Sandoz Ibandronate 2mg/2ml, 6mg/6ml Injection

Treatment of tumour-induced hypercalcaemia, with or without metastases.

Prevention of skeletal complications requiring radiotherapy (or surgery) in patients with breast cancer and bone metastases.

Prevention of skeletal events in patients with breast cancer and bone metastases: Recommended dose is 6 mg given every 3 to 4 weeks administered as intravenous infusion in 100 ml 0,9 % sodium chloride or 100 ml 5 % dextrose solution. The dose should be infused over at least 15 minutes.

Tumour-induced hypercalcaemia: Adults and elderly Consideration should be given to the severity of hypercalcaemia as well as tumour type. In general, patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia.

Recommended single dose: Prior to treatment with SANDOZ IBANDRONATE injection solution, the patient should be adequately rehydrated with 0,9 % sodium chloride. The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.

Warning: Overhydration should be avoided in patients at risk of cardiac failure. SANDOZ IBANDRONATE injection solution should be administered as an intravenous infusion. The contents of the ampoules/vial are to be added to 500 ml isotonic (0,9 %) sodium chloride or 500 ml 5 % dextrose solution and infused over two hours. SANDOZ IBANDRONATE injection solution should not be mixed with calcium containing solutions.

SANDOZ IBANDRONATE injection solution must not be used in patients with known hypersensitivity to ibandronate or other bisphosphonates or any of the other excipients.

SANDOZ IBANDRONATE injection solution should not be used during pregnancy and lactation due to lack of clinical experience.

SANDOZ IBANDRONATE injection should not be used in children under 18 years.

Renal function impairment.

Impaired liver function.

Ibandronate injection solution should not be used in children below the age of 18 due to insufficient clinical data on safety and efficacy.

Renal function, calcium, phosphate and magnesium must be monitored during and after treatment with SANDOZ IBANDRONATE.

Overhydration should be avoided in patients at risk of cardiac failure.

The inadvertent intra-arterial administration as well as paravenous administration is not recommended. This can lead to tissue damage.

Ensure that SANDOZ IBANDRONATE injection is only administered intravenously.

When SANDOZ IBANDRONATE is administered with aminoglycosides, both agents can lower serum calcium levels for prolonged periods. Attention should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).

SANDOZ IBANDRONATE injection should not be mixed with calcium containing solutions.

There are no adequate data from use of ibandronic acid in pregnant women. Therefore SANDOZ IBANDRONATE injection solution should not be used during pregnancy.

It is not known whether ibandronic acid is excreted in human milk. SANDOZ IBANDRONATE injection solution should not be used during lactation.

SANDOZ IBANDRONATE may influence the ability to drive and use machines. SANDOZ IBANDRONATE can cause headache and dizziness.

Side effects: Infection and infestation: Frequent: Infection. Less frequent: Cystitis, vaginitis, oral candidiasis.

Neoplasms benign and malignant (including cysts and polyps): Less frequent: Benign skin neoplasm.

Blood and lymphatic system: Less frequent: Anaemia, blood dyscrasia.

Immune system disorders: Less frequent: Hypersensitivity, angioedema, anaphylactic reaction/shock.

Endocrine disorders: Frequent: Parathyroid disorder.

Metabolism and nutrition disorders: Frequent: Hypocalcaemia. Less frequent: Hypophosphatemia.

Psychiatric disorders: Less frequent: Sleep disorder, anxiety, affection lability.

Nervous system disorders: Frequent: Headache, dizziness, dysgeusia (taste perversion). Less frequent: Cerebrovascular disorder, nerve root lesion, amnesia, migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia.

Eye disorders: Frequent: Cataract. Less frequent: Ocular inflammation.

Ear and labyrinth disorders: Less frequent: Deafness.

Cardiac disorders: Frequent: Bundle branch block. Less frequent: Myocardial ischaemia, cardiovascular disorder, palpitations.

Vascular disorders: Less frequent: Hypertension, lymphoedema, varicose veins.

Respiratory, thoracic and mediastinal disorders: Frequent: Pharyngitis. Less frequent: Lung oedema, stridor, bronchospasm.

Gastrointestinal disorders: Frequent: Diarrhoea, vomiting, dyspepsia, gastrointestinal pain, tooth disorder. Less frequent: Gastroenteritis, dysphagia, gastritis, mouth ulceration, cheilitis.

Hepato-biliary disorders: Less Frequent: Cholelithiasis.

Skin and subcutaneous tissue disorders: Frequent: Skin disorder, ecchymosis. Less frequent: Rash, alopecia.

Musculoskeletal, connective tissue and bone disorders: Frequent: Myalgia, arthralgia, joint disorder, osteoarthritis, bone pain. Less frequent: Atypical subtrochanteric and diaphyseal femoral fractures, osteonecrosis of jaw.

Renal and urinary disorders: Less frequent: Urinary retention, renal cyst.

Reproductive system and breast disorders: Less frequent: Pelvic pain.

General disorders and administration site conditions: Frequent: Asthaenia, influenza-like illness, pyrexia, peripheral oedema, thirst. Less frequent: Hypothermia, rigors.

Investigations: Frequent: Increased gamma-GT, increased creatinine. Less frequent: Blood alkaline phosphatase increase, weight decrease.

Injury, poisoning and procedural complications: Less frequent: Injury, injection site pain.

Up to now there is no experience of acute poisoning with SANDOZ IBANDRONATE injection solution. Since both the kidney and the liver were found to be target organs for toxicity, kidney and liver function should be monitored. Clinically relevant hypocalcaemia should be corrected by intravenous administration of calcium gluconate. Treatment should be symptomatic and supportive.