Meds A-Z
Tigilanol Tiglate
Detailed information about Tigilanol Tiglate
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually 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
What it does:
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
When it's needed:
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
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (1 reports)
What to ask your vet today:
- Is this medicine the right fit for my pet’s current symptoms?
- Which warning signs mean I should call back right away?
- How should I handle missed doses or refusal to take the medicine?
Tigilanol Tiglate
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141541 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
No contraindication summary is linked yet.
No owner-focused warning rows are linked yet.
Adverse Reactions
Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.
Tap or hover a reaction to see what it means in plain language.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 2 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 |
Species coverage: Dog (26) Cat (6)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-055852
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 4 • Secondary summaries: 0
- FOI Summary oN 141-541 Approved November 16, 2020.pdf · FOI
- STELFONTA N141541G0008.pdf · Labeling
- STELFONTA N141541G0008.pdf · Labeling
- STELFONTA® · SPL
No source yet.
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/9988 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/911 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadLabeling/912 · document · Labeling
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/10070/STELFONTA%C2%AE · document · SPL
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.
At a Glance
Quick facts and links to official labeling and safety signals.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:03 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 51311-993-02 | 51311 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
STELFONTA N141541G0008.pdf
• Official label • Official
• Oct. 26, 2023
FDA official labeling for application 141541
-
STELFONTA N141541G0008.pdf
• Official label • Official
• Oct. 26, 2023
FDA official labeling for application 141541
-
FOI Summary oN 141-541 Approved November 16, 2020.pdf
• FOI summary • Official
• Oct. 26, 2023
FDA FOI summary for application 141541
Data Sources & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Injection site swelling, Wound, Injection site pain, Swelling NOS, Pain NOS. (Official, 2026-02-12)
- usage: 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 … (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
FDA Products & Applications (Animal Drugs @ FDA)
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).
What It's For (FDA Label Highlights)
Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.
Composition / specifications
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
Administer as an intratumoral injection at a dose of 0.5 mL per cm3 of tumor volume, as determined by the following calculations:
- Determine the Tumor Volume in cm3:
0.5 x [length (cm) x width (cm) x height (cm)] - Confirm the Tumor Volume does not exceed 10 cm3. Do not use STELFONTA® if tumor volume is > 10 cm3.
- Calculate the Dose volume (mL) of STELFONTA® to inject: Tumor Volume x 0.5 mL
- Confirm the dose of STELFONTA® does not exceed 0.25 mL/kg body weight.
- Do not exceed 5 mL per dog, regardless of tumor volume or body weight.
- The minimum dose of STELFONTA® is 0.1 mL, regardless of tumor volume or body weight. If the calculated dose is less than 0.1 mL, administer 0.1 mL.
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
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
-
Labeling STELFONTA N141541G0008.pdf
-
Labeling STELFONTA N141541G0008.pdf
- STELFONTA® (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
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
Contraindications
No approved contraindication text is linked yet. Review FDA label highlights and openFDA safety reports before making treatment decisions.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 7 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Adverse Event Case Summaries (openFDA)
These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.
Dog, Retriever - Golden, Female, 8 year, 27.216 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.10 mL per dose, Frequency: 1 per day • Reactions: Lack of efficacy, Injection site skin discolouration, Injection site swelling • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-056090
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 8.00 Year
- Weight: 27.216 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 0.10 mL per dose
- Frequency: 1 per day
Dog, Boxer (German Boxer), Female, 2.3 year, 28.7 kilogram • Drug: MSK, Solution, Parenteral, Dose: 2.20 mL per dose, Frequency: 1 per day • Reactions: Death, Injection site discharge NOS, Swollen limb, Pain NOS, Not eating… • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-055852
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 2.30 Year
- Weight: 28.700 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 2.20 mL per dose
- Frequency: 1 per day
Dog, Retriever - Labrador, Male, 11 year, 33.747 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.50 mL per dose, Frequency: 1 per day • Reactions: Diarrhea, Injection site discharge NOS • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055855
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 11.00 Year
- Weight: 33.747 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 1.50 mL per dose
- Frequency: 1 per day
Dog, Pit Bull, Female, 10 year, 38.782 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Lack of efficacy - NOS, Injection site inflammation, Injection site reaction NOS, Dermal nodule, Skin lesion NOS… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055327
- Serious AE: Yes
- Treated For AE: No
- Sex: Female
- Age: 10.00 Year
- Weight: 38.782 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 1 dose per animal
- Frequency: 1 per day
Dog, Poodle - Toy, Female, 13 year, 4.082 kilogram • Drug: MSK, Solution, Parenteral, Dose: 0.25 mL per dose, Frequency: 1 per day • Reactions: Injection site bleeding, Diarrhea, Injection site erythema, Elevated serum alkaline phosphatase, Elevated cholesterol… • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055764
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 13.00 Year
- Weight: 4.082 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 0.25 mL per dose
- Frequency: 1 per day
Cat, Domestic Shorthair, Male, 13 year, 9.616 kilogram • Drug: MSK, Solution, Subcutaneous, Dose: 1 dose per animal, Frequency: 12 per hour • Reactions: Injection site lesion, Injection site reaction NOS, Medication error NOS • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-020052
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 13.00 Year
- Weight: 9.616 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Subcutaneous
- Form: Solution
- Dose: 1 dose per animal
- Frequency: 12 per hour
Cat, Domestic Shorthair, Male, 13 year, 6.8 kilogram • Drug: MSK, Solution, Parenteral, Dose: 1.40 mL per dose, Frequency: 1 per day • Reactions: Hypotension, Bradycardia, Cardiac arrest, Death • Outcome: Died
- Report ID: USA-USFDACVM-2022-US-050117
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 13.00 Year
- Weight: 6.800 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Parenteral
- Form: Solution
- Dose: 1.40 mL per dose
- Frequency: 1 per day
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
Share Your Thoughts
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