STELFONTA 1 MG/ML- tigilanol tiglate injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TIGILANOL TIGLATE (UNII: R1ZJT87990) (TIGILANOL TIGLATE - UNII:R1ZJT87990)

Available from:

Virbac AH Inc

Administration route:

intratumor

Prescription type:

PRESCRIPTION

Therapeutic indications:

Do not inject STELFONTA into subcutaneous mast cell tumors located above the elbow or hock (e.g. on the body, head, or neck). This may result in accumulation of necrotic debris in the subcutaneous space increasing the risk of systemic adverse reactions, including death, from mast cell degranulation (see Adverse Reactions ).

Product summary:

STELFONTA is supplied as a sterile, colorless liquid in a 5 mL clear, single-use glass vial containing 2 mL of STELFONTA at a concentration of 1 mg/mL tigilanol tiglate in sterile water for injection.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

STELFONTA 1 MG/ML- TIGILANOL TIGLATE INJECTION SOLUTION
VIRBAC AH INC
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STELFONTA® (TIGILANOL TIGLATE INJECTION)
STELFONTA® (TIGILANOL TIGLATE INJECTION)
For intratumoral injection in dogs only
Antineoplastic
Single use vial
WARNING: SEVERE WOUND FORMATION IN HUMANS;
EXTENSIVE WOUND FORMATION, MAST CELL DEGRANULATION, AND
DEATH IN DOGS DUE TO MAST CELL DEGRANULATION
HUMAN SAFETY
ACCIDENTAL SELF-INJECTION OF STELFONTA® MAY CAUSE SEVERE WOUND
FORMATION. TO DECREASE THE RISK OF ACCIDENTAL SELF-INJECTION, SEDATION
OF THE DOG MAY BE NECESSARY (SEE DOSAGE AND ADMINISTRATION, HUMAN
WARNINGS AND ADVERSE REACTIONS).
DOG SAFETY
ALWAYS ADMINISTER A CORTICOSTEROID (E.G. PREDNISONE OR PREDNISOLONE),
AN H1 RECEPTOR BLOCKING AGENT (E.G. DIPHENHYDRAMINE), AND AN H2
RECEPTOR BLOCKING AGENT (E.G. FAMOTIDINE) WHEN TREATING WITH
STELFONTA TO DECREASE THE POTENTIAL FOR SEVERE SYSTEMIC ADVERSE
REACTIONS, INCLUDING DEATH, FROM MAST CELL DEGRANULATION (SEE
CONTRAINDICATIONS AND DOSAGE AND ADMINISTRATION).
DO NOT INJECT STELFONTA INTO SUBCUTANEOUS MAST CELL TUMORS LOCATED
ABOVE THE ELBOW OR HOCK (E.G. ON THE BODY, HEAD, OR NECK). THIS MAY
RESULT IN ACCUMULATION OF NECROTIC DEBRIS IN THE SUBCUTANEOUS SPACE
INCREASING THE RISK OF SYSTEMIC ADVERSE REACTIONS, INCLUDING DEATH,
FROM MAST CELL DEGRANULATION (SEE CONTRAINDICATIONS, WARNINGS AND
ADVERSE EVENTS).
TREATMENT WITH STELFONTA HAS BEEN ASSOCIATED WITH CELLULITIS AND
SEVERE TISSUE SLOUGHING EXTENDING AWAY FROM THE TREATED SITE
RESULTING IN EXTENSIVE WOUNDS THAT REQUIRE ADDITIONAL TREATMENT AND
PROLONGED RECOVERY TIMES (SEE WARNINGS, PRECAUTIONS AND ADVERSE
EVENTS).
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
The active ingredient for tigilanol tiglate injection is a phorbol
ester that activates alpha,
beta I, beta II, and gamma isoforms of protein kinase C. The chemical
name is
(4S,5S,6R,7S,8R,9R,10S,11R,12R,13S,14R)-12-(2E)-2-methylbut-2-enoatyl-13-
[(2S)-2-
methylbutyroyl]-6,7-epoxy-4,5,9,12,13,20-hexahydroxy-1-t