Immunocidin (Canada)

Company: NovaVive

MYCOBACTERIAL CELL WALL FRACTION IMMUNOSTIMULANT

For Veterinary Use Only

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

Indications: Immunocidin^® is recommended for the immunotherapy of mixed mammary tumour and mammary adenocarcinoma in dogs. Although Immunocidin^® is administered by intratumoural injection, the response is generalized, and untreated sites frequently undergo regression. Prognosis should be guarded in advanced malignant disease with metastases, as remissions will be less frequent. 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^® 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 often may be stopped by the application of astringents such as silver nitrate and 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 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^® therapy in animals which develop these signs. This product may cause an anaphylactic reaction. Antidote: epinephrine. The product contains gentamicin as a preservative. KEEP OUT OF REACH OF CHILDREN.

Administration and Dosage: Immunocidin^® 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 mix the emulsion thoroughly and inject the tumour as quickly as possible because the emulsion may begin to separate soon after mixing. The tumour tissue may be very firm and excessive 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 may be used without decreasing the immunotherapeutic effect. Dosage varies with tumour size but 1 mL should be considered a minimum dose.

Immunocidin^® proved to be effective against mixed mammary tumours and mammary adenocarcinomas in dogs but was not effective against liposarcomas in dogs. Canine mammary tumours may be treated once, 2 to 4 weeks prior to surgery. Whereas surgical removal of mammary tumours produces a desirable cosmetic result, tumour-free survival is not significantly improved. On the other hand, dogs treated with mycobacterial cell wall fractions, prior to surgery, experience significantly extended mean tumour-free survival time, and a significantly greater number of dogs survive free of tumours.⁴ Immunocidin^® is well tolerated by aged dogs with chronic cardiovascular and renal disease. This makes immunotherapy without surgery an attractive method of treatment for those patients that are poor surgical risks. Treatment should be repeated every 1 to 3 weeks. Tumours that fail to respond after 4 treatments should be considered refractory and therapy discontinued. Eighty-eight percent of dogs treated with immunotherapy alone were free of tumours two years later. Individual doses range from 1 to 30 mL (average about 2.5 mL). The average cumulative dose is about 10 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: 2.5 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 Winters, W.D. and S.C. Harris, 1982. Increased survival and interferon induction by BCG cell wall immunotherapy in pet dogs with malignant mammary tumors. Proc. 73rd Ann. Mtg. Amer. Assoc. Cancer Res. 23:244.

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: 1842000.1