Ibandronic acid


Full Generic Medicine Info
Dosage/Direction for Use

Oral
Postmenopausal osteoporosis
Adult: Prophylaxis and treatment: 150 mg once monthly on the same date each month. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Not recommended.


Oral
Prophylaxis of skeletal events in patients with breast cancer
Adult: Recommended dose: 50 mg daily. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<3050 mg once weekly.
30-<5050 mg every other day.


Oral
Prophylaxis of skeletal events in patients with bone metastases
Adult: Recommended dose: 50 mg daily. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<3050 mg once weekly.
30-<5050 mg every other day.


Intravenous
Postmenopausal osteoporosis
Adult: Prophylaxis and treatment: 3 mg via inj over 15-30 seconds once every 3 months.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Not recommended.


Intravenous
Prophylaxis of skeletal events in patients with breast cancer
Adult: 6 mg via infusion over at least 15 minutes every 3-4 weeks. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<302 mg via infusion over 1 hour every 3-4 weeks.
30-<504 mg via infusion over 1 hour every 3-4 weeks.

Reconstitution: Concentrated solution for IV infusion: Add contents of the vial to 100 mL solution of NaCl 0.9% or dextrose 5% in water.
Incompatibility: Incompatible with Ca-containing solutions.

Intravenous
Prophylaxis of skeletal events in patients with bone metastases
Adult: 6 mg via infusion over at least 15 minutes every 3-4 weeks. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<302 mg via infusion over 1 hour every 3-4 weeks.
30-<504 mg via infusion over 1 hour every 3-4 weeks.

Reconstitution: Concentrated solution for IV infusion: Add contents of the vial to 100 mL solution of NaCl 0.9% or dextrose 5% in water.
Incompatibility: Incompatible with Ca-containing solutions.

