A message from Tibor Nemes, Head of Stallergenes Greer Americas, regarding the company’s response to COVID-19:
A message from Tibor Nemes, Head of Stallergenes Greer Americas, regarding the company’s response to COVID-19:
In this uncertain environment as a result of the global spread of the coronavirus COVID-19, I wanted to reassure you that our team at Stallergenes Greer remains fully committed to taking care of each other, our partners and our customers. We are quickly adapting to this rapidly evolving situation, implementing a variety of safety measures and supporting the allergy community in any way we can.
The industry within which Stallergenes Greer operates has been deemed essential by U.S. Department of Homeland Security. Our allergy immunotherapy products are vital to the health and safety of our global community, especially in this time of national emergency. As a result, we have continued to operate throughout the crisis and have product available to ship to physicians for use with their patients. Our Customer Service team is also on hand who can answer questions and address concerns.
Ensuring the health and safety of the people who manufacture our products and service our customers is our top priority. We are following all guidelines from the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC) and county health departments.
In addition to implementing global travel and meeting restrictions, we have flexible work arrangements in place for employees who can work from home, equipped our essential manufacturing staff with additional safety protocols, applied social distancing guidelines and increased cleaning and sanitization of all Stallergenes Greer facilities and offices as precautionary measures.
While I am pleased that our business practices have thus far prepared us for the challenges we are confronting, we will continue to quickly respond to this everchanging situation, and remain committed to supporting our people, our customers and our partners during this unprecedented time. If you have questions or concerns, please contact a member of our customer service team at 800.378.3906.
Head of Stallergenes Greer Americas
IMPORTANT SAFETY INFORMATION
WARNING: SEVERE ALLERGIC REACTIONS
- Allergenic extracts can cause severe life-threatening systemic reactions, including anaphylaxis.
- Do not administer allergenic extracts to patients with severe, unstable, or uncontrollable asthma.
- Observe patients in the office for at least 30 minutes following treatment. Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction.
- Immunotherapy may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a systemic allergic reaction.
- Allergenic extracts may not be suitable for patients receiving medications such as beta-blockers that may make them unresponsive to epinephrine or inhaled bronchodilators.
Do not inject intravenously. Initial dose should be based on skin test reactivity.
The most common adverse reactions include localized erythema, itching, swelling, tenderness, and pain. Systemic adverse reactions include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, chest tightness,1 laryngeal edema, and hypotension.
Non-Standardized Allergenic Extracts: Allergenic extracts are indicated for skin test diagnosis of patients with a clinical history of allergies to one or more of the specific allergens and treatment for reduction of allergen-induced allergic symptoms confirmed by positive skin tests or in vitro testing for allergen-specific IgE antibodies. Food extracts have not been proven safe or effective in allergen immunotherapy.
Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract: Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract are indicated for skin test diagnosis of patients with a clinical history of allergy to ragweed pollen (Short Ragweed or Short and Giant Ragweed pollen), and immunotherapy for the reduction of ragweed pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Short and/or Giant Ragweed pollen.
1Standardized Cat Hair Allergenic Extract: Standardized Cat Hair Allergenic Extract is indicated for skin test diagnosis of patients with a history of allergy to cats and treatment of cat hair-induced allergic asthma, rhinitis and conjunctivitis when avoidance is not possible.
Standardized Grass Pollen Allergenic Extracts: Standardized Grass Pollen Allergenic Extracts are indicated for skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy; and immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, or Timothy grass pollens.
Standardized Mite Extracts: Standardized Mite Allergenic Extracts are indicated for diagnosis of skin test reactivity to dust mite allergen and treatment of mite-induced allergic asthma, rhinitis and conjunctivitis in patients that show hypersensitivity to dust mites based on clinical history, allergen exposure history, and skin test reactivity.
Please click here for Package Inserts with full Prescribing Information, including Boxed Warnings.
To report suspected adverse reactions, contact Stallergenes Greer at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.
