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Roxee Medication Guide
Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.
Veterinary professional?
These are the reference facts Roxee uses on browse cards and quick facts.
Sponsor, product, and application records imported from Animal Drugs @ FDA.
openFDA reaction terms and case summaries are supporting evidence, not proof of causality.
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Virbac AH Inc
Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.
For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock Species commonly shown: Both, Dog.
For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Top reported reactions (openFDA): Lack of efficacy - NOS, Injection site swelling, Wound, Injection site pain, Swelling NOS, Pain NOS.
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Used for:
For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Dosing note:
Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.
What to watch for:
When to call the vet:
What to tell or ask your vet today:
A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.
Roxee has limited cited overview evidence for Tigilanol Tiglate; use the official documents and your veterinarian's instructions for product-specific decisions.
32 tracked reaction signals; 32 reported cases; 30 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.
Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.
Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.
Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.
Trouble breathing (dyspnea) (1 reports), Loss of appetite (1 reports), Generalised skin slough (1 reports), General pain (1 reports), Fixed pupil (1 reports)
Digestive (3), Neurologic (1), Other (28)
Dog (29 reports), Cat (3 reports)
Bulldog - French (2), Retriever - Labrador (2), ['Spitz - German Pomeranian', 'Spitz - American Eskimo Dog'] (1), Pug (1). These are report metadata, not proof that a breed is at higher risk.
Verify whether Tigilanol Tiglate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.
Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.
trouble breathing, Loss of appetite, Generalised skin slough
Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.
Review status / Updated / Sources
Review status: Clinical reviewer not listed
Updated: February 12, 2026, 10:44 PM UTC
Side effects to monitor:
Most reported reactions:
Emergency warning signs:
Source-backed clinical checkpoints for quick review.
Official label facts first, then secondary summaries. Marketing content is separated below.
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.
Received 2025-11-20 · MSK · MSK
Received 2025-11-20 · MSK · MSK
Received 2025-11-04 · MSK · MSK
Tap or hover a reaction to see what it means in plain language.
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Other | 1 | Dog | 1 | |
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (29) Cat (3)
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.
Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.
Full source previews and metadata remain in the veterinary/professional layer.
Official label / PI · Labeling
Official label / PI · Labeling
SPL · SPL
Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.
For use in dogs for the treatment of:
Administer as an intratumoral injection at a dose of 0.5 mL per cm3 of tumor volume, as determined by the following calculations:
SPL · Structured Product Label
FOI · FOI
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
Quick facts and links to official labeling and safety signals.
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 51311-993-02 | 51311 | - |
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
Every non-trivial field is expected to include provenance and update timestamps.
Official sponsor/proprietary-name/application-status records linked by active ingredient.
| Product | Sponsor | Application | Status | Published |
|---|---|---|---|---|
|
STELFONTA®
RX
Tigilanol tiglate
Injectable Solution
• Intratumoral
|
QBiotics Group Ltd. | NADA 141-541 | Approved | Oct 26, 2023 |
Data source: FDA Animal Drugs @ FDA (public search export).
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
For use in dogs for the treatment of:
Administer as an intratumoral injection at a dose of 0.5 mL per cm3 of tumor volume, as determined by the following calculations:
FDA page: Open in Animal Drugs @ FDA
For use in dogs for the treatment of: non-metastatic cutaneous mast cell tumors non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock
Source: FDA Animal Drugs @ FDA • Reference
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Neurologic.
Showing top 5 for Other.
Data source: FDA openFDA Animal & Veterinary adverse event reports.
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, ['Spitz - German Pomeranian', 'Spitz - American Eskimo Dog'], Female, 6 year, 6.35 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.25 Milligram per kilogram, Frequency: 1 per day • Reactions: Injection site swelling, Reluctant to move, Swollen limb, Partial anorexia, Injection site skin discolouration… • Outcome: Outcome Unknown
Dog, Bulldog - French, Female, 11 year, 12.066 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.28 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Swollen limb, Wound, Local erythema, Bruising • Outcome: Outcome Unknown
Dog, Pug, Female, 6 year, 9.344 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.50 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Pain NOS, Bruising, Local erythema… • Outcome: Ongoing
Dog, Bulldog - French, Female, 5 year, 11.34 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.30 mL per dose, Frequency: 1 per day • Reactions: Injection site swelling, Local swelling, Local skin slough, Enlarged lymph node, Application site skin slough… • Outcome: Ongoing
Dog, Shepherd Dog - Australian, Male, 5 year, 21.772 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.70 mL per dose, Frequency: 1 per day • Reactions: Swollen limb, Limb non-weight bearing, Injection site reaction NOS • Outcome: Ongoing
Dog, ['Pointing Dog - Hungarian Short-haired (Vizsla)', 'Retriever - Labrador'], Male, 8 year, 40.415 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.10 mL per dose, Frequency: 1 per day • Reactions: Application site scar, Injection site alopecia, Injection site reaction NOS, Injection site nodule, Mast cell tumour… • Outcome: Outcome Unknown
Dog, Retriever - Labrador, Male, 12 year, 28.576 kilogram • Drug: MSK, Intralesional, Dose: 4.90 mL per other • Reactions: Application site dry skin, Lack of efficacy, Injection site hair loss, Injection site scab, Mast cell tumour… • Outcome: Outcome Unknown
Dog, Retriever - Labrador, Female, 6.5 year, 29.484 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Lack of efficacy • Outcome: Outcome Unknown
Data source: FDA openFDA Animal & Veterinary adverse event reports.
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Let others know your experience or advice regarding this medication.
This medication has not been reviewed by a veterinarian yet.