Pedmarqsi

Package leaflet: Information for the patient

Pedmarqsi 80 mg/mL solution for infusion

sodium thiosulfate
Please read this leaflet carefully before you/your child is given this medicine, because
it contains important information.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you/your child experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Pedmarqsi is and what it is used for
2. What you need to know before you/your child is given Pedmarqsi
3. How Pedmarqsi is administered
4. Possible side effects
5. How to store Pedmarqsi
6. Contents of the pack and other information

1. What Pedmarqsi is and what it is used for

Pedmarqsi contains the active substance sodium thiosulfate.
Pedmarqsi is used to reduce the risk of hearing loss caused by cisplatin, an anticancer medicine. It is given to children and adolescents aged 1 to 18 years who are receiving treatment with cisplatin for solid tumours that have not spread to other parts of the body.

2. What you should know before your child receives Pedmarqsi

Do not administer Pedmarqsi
if the child:

• is allergic to sodium thiosulfate or to any of the other components of this medicine (listed in section 6)
• is under 1 month of age

Warnings and precautions
Talk to the doctor or nurse before your child receives Pedmarqsi if your child:

• has previously experienced symptoms of allergic reactions, such as rash, rapid heartbeat, hives, or difficulty breathing, after receiving sodium thiosulfate
• has a known allergy to chemicals called sulfites; this may increase the likelihood of developing an allergic reaction to this medicine
• has impaired kidney function or severe kidney disease
• requires a low-salt diet due to another medical condition

Other medicines and Pedmarqsi
Inform the doctor or nurse if your child is taking, has recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
This medicine must not be administered if you or your child is pregnant (or might be pregnant) or is breastfeeding. This medicine is administered only after cisplatin-based chemotherapy; cisplatin may cause harm to the unborn baby. Consult your doctor to evaluate the need for contraceptive measures during treatment and for 6 months after treatment.
Pedmarqsi contains boric acid
This medicine contains boric acid, which may impair fertility if administered chronically.
Pedmarqsi contains sodium
This medicine contains 23 mg of sodium (a main component of table salt) per mL.
This corresponds to 1–2% of the safe sodium intake for children aged 1 to 17 years and 12% for infants aged 7 to 11 months.

3. How Pedmarqsi is administered

Before you or your child receive this medicine, anti-nausea medicines will be given to prevent vomiting.
This medicine is a solution administered by a doctor or nurse as an intravenous infusion (drip) into a vein. The infusion is usually delivered through a tube inserted into a vein in the chest, known as a central venous catheter. The infusion is given over 15 minutes. Treatment starts 6 hours after the completion of the cisplatin infusion.
The dose of this medicine is based on your total body surface area in m², calculated from height and weight.
The recommended dose for individuals weighing 10 kg or more is 12.8 g/m².
The recommended dose for individuals weighing between 10 kg and 5 kg is 9.6 g/m².
The recommended dose for individuals weighing less than 5 kg is 6.4 g/m².
Your doctor will determine the correct dose for you or your child.
If you/your child receives more Pedmarqsi than you should
Since the dose is determined and controlled by healthcare professionals, it is unlikely that you or your child will receive an incorrect amount. In case of overdose, you/your child may experience nausea, vomiting, changes in blood levels of sodium, phosphate or potassium, changes in blood pressure, or acidic blood (metabolic acidosis), which may cause nausea, vomiting, drowsiness, and shortness of breath. Your doctor may provide symptomatic treatment for these side effects.
If you have any questions about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If you or your child has a severe allergic reaction to this medicine, with symptoms such as rash, chest tightness, wheezing, shortness of breath, or feeling cold, you must contact a doctor or nurse immediately.

Other side effects

Other side effects observed with this medicine are usually mild. The side effects you or your child may experience are:

Very common (may affect more than 1 in 10 people)

• feeling unwell (nausea)
• vomiting
• decrease in phosphate or potassium levels observed in blood tests
• increase in sodium levels observed in blood tests

Common (may affect more than 1 in 100 people)

• increase or decrease in blood pressure
• decrease in calcium levels observed in blood tests
• blood acidity (metabolic acidosis) which may cause nausea, vomiting, drowsiness, and shortness of breath

Reporting of side effects

If you or your child experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pedmarqsi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pedmarqsi contains

• The active substance is sodium thiosulfate, in anhydrous form. Each 100 ml vial contains 8 g of sodium thiosulfate.
• The other components are:
  • boric acid (0.25 mg/mL)
  • water for injections
  • hydrochloric acid and sodium hydroxide for pH adjustment (see section 2, Pedmarqsi contains sodium).

Description of the appearance of Pedmarqsi and contents of the pack
This medicine is a solution for infusion.
This medicine is a clear, colourless, sterile solution supplied in clear glass vials sealed with a rubber stopper and an aluminium crimp cap. Each carton contains one vial.

Marketing Authorisation Holder and Manufacturer
Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
The Netherlands

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website (http://www.ema.europa.eu).
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The following information is intended for healthcare professionals only:

Dosage and method of administration

Timing of administration relative to cisplatin

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

If sodium thiosulfate is administered:

• less than 6 hours after the end of cisplatin infusion: it may reduce the antitumour efficacy of cisplatin
• more than 6 hours after the end of cisplatin infusion: it may not be effective in preventing ototoxicity.

Sodium thiosulfate should only be used after a cisplatin infusion lasting 6 hours or less.
Do not use sodium thiosulfate if:

• the duration of cisplatin infusion exceeds 6 hours, or
• a subsequent cisplatin infusion is scheduled within 6 hours.

If cisplatin is administered on consecutive days, a minimum interval of 6 hours must be ensured after sodium thiosulfate infusion before administering the next cisplatin infusion.

At the end of cisplatin infusion:

• administer a highly effective, multi-agent intravenous antiemetic therapy 30 minutes prior to sodium thiosulfate administration, i.e., 5.5 hours after completion of cisplatin infusion (see section 4.4)
• this medicine is a ready-to-use solution for infusion
• visually inspect the contents of the vial(s) for particulate matter and discoloration prior to administration
• prepare the required dose of sodium thiosulfate from the vial(s), either in a syringe or by adding to an empty sterile infusion bag
• interrupt cisplatin hydration fluid and flush the infusion line with 0.9% sodium chloride
• infuse sodium thiosulfate over 15 minutes (6 hours after completion of cisplatin infusion)
• flush the infusion line with 0.9% sodium chloride and immediately resume cisplatin hydration

Refer to "Timing of administration relative to cisplatin" for essential information on the timing of sodium thiosulfate administration.
This medicine is supplied as a single-use vial containing 8 g in 80 mg/mL. The recommended dose of sodium thiosulfate for intravenous infusion to prevent cisplatin-induced ototoxicity is based on body weight and normalised to total body surface area according to the following table:

Recommended dose of sodium thiosulfate for intravenous infusion

Instructions for use, handling, and disposal
This medicinal product is for single use only. Any unused portions of the solution must be disposed of
in accordance with local regulations.
Chemical and physical in-use stability has been demonstrated for 24 hours at controlled room temperature
for the medicinal product stored in polyvinyl chloride, ethylene-vinyl acetate, and polyolefin intravenous infusion bags.
From a microbiological point of view, the medicinal 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 should generally
not exceed 24 hours at a temperature between 2 °C - 8 °C.