Tildren®

(tiludronate disodium)

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BISPHOSPHONATE DRUG FOR INTRAVENOUS INFUSION.

For use in horses only

WARNINGS

Do not use in horses intended for human consumption.
NSAIDs should not be used concurrently with Tildren®. Concurrent use of NSAIDs with Tildren® may increase the risk of renal toxicity and acute renal failure.

HUMAN WARNINGS

Not for human use. Keep this and all drugs out of the reach of children. Consult a physician in case of accidental human exposure.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATION

Tildren® is indicated for the control of clinical signs associated with navicular syndrome in horses.

CONTRAINDICATIONS

Do not use in horses with known hypersensitivity to tiludronate disodium or to mannitol. Do not use in horses with impaired renal function or with a history of renal disease. Bisphosphonates are excreted by the kidney; therefore, conditions causing renal impairment may increase plasma bisphosphonate concentrations resulting in an increased risk for adverse reactions.

PRECAUTIONS

Approximately 30-45% of horses administered Tildren® will demonstrate transient signs consistent with abdominal pain (colic). Horses should be observed closely for 4 hours post-infusion for the development of clinical signs consistent with colic or other adverse reactions. Colic signs can last approximately 90 minutes and may be intermittent in nature. Hand walking the horse may improve or resolve the colic signs in many cases. If a horse requires medical therapy, non-NSAID treatments should be administered due to the risk for renal toxicity. Avoid NSAID use.

Horses should be well hydrated prior to administration of Tildren® due to the potential nephrotoxic effects of Tildren®.

Tildren® should be used with caution in horses receiving concurrent administration of other drugs that may reduce serum calcium (such as tetracyclines) or whose toxicity may exacerbate a reduction in serum calcium (such as aminoglycosides).

Horses with HYPP (heterozygous or homozygous) may be at an increased risk for adverse reactions, including colic signs, hyperkalemic episodes, and death.
The safe use of Tildren® has not been evaluated in horses less than 4 years of age.

Bisphosphonates should not be used in pregnant or lactating mares, or mares intended for breeding. Bisphosphonates have been shown to cause fetal developmental abnormalities in laboratory animals.

DOSAGE AND ADMINISTRATION

A single dose of Tildren® should be administered as an intravenous infusion at a dose of 1 mg/kg (0.45 mg/ lb). The infusion should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions. Maximum effect may not occur until 2 months post-treatment.

For ADMINISTRATION INSTRUCTIONS (preparation of the reconstituted solution (20mg/mL) and preparation of the solution for infusion) and for complete product information, please read the insert contained within the product packaging.

STORAGE

Sterile powder (not reconstituted): Store at controlled room temperature 68°F-77°F (20°C-25°C). After preparation, the infusion should be administered either within 2 hours of preparation, or it can be stored for up to 24 hours under refrigeration at 36°F-46° F (2°C-8°C) and protected from light.

HOW SUPPLIED

Tildren® is supplied in a 30mL glass vial as a white, sterile lyophilized powder containing 500mg tiludronic acid (as tiludronate disodium) packaged in a folding carton. For technical assistance or to report suspected adverse reactions, call 1-888-524-6332.

INFORMATION FOR OWNERS

Prior to Tildren® administration, owners should be advised of the potential for adverse reactions in the hours or days following treatment. Adverse reactions within 4 hours post dosing may include signs of colic (manifested as pawing, stretching, getting up and down, sweating, rolling, looking at flanks, kicking at belly, frequent gas, and pacing). Owners should be instructed to contact their veterinarian immediately if any adverse reactions are observed. Owners should be advised to consult with their veterinarian prior to the administration of an NSAID following Tildren® administration.

Made in Canada
Patent information: U.S. patent 6,057,306

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Do not use in horses with impaired renal function or with a history of renal disease. NSAIDs should not be used concurrently with TILDREN® . Concurrent use of NSAIDs with TILDREN® may increase the risk of renal toxicity and acute renal failure. Horses should be observed closely for 4 hours post-infusion for the development of clinical signs consistent with colic or other adverse reactions.

Caution should be used when administering TILDREN® to horses with conditions affecting mineral or electrolyte homeostasis (e.g. HYPP, hypocalcemia) and conditions which may be exacerbated by hypocalcemia (e.g. cardiac disease). The safe use of TILDREN® has not been evaluated in horses less than 4 years of age, in pregnant or lactating mares, or in breeding horses. See package insert for full prescribing information.