References: 1. Asthma and Allergy Foundation of America. Allergy Facts and Figures. http://www.aafa.org/page/allergy-facts.aspx. Accessed May 11, 2017. 2. Senna G, Ridolo E, Calderon M, Lombardi C, Canonica GW, Passalacqua G. Evidence of adherence to allergen-specific immunotherapy. Curr Opin Allergy Clin Immunol. 2009;9(6):544–548. 3. Bousquet J, Khaltaev N, Cruz AA. ARIA (allergic rhinitis and its impact on asthma) 2008 update in collaboration with the World Health Organization, GA2LEN and AllerGen. Allergy. 2008;63(suppl 86):8-160. 4. Canonica GW. Bousquet J, Casale T, et al. Sub-lingual immunotherapy: World Allergy Organization position paper 2009. Allergy. 2009;64(suppl 91):1-59. 5. American Academy of Allergy, Asthma & Immunology. Statement of the American Academy of Allergy Asthma and Immunology to the House Committee on Energy and Commerce on the 21st Century Cures Initiative. http://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Advocacy/allergy-energy-and-commerce-21st-century-cures-comments.pdf. Accessed May 11, 2017. 6. Incorvaia C, Mauro M, Ridolo E, et al. Patient’s compliance with allergen immunotherapy. Patient Prefer Adherence. 2008;2:247-251. 7. American College of Allergy, Asthma, and Immunology. Allergy immunotherapy. http://acaai.org/allergies/allergy-treatment/allergy-immunotherapy. Accessed May 11, 2017. 8. Durham SR, Walker SM, Varga EM, et al. Long-term clinical efficacy of grass-pollen immunotherapy. N Engl J Med. 1999;341(7):468-475. 9. Jutel M, Agache I, Bonini S, et al. International consensus on (ICON) allergy immunotherapy (AIT). J Allergy Clin Immunol. 2015;136(3):556-568. 10. Li JT, Bernstein DI, Calderon, MA, et al. Sublingual grass and ragweed immunotherapy: clinical considerations—a PRACTALL consensus report. J Allergy Clin Immunol. 2016;137(2):369-376. 11. Giovane AL, Bardare M, Passalacqua G, et al. A three-year double-blind placebo-controlled study with specific oral immunotherapy to Dermatophagoides: evidence of safety and efficacy in paediatric patients. Clin Exp Allergy. 1994;24(1):53-59. 12. ORALAIR® full Prescribing Information, Stallergenes SAS 2014. 13. GRASTEK® full Prescribing Information. Merck & Co, Inc. 2016. 14. Allergenic Extracts Standardized Mite Extract [package insert]. GREER. 2009. 15. Allergenic Extract Standardized Cat Hair [package insert]. GREER. 2015. 16. Allergenic Extract Prescription Set of Serial Dilutions [or Maintenance Vials[s]] [package insert]. GREER. 2004. 17. Allergenic Extracts Short Ragweed and G.S. Ragweed Mix [package insert]. GREER. 2005. 18. Allergic Extracts Pollens, Molds, Epidermals, Insects, Dusts, Foods and Miscellaneous Inhalants [package insert]. GREER. 2004. 19. Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. 2011;127(suppl 1):S1-55 20. Abramson MJ, Puy RM, Weiner JM. Allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2003;(4):CD001186. 21. Abramson MJ, Puy RM, Weiner JM. Is allergen immunotherapy effective in asthma?: a meta-analysis of randomized controlled trials. Am J Respir Crit Care Med. 1995;151(4):969-974. 22. Abramson MJ, Puy RM, Weiner JM. Immunotherapy in asthma: an updated systematic review. Allergy. 1999; 54(10):1022-1041. 23. Nanda A, O’Connor M, Anada M, et al. Dose dependence and time course of the immunologic response to administration of standardized cat allergen extract. J Allergy Clin Immunol. 2004;114(6):1339-1344 24. Caminati M, Dama A, Schiappoli M, Senna G. Balancing efficacy against safety in sublingual immunotherapy with inhalant allergens: what is the best approach? Expert Rev Clin Immunol. 2013;9(10):937-47. 25. Drachenberg KJ, Urban E, Pröll S, Woroniecki SR. Sublingual specific immunotherapy for adults and children: a post-marketing surveillance study. Allergol Immunopathol. 2004;32(2):76-81. 26. Allergenic Extracts For Diagnostic Use Only Scratch, Prick, Puncture or Intradermal Testing [package insert]. GREER. 2004. 27. Allergenic Extracts Standardized Grass Pollen Extracts [package insert]. GREER. 2004. 28. Epstein TG, Liss GM, Murphy-Berendts KM, Bernstein DI. Risk factors for fatal and nonfatal reactions to subcutaneous immunotherapy: National surveillance study on allergen immunotherapy (2008-2013). Ann Allergy Asthma Immunol. 2016;116(4):354-359. 29. Greenberg MA, Kaufman CR, Gonzalez GE, Rosenblatt CD, Smith LJ, Summers RJ. Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol. 1986;77(6):865-870. 30. Ragusa VF, Massolo A. Non-fatal systemic reactions to subcutaneous immunotherapy: a 20-year experience comparison of two 10-year periods. Eur Ann Allergy Clin Immunol. 2004;36(2):52-55. 31. American College of Allergy, Asthma, and Immunology. Allergy Immunotherapy. Allergy Shots. http://acaai.org/allergies/treatment/allergy-shots-immunotherapy. Accessed May 11, 2017. 32. Agency for Healthcare Research and Quality. Subcutaneous and Sublingual Immunotherapy To Treat Allergic Rhinitis/Rhinoconjunctivitis and Asthma. http://www.ncbi.nlm.nih.gov/books/NBK158932/pdf/Bookshelf_NBK158932.pdf. Accessed May 11, 2017. 33. American Academy of Allergy, Asthma & Immunotherapy. Allergy Shots (Immunotherapy). http://www.aaaai.org/conditions-and-treatments/treatments/allergy-shots-(immunotherapy). Accessed May 11, 2017. 34. American College of Allergy, Asthma & Immunology. Sublingual Immunotherapy (SLIT). http://acaai.org/allergies/allergy-treatment/allergy-immunotherapy/sublingual-immunotherapy-slit. Accessed May 11, 2017.