Dosing and uses of Skelid (tiludronate)
Adult dosage forms and strengths
tablet
- 200mg
Paget's Disease
400 mg PO qDay for 3 months
Renal Impairment
ClCr< 30 mL/min: Not recommended
Not removed by dialysis
Administration
Take with 6-8 oz plain water
2 hours before or after food
Other Indications & Uses
Off-label: Osteoporosis
Pediatric dosage forms and strengths
Safety & efficacy not established
Geriatric dosage forms and strengths
Paget's disease
400 mg PO qDay for 3 months
Skelid (tiludronate) adverse (side) effects
1-10%
Dizziness (4%)
Edema (2.7%)
Insomnia
Flushing
Hypertension
Chest pain
Frequency not defined
Back pain
Musculoskeletal pain
Diarrhea
Dyspepsia
Flushing
Headache
Nausea
Rhinitis
Sinusitis
URI
Warnings
Contraindications
Hypersensitivity
Inability to stand or sit upright for at least 30 minutes
Abnormalities of the esophagus which delay emptying such as stricture or achalasia
Hypocalcemia
Cautions
Risk of esophageal adverse effects, including esophagitis, esophageal ulceration/erosion, or esophageal bleeding with strictures or perforation
Following therapy, allow 3 months interval to assess response
Not recommended in severe renal failure (CrCl <30 mL/min)
Take with plain water only-NOT coffee, juice or mineral water; sit or stand upright for at least 30 minutes after administration
Risk of osteonecrosis of jaw
Food reduces bioavailability
Risk of severe bone, joint &/or muscle pain
Avoid concurrent multivalent cation-containing medicines or food
Esophageal cancer risk (July 21, 2011 FDA safety communication)
- Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
- Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with full glass of water)
- An ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
- The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
- There are insufficient data to recommend endoscopic screening of asymptomatic patients
- FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
- Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if crosses in to breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Skelid (tiludronate)
Mechanism of action
Bisphosphanate that inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone formation
Pharmacokinetics
Half-Life: 50 (single dosing) -150 hr (repeated dosing)
Onset: 2 days -1 month
Peak Effect: 3 month
Duration: 3-6 months after completion (multiple doses)
Peak plasma time: 2 hr
Bioavailability: 6%; food reduces bioavailability by up to 90%
Protein bound: 90%
Metabolism: None
Excretion: Urine
