leading [30:<30 mL/min (see CLINICAL PHARMACOLOGY, Renal Insufficiency ). Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease). Most reported cases have been in patients treated with bisphosphonates intravenously but some have been in patients treated orally. For patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. Musculoskeletal Pain In post marketing experience, severe and occasionally incapaciting bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. However, such reports have been infrequent. This category of drugs includes Skelid. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Information for Patients Patients receiving Skelid should be instructed to: Take Skelid with 6 to 8 ounces of plain water. Not lie down for at least 30 minutes after taking this medication. Skelid should not be taken within 2 hours of food. Maintain adequate vitamin D and calcium intake. Calcium supplements, aspirin, and indomethacin should not be taken within 2 hours before or 2 hours after Skelid. Aluminum- or magnesium-containing antacids, if needed, should be taken at least 2 hours after taking Skelid. Drug Interactions The bioavailability of Skelid is decreased 80% by calcium, when calcium and Skelid are administered at the same time, and 60% by some aluminum- or magnesium-containing antacids, when administered 1 hour before Skelid. Aspirin may decrease bioavailability of Skelid by up to 50% when taken 2 hours after Skelid. The bioavailability of Skelid is increased 2 4 fold by indomethacin but is not significantly altered by coadministration of diclofenac. The pharmacokinetic parameters of digoxin are not significantly modified by Skelid coadministration. In vitro studies show that tiludronate does not displace warfarin from its binding site on protein. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not yet been completed. Tiludronate was not genotoxic in the following assays: an in vitro microbial mutagenesis assay with and without metabolic activation, a human lymphocyte assay, a yeast cell assay for forward mutation and mitotic crossing over, or the in vivo mouse micronucleus test. Tiludronate had no effect on rat fertility (male or female) at exposures up to two times the 400 mg/day human dose, based on surface area, mg/m 2 (75 mg/kg/day tiludronic acid dose). Pregnancy Pregnancy Category C In a teratology study in rabbits dosed during days 6 18 of gestation at 42 mg/kg/day and 130 mg/kg/day (2 and 5 times the 400 mg/day human dose based on body surface area), there was dose-related scoliosis likely attributable to the pharmacologic properties of the drug. Mice receiving 375 mg/kg/day tiludronic acid (7 times the 400 mg/day human dose based on body surface area, mg/m 2 ) for days 6 15 of gestation showed slight maternal toxicity (decreased body weight gain), increased post-implantation loss, decreased number of fetuses/dam, and decreased fetus body weight. Uncommon malformations of the paw (shortened or missing digits, blood blisters between or in place of digits) were present in six fetuses at 375 mg/kg/day, all from the same litter. Maternal toxicity (decreased body weight) was also observed in a teratology study in rats dosed during days 6 18 of gestation at 375 mg/kg/day tiludronic acid (10 times the 400 mg/day human dose based on body surface area, mg/m 2 ). There were reduced percent implantations, increased postimplantation loss, and increased intra-uterine deaths in the rats. There were no teratogenic effects on fetuses. Protracted parturition and maternal death, presumably due to hypocalcemia, occurred at 75 mg/kg/day tiludronic acid (two times the 400 mg/day human dose based on body surface area, mg/m 2 ) when rats were treated from day 15 of gestation to day 25 postpartum. There are no adequate and well-controlled studies in pregnant women. Skelid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bisphosphonates are incorporated into the bone matrix, from where they are gradually released over periods of weeks 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. Although there are no data on fetal risk in humans, bisphosphonates do cause fetal harm in animals, and animal data suggest that uptake of bisphosphonates into fetal bone is greater than into maternal bone. Therefore, there is a theoretical risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been established. Nursing Mothers It is not known whether tiludronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Skelid is administered to a nursing woman. Pediatric Use Safety and effectiveness of Skelid in pediatric patients have not been established. Adverse Reactions The safety of Skelid has been studied in more than 1100 patients, and the adverse experience profile is similar between controlled and uncontrolled clinical trials. Adverse events occurring in placebo-controlled trials of pagetic patients treated with Skelid 400 mg/day are presented in the table below. The most frequently occurring adverse events in patients who received Skelid 400 mg/day were in the gastrointestinal body system: nausea (9.3%), diarrhea (9.3%), and dyspepsia (5.3%). Adverse events associated with Skelid usually have been mild, and generally have not required discontinuation of therapy. In two placebo-controlled trials, 1.3% of patients receiving 400 mg Skelid and 5.4% of patients receiving placebo discontinued therapy due to any clinical adverse event. Adverse Events * (%) Reported in> 2% of Pagetic Patients from Placebo-Controlled Studies Skelid 400 mg/day (n=75) Placebo (n=74) * Reported using WHO terminology All events reported, irrespective of causality BODY AS A WHOLE Pain 21.3 23.0 Back Pain 8.0 8.1 Accidental Injury 4.0 2.7 Influenza-like Symptoms 4.0 5.4 Chest Pain 2.7 0 Peripheral Edema 2.7 1.4 CARDIOVASCULAR, GENERAL Dependent Edema 2.7 