Dr. Cameron Durrant, the founder of PediatRx, said, “We are excited to be able to bring this important product to market as the first commercial entry for PediatRx. For patients undergoing chemo- or radio-therapy who may be unsuitable for other modes of administration of granisetron, or prefer an oral liquid anti-emetic, GRANISOL may offer an alternative. In addition, PediatRx is offering a co-pay assistance program to help with access to GRANISOL.”
GRANISOL, used to prevent nausea and vomiting, is the only granisetron available in the USA as an orange flavored, ready-to-use oral liquid solution. GRANISOL may be dosed once or twice daily on the day of chemo- or radio-therapy and is packaged in a 30mL bottle containing 2mg/10mL.
Customers are able to order GRANISOL (NDC number 52547-0801-30) through their usual channels.
About GRANISOL
Granisetron is indicated for the prevention of:
- Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
- Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
Selected Safety Information
- Granisetron is contraindicated in patients with known hypersensitivity to the drug or any of its components.
- QT prolongation has been reported with granisetron. Use of Granisol Oral Solution in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic, this may result in clinical consequences. - This drug should be used during pregnancy only if clearly needed.
- It is not known whether granisetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when granisetron is administered to a nursing woman.
- Efficacy and safety were maintained with increasing age in the geriatric population.
- Safety and effectiveness in pediatric patients have not been established.
- The most common side effects observed with administration of granisetron were headache, constipation, asthenia, diarrhea, abdominal pain, and dyspepsia.
About PediatRx Inc.
PediatRx Inc. is a specialty pharmaceutical company that brings prescription, branded products to healthcare professionals for the treatment of serious medical conditions with an initial focus on oncology supportive care.
Further Information
PediatRx Inc. Research & Business Development Email: info@pediatrx.com
Shareholder & Media Relations Toll-free: 1 (866) 437-9552 Outside North America: +1 (416) 489-0092 Email: ir@pediatrx.com
