Ibandronic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Prophylaxis of skeletal events in patients w/ breast cancer and bone metastases 50 mg/day. Treatment and prophylaxis of postmenopausal osteoporosis 150 mg once mthly on the same date each mth, or 2.5 mg/day. IV Hypercalcaemia of malignancy 2-4 mg as a single infusion. Max: 6 mg. Postmenopausal osteoporosis 3 mg by inj once every 3 mth. Prophylaxis of skeletal events in patients w/ breast cancer and bone metastases 6 mg by infusion 3-4 wkly.
Dosage Details
Intravenous
Hypercalcaemia of malignancy
Adult: 2-4 mg as a single infusion over 2 hr. Max: 6 mg.

Intravenous
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.

Intravenous
Prophylaxis of skeletal events in patients with bone metastases, Prophylaxis of skeletal events in patients with breast cancer
Adult: 6 mg by infusion over at least 15 min 3-4 wkly.

Oral
Prophylaxis of skeletal events in patients with bone metastases, Prophylaxis of skeletal events in patients with breast cancer
Adult: 50 mg daily

Oral
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.
Renal Impairment
Oral:
Prophylaxis of skeletal events in patients with breast cancer and bone metastases:
CrCl (mL/min) Dosage
<30 50 mg once wkly.
30-49 50 mg every other day.
Postmenopausal osteoporosis; Prophylaxis of postmenopausal osteoporosis:
CrCl (mL/min) Dosage
<30 Not recommended.
Intravenous:
Hypercalcaemia of malignancy; Postmenopausal osteoporosis:
CrCl (mL/min) Dosage
<30 Not recommended.
Prophylaxis of skeletal events in patients with breast cancer and bone metastases:
CrCl (mL/min) Dosage
<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
Prevention of skeletal events: Add contents of vial to 100 mL of NaCl 0.9% or dextrose 5%.
Treatment of hypercalcaemia of malignancy: Add contents of vial to 500 mL of NaCl 0.9% or dextrose 5%.
Incompatibility
Ca-containing soln.
Contraindications
Hypocalcaemia; oesophageal abnormalities which may delay emptying (e.g. stricture or achalasia), inability to stand or sit upright for at least 60 min (oral).
Special Precautions
Patient w/ disturbances of bone and mineral metabolism. Severe renal impairment (CrCl <30 mL/min). Pregnancy and lactation.
Adverse Reactions
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.
IV/Parenteral/PO: C
Patient Counseling Information
Ensure adequate Ca and vit D intake.
MonitoringParameters
Monitor serum Ca, Mg and phosphate; serum creatinine prior to each IV dose; bone mineral density (osteoporosis).
Overdosage
Symptoms: IV: Hypocalcaemia;, hypophosphatemia and hypomagnesaemia. Oral: Upper GI effects (e.g. stomach upset, oesophagitis, dyspepsia, gastritis, ulcer). Management: IV: Admin IV Ca gluconate, K or Na phosphate, and Mg sulfate when appropriate. Oral: May give milk or antacid to bind the drug.
Drug Interactions
Decreased absorption w/ Ca supplements, antacids and other multivalent cation-containing oral drugs. Increased incidence of GI irritation w/ aspirin or NSAIDs.
Food Interaction
Food may reduce absorption.
Lab Interference
May interfere w/ diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Description: Ibandronic acid inhibits osteoclast activity w/o directly affecting bone formation resulting to increased bone mass and a decreased incidence of fractures through reduction of elevated bone turnover.
Pharmacokinetics:
Absorption: Poorly absorbed from the GI tract. Decreased absorption w/ food. Bioavailability: <1%. Time to peak plasma concentration: 0.5-2 hr (oral).
Distribution: Plasma protein binding: Approx 87%.
Metabolism: Not metabolised.
Excretion: Via urine (approx 50-60% of absorbed dose) as unchanged drug; faeces (unabsorbed drug). Terminal half-life: Approx 5-25 hr (IV); 37-157 hr (oral).
Chemical Structure

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Storage
Store between 15-30°C.
ATC Classification
M05BA06 - ibandronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Disclaimer: This information is independently developed by MIMS based on Ibandronic acid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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