Generic Name

Ibandronic Acid

Precaution

History of bone/joint/muscle pain; dysphagia, oesophageal disease, gastritis, duodenitis, ulcers. Risk factors for osteonecrosis of the jaw. Pregnancy and lactation.

Indication

Post-menopausal osteoporosis, Hypercalcaemia of malignancy, Breast cancer, bone metastases

Contra Indication

Severe renal impairment, uncorrected hypocalcaemia, acute upper GI inflammation, inability to stand or sit upright for at least 60 min (oral).

Dose

N/A

Side Effect

Flu-like symptoms (e.g. myalgia, arthralgia, fever, chills, fatigue, nausea, loss of appetite, bone pain), atypical fractures, osteonecrosis of the jaw, ocular inflammation, acute renal failure, hypocalcaemia, musculoskeletal pain. Rarely, anaemia, bronchospasm, taste disturbance, paraesthesia, uraemia; transient fever (IV); abdominal pain, dyspepsia, severe oesophageal reactions (oral).) Potentially Fatal: Anaphylactic reaction/shock.

Pregnancy Category

Mode of Action

Ibandronic acid is a potent bone resorption inhibitor, which acts on osteoclasts or on osteoclast precursors. It increases bone mineral density by reducing the rate of bone resorption.

Interaction

Decreased absorption w/ Ca supplements, antacids and other multivalent cation-containing oral drugs. Increased incidence of GI irritation w/ aspirin or NSAIDs.

Pregnancy Category Note

N/A

Adult Dose

Oral Prophylaxis of skeletal events in patients with breast cancer and bone metastases Adult: 50 mg daily. Postmenopausal osteoporosis; Prophylaxis of postmenopausal osteoporosis Adult: 150 mg once mthly on the same date each mth, alternatively, 2.5 mg daily. Missed once-mthly dose: If next scheduled dose is >7 days away: Take dose the next morning and return to original schedule; if next dose is <7 days away: Wait until the next scheduled dose; 2 tabs must not be taken w/in the same wk. Intravenous Hypercalcaemia of malignancy Adult: 2-4 mg as a single infusion over 2 hr. Max: 6 mg. Postmenopausal osteoporosis Adult: 3 mg by inj over 15-30 seconds once every 3 mth. Missed dose: Give inj as soon as possible; then re-schedule next inj 3 mth from this inj; should not be given more frequently than once every 3 mth. Prophylaxis of skeletal events in patients with breast cancer and bone metastases Adult: 6 mg by infusion over at least 15 min 3-4 wkly.

Child Dose

N/A

Renal Dose

Oral Prophylaxis of skeletal events in patients with breast cancer and bone metastases Renal impairment: CrCl (ml/min) Dosage Recommendation <30 50 mg once wkly. 30-49 50 mg every other day. Oral: Postmenopausal osteoporosis; Prophylaxis of postmenopausal osteoporosis Intravenous: Hypercalcaemia of malignancy, Postmenopausal osteoporosis Renal impairment: CrCl (ml/min) Dosage Recommendation <30 Not recommended. Intravenous Prophylaxis of skeletal events in patients with breast cancer and bone metastases Renal impairment: CrCl (ml/min) Dosage Recommendation <30 2 mg in 500 mL soln infused over 1 hr 3-4 wkly. 30-49 4 mg in 500 mL soln infused over 1 hr 3-4 wkly.

Administration

Should be taken on an empty stomach. Must be taken at least 1 hr before the 1st food, drink or medication of the day. Take w/ a full glass of only plain water upon arising for the day & remain in sitting/upright position for at least 1 hr. Do not lie down, eat/drink anything except plain water or take other oral medicines for at least 1 hr. Swallow whole, do not chew/crush/suck. Reconstitution: Add contents of vial to 100-500 mL of NaCl 0.9% or dextrose 5%.