Allogeneic Cultured Keratinocytes/Fibroblasts in Bovine Collagen

Allogeneic cultured keratinocytes/fibroblasts in bovine collagen are used for topical (nonsubmerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. Allogeneic cultured keratinocytes/fibroblasts in bovine collagen are not intended to provide root coverage.

Allogeneic cultured keratinocytes/fibroblasts in bovine collagen is available under the following different brand names: Gintuit.

Dosage Forms and Strengths

Cellular Sheet

• Approximately 75mm in diameter and 0.75mm thick

Dosage Considerations – Should be Given as Follows:

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 in pediatric patients

Common side effects of allogeneic cultured keratinocytes/fibroblasts in bovine collagen include:

• Sinus infections
• Runny or stuffy nose
• Respiratory tract infection
• Inflammation of the mouth and lips
• Mouth ulcers
• Mouth pain
• Mouth injury
• Facial numbness and tingling

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of allogeneic cultured keratinocytes/fibroblasts in bovine collagen include:

• bacitracin topical
• carbamide peroxide oral
• chlorhexidine oral
• doxycycline
• minocycline dental
• neomycin
• nystatin
• polymyxin B
• povidone iodine
• Allogeneic cultured keratinocytes/fibroblasts in bovine collagen has no listed serious interactions with other drugs.

Allogeneic cultured keratinocytes/fibroblasts in bovine collagen has no listed moderate interactions with other drugs.
Allogeneic cultured keratinocytes/fibroblasts in bovine collagen has no listed mild interactions with other drugs.
 

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings
 

This medication contains allogeneic cultured keratinocytes/fibroblasts in bovine collagen. Do not take Gintuit if you are allergic to allogeneic cultured keratinocytes/fibroblasts in bovine collagen or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Do not use if oral infection present
• Known allergies to bovine products

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Allogeneic Cultured Keratinocytes/Fibroblasts in Bovine Collagen?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Allogeneic Cultured Keratinocytes/Fibroblasts in Bovine Collagen?”

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 and Lactation

Use allogeneic cultured keratinocytes/fibroblasts in bovine collagen with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.

It is unknown whether allogeneic cultured keratinocytes/fibroblasts in bovine collagen is distributed in breast milk. Consult your doctor before breastfeeding.