Gelclair References and Information

References and Information

[1] Avritscher EBC, Cooksley CD, Elting LS. Scope and epidemiology of cancer therapy-induced oral and gastrointestinal mucositis. Semin Oncol Nurs. 2004;20:3-10.

[2] Brown CG, Wingard J. Clinical consequences of oral mucositis. Semin Oncol Nurs. 2004;20:16-21.

[3] Köstler WJ, Hejna M, Wenzel C, Zielinski CC. Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer Clin J. 2001;51:290-315.

[4] Woo S-B, Treister N. Chemotherapy-induced oral mucositis. Available at http://www.emedicine.com.

[5] Sonis ST. Mucositis is a biological process: a new hypothesis for the development of chemotherapy-induced stomatotoxicity. Oral Oncol. 1998;34:39-43.

[6] Berger AM, Kilroy TJ. Oral complications. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins;2001:2881-2892.

[7] Wilkes JD. Prevention and treatment of oral mucositis following cancer chemotherapy. Semin Oncol. 1998;25:538-551.

[8] National Cancer Institute. Oral complications of chemotherapy and head/neck radiation (PDQ)®. Available at: http://cancer.gov/cancertopics/pdq/supportivecare/oralcomplications/Patient/page5.

[9] Rosenbaum EH, Silverman, S, Festa B, et al. Mucositis-esophageal and gastrointestinal problems and solutions. Available at www.cancersupportivecare.com/gastro.html.

[10] Gelclair®[package insert]. EKR Therapeutics, Inc.; Cedar Knolls, NJ: 2006.

[11] Innocenti M, Moscatelli G, Lopez S. Efficacy of Gelclair® in reducing pain in patients with oral lesions-preliminary findings from an open pilot study. J. Pain Symptom Manage. 2002;24:455-457.

[12] Data on file, EKR Therapeutics, Inc.; Cedar Knolls, NJ

[13] Epstein and Schubert, Oncology 3003, 17:1767-1782.

GELCLAIR^® is a concentrated bioadherent oral gel for the relief and management of pain

GELCLAIR^® has a mechanical action indicated for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused by braces or ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

GELCLAIR^® should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. Please see Special Considerations for additional information.

Federal law restricts GELCLAIR^® to sale by or on the order of a physician or properly licensed practitioner.

Special considerations

Patients with severe mucositis pain may require additional dosing for optimal results

Do not eat or drink for at least 1 hour following treatment

If GELCLAIR^® is swallowed accidentally, no adverse effects have been reported in clinical trials with the use of GELCLAIR^®. Postmarketing reports have included infrequent complaints of a burning sensation in the mouth

GELCLAIR^® should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients

If no improvement is noticed after 7 days, patients should consult a physician

Do not use any packet that is not intact (torn, split, or otherwise damaged in any way)

Keep out of reach of children

GELCLAIR^® is a registered trademark of Helsinn Healthcare SA, Lugano, Switzerland.
Manufactured in Italy under license.
Marketed and distributed by: EKR Therapeutics, Inc., Cedar Knolls, NJ 07927 under license of Helsinn Healthcare SA, Lugano, Switzerland.