Pedmark is a prescription medicine used to decrease the risk of hearing loss in children 1 month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.

It is not known if this medicine is safe and effective when given after cisplatin infusions longer than 6 hours.

It is not known if this medicine is safe and effective in children less than 1 month of age.

Pedmark is not recommended in children younger than 1 month of age.

Usual Pediatric Dose for Prevention of Cisplatin-Induced Ototoxicity

- Comments: Administer Pedmark as an intravenous infusion over 15 minutes starting 6 hours after completion of cisplatin infusion. For multiday cisplatin regimens, administer Pedmark 6 hours after each cisplatin infusion but at least 10 hours before the next cisplatin infusion. Do not start Pedmark if less than 10 hours before starting the next cisplatin infusion.

Use: To reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Do not allow your child to receive Pedmark if they have had a severe allergic reaction to sodium thiosulfate or any of the other ingredients. See the end of this page for a complete list of ingredients.

Before receiving Pedmark

Before receiving Pedmark, tell your healthcare provider about all of your child’s medical conditions, including if your child:

• is allergic to sulfites
• has asthma
• has kidney problems
• is on a low salt diet
• is pregnant or plans to become pregnant. It is not known if Pedmark will harm the unborn baby.
• is breastfeeding or plans to breastfeed. It is not known if Pedmark passes into the breastmilk.

You should also read the cisplatin Prescribing Information for important pregnancy and breastfeeding information.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines your child takes. Keep a list of them to show to your healthcare provider or pharmacist when your child gets a new medicine.

How will your child receive Pedmark?

• Pedmark will be given to your child as an intravenous (IV) infusion into a vein, usually over 15 minutes.
• Pedmark is given 6 hours after the end of a cisplatin treatment. Your healthcare provider may decide not to treat your child with Pedmark if it is too soon before the next cisplatin treatment.
• Your healthcare provider may temporarily stop or completely stop your child’s treatment with Pedmark if your child develops certain side effects.

Pedmark may cause serious side effects, including:

• Allergic reactions. Allergic reactions can happen with Pedmark and can be serious and life-threatening. Your healthcare provider will monitor your child for allergic reactions during infusion. Your healthcare provider will stop the infusion and provide treatment if your child has an allergic reaction. If your child has an allergic reaction, your healthcare provider will give your child certain medicines before each infusion.
  Tell your healthcare provider right away if your child develops any of these signs of an allergic reaction:
  • rash
  • hives (raised bumps)
  • chest tightness
  • wheezing
  • trouble breathing
  • swelling of the face, lips, tongue, or throat
• Increased salt (sodium) and decreased potassium levels in the blood. Changes in these levels are common with Pedmark but can also be serious. Your healthcare provider will do blood tests to check your child’s sodium and potassium levels before starting and as needed during treatment. Tell your healthcare provider right away if your child develops any of the following signs or symptoms:
  • feeling tired or weak
  • feeling restless
  • muscle weakness
  • seizures
• Nausea and vomiting. Nausea and vomiting are common with Pedmark but can also be serious. Your healthcare provider will give your child medicines before each infusion to help prevent nausea and vomiting.

The most common side effects of include decreased red blood cells (anemia).

These are not all the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Fennec Pharmaceuticals, Inc. at 1-833-336-6321.