Stelfonta (Tigilanol Tiglate): Intratumoral Canine Mast Cell Tumor Therapy

Stelfonta is an FDA-approved intratumoral treatment for narrowly defined canine mast cell tumors, with important current warnings about degranulation, wounds, pain, tissue loss, amputation, and death.

Therapy class: Prescription intratumoral antineoplastic; protein kinase C activator

Form and route: Veterinarian-administered intratumoral solution for injection

Tigilanol tiglate 1 mg/mL

Tigilanol tiglate activates protein kinase C signaling locally, producing rapid vascular disruption and necrosis in directly exposed tumor tissue and an inflammatory response. The resulting tumor-breakdown wound is an expected treatment process, not proof that every eligible tumor will resolve without serious complications.

Manufacturer positioning: QBiotics and regional product materials position Stelfonta as a local intratumoral option for label-eligible canine mast cell tumors. Directory should not simplify it into a minor injection or omit the expected wound and serious post-approval risks.

Suitability depends on diagnosis, anatomy, molecular or label criteria where applicable, prior treatment, access, and the intended local or systemic goal. A named modality is not a promise of response and should be compared with surgery, conventional chemotherapy, radiation, or comfort-focused care.

A veterinary oncologist or radiation oncologist should define eligibility, treatment intent, current regulatory or licensing status in the relevant country, monitoring, expected burdens, and alternatives. Product labels and local rules take precedence over summaries.

Approval/authorisation applies only to tumors and patients meeting the current regional label. It does not guarantee uncomplicated healing, avoid surgery in every case or establish use for metastatic, ulcerated, inaccessible or otherwise label-ineligible tumors.

Mast cell degranulation, severe swelling and pain, extensive wound formation, tissue sloughing, infection, prolonged care, tongue injury, limb amputation, and death are described in current FDA safety information. This is not a home injection or a minor wound-care decision.

Risks vary widely across radiation fields, oral targeted medicines, biologics, and intratumoral procedures. Do not transfer instructions between modalities or countries, and do not assume that a biomarker, license, or commercial availability proves benefit for an individual patient.

United States: FDA-approved prescription animal drug, NADA 141-541, initially approved in 2020 for the defined canine mast cell tumor indication; FDA approved major safety-related labeling changes in January 2025. European Union: centrally authorised veterinary medicinal product, EMEA/V/C/005018. Great Britain: currently authorised POM-V product under QBiotics Netherlands B.V. Australia: APVMA-registered product 88412 (registration decision published in 2021). QBiotics also states Swiss approval; this audit did not separately retrieve the current Swissmedic record.

Verified regulatory records: United States, European Union/EEA, Great Britain and Australia. Region-specific tumor eligibility, product information and companion-medication instructions differ and must not be merged into a single global label.

Before treatment, confirm staging, tumor dimensions/location/surface integrity, label eligibility and the household's capacity for wound care. Follow the current regional instructions for required concomitant medicines and administration. Monitor the expected 4–6 week tumor-breakdown and healing process, wound extent/discharge/odor, swelling, pain, tissue sloughing, infection, limb function and systemic signs. Treat breathing difficulty, excessive swelling/bruising, vomiting/diarrhea, hives, marked weakness or other mast-cell-degranulation signs as urgent according to the current client sheet. FDA post-approval information includes extensive wounds, tongue injury/necrosis, limb amputation and death.