Pedmarqsi 80 mg/mL solution for infusion

• 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.

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

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

Talk to a doctor or nurse before you or your child receives Pedmarqsi if the child:

• has had an allergic reaction like a rash, 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

Tell the doctor or nurse if you or your child is taking, has recently taken or might take any other medicines.

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.

This medicine contains boric acid which may impair fertility when given chronically.

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.

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 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.

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

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is sodium thiosulfate, in anhydrous form.
• The other ingredients are:
  • boric acid (0.25 mg/mL)
  • water for injections
  • hydrochloric acid and sodium hydroxide for pH adjustment (see section 2; Pedmarqsi contains sodium).

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.