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Not actual patient.
Cisplatin fights cancer with a caveat: A significant risk of permanent hearing loss1,3
Not actual patient.
Not actual patient.
Platinum chemotherapy may save their life—while lingering in their ears4,5
Each year, half a million Americans are diagnosed with cancers that may be treated by platinum-based chemotherapy. Cisplatin is often the backbone—damaging DNA to stop cancer cells and trigger cell death. It’s powerful, effective, and lifesaving.2-4
But here’s the caveat. Once infused, cisplatin rapidly binds to plasma proteins. By 4 hours, 90% is deactivated in the bloodstream. In the inner ear, where proteins are scarce, deactivation is nearly impossible.5-7
Inside the cochlea, fragile hair cells and neurons handle hearing. Fully formed by 23 weeks in utero, they don’t regenerate.1,8
Cisplatin overwhelms them with reactive oxygen species. The result? Permanent hearing loss. Often tinnitus. Sometimes vertigo. Always irreversible.1,2
While cisplatin clears the body in hours, it lingers in the cochlea—causing damage long after treatment ends. And too often, this goes unmentioned.1,2
The majority of cisplatin-treated patients will develop ototoxicity2
- Each year, approximately half a million people in the US are diagnosed with cancers that may be treated with platinum-based chemotherapy4
- Cisplatin is often the backbone of that treatment. It’s powerful, effective, and can be lifesaving. But for many, survival comes with irreversible hearing loss4
Cisplatin carries the highest risk of ototoxicity among all FDA-approved platinum compounds2
They rang the bell. But some couldn’t hear it1,2,11,12
Just one cycle of cisplatin can lead to permanent hearing loss—silencing the laughter, conversations, and sounds that fill daily life after cancer.
Progressive hearing loss during cisplatin therapy2,13,14
Left ear audiogram of a single patient at baseline before cisplatin treatment, after the first cycle, and after 4 cycles of cisplatin.
Data may not be representative of all patients.2
Adapted from Langer T, et al.
Progressive hearing loss during cisplatin therapy2,13,14
Survival isn’t always loud
For many treated with cisplatin, it’s lifesaving, making the permanent and progressive impact of ototoxicity an important consideration.2
The burden of hearing loss in survivors exerts a toll on many crucial aspects of their lives, such as:
Speech and language skills15
Social-emotional development15,16
Career potential16
Ability to live independently16
Academic performance15,16
Too often, hearing loss goes undiscussed—until it’s permanent1,10
CIO is a caveat that is too often overlooked. Despite the known risks, audiologic monitoring is often underutilized
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Cisplatin-induced ototoxicity prevalence may vary based on how or if hearing loss is assessed.
IMPORTANT SAFETY INFORMATION
- PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.
- Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
- PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
- Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.
- Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73 m2.
- Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.
- The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK.
INDICATIONS AND USAGE
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non‑metastatic solid tumors.
Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.