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

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.

DIRECTIONS FOR ADMINISTRATION

Do not reconstitute or mix TILDREN with calcium containing solutions or other solutions containing divalent cations such as Lactated Ringers as it may form complexes with these ions.

STEP 1: Preparation of the reconstituted solution (20 mg/mL). TILDREN should be reconstituted using strict aseptic technique. Remove 25 mL of solution from a 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP and add it to one vial of TILDREN. Shake gently until the powder is completely dissolved. This reconstituted solution contains 20 mg of tiludronate disodium per mL. After reconstitution further dilution is required before administration.

STEP 2: Preparation of the solution for infusion. Using strict aseptic technique, withdraw the appropriate volume of the reconstituted solution based on the horse’s body weight (see Table 1 below). Inject that volume back into the 1 liter bag of sterile 0.9% Sodium Chloride Injection, USP. Horses greater than 1,210 lbs. will require a second vial of reconstituted TILDREN solution. Invert the infusion bag to mix the solution before infusion. Label the infusion bag to ensure proper use.

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 36-46° F (2-8° C) and protected from light.

STEP 3: Administer for infusion through a suitable intravenous catheter inserted into a jugular vein and connected to the infusion bag using sterile disposable infusion tubing.

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.

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. Acute renal failure has been reported in horses concurrently administered NSAIDs and TILDREN within a 48 hour period. Additionally, horses concurrently administered TILDREN and NSAIDs in field studies demonstrated a statistically significant increase in serum blood urea nitrogen (BUN) and creatinine concentrations. These elevations were not always associated with clinical signs of renal dysfunction. Therefore, appropriate wash-out periods should be observed between NSAID and TILDREN administration, and BUN and creatinine should be monitored. If treatment for discomfort is required after TILDREN administration, a non-NSAID treatment should be used.

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.

PRECAUTIONS

Approximately 30-45% of horses administered TILDREN will demonstrate transient signs consistent with abdominal pain (colic). Clinical signs usually occur shortly after TILDREN administration and may be associated with alterations in intestinal motility. 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. (See Warnings.)

TILDREN should be administered slowly and evenly over 90 minutes to minimize the risk of adverse reactions. Field studies demonstrated a higher incidence of adverse reactions when the infusion was administered over shorter periods of time.

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

Concurrent administration of other potentially nephrotoxic drugs should be approached with caution, and if administered, renal function should be monitored.

TILDREN affects plasma concentrations of certain minerals and electrolytes, including calcium, magnesium and potassium, immediately post-treatment, with effects lasting up to several hours. Caution should be used when administering TILDREN to horses with conditions affecting mineral or electrolyte homeostasis (e.g. hyperkalemic periodic paralysis (HYPP), hypocalcemia, etc.) and conditions which may be exacerbated by hypocalcemia (e.g. cardiac disease). 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. In one field study, one horse that was an unknown carrier (heterozygous) for HYPP died after receiving TILDREN. In a study evaluating the safety of TILDREN in horses with HYPP, an increased percentage of horses showed colic signs following the second TILDREN infusion (See Animal Safety). Genetic testing for HYPP in horses with possible or known Impressive bloodlines should be considered prior to the administration of TILDREN.

The safe use of TILDREN has not been evaluated in horses less than 4 years of age. The effect of bisphosphonates on the skeleton of growing horses has not been studied; however, bisphosphonates inhibit osteoclast activity which impacts bone turnover and may affect bone growth.

Bisphosphonates should not be used in pregnant or lactating mares, or mares intended for breeding. The safe use of TILDREN has not been evaluated in pregnant or lactating mares, or in breeding horses; however, bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of months to years. The extent of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the total dose and duration of bisphosphonate use. Bisphosphonates have been shown to cause fetal developmental abnormalities in laboratory animals. The uptake of bisphosphonates into fetal bone may be greater than into maternal bone creating a possible risk for skeletal or other abnormalities in the fetus. Many drugs, including bisphosphonates, may be excreted in milk and may be absorbed by nursing animals.

Increased bone fragility has been observed in laboratory animals treated with bisphosphonates at high doses or for long periods of time. Bisphosphonates inhibit bone resorption and decrease bone turnover which may lead to an inability to repair microdamage within the bone. In humans, atypical femur fractures have been reported in patients on long term bisphosphonate therapy; however, a causal relationship has not been established.

ADVERSE REACTIONS

Three field studies were conducted evaluating the use of TILDREN in horses: a controlled field effectiveness study, a 6-month open use field study, and an infusion rate field safety study. In the controlled field effectiveness study, 139 horses were treated with a single intravenous infusion of TILDREN over 30-60 minutes and 69 horses were treated with vehicle control. Adverse reactions were most common during the infusion or within 4 hours following the end of the infusion (see Table 2). Fifty-seven TILDREN-treated horses (41%) and seven vehicle control horses (10%) exhibited at least one sign consistent with abdominal discomfort or colic (pawing, evidence of pawing, getting up and down, pacing, restlessness, rolling, trying to roll, looking at or biting at side, stretching out/straining, kicking at belly/walls, and shifting weight). Adverse reactions were also reported for horses in the controlled field effectiveness study that continued into a 6-month open use field study where 250 doses were administered to 97 horses. Incidence of adverse reactions was similar to the controlled field effectiveness study.

Table 2: Number of Adverse Reactions in the Controlled Field Effectiveness Study and in the 6-month Open Use Field Study

TILDREN is a sterile powder. Each vial of TILDREN contains 500 mg of tiludronic acid (as tiludronate disodium) and 250 mg mannitol USP (excipient).INDICATION 

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