Intravenous Prophylaxis of skeletal events in patients with bone metastases, 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).
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).
Intravenous Postmenopausal osteoporosis
Adult: Prophylaxis and treatment: 3 mg via inj over 15-30 seconds once every 3 months.
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).
Oral Prophylaxis of skeletal events in patients with bone metastases, 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
Oral: 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
50 mg once weekly.
30-<50
50 mg every other day.
Intravenous: 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 via infusion over 1 hour every 3-4 weeks.
30-<50
4 mg via infusion over 1 hour every 3-4 weeks.
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
Concentrated solution for IV infusion: Prophylaxis of skeletal events: Add contents of the vial to 100 mL solution of NaCl 0.9% or dextrose 5% in water. Hypercalcaemia of malignancy: Add contents of the vial to 500 mL solution of NaCl 0.9% or dextrose 5% in water.
Incompatibility
IV: Incompatible with Ca-containing solutions.
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.
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.
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.
Overdosage
Symptoms: Hypophosphataemia, hypocalcaemia. Oral: Upper gastrointestinal effects (e.g. heartburn, upset stomach, dyspepsia, gastritis or ulcer, oesophagitis). IV: Hypomagnesaemia. Management: Correct through IV administration of K or Na phosphate, Ca gluconate, and Mg sulfate as clinically indicated. 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.
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
Description: Mechanism of 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. Pharmacokinetics: 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).
Chemical Structure
Ibandronic acid Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 60852, Ibandronic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Ibandronic-Acid. Accessed Feb. 22, 2024.
Storage
Tab/unopened vial/pre-filled syringe: Store between 15-30°C. Reconstituted solution: Store between 2-8°C after reconstitution for up to 24 hours. Do not freeze.
M05BA06 - ibandronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
References
Anon. Ibandronate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/11/2023.Anon. Ibandronic Acid [Ibandronate]. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/11/2023.Bondronat 2 mg Concentrate for Solution for Infusion (Atnahs Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 15/11/2023.Bondronat 50 mg Film-coated Tablets (Atnahs Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 15/11/2023.Bonviva 3 mg/3 mL Solution for IV Injection (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 15/11/2023.Bonviva Film-coated Tablets 150 mg (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 15/11/2023.Buckingham R (ed). Ibandronate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/11/2023.Ibandronate Sodium Injection (Apotex Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/02/2024.Ibandronate Sodium Tablet (Alvogen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/11/2023.Ibandronic Acid 3 mg Solution for Injection (Accord UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 15/11/2023.Ibandronic Acid Aspire 150 mg Film-coated Tablets (Aspire Pharma Ltd). MHRA. https://products.mhra.gov.uk. Accessed 15/11/2023.Joint Formulary Committee. Ibandronic Acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/11/2023.
Sign Out
