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Safety
Not actual patient.
There’s only one PEDMARK
- PEDMARK was specifically developed for use in children
- The safety of PEDMARK was studied in 232 children between 1 month and 18 years of age who received either cisplatin alone or PEDMARK + cisplatin. Only 1 child in each study stopped PEDMARK due to side effects. The most commonly reported side effect was decreased red blood cells
See full Prescribing Information for more information about side effects.
Additional PEDMARK safety information
- Allergic reactions can happen with PEDMARK and can be serious and life-threatening. A doctor will monitor someone for allergic reactions during the PEDMARK infusion
- Tell a doctor right away if someone 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
- PEDMARK adds sodium to the blood. A doctor will check to make sure a person’s sodium levels aren’t too high before starting PEDMARK
- Newborns younger than 1 month of age should not receive PEDMARK
- They are not able to control sodium levels in the blood
- During treatment with PEDMARK, blood levels of magnesium and potassium will be monitored
- If needed, a doctor will prescribe supplements to correct any electrolyte imbalance
- Electrolytes are minerals in blood, sweat, and urine. They help nerves and muscles work the way they should, so it’s important that they stay at certain levels
There is no substitute for FDA approval
- PEDMARK and its dosing schedule were approved together to make sure it was safe and effective in people with solid tumors
- PEDMARK dosing, including any dose modifications, are specific to the brand
- PEDMARK is not substitutable with any other sodium thiosulfate product
Ask for PEDMARK by name.
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Fennec HEARS™ is the single source for both financial and patient support. Call 1-833-7PEDMARK.
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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.
