Pedmark

Generic name: Sodium Thiosulfate
Dosage form: injection for intravenous use
Drug class: Antineoplastic detoxifying agents

Usage of Pedmark

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.

Pedmark 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.

Before taking Pedmark

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.

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How to use Pedmark

Usual Pediatric Dose for Prevention of Cisplatin-Induced Ototoxicity

Actual Body Weight Pedmark Dose Less than 5 kg 10 g/m2 5 to 10 kg 15 g/m2 Greater than 10 kg 20 g/m2

- 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.

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