SKELID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SKELID (SKELID).
SKELID (tiludronate disodium) is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite crystals in bone and inhibiting osteoclast activity and recruitment.
| Metabolism | Tiludronate is not metabolized and is excreted unchanged primarily by the kidneys. |
| Excretion | Renal: 50-60% unchanged drug; biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 10-12 hours (prolonged in renal impairment; no dose adjustment required for mild-moderate impairment but contraindicated in severe impairment [CrCl <30 mL/min]) |
| Protein binding | ~90% bound, primarily to albumin |
| Volume of Distribution | Vd: 0.5-1.0 L/kg (large, indicating extensive tissue distribution, especially to bone) |
| Bioavailability | Oral: 1.5-2.5% (low and variable; must be taken on an empty stomach with plain water only) |
| Onset of Action | Oral: 2-4 weeks for measurable reduction in bone turnover markers; full therapeutic effect may take 3-6 months |
| Duration of Action | Duration: 24 hours for single dose; sustained effect on bone resorption persists for weeks after discontinuation due to binding to hydroxyapatite |
400 mg (2 tablets) orally once daily, taken on an empty stomach at least 2 hours before or after food, for 2 hours with 8 oz plain water; avoid other beverages, food, and medications for 2 hours post-dose.
| Dosage form | TABLET |
| Renal impairment | CrCl ≥30 mL/min: no adjustment. CrCl <30 mL/min: contraindicated. No data for dialysis. Avoid in severe renal impairment (CrCl <30 mL/min). |
| Liver impairment | No dose adjustment recommended for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C), use with caution. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. Use only in clinical trials if appropriate. |
| Geriatric use | No specific dose adjustment. Consider age-related renal function, monitor renal function (CrCl) and avoid in CrCl <30 mL/min. Ensure adequate calcium and vitamin D intake. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SKELID (SKELID).
| Breastfeeding | Excretion into human milk is unknown. Because of potential for bone growth suppression, breastfeeding is not recommended during therapy. M/P ratio not established. |
| Teratogenic Risk | Skélid (tiludronate disodium) is a bisphosphonate. Based on animal studies, there is a risk of fetal skeletal abnormalities. In humans, data are limited. Avoid use during pregnancy, especially in the first trimester. For women of childbearing potential, consider discontinuation prior to conception. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to tiludronate or any component of the formulation","Hypocalcemia","Severe renal impairment (creatinine clearance <30 mL/min)"]
| Precautions | ["Renal function impairment: Use with caution in patients with mild-to-moderate renal impairment (creatinine clearance 30-50 mL/min); not recommended in severe impairment (creatinine clearance <30 mL/min).","Hypocalcemia: Correct before therapy due to risk of worsening. Ensure adequate calcium and vitamin D intake.","Upper GI adverse events: Use caution in patients with active upper GI problems (dysphagia, esophagitis, gastritis, ulcers).","Musculoskeletal pain: May cause bone, joint, or muscle pain.","Osteonecrosis of the jaw: Associated with bisphosphonates; maintain good oral hygiene and regular dental care."] |
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| Monitor maternal renal function, serum calcium, phosphate, and bone turnover markers (e.g., CTX). Fetal monitoring includes ultrasound for skeletal development if exposure occurs. |
| Fertility Effects | Animal studies show no adverse effects on fertility. Human data insufficient. Potential for long-term bone turnover suppression may theoretically affect reproductive outcomes, but no direct evidence. |