Immunocidin Equine (Canada)

Company: NovaVive

MYCOBACTERIUM CELL WALL FRACTION IMMUNOSTIMULANT

For Veterinary Use Only

Description and Action: The Mycobacteriaceae have been known for many years to have antitumour activity. Immunocidin^® Equine is an emulsion of mycobacterial cell wall fractions that have been modified to reduce their toxic and allergic effects, but retain their antitumour activity. Immunocidin^® Equine stimulates the activation of macrophages and thymic lymphocytes which kill tumour cells.

Indications: Immunocidin^® Equine is recommended for the immunotherapy of sarcoid tumours in horses. Although Immunocidin^® Equine is administered by intratumoural injection, the response is generalized, and untreated sites frequently undergo regression. Remissions cannot be guaranteed as each tumour will vary in its response.

Adverse Reactions

Mild fever, drowsiness, and an increased metabolic rate leading to decreased appetite may occur for one to two days following an Immunocidin^® Equine injection. These are all normal responses to the release of cytokines.^1,2,3 An elevated body temperature enhances the immune function by stimulating lymphocyte activity², and thus, should not be considered an adverse side effect. Local inflammation which is sensitive to the touch occurs fairly often, but it usually is not bothersome to the patient. Necrosis with suppuration may occur in regressing tumours and clients should be informed that the tumour may drain for several weeks. Tumours may be aspirated with a sterile syringe and needle to help prevent drainage. If inconvenient drainage develops, it can often be stopped by the application of astringents such as silver nitrate or styptic powders.

Contraindications

Immunotherapy may not be as effective in animals receiving concurrent immunosuppressive therapies. Avoid the use of corticosteroids or ACTH where possible.

Immunocidin Equine Caution

The inflammatory response with edema and malaise occasionally is severe after the initial treatment. Therapy should be discontinued until the reaction has subsided. Animals with a history of hyper-immune disease (vaccine bumps, allergies, etc.) should be closely monitored. In the event of urticaria, lymphadenitis, cellulitis, or abscessation, treat appropriately. Discontinue Immunocidin^® Equine therapy in animals which develop these signs. This product may cause an anaphylactic reaction. Antidote: epinephrine. The product contains gentamicin as a preservative. Do not administer within 21 days of slaughter. KEEP OUT OF REACH OF CHILDREN.

Administration and Dosage: Immunocidin^® Equine is administered only by intratumoural injection. The entire tumour and a small region of adjacent and underlying tissue must be thoroughly infiltrated using no larger than a 20-gauge needle. Injection without careful infiltration of the tumour may not be effective. It is important to make sure that the emulsion is thoroughly mixed prior to injection. The sarcoid tissue may be very firm and extra pressure on the syringe plunger may be required to infiltrate the tumour. The injection may produce pain in some animals; anesthetics, local analgesics or NSAIDs may be used without decreasing the immunotherapeutic effect. Dosage varies with tumour size, but 1 mL should be considered a minimum dose.

Equine sarcoids are very responsive to immunotherapy with mycobacterial cell wall fractions.⁴ Large, pedunculated sarcoids should be debulked by partial excision prior to therapy. Immunocidin^® Equine is safe for use in pregnant mares. Treatment should be repeated every 1 to 3 weeks. Tumours that fail to respond after 4 treatments should be considered refractory and therapy discontinued. Ninety-four percent of treated horses were free of tumour two years later. Individual doses range from 1 to 60 mL and average about 5 to 10 mL. The average cumulative dose is about 30 mL.

Precaution: Store at 2-7°C in a refrigerator. Do not freeze. The emulsion may separate on standing. Resuspend by shaking or rotating the vial between the hands until the emulsion has a homogeneous “milky” appearance. Use entire contents when first opened.

Volume: 5 mL

References

1 Dinarello, C.A., 1988. Biology of interleukin-1. FASEB J. 2:108-115.

2 Tizard, I., 1986. Basic Immunology-3: The importance of macrophages. Vet. Med. Pp. 250-257.

3 Tizard, I., 1986. Basic Immunology-4: The indispensable lymphocyte. Vet. Med. Pp. 332-346.

4 Murphy, J.M., G.A. Severin, J.D. Lavach, D.l. Hepler, and D.C. Lueker, 1979. lmmunotherapy in ocular equine sarcoid, JAVMA 174:269.

Manufactured for: NovaVive Inc., Belleville, Ontario, Canada

by NovaVive USA Inc., Athens, Georgia, 30601 U.S.A.

USDA Establishment License Number 289

TOLL FREE: 1-844-663-3349

info@novavive.ca

Protected by one or more of the following patents:

US: 4744984, 5632995, 5759554, 6139844, 6890541

CA: 1293190, 2154689, 2170142, 2284932, 2284937, 2378888

CPN: 1842002.0