Ibandronate

Name: Ibandronate

Ibandronate Drug Class

Ibandronate is part of the drug class:

  • Bisphosphonates

Pharmacology

A bisphosphonate which inhibits bone resorption via actions on osteoclasts or on osteoclast precursors; decreases the rate of bone resorption, leading to an indirect increase in bone mineral density.

Distribution

Terminal Vd: 90 L; 40% to 50% of circulating ibandronate binds to bone

Metabolism

Not metabolized

Excretion

Urine (50% to 60% of absorbed dose, excreted as unchanged drug); feces (unabsorbed drug)

Time to Peak

Oral: 0.5 to 2 hours

Half-Life Elimination

Oral: 150 mg dose: Terminal: 37 to 157 hours

IV: Terminal: ∼5 to 25 hours

Protein Binding

85.7% to 99.5%

Special Populations Renal Function Impairment

Patients with CrCl 40 to 70 mL/minute had 55% higher AUC and patients with CrCl 30 mL/minute had more than a 2-fold increase in exposure.

Dosing Geriatric

Refer to adult dosing.

Dosing Renal Impairment

Osteoporosis: Oral, IV:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Use not recommended.

Oncologic uses (off-label): IV: CrCl <30 mL/minute: 2 mg every 3 to 4 weeks (von Moos 2005)

Dietary Considerations

Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Women and men should consume:

Calcium: 1,000 mg/day (men: 50 to 70 years) or 1,200 mg/day (women ≥51 years and men ≥71 years) (IOM 2011; NOF [Cosman 2014])

Vitamin D: 800 to 1,000 int. units daily (men and women ≥50 years) (NOF [Cosman 2014]). Recommended Dietary Allowance (RDA): 600 int. units daily (men and women ≤70 years) or 800 int. units daily (men and women ≥71 years) (IOM 2011).

Ibandronate tablet should be taken with a full glass (6 to 8 oz) of plain water, at least 60 minutes prior to any food, beverages, or medications. Mineral water with a high calcium content should be avoided.

Adverse Reactions

Percentages vary based on frequency of administration (daily vs monthly). Unless specified, percentages are reported with oral use.

>10%:

Gastrointestinal: Dyspepsia (4% to 12%)

Neuromuscular & skeletal: Back pain (4% to 14%)

Respiratory: Upper respiratory tract infection (2% to 34%)

1% to 10%:

Cardiovascular: Hypertension (6% to 7%)

Central nervous system: Headache (3% to 7%), dizziness (1% to 4%), fatigue (3%), insomnia (1% to 2%), depression (2%)

Dermatologic: Skin rash (1% to 2%)

Gastrointestinal: Abdominal pain (5% to 8%), diarrhea (2% to 7%), nausea (4% to 5%), dental disease (4%), constipation (3% to 4%), vomiting (3%), gastritis (2%), gastroenteritis (3%)

Genitourinary: Urinary tract infection (2% to 6%), cystitis (3%)

Hypersensitivity: Acute phase reaction-like symptoms (IV: 10%; oral: 3% to 9%), hypersensitivity reaction (3%)

Infection: Influenza (4% to 8%)

Local: Injection site reaction (<2%)

Neuromuscular & skeletal: Limb pain (1% to 8%), arthralgia (4% to 9%), myalgia (1% to 6%), arthropathy (4%), weakness (4%), localized osteoarthritis (1% to 3%), muscle cramps (2%)

Respiratory: Bronchitis (3% to 10%), pneumonia (6%), nasopharyngitis (3% to 4%), flu-like symptoms (1% to 3%), pharyngitis (3%)

Postmarketing and/or case reports: Acute renal failure, anaphylactic shock, anaphylaxis, angioedema, bronchospasm, bullous dermatitis, erythema multiforme, exacerbation of asthma, femur fracture (diaphyseal or subtrochanteric), hypocalcemia, iritis, musculoskeletal pain (bone, joint, or muscle; incapacitating), ophthalmic inflammation, osteonecrosis (oro-facial sites including the external auditory canal), osteonecrosis of the jaw, prolonged Q-T interval on ECG (Bonilla 2014), scleritis, Stevens-Johnson syndrome, uveitis

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, diarrhea, flu-like symptoms, back pain, or painful extremities. Have patient report immediately to prescriber signs of low calcium (muscle cramps or spasms, numbness and tingling, or seizures); signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain); severe injection site redness, burning, pain, edema, or irritation; painful urination; eye pain; vision changes; severe abdominal pain; severe bone pain; severe muscle pain; severe joint pain; groin, hip, or back pain; severe dizziness; severe headache; polyuria; jaw pain or edema; angina; heartburn; black, tarry, or bloody stools; coughing up blood; vomiting blood; difficulty swallowing; pain with swallowing; or mouth sores (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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