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What is PEDMARK?
Not actual patient.
PEDMARK is the first and only FDA approved treatment designed to decrease the risk of hearing loss from cisplatin-induced toxicity
PEDMARK is for people 1 month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.
PEDMARK is:
- Proven to lower the risk of cisplatin-induced hearing loss
- Approved for people 1 month of age and older with localized tumors (cancer) that have not spread to other parts of the body receiving cisplatin infusions lasting less than 6 hours
- Given as a 15-minute infusion 6 hours after cisplatin infusion
- A healthcare provider will give medicines before each PEDMARK infusion to help prevent nausea and vomiting, and will provide treatment in the case of an allergic reaction
- Next cisplatin infusion must be given at least 10 hours after PEDMARK
How is PEDMARK given?
Learn why the timing of PEDMARK infusions is so important.
How does PEDMARK work?
Learn how PEDMARK works in the body.
Frequently asked questions about PEDMARK
How old does someone have to be to get PEDMARK?
A patient must be at least 1 month old before receiving PEDMARK. Infants younger than 1 month of age cannot control sodium levels in their blood. They are at a higher risk for developing hypernatremia (hy-pur-nah-TREE-mee-ah), which is when someone has too much sodium in their blood. Hypernatremia can cause muscle weakness, extreme thirst, confusion, seizures, and unconsciousness.
What kind of chemotherapy does someone need to be taking to get PEDMARK?
PEDMARK is for people receiving cancer treatment that contains cisplatin. PEDMARK can only be used when the cisplatin infusion lasts 1 to 6 hours.
How long does someone have to wait after chemotherapy before getting PEDMARK?
PEDMARK is given 6 hours after the end of their 1- to 6-hour cisplatin treatment. If PEDMARK is given too soon, it may reduce the effectiveness of the cisplatin.
What if someone is getting a second chemotherapy treatment within 24 hours?
The second chemotherapy treatment must be scheduled 10 hours or longer after you receive PEDMARK. PEDMARK should not be given if a second cisplatin infusion is planned within 10 hours of the PEDMARK infusion.
How long does it take to receive PEDMARK?
PEDMARK is given as a 15-minute infusion.
How often should someone receive PEDMARK?
To lower the risk of hearing loss, PEDMARK should be given 6 hours after every cisplatin-based infusion.
Are there any safety concerns with PEDMARK?
The most common side effects of PEDMARK include:
- Nausea
- Vomiting
- Infection
- Low red blood cell count
- Electrolyte (or mineral) imbalances
- High level of salt in the blood
- Low level of potassium in the blood
- Low level of phosphate in the blood
- Fever
Please see full Prescribing Information, including Patient Information, for more information about safety.
Who should someone contact if they have questions about paying for PEDMARK?
Fennec HEARS™ has Care Coordinators who can work with their healthcare team, insurance company, and specialty pharmacy to help them get access to PEDMARK.
The source for access support
Fennec HEARS™ is the single source for both financial and patient support. Call 1-833-7PEDMARK.
Get more information about PEDMARK
Find helpful tools and resources.
IMPORTANT SAFETY INFORMATION
- 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 in PEDMARK.
- Allergic reactions can happen with PEDMARK and can be serious and life-threatening. Your healthcare provider will monitor your child for allergic reactions during the PEDMARK 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 PEDMARK infusion. Tell your healthcare provider right away if your child has 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.
- Changes in salt and potassium levels in the blood 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 with PEDMARK. 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 are common with PEDMARK but can also be serious. Your healthcare provider will give your child medicines before each PEDMARK infusion to help prevent nausea and vomiting.
- The most common side effects of PEDMARK include decreased red blood cells (anemia).
- These are not all the possible side effects of PEDMARK. Call your child’s 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.
Please see full Prescribing Information, including Patient Information, for PEDMARK.
WHAT IS 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 PEDMARK is safe and effective when given after cisplatin infusions longer than 6 hours.
It is not known if PEDMARK is safe and effective in children less than 1 month of age. PEDMARK is not recommended in children younger than 1 month of age.
