Tildren (8)
Tildren®
(tiludronate disodium)
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
Injectable Bisphosphonates in the Treatment of Postmenopausal Osteoporosis
Human Pharmacokinetics of Tiludronate
Tiludronate: Bone Pharmacology and Safety
TILDREN - tiludronate disodium powder, for solution Ceva Sante Animale
Pharmacological effects of tiludronate in horses after long-term immobilization
Stability and Sterility of Tildren® (tiludronate disodium) Post-Reconstitution
TILUDRONATE - Bibliography May 2016
TILUDRONATE - Bibliography Synopsis May 2016
Freedom of Information Summary - Original New Animal Drug Application
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Learn More About How Tildren® Works
- Tildren® binds preferentially to the mineral phase of the bone at remodeling sites.
- Acidification breaks the bond.
- Tildren® is taken into the osteoclast by endocytosis.
See Tildren® at Work
In navicular syndrome, excessive mechanical stress results in bone resorption outpacing bone formation.
Tildren® (tiludronate disodium) restores balance to the process of bone remodeling by partially inhibiting bone resorption by:
- Modulating excessive osteoclastic activity
- Not modifying osteoblastic activity
- Slowing the rate of bone turnover
By modulating excessive osteoclastic activity, bone remodeling can normalize.
The Proven Effectiveness of Tildren®
The active ingredient in Tildren® is tiludronate disodium, a bisphosphonate that regulates osteoclasts in areas of excessive activity.
- Tildren® is administered via intravenous infusion over a 90-minute period, quickly binding to the mineral matrix of the bone.
- The acidity of the remodeling environment releases Tildren® from the bone matrix, where it is then taken into the osteoclast.
- Once inside, Tildren® inhibits the bone re-absorption process and kills off excess osteoclasts.
Safe and Long-lasting Relief
A single 500 mg vial treats horses up to 1,210 lb.
Controlled administration – Reconstituted with 0.9% sodium chloride solution and administered through intravenous infusion over the course of 90 minutes.
Safe – Limited and transient side effects when used according to label.
Long-lasting relief – A single treatment lasts up to six months.
1 Freedom of Information Summary. NADA #141-420. Approved February 13, 2014.
In conjunction with corrective shoeing, Tildren® has been proven to be more effective in controlling the clinical signs of navicular syndrome than corrective shoeing alone.1
Product Safety
In a controlled 6-month open use field study1, Tildren® (tiludronate disodium) was evaluated under strict conditions. Horses were observed for four hours following infusion and adverse events were recorded.
The most common observations were clinical signs associated with colic, which are defined as outlined below. While colic may occur, clinical signs and incidence vary and may be intermittent.
Clinical signs that were considered to be indicative of colic:
Pawing, getting up and down, pacing, restlessness, rolling, trying to roll, looking or biting at side, stretching out/straining, kicking at belly/walls, repeatedly shifting weight behind.
1 Freedom of Information Summary. NADA #141-420. Approved February 13, 2014.
TILUDRONATE, Bibliography May 2016, Studies: 2003 to 2016, Source: PubMed
A Statement From Dr. Dave Ellefson Regarding Bisphosphonate Use
Dosing and Administration
Tildren® is administered through a single intravenous infusion of 1mg/kg (0.45mg/lb) in 0.9% Sodium Chloride, and is given slowly and evenly over 90 minutes. Of the administered dose, 30-50% of the tiludronate disodium distributes to the bone within 12 hours of dosing.
Bone concentrations are higher than plasma concentrations as early as 12 hours post-administration. The drug is slowly, but continuously, released in relation to the bone remodeling process and concentrations are still present at 6 months, but lower than at 3 months, in the bone.
Cause for Pain
Horses suffering from navicular syndrome feel pain in the palmar, or heel, region of the foot. They show gait abnormalities associated with degenerative lesions of the navicular bone.
Clinical Signs and Diagnosis
Clinical signs associated with navicular syndrome can vary but are typically indicated by a gait change or lameness which is aggravated when walking on hard ground or trotting circles.
If you suspect your horse may have navicular syndrome, please contact your veterinarian.
To diagnose navicular syndrome, the following methods may be used:
Podcast: Navicular Syndrome Update
From initial diagnosis to hoof care and bisphosphonate use, find out the newest information about this debilitating condition.
Recorded at Ask TheHorse Live