Pedmarqsi – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Pedmarqsi, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you or your child starts receiving this medicine because it contains important information.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask the doctor or nurse.
- If you or your child get any side effects, talk to the doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 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 from the cancer medicine cisplatin. It is given to children and adolescents aged 1 month to 18 years who are being treated with cisplatin for solid tumours that have not spread to other areas of the body.
⚠️ 2. What you need to know before you or your child receives Pedmarqsi
Do not give Pedmarqsi if the child is:
- allergic to sodium thiosulfate or any of the other ingredients of this medicine (listed in section 6)
- a baby under the age of 1 month
Warnings and precautions
Talk to a doctor or nurse before you or your child receives Pedmarqsi if the child:
- has had symptoms of allergic reactions like skin rash, fast heart-beat, hives or difficulty breathing after a previous dose of sodium thiosulfate
- has a known allergy to chemicals called sulfites – this may mean you or the child is more likely to have an allergic reaction to this medicine
- has poor kidney function or serious kidney disease
- needs a low salt diet because of another medical condition
Other medicines and Pedmarqsi
Tell the doctor or nurse if you or your child is taking, has recently taken or might take any other medicines.
Pregnancy and breast-feeding
24 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
This medicine should not be given if you or your child is pregnant (or could be pregnant), or is breast- feeding. This medicine is only given after cisplatin chemotherapy and cisplatin can harm your baby.
Discuss with your doctor whether there is a need for contraception both during treatment and for 6 months after treatment.
Pedmarqsi contains boric acid
This medicine contains boric acid which may impair fertility when given chronically.
Pedmarqsi contains sodium
This medicine contains 23 mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 1-2% of the safe dietary intake of sodium for children aged 1 to 17 years and 12% in babies aged 7 to 11 months.
💊 3. How Pedmarqsi is given
Before you or your child will receive this medicine, he/she will be given anti-sickness medicines to help prevent vomiting.
This medicine is a solution that is given as an infusion (drip) into a vein by a doctor or nurse. This is usually done via a tube inserted into a vein in the chest, known as a central line. The infusion is given over 15 minutes. Treatment is started 6 hours after the dose of cisplatin has finished.
The dose of this medicine is worked out based on your size (body surface area) in m2, which is calculated from height and weight.
The recommended dose for those weighing 10 kg or more is 12.8 g per m2.
The recommended dose for those weighing between 10 kg and 5 kg is 9.6 g per m2.
The recommended dose for those weighing less than 5 kg is 6.4 g per m2; Your doctor will work out the dose that is right for you or your child.
If you or your child receives more Pedmarqsi than he/she should Because the dose is worked out and checked by healthcare professionals, it is unlikely that you or your child will be given the wrong amount. In case of overdose, you or your child may experience nausea, vomiting, changes to levels of sodium, phosphate or potassium in the blood, changes to blood pressure, or acidic blood (metabolic acidosis) which can cause nausea, vomiting, drowsiness and breathlessness.
Your doctor may give you or your child symptomatic treatment for these side effects.
If you have any further questions on the use of this medicine, ask the 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 a skin rash, tight chest, wheezing, shortness of breath or feeling cold you or they should tell a doctor or nurse immediately.
Other side effects
25 The other side effects seen 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 sick (nausea) Vomiting Reduced level of phosphate or potassium seen in blood tests Increased level of sodium seen in blood tests
Common (may affect more than 1 in 100 people)
Increased or reduced blood pressure Reduced level of calcium seen in blood tests Acidic blood (metabolic acidosis) which can cause nausea, vomiting, drowsiness and breathlessness
Reporting of side effects
If you or your child get any side effects, talk to the doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 vial of 100 ml contains 8 g sodium thiosulfate.
- The other ingredients are:
- boric acid (0.25 mg/mL)
- water for injection
- hydrochloric acid and sodium hydroxide for pH adjustment (see section 2; Pedmarqsi contains sodium).
What Pedmarqsi looks like and contents of the pack
This medicine is a solution for infusion.
This medicine is a clear and colourless sterile solution supplied in clear glass vials sealed with a rubber stopper and an aluminium flip-off overseal. Each carton contains one vial.
Marketing Authorisation Holder and Manufacturer
Norgine B.V.
Antonio Vivaldistraat 150 1083 HP Amsterdam Netherlands
This leaflet was last revised in <{MM/YYYY}>
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . <————————————————————————————————————————>
🩺 Information intended for healthcare professionals only
Posology and method of administration 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 (see section 4.4) This medicine is a ready to use solution for infusion Inspect visually the content of the vial(s) for particulate matter and discoloration prior to administration Prepare the required dose of sodium thiosulfate from the vial(s), in a syringe or add to an empty, sterile infusion bag Stop cisplatin hydration fluid and flush line with 0.9% sodium chloride Infuse sodium thiosulfate over 15 minutes (6 hours after completion of cisplatin infusion) Flush line with 0.9% sodium chloride and restart the cisplatin hydration immediately afterwards CIS = cisplatin Stop CIS hydration and flush line with 0.9% Sodium Chloride Next CIS infusion 6 hour s wait after CIS infusion is complete Flush line with 0.9% Sodium Chloride and restart CIS hydration Administer anti-emeti c pre-medication 30 mins before Pedmarqsi (5.5 hours post CIS completion) CIS infusion duration maximum of 6 hours Pedmarqsi 15 min infusion 6 hour s minimum gap post Pedmarqsi 27 See ‘ Time of administration in relation to cisplatin ’ for critical information regarding timing of sodium thiosulfate administration.
This medicine is provided as a single use vial containing 8 g as 80 mg/mL. 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:
Recommended dose of sodium thiosulfate for intravenous infusion Body Weight Dose Volume > 10 kg 12.8 g/m2 160 mL/m2 5 to 10 kg 9.6 g/m2 120 mL/m2 < 5 kg 6.4 g/m2 80 mL/m2 Instructions for use and handling, and disposal This medicine is intended only for single use. Any unused portion of the solution should be disposed of in accordance with the local requirements.
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.
From a microbial 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 2ºC – 8ºC.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pedmarqsi (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1734).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.