients with renal impairment (see section 4.4).

Hepatic impairment

No dose adjustment is recommended for patients with hepatic impairment (see section 5.2).

Method of administration

For intravenous use.

Due to the hypertonic formulation, administration through a central vein is recommended.

For single use only.

Sodium thiosulfate is administered as a 15-minute infusion.

Time of administration in relation to cisplatin

The timing of sodium thiosulfate administration relative to cisplatin chemotherapy is critical.

If sodium thiosulfate is administered:

• Less than 6 hours after end of cisplatin infusion: may reduce cisplatin efficacy against the tumour
• More than 6 hours after end of cisplatin infusion: may not be effective in preventing ototoxicity

Only use sodium thiosulfate following cisplatin infusion duration of 6 hours or less. Do not use sodium thiosulfate if:

• Cisplatin infusion exceeds 6 hours, or
• A subsequent cisplatin infusion is planned within 6 hours

When cisplatin is administered on consecutive days, ensure a minimum 6-hour gap after sodium thiosulfate infusion before a subsequent cisplatin infusion is given.

After end of cisplatin infusion:

• Provide highly effective multi-agent intravenous antiemetic therapy 30 minutes prior to administration of sodium thiosulfate i.e. 5.5 hours after completion of cisplatin infusion
• This medicinal product is a ready to use solution for infusion
• Prepare the required mL of sodium thiosulfate, 80 mg/mL, in a syringe or add to an empty, sterile infusion bag
• Stop cisplatin hydration fluid and flush line with sodium chloride 0.9%
• Infuse sodium thiosulfate over 15 minutes (6 hours after completion of cisplatin infusion)
• Flush line with sodium chloride 0.9% and restart the cisplatin hydration immediately afterwards

CIS = cisplatin

Excessive doses of sodium thiosulfate may be expected to produce severe nausea and vomiting as well as electrolyte imbalance, changes to blood pressure and acidosis. Treatment of an overdose should consist of general supportive measures including administration of fluids and observation of the clinical status of the patient. There is no specific antidote for overdose with sodium thiosulfate.

2 years.

From a microbiological point of view, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C.

Chemical and physical in-use stability has been demonstrated for 24 hours at controlled room temperature for product stored in polyvinyl chloride, ethylene vinyl acetate and polyolephine intravenous bags.

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.

Type I, 100 mL, clear glass vials sealed with a chlorinated butyl rubber stopper and an aluminium flipoff overseal. Each vial contains 100 mL of solution for infusion.

Vials are supplied in cartons of 1 vial pack.

This medicinal product is a sterile and ready to use solution for infusion.

Each vial is intended for single use only, and any unused solution should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.