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FDA-CVM 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, 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).

IMPORTANT SAFETY INFORMATION
Formation of wounds, possibly extensive, is an intended and likely response to treatment with STELFONTA along with associated swelling, bruising and pain; these wounds are expected to heal. Appropriate pre- and post-treatment medications must be given, including a corticosteroid plus blocking agents for both H1 and H2 receptors, in order to decrease the potential for severe systemic adverse reactions, including death, from mast cell degranulation.

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