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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions may occur with GINTUIT. ( 5.1 ) Monitor for signs of wound infection. ( 5.2 ) The potential for oral cancers is unknown. ( 5.3 ) Transmission of infectious diseases is a theoretical possibility. ( 5.4 ) Sterility tests are not completed prior to shipping. ( 5.5 ) Hypersensitivity Reactions There is a potential for hypersensitivity reactions to occur with GINTUIT. Monitor for both early and later signs of hypersensitivity reaction following GINTUIT application. Evaluate and treat signs and symptoms of potential allergic reactions according to standard practice. If necessary, remove GINTUIT as part of the treatment for the allergic reaction. 5.2 Wound Infection Monitor for signs and symptoms of wound infection. Signs of surgical site infection may include pain, edema, erythema, drainage, odor, warmth, or fever. The diagnosis of wound infection may be complicated by the white or yellow appearance of GINTUIT after it becomes hydrated with wound fluid. 5.3 Malignancies The safety of this product for oral administration has not been evaluated beyond six months. The long-term potential for oral mucosal cancers to arise from, or in response to, this product is unknown. 5.4 Transmission of Infectious Diseases Transmission of infectious diseases by known or unknown infectious agents may occur with GINTUIT. GINTUIT contains cells derived from donated human newborn foreskin tissue. The foreskin donor’s mother was tested and found negative for human pathogens, including antibodies to human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2), human T-lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), West Nile virus (WNV), Epstein-Barr virus (EBV), cytomegalovirus (CMV), and syphilis. GINTUIT cells are tested for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. Product manufacture also includes reagents derived from animal materials, including bovine pituitary extract (BPE). All animal-derived reagents are tested for viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma before use. Bovine materials are sourced to minimize bovine spongiform encephalopathy (BSE), the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease (vCJD). vCJD has never been attributed to use of any medical product manufactured with BPE, but the theoretical possibility cannot be dismissed. These measures do not totally eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Report the occurrence of a transmitted infection to Organogenesis Inc. at 1-888-943-8235. 5.5 Sterility Testing GINTUIT is shipped after passing primary test results from in-process microbial tests. A final sterility test is initiated prior to shipping, but the result will not be available for up to 14 days. If microbial contamination is detected after the product has been shipped, Organogenesis will notify health care providers and recommend appropriate actions.
6 ADVERSE REACTIONS The most common adverse reactions observed in the clinical trials (≥1%) included sinusitis, nasopharyngitis, respiratory tract infections, aphthous stomatitis, and the local effects of oral surgery. The most common adverse reactions observed in the clinical trials (≥1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Organogenesis Inc. at 1-888-943-8235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of GINTUIT cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice. GINTUIT has been studied in two randomized, within-subject controlled (i.e., each subject received both GINTUIT and control treatment) clinical studies. The control treatment was a free gingival graft (FGG), using donor graft tissue from the subject’s palate. The duration of the studies was six months following GINTUIT application. Study One was a single-center study (n=25) to evaluate the safety and efficacy of GINTUIT in establishing a zone of attached gingiva. Study Two was a multicenter study (n=96) to evaluate the safety and efficacy of GINTUIT in establishing keratinized tissue (KT) in a similar study population. Overall, 34% of subjects reported at least one adverse reaction. Table 1 lists all reported adverse reactions that occurred at an incidence of 1% or greater. Table 1: Adverse Reactions Reported at a Frequency of ≥1% (n=121)* Reported Adverse Reaction (MedDRA Preferred Term) Subject n (%) Events n OVERALL 41 (34%) 65 Sinusitis 5 (4%) 6 Nasopharyngitis 2 (2%) 2 Respiratory Tract Infection 2 (2%) 2 Upper Respiratory Tract Infection 2 (2%) 2 Aphthous Stomatitis 2 (2%) 2 Oral Pain 2 (2%) 2 Mouth Injury 2 (2%) 2 Hypoaesthesia Facial 2 (2%) 2 * Study One (n=25); Study Two (n=96) In Studies One and Two, local (occurring at the site of GINTUIT application) adverse reactions included gingival pain, gingival injury (due to inadvertent failure to remove a polycarbonate base from GINTUIT before application), and ulceration. In another study (n=15), in which the placement of GINTUIT was under a mucosal flap, local (occurring at the site of GINTUIT application) adverse reactions included impaired healing and suture-related complications. The safety of GINTUIT beyond six months was not evaluated in the clinical trials. 6.2 Postmarketing Experience GINTUIT is manufactured using a similar process as Apligraf, an FDA-approved medical device. Localized allergic reaction, skin inflammation and erosion, skin blistering, localized wound infection, and cellulitis have been reported during post-approval use of Apligraf for the treatment of chronic cutaneous wounds. Because these reactions are reported voluntarily by a population of uncertain size, and because there are no controls, it is not possible to determine their frequency in the exposed population or establish a causal relationship to exposure to Apligraf. It is uncertain whether information obtained from the postmarketing safety database from use of Apligraf in chronic cutaneous wounds can be extrapolated to use of GINTUIT in the oral environment.