GELCLAIR treatment for radiation-
or chemotherapy-related mucositis

GELCLAIR is a bioadherent oral gel that provides effective pain relief by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including:

  • Oral mucositis (OM)/stomatitis
  • Irritation due to oral surgery
  • Traumatic ulcers caused by braces or ill-fitting dentures
  • Aphthous ulcers

Bioadherent alcohol-free GELCLAIR coats, soothes, and protects denuded tissue and nerves

GELCLAIR lubricates, hydrates, and coats to significantly reduce pain associated with OM1

  • Concentrated alcohol-free gel formulation with hyaluronic acid and polyvinylpyrrolidone creates a barrier that protects damaged tissue1
  • No stinging, drying, or numbing
  • GELCLAIR improves the ability to eat and drink by reducing pain associated with OM2

GELCLAIR has a pH very similar to the physiological pH of saliva—between 5.5 and 6.5—and contains 3 main ingredients:

  • Hyaluronic acid (sodium hyaluronate)
    • A natural polysaccharide with anti-inflammatory and wound healing properties. In the formulation of GELCLAIR, it acts as a mucoadhesive substance, forming a film on the mucosal surface.
  • Polyvinylpyrrolidone
    • A polymer characterized by mucoadhesive and film-forming properties that boost the action of sodium hyaluronate.
  • Contains no alcohol
    • GELCLAIR does not contain alcohol, which can cause stinging and dry the oral mucosa.

Incidence and Causes of Mouth
Ulcers, Pain, and Soreness
from OM

Causes of mouth ulcers and OM

OM is a common and debilitating complication of cancer treatment caused by the disruption of rapidly dividing epithelial progenitor cells.3

The consequences of mucositis can be far-reaching and include administration of opioids, morbidity, and hospitalization.3

OM incidence occurs in:
30% to 75% of patients receiving chemotherapy4

The severity and duration of OM in patients treated with chemotherapy depends upon the antineoplastic agents, treatment combinations, dosages, and number of cycles.4

Lesions are seen mostly on the movable mucosae of the buccal mucosae, and lateral and ventral surfaces of the tongue.4

The early clinical sign of mucositis is erythema, presenting about 4 to 5 days following CT infusion: 7 to 10 days after CT, ulcers develop, often requiring opioid intervention.3

CT-induced mucositis lasts approximately 1 week and generally heals spontaneously by 21 days after infusion5,6

Antineoplastic therapies with an incidence of severe (grades 3 & 4) mucositis6

5-FU, 5-fluorouracil.

OM incidence occurs in:
Up to 100% of patients receiving head and neck radiotherapy4

OM will develop in nearly all patients receiving RT for head and neck cancer,4 and in most patients undergoing total body RT.7

Mucositis severity and duration in patients treated with RT depends upon radioactive source, cumulative dosage, dose intensity, and volume of the irradiated mucosa4:

  • Inflammation appears at week 1 or 2 and can persist for 4 to 6 weeks
  • The most acute period is generally at the end of RT (4 weeks of treatment)
  • Nearly all patients will experience mucositis during RT (head and neck cancer)

OM incidence occurs in:
Up to 100% of patients undergoing high-dose chemotherapy with hematopoietic stem cell transplantation8

Clinical Studies on Pain Relief for Mouth Ulcers, Soreness, and Infection from OM

GELCLAIR provides rapid and effective pain relief for mouth ulcers, resulting in an improvement in patients’ ability to maintain normal dietary and fluid intake1,2,9-11

  • Unique alcohol-free oral gel soothes on contact, with improvement in pain and function seen as early as day 11,9
  • Improvement in OM severity usually seen in 2 to 3 days9-11

Reduction of pain scores, impairment of functionality, and OM grade with GELCLAIR in patients undergoing chemotherapy9

Study design
Open-label study of patients (N=30) receiving chemotherapy for oral cavity, breast, lung, stomach, and colorectal cancers, and non-Hodgkin lymphoma. GELCLAIR was dosed 3 times daily (TID) for 3 consecutive days separate from meals. Symptom assessments conducted on days 0, 1, and 3 measured pain via the visual numeric scale, functionality as ability to eat solid and liquid foods and concomitant presence of pain, and mucositis severity according to the World Health Organization scale for oral mucositis. Data were reported for day 3.9

Reduces need for analgesics/opioids related to pain associated with OM10,12

GELCLAIR reduces oral pain and opioid use10

  • In a second study, patients with cancer treatment–related OM reduced their analgesia doses by 46% by the end of day 310

Study design
In a randomized study of bone marrow transplant patients receiving high-dose chemotherapy for pretransplant conditioning (N=15), the addition of GELCLAIR to an SR containing distilled water, chlorhexidine, and bicarbonate powder at the time of conditioning reduced the number of patients experiencing oral pain and requiring opioid analgesics.12

See The mode of action of GELCLAIR

Dosing Information for GELCLAIR Bioadherent Oral Gel

GELCLAIR should be used 3 times a day or as needed

The recommended dose of GELCLAIR is one packet TID or as needed. The portable packet may be diluted with water or used without dilution.

