STELFONTA 1 MG/ML- tigilanol tiglate solution
Virbac AH Inc
For intratumoral injection in dogs only
Single use vial
WARNING: SEVERE WOUND FORMATION IN HUMANS; EXTENSIVE WOUND FORMATION, MAST CELL DEGRANULATION, AND DEATH IN DOGS DUE TO MAST CELL DEGRANULATION
- 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).
- 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).
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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-tigliaen-3-one. The molecular formula is C30H42O10 and its molecular weight is 562.65 g mol-1. Each mL of STELFONTA contains 1 mg tigilanol tiglate and sterile water for injection (60% v/v), propylene glycol (40% v/v), sodium acetate (<0.1% w/v), and glacial acetic acid (<0.1% w/v).
The chemical structure for tigilanol tiglate is:
<p class=”First”>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-tigliaen-3-one. The molecular formula is C30H42O10 and its molecular weight is 562.65 g mol-1. Each mL of STELFONTA contains 1 mg tigilanol tiglate and sterile water for injection (60% v/v), propylene glycol (40% v/v), sodium acetate (<0.1% w/v), and glacial acetic acid (<0.1% w/v).</p><p>The chemical structure for tigilanol tiglate is:</p>
STELFONTA injection is indicated 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
ALWAYS PROVIDE THE CLIENT INFORMATION SHEET TO THE DOG OWNER
BEFORE DOSE ADMINISTRATION.
Administer the following medications to decrease the potential for severe systemic adverse reactions from mast cell degranulation:
- Corticosteroid (e.g. oral prednisone or prednisolone at anti-inflammatory dose): Start medication 2 days prior to STELFONTA treatment and continue for 8 days post-treatment (10 days total).
- H1 receptor blocking agent (e.g. oral diphenhydramine): Start medication on the day of STELFONTA treatment and continue for a total of 8 days.
- H2 receptor blocking agent (e.g. oral famotidine): Start medication on the day of STELFONTA treatment and continue for a total of 8 days.
Administer STELFONTA 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 <0.1 mL, administer 0.1 mL
Administration of STELFONTA:
Sedation may be necessary to safely and accurately administer STELFONTA to decrease the chance of accidental self-injection. Wear gloves, eye protection, and lab coat or gown in the preparation and administration of STELFONTA. Care should be taken to restrict injections to the tumor only. STELFONTA should not be injected into the margins, beyond the periphery, or deep to the tumor.
- Shave the tumor site. Avoid manipulation of the tumor.
- Draw the calculated volume of STELFONTA into a sterile Luer-lock syringe with a 23 gauge needle.
- Identify an appropriate injection point on the edge of the tumor. See Figure 1. Insertion of the needle depends on the tumor’s location, form, and appearance. If a tumor protrudes above the surface of the skin, insert the needle at an oblique angle of approximately 45°.
- Insert and embed the needle in the tumor through a single injection site and draw the syringe plunger back slightly to ensure STELFONTA is not injected into a blood vessel. While applying even pressure on the syringe plunger move the needle back and forth in a fanning manner to inject STELFONTA into the tumor. See Figure 1. The drug should fully perfuse the entire tumor.
- When the total dose of STELFONTA has been administered, pause to allow tissue dispersion before removing the needle from the tumor. Pull back on the syringe plunger to create a small negative pressure before removing the needle to minimize leakage from the injection site.
- After the needle is withdrawn, apply light pressure for 30 seconds over the needle exit hole using a gloved finger. If leakage does occur, rinse injection site with saline to wash STELFONTA from the skin surface. Do not readminister.
- To minimize risk of accidental self-injection, do not recap the needle. Disposeof the needle and syringe.
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).
NOT FOR USE IN HUMANS. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
Caution is required during treatment to avoid accidental self-injection. Dogs undergoing treatment with STELFONTA should be adequately restrained and sedation used if necessary. Use a Luer-lock syringe to administer STELFONTA. Do not recap the needle. Accidental self-injection may result in local inflammatory reactions, including swelling, redness and severe wound formation. In case of accidental self-injection, immediately rinse the area with water, seek medical advice immediately, and show the package insert to the physician.
Wear personal protective equipment consisting of disposable gloves, protective eye wear, and a lab coat or gown when handling STELFONTA. STELFONTA is an irritant and accidental exposure to skin, eye, or by ingestion should be avoided. In case of dermal or ocular exposure, repeatedly wash the exposed skin or eye with water. If wearing contacts, rinse the eyes first then remove contacts and continue to rinse with water. If symptoms such as local signs of redness and swelling occur, or if there has been ingestion, seek the advice of a physician and show them the package insert.
Limited data is available on the potential teratogenic effects of STELFONTA. Therefore, STELFONTA should not be administered by women who are pregnant or planning to become pregnant.
People with known hypersensitivity to tigilanol tiglate or to any of the excipients should avoid contact with STELFONTA.
Dogs should be monitored during and for 5-7 days after intratumoral treatment with STELFONTA for signs of systemic mast cell degranulation such as vomiting, diarrhea, lethargy, anorexia/hyporexia, altered breathing, hypotension, urticaria, edema at or away from the treated site, or bruising at or away from the treated site. If signs are observed, appropriate treatment should be started immediately.
Always administer the recommended concomitant medications (corticosteroids, H1, and H2 receptor blocking agents) with STELFONTA. Death has occurred following mast cell degranulation when these concomitant medications were not administered according to this Package Insert (see Dosage and Administration and Adverse Reactions).
STELFONTA can induce a substantial local inflammatory reaction which may result in pain, bruising, and swelling. During this time, an analgesic may be needed in addition to the use of corticosteroids and both H1 and H2 receptor blocking agents.
Treatment with STELFONTA causes tumor necrosis which is part of the mechanism of action of the drug. Bruising, heat, pain, and swelling may begin at the site within 2 hours of treatment. By day 7 after treatment, wound formation including full thickness dermal necrosis with exudate, peripheral tissue edema, erythema, skin discoloration, tissue sloughing, and necrotic eschar may occur. In addition to tumor necrosis, treatment with STELFONTA has been associated with cellulitis and severe tissue sloughing extending away from the treated site resulting in extensive wounds (see Adverse Reactions).
Do not inject STELFONTA into normal subcutaneous tissue or adjacent tissues (e.g. beyond tumor margins) because severe edema, erythema and necrosis of the injected tissue may occur.
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