Ibandronic Acid

Registered South African indicatations:

• Osteoporosis in postmenopausal women
• Tumour-induced hypercalcaemia
• Prevention of skeletal complications in patients with breast cancer and bone metastases

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypocalcaemia
• Abnormalities of the oesophagus which delay oesophageal emptying such as stricture or achalasia (tab)
• Inability to stand or sit upright for at least 60 minutes (tab)

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment (CrCl <50ml/min) (inj, 50mg tab)
• Severe renal impairment (CrCl <30ml/min) (150mg tab)
• Active upper gastrointestinal problems (tab)
• Local risk factors for external necrosis of the auditory canal 
• Unhealed open soft tissue lesions in the mouth 
• Cancer
• Anaemia
• Coagulopathy 
• Infection
• Smoking 
• Poor oral hygiene 
• Periodontal disease
• Poorly fitting dentures 
• History of dental disease
• Invasive dental procedures
• Overhydration in patients at risk for cardiac failure (inj)
• Long term treatment for osteoporosis 
• Galactose intolerance (tab)
• Lapp lactase deficiency (tab)
• Glucose-galactose malabsorption (tab)

Forms avail. in SA and covered in this monograph: inj, tab

Osteoporosis in postmenopausal women

• IV: 3mg, administered over 15-30sec, 3 monthly
• Oral (tab): 150mg, monthly

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Patients must receive supplemental calcium and vitamin D

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Prevention of skeletal complications in patients with breast cancer and bone metastases who require radiotherapy

• IV: 6mg, administered over 15min, every 3-4 weeks
• Oral (tab): 50mg, dly

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The contents of the vial should be added to 100ml of normal saline or 5% dextrose solution prior to administration 

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Tumour-induced hypercalcaemia with or without metastasis

• IV: Max cumulative dose: 6mg

	Albumin-corrected serum calcium after adequate hydration	Dose
Severe hypercalcaemia	> 3.5mmol/l (>12mg/dl)	2-4mg
Moderate hypercalcaemia	< 3.5mmol/l (<12mg/dl)	1-2mg

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The contents of the vial should be added to 500ml of normal saline or 5% dextrose solution prior to administration and should be infused over 2 hours

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Ensure patient adequately hydrated prior to injection

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Take tablet after an overnight fast (> 6hrs) and 30-60min before first food/drink

Do not lie down for 1 hour after taking tablet

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Do not cut/crush/chew/dissolve tab

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no adequate data from the use of ibandronic acid in pregnant women. Studies in rats have shown reproductive toxicity. The potential risk for humans is unknown. Therefore, ibandronic acid, should not be used during pregnancy

Breastfeeding

• Caution; not recommended
• It is not known whether ibandronic acid is excreted in human milk. Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration. Ibandronic acid should not be used during breastfeeding

Fertility

• There are no data on the effects of ibandronic acid from humans. In reproductive studies in rats by the oral route, ibandronic acid decreased fertility
• In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses

Renal Impairment

• Oral (150mg): CrCl ≥30ml/min: No dose adjustment recommended
• Oral (150mg): CrCl <30ml/min: Caution; no dose adjustment recommended
• IV and oral (50mg): CrCl  ≥50-<80ml/min: No dose adjustment recommended
• IV and oral (50mg): CrCl <50ml/min: Caution; dose adjustment recommended

CrCl (ml/min)	Oral Doses	IV Doses: Prevention of skeletal complications in patients with breast cancer and bone metastases who require radiotherapy
≥50-<80	No adjustment necessary	No adjustment necessary
≥30-<50	Oral (150mg): No adjustment necessary Oral (50mg): 50mg, 48hrly	4mg, as an infusion over 60mins (Add to 500ml 0,9% sodium chloride or 5% glucose solution prior to administration)
<30	Oral (150mg): Use is not recommended Oral (50mg): 50mg, weekly	2mg, as an infusion over 60mins (Add to 500ml 0,9% sodium chloride or 5% glucose solution prior to administration)

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Paraesthesia
• Dysgeusia
• Malaise
• Sleep disorder (inj)
• Anxiety (inj)
• Affection lability (inj)
• Headache (inj)
• Dizziness (inj)
• Cerebrovascular disorder (inj)
• Nerve root lesion (inj)
• Amnesia (inj)
• Migraine (inj)
• Neuralgia (inj)
• Hypertonia (inj)
• Hyperaestesia (inj)
• Paraesthesia circumoral (inj)
• Parosmia (inj)

