TruScient® Prescribing Information

TruScient® kit for implant for dogs contains 0.66 mg dibotermin alfa (rhBMP-2); 0.2 mg/ml after reconstitution. It also includes two sponges of Bovine Type I collagen. Indicated for treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs. This veterinary medicinal product should be used by an appropriately qualified veterinarian. Do not use in dogs with a known hypersensitivity to the active substance or excipients. Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy. Only to be used by an appropriately qualified veterinarian. Failure to follow instructions for preparation & use may compromise safety & effectiveness. To avoid excessive postoperative swelling, use only the amount of TruScient sponge needed to achieve coverage of accessible fracture lines and defects (max 2 prepared sponges). Can cause initial resorption of surrounding trabecular bone. In absence of clinical data, should not be used for direct applications to trabecular bone when transient bone resorption may create a risk of bone fragility and, thus, increase the risk of implant failure. Does not provide mechanical stability; not to be used to fill space in the presence of compressive forces. Long-bone fracture & soft-tissue management procedures should be based on standard practice, including control of infection. Both rhBMP-2 and bovine Type I collagen can elicit an immune response in dogs; although no clear association with clinical outcome or undesirable effects could be observed in clinical/safety studies, the possibility of developing neutralising antibodies or hypersensitivity-type reactions cannot be excluded. The possibility of an immune response should be evaluated in cases where an undesirable effect with immunological background is suspected. Adverse reactions have been observed in lab studies: heterotopic ossification of surrounding tissues; exuberant bone formation at site of placement and ectopic bone formation; excessive bone and fluid filled cysts that remodel into normal bone over time; increased swelling at site of placement has been observed 2-3 weeks post surgery. These swellings are the result of local proliferation of mesenchymal tissue maturing to new bone and are consistent with the pharmacologic activity of rhBMP-2. Very common (more than 1 in 10 animals): mild to moderate - lameness, firm swelling within the first 3 weeks postoperatively which recedes gradually over several months, soft swelling

which recedes within 3 weeks. Common (more than 1 but less than 10 animals in 100 animals): mild to moderate - seroma, excessive licking of incision area, joint stiffness, local swelling, skin ulcer, incisional discharge, incisional dehiscence, soft swelling generally resolved by week 6 postoperatively. Uncommon (more than 1 but less than 10 animals in 1000 animals): mild to moderate - exuberant bony callus associated with persistent (>10 weeks) moderate soft tissue swelling and excessive licking of the incision area. Severe - lameness. Observed clinical signs were listed as adverse reactions for TruScient when they exceeded in intensity and/or duration of what would be considered normal for fracture healing after Standard of Care (SOC). The safety, including potential immune responses, and effectiveness of repeated administration have not been evaluated in dogs. No studies have been performed in dogs with known autoimmune diseases. No studies have been performed in dogs with metabolic bone diseases. The safety has not been established during breeding, pregnancy and lactation. BMP-2 plays a critical role during foetal development. The influence of anti-BMP-2 antibody formation on foetal development has not been assessed. The incidence of antibody titres in treated dogs under field conditions is low and the puppies will have no or very limited exposure to anti-BMP-2 antibodies due to the potential for limited transfer across the placenta in dogs. Only use in breeding, pregnant and lactating dogs following a risk/benefit assessment by the responsible veterinarian. Used in concentrations or amounts greater than those recommended is associated with excessive bone formation and increased generation of fluid-filled void spaces within the induced bone. Excessive bone and fluid filled cysts remodel into normal bone over time. Biomechanical data suggest these voids had little influence on the biomechanical properties of the induced bone or its integration with the abutting cortices. In the case of dogs receiving concentrations or amounts greater than those recommended, treatment of adverse effects, where required, should be symptomatic. No interaction studies have been performed. As dibotermin alfa (rhBMP-2) is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions. Do not mix with other agents. Shelf-life after reconstitution: 3 hours. For further information, please contact Pfizer Animal Health, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK.