Not actual patient.
Safety
Not actual patient.
PEDMARK safety was studied in 2 clinical trials
The safety of PEDMARK was studied in 232 children who received either cisplatin alone or PEDMARK + cisplatin. Only 1 child in each study stopped using 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.
Other things you should know about PEDMARK safety
- Allergic reactions can happen with PEDMARK and can be serious and life-threatening. Your doctor will monitor your child for allergic reactions during the PEDMARK infusion
- Tell your doctor 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
- PEDMARK adds sodium to the blood. Your doctor will check your child to make sure their sodium levels aren’t too high before starting PEDMARK
- Children younger than 1 month of age should not receive PEDMARK
- Newborns 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, your 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
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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.