Cardiovascular Disorders

• Chest pain
• Bundle branch block (inj)
• Myocardial ischaemia (inj)
• Cardiovascular disorder (inj)
• Palpitations (inj)

Respiratory Disorders

• Pharyngitis (inj)
• Lung oedema (inj)
• Stridor (inj)
• Exacerbation of asthma 
• Bronchospasm 

Gastrointestinal Disorders

• Oesophagitis
• Abdominal pain
• Dyspepsia
• Nausea and vomiting 
• Haemorrage
• Duodenal ulcer
• Gastritis
• Dysphagia
• Dry mouth
• Diarrhoea (inj)
• Tooth disorder (inj)
• Gastroenteritis (inj)
• Gastritis (inj)
• Mouth ulceration (inj)
• Dysphagia (inj)
• Cheilitis (inj)

Hepatobiliary Disorders

• Cholelithiasis (inj)
• Increased gamma-glutamyl transferase  (inj)

Genitourinary Disorders

• Azotaemia
• Urinary retention (inj)
• Renal cyst (inj)
• Pelvic pain (inj)
• Increased creatinine (inj)

Endocrine and Metabolic Disorders

• Hypocalcaemia
• Increased blood parathyroid hormone 
• Parathyroid disorder (inj)
• Hypocalcaemia (inj)
• Hypophosphataemia (inj)
• Increased blood alkaline phosphatase (inj)
• Decreased weight (inj)
• Thirst (inj)
• Hypothermia (inj)

Musculoskeletal Disorders

• Atypical subtrochanteric and diaphyseal femoral fractures
• Osteoarthritis (inj)
• Myalgia (inj)
• Arthralgia (inj)
• Joint disorder (inj)
• Bone pain (inj)
• Atypical subtrochanteric and diaphyseal femoral fractures (inj)
• Osteonecrosis of the jaw (inj)
• Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) (inj)

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Skin disorder (inj)
• Ecchymosis (inj)
• Rash (inj)
• Alopecia (inj)
• Stevens-Johnson syndrome (inj)
• Erythema Multiforme (inj)
• Bullous dermatitis (inj)
• Injection site pain (inj)
• Peripheral oedema (inj)

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Hypersensitivity
• Angioedema
• Anaphylactic reaction/shock
• Influenza-like illness
• Infection (inj)
• Cystitis (inj)
• Vaginitis (inj)
• Oral candidiasis (inj)
• Benign skin neoplasm (inj)
• Anaemia (inj)
• Blood dyscrasia (inj)
• Bronchospasm (inj)
• Pyrexia (inj)
• Influenza-like illness (inj)

Sensory Disorders

• Ocular inflammation
• Cataract (inj)
• Deafness (inj)

• Food (tab)
• Calcium supplements (tab)
• Antacids (tab)
• Oral medicinal products containing multivalent cations (tab)
• Non-steroidal anti-Inflammatory drugs (tab)
• Acetylsalicylic acid (tab)
• Proton pump inhibitors (tab)
• Hydrogen blockers (tab)
• Steroid use (tab)
• Chemotherapy (tab)
• Radiotherapy 
• Angiogenesis inhibitors 
• Aminoglycosides (inj)

• Renal function
• Serum calcium
• Phosphate 
• Magnesium

Specific cases may require

• Bone and mineral density 
• Height 
• Weight

• In case a dose is missed, patients should be instructed to take one ibandronic acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days
• Patients should then return to taking their dose once a month on their originally scheduled date
• If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled
• Patients should not take two tablets within the same week

Ibandronic acid is a bisphosphonate belonging to the nitrogen-containing group of isphosphonates, which acts selectively on bone tissue and specifically inhibits osteoclast activity without directly affecting bone formation. It does not interfere with osteoclast recruitment. Ibandronic acid leads to reduction of elevated bone turnover towards premenopausal levels in postmenopausal women.

Tablet 50mg

• Bondronat 50 (Adcock Ingram Limited) originator

Tablet 150mg

• Boniva (Adcock Ingram Limited) originator

Injection (per 2ml) 2mg

• Aspen ibandronate (Pharmacare)
• Bondronat 2mg/2ml (Adcock Ingram Limited) originator
• Bonrix (Accord)

Injection (per 3ml) 3mg

• Boniva pre-filled syringe (Adcock Ingram Limited) originator

Injection (per 6ml) 6mg

• Aspen ibandronate (Pharmacare)
• Bondronat 6mg/6ml (Adcock Ingram Limited) originator 
• Bonrix (Accord)