0 Central and Peripheral Nervous Systems Headache 6.7 12.2 Dizziness 4.0 6.8 Paresthesia 4.0 0 ENDOCRINE Hyperparathyroidism 2.7 0 GASTROINTESTINAL Diarrhea 9.3 4.1 Nausea 9.3 5.4 Dyspepsia 5.3 8.1 Vomiting 4.0 0 Flatulence 2.7 0 Tooth Disorder 2.7 1.4 Metabolic and Nutritional Vitamin D Deficiency 2.7 2.7 Musculoskeletal System Arthralgia 2.7 5.4 Arthrosis 2.7 0 Resistance Mechanism Infection 2.7 0 Respiratory System Rhinitis 5.3 0 Sinusitis 5.3 1.4 Upper Respiratory Tract Infection 5.3 14.9 Coughing 2.7 2.7 Pharyngitis 2.7 1.4 Skin and Appendage Rash 2.7 1.4 Skin Disorder 2.7 1.4 Vision Cataract 2.7 0 Conjunctivitis 2.7 0 Glaucoma 2.7 0 Other adverse events not listed in the table above but reported in 1% of pagetic patients treated with Skelid in all clinical trials of at least one month duration, regardless of dose and causality assessment, are listed below. The adverse event terms within each body system are listed in the order of decreasing frequency occurring in the population. Body as a Whole: Asthenia, syncope, fatigue Cardiovascular: Hypertension Central and Peripheral Nervous Systems: Vertigo, involuntary muscle contractions Gastrointestinal: Abdominal pain, constipation, dry mouth, gastritis Musculoskeletal: Fracture pathological Psychiatric: Anorexia, somnolence, anxiety, nervousness, insomnia Respiratory System: Bronchitis Skin and Appendages: Pruritus, increased sweating Urinary System: Urinary tract infection Vascular (extracardiac): Flushing Stevens-Johnson type syndrome has been observed rarely; the causality relationship of this to Skelid has not been established. Overdosage Based on the known action of tiludronate, hypocalcemia is a potential consequence of Skelid overdose. In one patient with hypercalcemia of malignancy, intravenous administration of high doses of Skelid (800 mg/day total dose, 6 mg/kg/day for 2 days) was associated with acute renal failure and death. No specific information is available on the treatment of overdose with Skelid. Dialysis would not be beneficial. Standard medical practices may be used to manage renal insufficiency or hypocalcemia, if signs of these develop. Skelid Dosage and Administration A single 400-mg daily oral dose of Skelid, taken with 6 to 8 ounces of plain water only, should be administered for a period of 3 months. Beverages other than plain water (including mineral water), food (see below), and some medications (see PRECAUTIONS, Drug Interactions ) are likely to reduce the absorption of Skelid (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). Patients should not lie down for at least 30 minutes after taking this medication. In patients who cannot comply with dosing instructions due to mental or physical disability, therapy with Skelid should be used under appropriate supervision (See WARNINGS ). Skelid should not be taken within 2 hours of food. Calcium or mineral supplements should be taken at least 2 hours before or two hours after Skelid. Aluminum- or magnesium-containing antacids, if needed, should be taken at least two hours after taking Skelid. Skelid should not be taken within 2 hours of indomethacin. Following therapy, allow an interval of 3 months to assess response. Specific data regarding retreatment are limited, although results from uncontrolled studies indicate favorable biochemical improvement similar to initial Skelid treatment. How is Skelid Supplied Skelid is supplied as white to practically white, biconvex round tablets containing 240 mg tiludronate disodium, which is the molar equivalent of 200 mg tiludronic acid. Skelid tablets are engraved with "S.W" on one side and "200" on the other side and packaged in foil strips in cartons of 56 tablets per carton (0024-1800-16). Storage Skelid should be stored at 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F) [see USP Controlled Room Temperature]. Tablets should not be removed from the foil strips until they are to be used. sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Country of origin: France Revised March 2010 2010 sanofi-aventis U.S. LLC PRINCIPAL DISPLAY PANEL - 200 mg Tablet Carton S-165 NDC 0024-1800-16 56 Tablets Skelid tiludronate disodium 200 mg Each tablet contains 240 mg tiludronate disodium, equivalent to 200 mg tiludronic acid. Rx only sanofi aventis Skelid tiludronate disodium tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0024-1800 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength tiludronate disodium (tiludronic acid) tiludronic acid 200 mg Inactive Ingredients Ingredient Name Strength sodium lauryl sulfate crospovidone magnesium stearate lactose monohydrate Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code S;W;200 Contains Packaging # Item Code Package Description 1 NDC:0024-1800-16 56 TABLET (TABLET) in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020707 03/07/1997 Labeler - sanofi-aventis U.S. LLC (824676584) Establishment Name Address ID/FEI Operations Sanofi Winthrop Industrie 763683216 MANUFACTURE Revised: 03/2012 sanofi-aventis U.S. LLC Next Interactions Print this page Add to My Med List More about Skelid (tiludronate) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: bisphosphonates Consumer resources Skelid (Advanced Reading) Related treatment guides Paget's Disease ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Discontinued C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 1997 Drug Class Bisphosphonates Related Drugs bisphosphonates alendronate , Fosamax , Boniva , Actonel , Reclast , ibandronate Paget's Disease alendronate , Fosamax , Actonel , Reclast , Zometa , risedronate , zoledronic acid , calcitonin , Miacalcin , Aredia , pamidronate , Fortical , Binosto , etidronate , Aclasta , Miacalcin Nasal , Didronel , tiludronate , More... 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