Acemannan Immunostimulant

Manufacturer: V.P.L.

U.s. Vet. Lic. No.

384

Description

ACEMANNAN IMMUNOSTIMULANT consists of long-chain polydispersed β-(1,4)-linked mannan polymers interspersed with O-acetyl groups. This product is prepared in a lyophilized form. Reconstitution in normal saline produces a solution for intraperitoneal and intralesional injection.

Acemannan Immunostimulant Indications

ACEMANNAN IMMUNOSTIMULANT is indicated for use in the dog and cat as an aid in treatment (i.e. surgery) and clinical management of fibrosarcoma.

Acemannan Immunostimulant Dosage And Administration

Prior to use, reconstitute ACEMANNAN IMMUNOSTIMULANT with 10 mL sterile diluent. Five to 10 minutes may be necessary for complete dissolution. Shake well before using. Use within 4 hours after rehydration.

ACEMANNAN IMMUNOSTIMULANT is administered by concurrent intraperitoneal (IP) and intralesional injections weekly for a minimum of 6 treatments. Recommended IP dose is 1 mg/kg. Recommended intralesional dose is 2 mg injected deep into each tumor mass.

When ACEMANNAN IMMUNOSTIMULANT is used as a prelude to surgery, give concurrent IP and intralesional injections weekly. Continue until delineation, necrosis or maximum tumor enlargement due to edema and immune cellular infiltration occur. Rapid necrosis, which accompanies this response, may happen within 2 to 4 weeks. Surgical excision is recommended immediately upon delineation, necrosis or maximum tumor enlargement.

Benefits of long-term post-surgery treatment have not been clinically established, however, no tumor regrowth has been observed in 5 animals treated with monthly IP injections of 1 mg/kg for 6 months following surgery.

Contraindication(s)

There are no known contraindications for use of acemannan.

Precaution(s)

Do not store over 35°C. Protect from extremes of heat or light.

Acemannan Immunostimulant Caution(s)

The effects of this compound have not been studied in pregnant animals. However, the chemical nature of acemannan and the absence of significant toxicity in several animal species suggest the compound is not a teratogen.

Trial Data

Acemannan is a potent stimulator of macrophage activity. It has been shown to increase TNF-α and IL-1 production in animals. A study was done in 9 dogs and 9 cats with histopathologically confirmed fibrosarcoma. Animals were treated with intraperitoneal and intralesional injections. Eleven of the 18 had surgery in addition to immunotherapy. Twelve of the 18 showed gross tumor necrosis.

Twelve had tumors that increased in size - usually very rapidly (2-4 weeks). This rapid increase suggests an effect attributable to TNF-α. Lymphocytic infiltration and tumor encapsulation were also seen. Benefits of long-term treatment have not been clinically established, however, no tumor regrowth has been observed in 5 animals treated with monthly IP injections of 1 mg/kg for 6 months following surgery.

Manufactured By

Carrington Laboratories, Inc.

Presentation

ACEMANNAN IMMUNOSTIMULANT is supplied in kit form. Each kit contains four 10 mg vials of lyophilized acemannan and four 10 mL vial of sterile normal saline diluent for reconstitution.

Nac No.

11430001