SANTYL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SANTYL (SANTYL).
SANTYL (collagenase) is a proteolytic enzyme that specifically cleaves collagen in necrotic tissue, aiding in debridement of chronic dermal ulcers and severe burns.
| Metabolism | Collagenase is a protein; metabolism is via proteolytic degradation. No specific CYP enzymes involved. |
| Excretion | SANTYL (collagenase) is applied topically and acts locally; systemic absorption is minimal. Excretion of absorbed fragments is presumed to be via renal and biliary routes, but specific percentages are not established. |
| Half-life | Collagenase is a large protein that is degraded locally; systemic half-life is not clinically relevant due to negligible absorption. The enzyme activity at the wound site persists for approximately 24 hours after application. |
| Protein binding | Not applicable; collagenase acts locally and is not significantly absorbed systemically. If absorbed, it would be a protein that may bind to proteases, but no specific binding data are available. |
| Volume of Distribution | Not applicable due to negligible systemic absorption. Vd is not clinically meaningful. |
| Bioavailability | Topical administration results in negligible systemic bioavailability (<1%). Bioavailability is not relevant as the drug acts locally. |
| Onset of Action | Clinical effect (debridement) is typically observed within 3 to 7 days of daily application. |
| Duration of Action | The enzymatic activity at the wound site lasts for about 24 hours per application; daily dressing changes are recommended. Duration of treatment varies based on wound healing, typically up to 14 to 30 days. |
Apply topically once daily. The thickness of the SANTYL ointment should be sufficient to cover the wound area, approximately 1/16 inch (1.5 mm).
| Dosage form | OINTMENT |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established; no specific dosing guidelines available. |
| Geriatric use | No specific dosing adjustments recommended; use standard adult dosing with careful monitoring for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SANTYL (SANTYL).
| Breastfeeding | It is not known if collagenase is excreted in human milk. M/P ratio is not available. Due to low systemic absorption after topical use, risk to nursing infant is likely low. Caution is advised. |
| Teratogenic Risk | SANTYL (collagenase clostridium histolyticum) is not systemically absorbed after topical application; thus, no fetal risk is expected. No well-controlled studies in pregnant women; animal studies are lacking. Risk cannot be ruled out. Use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to collagenase or any component of the formulation"]
| Precautions | ["Contains collagenase, which may cause allergic reactions","Avoid contact with eyes","Do not use in wounds that are clean or healing by primary intention","Use with caution in patients with known hypersensitivity to collagenase or its components"] |
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| No specific monitoring is required due to negligible systemic absorption. Routine pregnancy monitoring if used during gestation. |
| Fertility Effects | No studies on fertility in humans. Animal studies have not been conducted. No known effect on fertility is anticipated. |