Tiludronate

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)

In the U.S.

• Skelid

Available Dosage Forms:

• Tablet

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Tiludronate is used to treat Paget's disease of the bone. tiludronate is a bisphosphonate that helps make the bones stronger.

tiludronate is available only with your doctor's prescription.

Applies to tiludronate: oral tablet

General

The most frequently occurring adverse reactions reported were: Diarrhea (9.3%), nausea (9.3%), and dyspepsia (5.3%).[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, flushing[Ref]

Dermatologic

Common (1% to 10%): Rash, skin disorder, pruritus, increased sweating[Ref]

Endocrine

Common (1% to 10%): Hyperparathyroidism[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dyspepsia, vomiting, flatulence, tooth disorder, abdominal pain, constipation, dry mouth gastritis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Metabolic

Common (1% to 10%): Vitamin D deficiency, anorexia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, arthrosis, fracture pathological, skeletal pain
Postmarketing reports: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, including this drug[Ref]

Bone, joint, and/or muscle pain, rarely severe and/or incapacitating have been reported.[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, paresthesia, vertigo, involuntary muscle contractions, somnolence, nervousness[Ref]

Ocular

Common (1% to 10%): Cataract, conjunctivitis, glaucoma[Ref]

Other

Common (1% to 10%): Pain, accidental injury, influenza like symptoms, chest pain, peripheral edema, infection, asthenia, syncope, fatigue[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety[Ref]

Respiratory

Common (1% to 10%): Rhinitis, sinusitis, upper respiratory tract infection, coughing, pharyngitis, bronchitis[Ref]

Hypersensitivity

Rare (less than 0.1%): Stevens-Johnson syndrome[Ref]

Some side effects of tiludronate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.