TRAVASE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASE (TRAVASE).
Travase (sutilains) is a topical enzyme preparation derived from Bacillus subtilis that promotes debridement of necrotic tissue by selective proteolysis of fibrin, collagen, and elastin in devitalized tissue, while sparing healthy granulation tissue.
| Metabolism | Not systemically absorbed; inactivated by proteolytic degradation at the site of application. |
| Excretion | Renal excretion of inactive metabolites; <1% unchanged |
| Half-life | Not applicable; removed by debridement; systemic absorption minimal |
| Protein binding | Not applicable; minimal systemic absorption |
| Volume of Distribution | Not applicable; local action only |
| Bioavailability | Topical: negligible systemic bioavailability |
| Onset of Action | Topical: onset within 24-48 hours of application |
| Duration of Action | Duration of action limited to contact time; remove after 6-12 hours |
Topical: Apply a thin layer to the wound bed once or twice daily, covering the entire area of necrotic tissue.
| Dosage form | OINTMENT |
| Renal impairment | No adjustment required for systemic absorption is negligible. |
| Liver impairment | No adjustment required for systemic absorption is negligible. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. |
| Geriatric use | No specific dose adjustment; use with caution due to potential age-related skin fragility. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASE (TRAVASE).
| Breastfeeding | It is not known if sutilains is excreted in human breast milk after topical application. Due to minimal systemic absorption, it is considered compatible with breastfeeding when used on small areas. Caution is advised if applied to extensive areas or near the breast. M/P ratio is not available. |
| Teratogenic Risk | TRAVASE (sutilains) is a topical enzyme preparation. Systemic absorption is minimal; however, no adequate human studies exist. Animal reproduction studies have not been conducted. Risk cannot be ruled out; use only if clearly needed. First trimester: theoretical risk of systemic effects if applied to large areas of denuded skin. Second and third trimesters: no known specific fetal risks, but avoid prolonged use on large wounds. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to sutilains or any component; application to wounds with active infection; application to healthy granulation tissue; use on mucous membranes or eyes.
| Precautions | Hypersensitivity reactions, including contact dermatitis; risk of systemic absorption if applied to large areas; discontinue if infection, cellulitis, or worsening occurs; avoid contact with eyes; use with caution in patients with known allergy to Bacillus subtilis products. |
Loading safety data…
| Fetal Monitoring | Monitor for signs of local irritation or allergic reaction. If applied to large surface areas, monitor for systemic effects (e.g., fever, hypotension). No specific fetal monitoring required unless signs of maternal systemic toxicity occur. |
| Fertility Effects | No studies on fertility effects in humans. Animal studies have not been reported. Based on minimal systemic absorption, unlikely to impact fertility. |