Directions for use

  1. Pour the entire contents of the single-dose GELCLAIR packet into a glass and add 1 tablespoon of water (15 mL). If the solution is too thick, you can dilute it with an additional 1 to 2 tablespoons of water until you have a consistency you like. If water is not available, or if you prefer, GELCLAIR may be used undiluted.
  2. Stir mixture well and use immediately.
  3. Rinse around the mouth for at least 1 minute or as long as possible to thoroughly coat all of your mouth tissue—tongue, palate, throat, and the inside of your cheeks.
  4. Gargle and spit out.
  5. Wait at least 30 to 60 minutes before eating or drinking.

For additional dosing information for GELCLAIR, please see full Prescribing Information.

References

  1. Innocenti M, Moscatelli G, Lopez S. Efficacy of Gelclair in reducing pain in palliative care patients with oral lesions: preliminary findings from an open pilot study [letter]. J Pain Symptom Manage. 2002;24(5):456-457.
  2. D’Andrea N, Giorgiutti E, De Corti D, Piga A. Oral pharyngeal mucositis: nursing assessment on the efficacy of a new treatment. Ann Oncol. 2003;14(suppl 4):iv97.
  3. Sonis ST. Pathobiology of oral mucositis: novel insights and opportunities. J Support Oncol. 2007;5:3-11.
  4. Epstein JB, Schubert MM. Oropharyngeal mucositis in cancer therapy. Oncology. 2003;17(12). http://www.cancernetwork.com/cancer-complications/oropharyngeal-mucositis-cancer-therapy-2. Accessed May 5, 2017.
  5. Rodríguez-Caballero A, Torres-Lagares D, Robles-García M, Pachón-Ibáñez J, González-Padilla D, Gutiérrez-Pérez JL. Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg. 2011;41(2):225-238.
  6. Sonis ST, Elting LS, Keefe D, et al. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004;100(suppl 9):1995-2025.
  7. Peterson DE, Bensadoun R-J, Roila F. Management of oral and gastrointestinal mucositis: ESMO Clinical Practice Guidelines. Ann Oncol. 2011;22(suppl 6):vi78-vi84.
  8. Silverman S Jr. Diagnosis and management of oral mucositis. J Support Oncol. 2007;5(suppl 1):13-21.
  9. De Cordi D, D’Andrea N, Giorgiutti E, Martina S. Gelclair: potentially an efficacious treatment for chemotherapy-induced mucositis. In: Proceedings from the Italian Anti-tumour League III Congress of Professional Oncology Nurses; October 10-12, 2001; Conegliano, Italy. Abstract.
  10. McLean M. An audit of the efficacy of Gelclair® for mouth pain in patients undergoing radiotherapy or chemotherapy. Poster presented at: British Association of Head and Neck Oncology Nurses National Study Day on Sharing Good Practice in Head and Neck Cancer Nursing; June 12, 2009; Leeds, United Kingdom.
  11. Bonassi L, Cotroneo G, Nastasi G. Treatment with Gelclair in patients suffering grade III-IV oral mucositis: efficacy and impact on quality of life (QOL). In: Annals of Oncology. [AIOM abstract E38]. Annals of Oncology. 2003;14(suppl 4):iv58.
  12. Pomper L, Ostojić A, Ruža J, et al. Prophylaxis of oral mucositis in patients treated with hematopoietic stem cell transplantation. In: Proceedings from 37th Annual Meeting of the European Group for Blood and Marrow Transplantation; April 3-6, 2011; Paris, France. Abstract.

INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

  • Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.
  • No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.
  • If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.
  • If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, or call Midatech at 1-855-273-0468 for medical inquiries.

Please see full Prescribing Information.

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INDICATIONS

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.

IMPORTANT SAFETY INFORMATION

  • Do not use GELCLAIR if there is a known or suspected hypersensitivity to any of its ingredients.
  • No adverse effects have been reported in clinical trials, although postmarketing reports have included infrequent complaints of burning sensation in the mouth.
  • If GELCLAIR is swallowed accidentally, no adverse effects are anticipated.
  • If no improvement is seen within 7 days, a physician should be consulted.

You are encouraged to report negative side effects of prescription medical products to the FDA.
Visit www.fda.gov/safety/medwatch, or call Midatech at 1-855-273-0468 for medical inquiries.

Please see full Prescribing Information.