Dosing & Uses
Dosage Forms & Strengths
cellular sheet
- ~75mm in diameter and 0.75mm thick
Mucogingival Conditions
An allogeneic, cellularized scaffold product indicated for topical (nonsubmerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults; not intended to provide root coverage
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (9)
- bacitracin topical
bacitracin topical decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been antibiotics shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- carbamide peroxide oral
carbamide peroxide oral decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- chlorhexidine oral
chlorhexidine oral decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antiseptics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- doxycycline
doxycycline decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- minocycline dental
minocycline dental decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- neomycin
neomycin decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- nystatin
nystatin decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- polymyxin B
polymyxin B decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antibiotics has been antibiotics shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
- povidone iodine
povidone iodine decreases effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen by Other (see comment). Contraindicated. Comment: Exposure to topical antiseptics has been shown to degrade Gintuit; if exposed, irrigate the wound thoroughly with saline and allow a suitable wash-out period to elapse before applying Gintuit.
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
1-10%
Sinusitis (4%)
Nasopharyngitis (2%)
Respiratory tract infection (2%)
Upper respiratory tract infection (2%)
Aphthous stomatitis (2%)
Oral pain (2%)
Mouth injury (2%)
Facial hypoesthesia (2%)
Warnings
Contraindications
Do not use if oral infection present
Known allergies to bovine products
Cautions
Hypersensitivity reactions possible; monitor for both early and later signs of hypersensitivity reaction following 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
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 the cellular sheet after it becomes hydrated with wound fluid
Safety of this product for oral administration has not been evaluated beyond 6 months; long-term potential for oral mucosal cancers to arise from, or in response to, this product is unknown
Transmission of infection
- Contains cells derived from donated human newborn foreskin tissue
- Transmission of infectious diseases may occur
- The foreskin donor’s mother was tested and found negative for human pathogens, including antibodies to HIV-1 and HIV-2, HTLV-1 and HTLV-2, HAV, HBV, HBsAg, HCV, WNV, EBV, CMV, and syphilis; also 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; 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, 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
- Only 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, the manufacturer will notify health care providers and recommend appropriate actions
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Unknown whether distributed in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Does not function as a tissue graft
The mechanism of action by which Gintuit increases keratinized tissue at the treated site has not been identified
Administration
Topical Administration
For single patient use only
Used as 1 application over a surgically created vascular wound bed in the oral cavity
Adjust the size of the cellular sheet for the size of the wound bed
The safety and efficacy of repeat application(s) have not been established
Preparation
Prepare the surgical site following local anesthesia by surgically creating a vascular wound bed with viable wound edges and establish adequate hemostasis
Prepare the cellular sheet by checking the following
- Examine the sealed polybag for leaks, damage, or contamination
- Verify expiration date (product expires at 11:59 PM ET on the date of expiration)
- Verify product pH (6.8-7.7) is within the acceptable range, using the agarose gel medium pH color chart
- Do not open the polybag until the surgical site has been prepared
- Use within 15 minutes of opening the sealed polybag
Application
See full prescribing information for a detailed, illustrated description on how to apply the cellular sheet to the prepared surgical site
Handle cellular sheet in aseptic manner
Do not use if there is evidence of contamination, visible particulates, or pungent odor
As supplied, Gintuit is not a biohazardous material; however, follow your local guidelines for disposal of any remaining cellular sheet
Storage
To maintain cell viability, store in the sealed polybag at 68-73°F (20-23°C) in its shipping box with all insulating components intact until use
Do not freeze or refrigerate, sterilize, or incubate
Images
Patient Handout
cultured skin substitute, human-bovine topical
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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