Composition
Inj 2 mg/6 mg: Per ml: Ibandronic acid 1 mg: 2 mg (2 ml Amp), 6 mg (6 ml vial). Inj 3 mg: Per ml: Ibandronic acid 1 mg: 3 ml pre-filled syringe. Tab 50 mg/150 mg: Ibandronic acid 50 mg/150 mg
Indications & Dosage
Reduction of bone damage in bone metastases in breast cancer: Adult: 50 mg daily, alternatively (by IV INF) 6 mg every 3-4 weeks. Hypercalcaemia of malignancy: BY IV INF: Adult: 2-4 mg as a single INF, dose to be adjusted according to serum calcium concentration. Treatment of postmenopausal osteoporosis: Adult (female): 150 mg once a month, alternatively (by IV injection) 3 mg every 3 months, to be administered over 15-30 seconds. Children: Not recommended.
Administration
Administer as a 15-30 seconds bolus. Do not mix with calcium containing solution or other drugs. For osteoporosis, do not administer more frequently than every three months. Infuse over 1 hour added to 500 ml isotonic NaCI soln (or 5% dextrose soln) for metastatic bone diseases due to breast cancer and over 1-2 hours for hypercalcaemia of malignancy.
Stability
Store at controlled room temperature of 25C; ex-cursions permitted to 15C-30C.
Contraindications
Hypersensitivity, children, hypocalcaemia, with oral use; abnormalities of the oesophagus, other factors which delay emptying (e.g. stricture or achalasia)
Precautions
Monitor renal function, serum calcium, phosphate and magnesium during therapy. Severe liver disease, atypical femoral fractures, cardiac disease (avoid fluid overload). Adequate intake of calcium and vitamin D. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates.
Interactions
Calcium containing soln. Calcium and other multivalentcations (Al, Mg, Fe) containing products including milk and food may interfere with absorption, sand should be taken 60 min after the dosage.
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated
Side Effects
Abdominal pain, asthenia, bone pain, chills, diarrhoea, dyspepsia, fever, gastritis, headache, hypocalcaemia, hypophosphataemia, influenza-like symptoms, muscle pain, nausea, pharyngitis, rash, vomiting, severe oesophageal reactions (discontinue). Rare: Anaemia, angioedema, atypical femoral fractures, bronchospasm, hypersensitivity reactions, injection-site reactions, pruritus, urticaria, osteonecrosis of the jaw