allogeneic cultured keratinocytes/fibroblasts in bovine collagen (Gintuit)

Dosing and uses of Gintuit (allogeneic cultured keratinocytes/fibroblasts in bovine collagen)

• Adult
• Pediatric

 

Adult dosage forms and 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

 

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

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Gintuit (allogeneic cultured keratinocytes/fibroblasts in bovine collagen) adverse (side) 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 and 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 of Gintuit (allogeneic cultured keratinocytes/fibroblasts in bovine collagen)

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