allogeneic cultured keratinocytes/fibroblasts in bovine collagen (Rx)

Brand and Other Names:Gintuit
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and allogeneic cultured keratinocytes/fibroblasts in bovine collagen

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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)

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                  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%)

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                  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
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                  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.

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                  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

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                  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

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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  DERMAGRAFT topical
                  -
                  2 X 3 sheet

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  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) 2021 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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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.