Drug information of Ibandronic

Mechanism of effect

The action of ibandronate on bone is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Pharmacodynamic

Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption in a dose-dependent manner. Maintains or increases bone mass in postmenopausal women. 

Pharmacokinetics

Absolute (compared with IV administration) oral bioavailability about 0.6%.

Reduction in bone turnover evident within 1–3 months of treatment initiation; maximal effects observed at 6 months.

Bioavailability decreased by 90% when administered with a standard breakfast compared with administration under fasting conditions. Widely distributed throughout the body and redistributed to bone. Plasma Protein Binding 84–99.5% at therapeutic drug concentrations. No evidence of metabolism. Excreted in urine (50–60% of circulating dose) as unchanged drug and in feces (unabsorbed drug).

Dosage

Usual Adult Dose for Osteoporosis

Oral: 150 mg orally once a month on the same day each month

IV Injection: 3 mg by IV injection over 15 to 30 seconds every three months.

Usual Adult Dose for Prevention of Osteoporosis

Oral: 150 mg orally once a month on the same day each month

IV Injection: 3 mg by IV injection over 15 to 30 seconds every three months.

Drug contraindications

Side effects

Interactions

Alerts

Ibandronate Sodium Injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting Ibandronate Sodium Injection therapy. Cases of anaphylaxis, including fatal events, have been reported in patients treated with Ibandronate Sodium Injection.

Appropriate medical support and monitoring measures should be readily available when Ibandronate Sodium Injection is administered. Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure.

 Ibandronate Sodium Injection must only be administered intravenously. Care must be taken not to administer Ibandronate Sodium Injection intra-arterially or paravenously as this could lead to tissue damage. Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including Ibandronate Sodium Injection. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking ibandronate sodium and other bisphosphonates. Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. 

Points of recommendation

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have cancer, anemia, asthma, blood clotting problems, kidney problems, or an infection
• if you have low blood calcium levels, low blood vitamin D levels, nutrient absorption problems (eg, malabsorption syndrome), or calcium metabolism problems, or you are unable to take calcium or vitamin D supplements
• if you have poor dental hygiene or other dental problems, or if you will be having a dental procedure (eg, tooth extraction)
• if you smoke or drink alcohol
• if you have had or will be having chemotherapy or radiation treatment
• if you are taking any medicines that can cause jaw bone problems. There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure.

If you miss your scheduled dose of ibandronate, contact your doctor to reschedule it as soon as possible. Do not receive your injection more often than once every 3 months.

Pregnancy level

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