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Tigilanol Tiglate

Detailed information about Tigilanol Tiglate

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

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 to watch for:

  • trouble breathing (1 reports)
  • Loss of appetite (1 reports)
  • Injection site inflammation (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
  • Blood in vomit or stool.

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?
Safety & side effects

What to watch:

  • trouble breathing
  • Loss of appetite
  • Injection site inflammation

Most reported reactions:

  • Trouble breathing (dyspnea) (1 reports)
  • Loss of appetite (1 reports)
  • Injection site inflammation (1 reports)

When to call your vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Facial swelling or hives.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:03 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 17, 2026, 11:07 AM UTC
Image coming soon
Tigilanol Tiglate

Tigilanol Tiglate

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Not available (source)

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Not available
Form: Injectable Solution
Identifiers:
NADA: 141541 NDC Package: 51311-993-02 NDC Product: 51311
Source metadata:

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.

Tracked signals
32
Reported cases
32
Serious reports
31
Species represented
2
Grouped by Body System
Digestive (3) · Loss of appetite, Drooling, Diarrhea Neurologic (1) · Convulsion Other (28) · Trouble breathing (dyspnea), Injection site inflammation, Injection site erythema
Most Reported Reactions
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)

View detailed reaction table
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 Cat 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 Dog Serious - 1
Neurologic Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Source metadata:

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (2)
SPL (1)
  • STELFONTA® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/10070/STELFONTA%C2%AE
FOI (1)
Source metadata:
Veterinary reference (advanced)

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.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:00 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:03 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 17, 2026, 11:07 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: STELFONTA®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Injectable Solution • Intratumoral
Applications: NADA 141-541
Documents: 3 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 28 • Cat 7 • View
Case summaries: 8 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Mast Cell Tumor (MCT)
Linked using: Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: C96.A
Mast cell neoplasm

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Top reaction signals
Trouble breathing (dyspnea) (1) Loss of appetite (1) Injection site inflammation (1) Injection site erythema (1) Injection site discharge NOS (1) Injection site bleeding (1) Increased respiratory rate (1) Increased heart rate (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141541 NDC Package: 51311-993-02 NDC Product: 51311
Package NDC Product NDC Form / Route Status
51311-993-02 51311 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 5 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • 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)
Recent Revisions
  • 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
Label highlights
Official documents
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.

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
1 mg/mL
Dogs
Indication

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
Dosage

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.
Limitations

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
SPL Packages

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

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Dog Drooling (1) • Dog Diarrhea (1) • Dog

Showing top 5 for Digestive.

Neurologic
Convulsion (1) • Dog

Showing top 5 for Neurologic.

Other
Trouble breathing (1) • Dog Injection site inflammation (1) • Dog Injection site erythema (1) • Dog Injection site discharge NOS (1) • Dog Injection site bleeding (1) • Dog
Show more (23)
Increased respiratory rate (1) • Dog Increased heart rate (1) • Dog Hypotension (1) • Cat Hyperthermia (1) • Dog General pain (1) • Dog Fixed pupil (1) • Dog Elevated triglyceride (1) • Dog Elevated temperature (1) • Dog Elevated serum alkaline phosphatase (1) • Dog Elevated cholesterol (1) • Dog Dilated pupils (1) • Dog Dermal nodule (1) • Dog Death (1) • Dog Cyanotic mucous membranes (1) • Dog Coma (1) • Dog Cellulitis (1) • Dog Cardiorespiratory arrest (1) • Dog Cardiac arrest (1) • Cat Bradycardia (1) • Cat Bacterial skin infection NOS (1) • Dog Asystole (1) • Dog Arthritis (1) • Dog Acid-base disorder (1) • Dog

Showing top 5 for Other.

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
Reactions Reported:
Lack of efficacy Injection site skin discolouration Injection site swelling
Outcomes: Outcome Unknown

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
Reactions Reported:
Death Injection site discharge NOS Swollen limb Pain NOS Not eating Not drinking Uncomfortable Elevated temperature Increased heart rate Increased respiratory rate Pitting oedema Injection site skin discolouration Injection site serosanguinous discharge Injection site reaction NOS Wound Cellulitis Local skin slough Convulsion Cardiorespiratory arrest Panting Fixed pupil Dilated pupils Cyanotic mucous membranes Coma Neurological signs NOS Premature ventricular contractions Ventricular fibrillation Asystole
Outcomes: Died

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
Reactions Reported:
Diarrhea Injection site discharge NOS
Outcomes: Outcome Unknown

Dog, Dog (unknown), Male, 10 year, 32.659 kilogram • Drug: MSK, Injection, solution, Parenteral, Dose: 3 mL per unknown • Reactions: Mass NOS, Lymph node abscess, Lymphadenopathy, Tachycardia, Drooling… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055759
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 10.00 Year
  • Weight: 32.659 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Injection, solution
  • Dose: 3 mL per unknown
Reactions Reported:
Mass NOS Lymph node abscess Lymphadenopathy Tachycardia Drooling Elevated serum alkaline phosphatase Monocytosis Neutrophilia Leucocytosis NOS Acid-base disorder Musculoskeletal disorder NOS Luxation/subluxation Arthritis Muscle tremor Tachypnoea Trouble breathing (dyspnea) Bacterial skin infection NOS Trauma NOS Hyperthermia Loss of appetite Oedema NOS Tiredness (lethargy) General pain
Outcomes: Outcome Unknown

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
Reactions Reported:
Lack of efficacy - NOS Injection site inflammation Injection site reaction NOS Dermal nodule Skin lesion NOS Bacterial skin infection NOS
Outcomes: Outcome Unknown

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
Reactions Reported:
Injection site bleeding Diarrhea Injection site erythema Elevated serum alkaline phosphatase Elevated cholesterol Elevated triglyceride Lack of efficacy
Outcomes: Outcome Unknown

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
Reactions Reported:
Injection site lesion Injection site reaction NOS Medication error NOS
Outcomes: Recovered/Normal

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
Reactions Reported:
Hypotension Bradycardia Cardiac arrest Death
Outcomes: Died

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.

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