Intravenous
Hypercalcaemia of malignancy
Adult: 2-4 mg as a single infusion over 2 hours. Adjust dose based on albumin-corrected serum Ca concentration and tumour type. May repeat treatment in case of insufficient efficacy or if hypercalcaemia recurs. Max: 6 mg. Treatment recommendations may vary between countries (refer to local or specific product guidelines).
Reconstitution: Concentrated solution for IV infusion: Add contents of the vial to 500 mL solution of NaCl 0.9% or dextrose 5% in water.
Incompatibility: Incompatible with Ca-containing solutions.
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.
Contraindications
Uncorrected hypocalcaemia. Oral: Oesophageal abnormalities which may delay oesophageal emptying (e.g. stricture or achalasia), inability to stand or sit upright for at least 60 minutes.
Special Precautions
Patient with risk factors for developing osteonecrosis of the jaw (e.g. cancer, co-morbid conditions including anaemia, coagulopathy, infection; history of dental disease, poor oral hygiene, periodontal disease, poorly fitting dentures, invasive dental procedures [e.g. tooth extractions]; smoking; concomitant treatment with chemotherapy, corticosteroids, angiogenesis inhibitors, radiotherapy to head and neck); or osteonecrosis of external auditory canal (e.g. infection, trauma); disturbances affecting bone and mineral metabolism (e.g. vitamin D deficiency), atypical femoral fractures. Oral: Patient with active upper gastrointestinal problems (e.g. dysphagia, duodenitis, gastritis, ulcer, known Barrett's oesophagus, other oesophageal diseases). IV: Avoid overhydration in patients with cardiac disease. Not for intra-arterial or paravenous administration. Renal impairment. Pregnancy and lactation. Patient Counselling Ensure adequate Ca and vitamin D intake. Maintain good oral hygiene. Monitoring Parameters Assess serum Ca (prior to and during treatment) and 25-hydroxyvitamin D; correct hypocalcaemia and other disturbances of bone and mineral metabolism before treatment initiation. Osteoporosis: Evaluate serial BMD at baseline and every 1-3 years during treatment then every 2-4 years during a drug holiday; serum creatinine (prior to each IV dose); height and weight (annually); biochemical markers of bone turnover (e.g. fasting serum C-terminal cross-linked telopeptide [CTX] or urinary N-terminal telopeptide [NTX]) at baseline, 3 months, and 6 months. Perform routine dental check-ups. Assess for signs and symptoms of oesophageal reaction (e.g. dysphagia, odynophagia, retrosternal pain, new or worsening heartburn), oral symptoms (e.g. dental mobility, pain or swelling, non-healing of sores or discharge), chronic back pain, and femur fractures in patients with pain in the thigh, hip, or groin during or after treatment. Evaluate contralateral limb if fracture is identified.
Adverse Reactions
Significant: Hypocalcaemia; osteonecrosis of the jaw and external auditory canal; severe (occasionally debilitating) bone, joint, and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures; ocular inflammation (e.g. uveitis, scleritis, episcleritis), acute phase reaction-like symptoms or influenza-like illness. Oral: Local irritation of the upper gastrointestinal mucosa, oesophageal reactions (e.g. oesophageal ulcers, oesophagitis, oesophageal erosions), and rarely with bleeding or perforation. IV: Renal deterioration and acute renal failure. Blood and lymphatic system disorders: Anaemia. Cardiac disorders: Bundle branch block (IV). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dysphagia, abdominal pain, flatulence, dyspepsia, constipation. General disorders and administration site conditions: Asthenia, fatigue; injection site reactions (IV). Investigations: Increased PTH. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Headache, dizziness. Renal and urinary disorders: Azotaemia, uraemia, UTI, cystitis (IV). Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, bronchitis, URTI. Skin and subcutaneous tissue disorders: Pruritus, rash, alopecia. Vascular disorders: Hypertension (oral); phlebitis, thrombophlebitis (IV).
Potentially Fatal: Allergic reactions including anaphylactic shock or reaction, angioedema, asthma exacerbation, bronchospasm, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis.
Overdosage
Symptoms: Hypophosphataemia, hypocalcaemia. Oral: Upper gastrointestinal effects (e.g. heartburn, upset stomach, dyspepsia, gastritis or ulcer, oesophagitis). IV: Hypomagnesaemia. Management: Oral: Do not induce vomiting to prevent oesophageal irritation; remain patient in a fully upright position. Milk or antacids may be given to bind to ibandronic acid. IV: Correct through IV administration of K or Na phosphate, Ca gluconate, and Mg sulfate as clinically indicated.
Drug Interactions
Antacids, Ca supplements, or other oral medications containing multivalent cations (Al, Mg, Fe) may decrease the oral absorption of ibandronic acid. Enhanced risk of gastrointestinal irritation with aspirin or NSAIDs. Enhanced hypocalcaemic effect with aminoglycosides.
Food Interaction
Food and beverages (including mineral water with high Ca content) may reduce the absorption of ibandronic acid.
Lab Interference
May interfere with diagnostic imaging agent (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Ibandronic acid, a synthetic bisphosphonate analogue of pyrophosphate, is an osteoclast-mediated bone resorption inhibitor. It acts selectively on the bone tissue and specifically inhibits osteoclast activity without directly affecting bone formation. It reduces the rate of bone resorption resulting in an indirect increase in bone mineral density (BMD). Synonym(s): Ibandronate.
Absorption: Rapidly absorbed from the upper gastrointestinal tract. Food, particularly products containing Ca and other polyvalent cations, may decrease absorption. Absolute bioavailability: 0.6%. Time to peak plasma concentration: Oral: 0.5-2 hours (fasted state).
Distribution: Rapidly binds to bone. Plasma protein binding: Approx 85.7-99.5%.
Metabolism: Not metabolised.
Excretion: Via urine (approx 50-60% of absorbed dose) as unchanged drug; faeces (as unabsorbed drug). Terminal elimination half-life: Approx 5-25 hours (IV); 37-157 hours (oral).
Storage
Intravenous: Store between 15-30°C. Oral: Store between 15-30°C.
CIMS Class
Agents Affecting Bone Metabolism
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 CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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