Index of drugs

Prevention of bone events (pathological fractures, bone complications requiring irradiation or surgical treatment) in adult patients with breast cancer with bone metastases.

1 tabl powl. contains 50 mg of ibandronic acid in the form of a monohydrate sodium salt. The preparation contains lactose.

A drug from the group of bisphosphonates showing high affinity to bone mineral components. It inhibits the activity of osteoclasts, reducing bone resorption and bone complications in cancer. In patients with bone metastatic breast cancer, a dose-dependent osteolysis inhibitory effect on bone has been demonstrated expressed by bone resorption markers and a dose-related effect on the occurrence of bone events. After oral administration, ibandronic acid is rapidly absorbed from the gastrointestinal tract (bioavailability approximately 0.6%). The degree of absorption is reduced if the drug is taken with food or drinks other than water. Maximum blood concentrations are achieved within 0.5-2 hours in fasting patients. Plasma protein binding is 87%. Ibandronic acid is rapidly bound by bones. It is excreted in urine and faeces in unchanged form. T_0,5 is 10-60 hours.

Hypersensitivity to ibandronic acid or to any of the excipients. Hypocalcaemia. An abnormality in the esophagus leading to a delay in its emptying, i.e. stenosis or contraction of the lower esophagus. Inability to maintain standing or sitting position for at least 60 minutes.

The safety and efficacy of the preparation in children and adolescents under 18 years of age have not been established. Caution should be used in patients with hypersensitivity to other bisphosphonates and patients with active disease of the upper gastrointestinal tract (eg Barret's esophagus, dysphagia, other diseases of the esophagus, gastritis, duodenitis or ulcer). If any symptoms appear on the part of the esophagus (dysphagia, diarrhea, retrosternal pain or heartburn), the preparation should be discontinued. Caution should be exercised with the simultaneous use of NSAIDs. Before starting treatment in patients with concurrent risk factors (eg cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene), a dental examination and proper prophylaxis should be considered because of the risk of osteonecrosis of the jaw. In this group of patients, if possible, invasive dental procedures should be avoided during treatment. In patients who develop osteonecrosis of the jaw during treatment with bisphosphonates, surgical dental procedures may exacerbate this complication. For patients requiring dental procedures, there are no data suggesting whether termination of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. The management of each patient should be based on the clinical assessment made by the attending physician, based on an individual assessment of the benefit / risk ratio. There have been reports of atypical subtrochanteric fractures and femoral shaft in persons using bisphosphonates, mainly in patients who have been treated for a long time due to osteoporosis. This type of fracture occurs after minimal injury or without injury, and some patients experience thigh pain or groin pain. In imaging examinations, the features of fractures from overload are often visible for a few weeks or months before a complete fracture of the femur. Fractures often occur on both sides, so patients with bisphosphonates who have had a fracture of the femoral shaft should be examined for the femur in the other limb. Poor healing of these fractures has also been reported. Based on an individual benefit / risk assessment for patients suspected of an atypical hip fracture, discontinuation of bisphosphonates should be considered pending evaluation. The product contains lactose and should not be used in patients with rare hereditary problems of lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Due to the lack of adequate data on the use of the product, it should not be used during pregnancy and breastfeeding (in animal studies, reproductive toxicity and the presence of low concentrations of ibandronic acid in breast milk have been demonstrated).

Hypocalcaemia, oesophagitis, dyspepsia, nausea, abdominal pain and asthenia were often observed. Uncommon: anemia, paresthesia, dysgeusia, bleeding, duodenal ulceration, gastritis, dysphagia, dry mouth, pruritus, azotemia, chest pain, flu-like symptoms, pain, malaise, increased levels of parathyroid hormones. Rarely: inflammation of the eye, unusual subtrochanteric fracture and femoral shaft (side effect of bisphosphonates). There have been reports of osteonecrosis of the jaw, mostly in cancer patients. Its occurrence is generally associated with tooth extraction and / or local infection (including osteomyelitis). Risk factors are also: diagnosed cancer, use of chemotherapy, radiotherapy, corticosteroids and incorrect oral hygiene. Gastric and oesophageal ulcers have been reported post-marketing.

The therapy should only be initiated by a doctor who has experience in the treatment of cancer.
Orally. Adults: the recommended dose is 50 mg daily. In patients with liver failure and in the elderly, no dosage adjustment is necessary. No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml / min and <80 ml / min); in patients with moderate renal impairment (creatinine clearance ≥ 30 ml / min and <50 ml / min) a dose adjustment of 50 mg every 2 days is recommended; in patients with severe renal impairment (creatinine clearance <30 ml / min), the recommended dose is 50 mg once a week. The preparation in the form of tablets should be taken after an overnight fast (at least 6 h) and before the first drink during the day. Avoid taking medications and supplements that are deficient (including calcium) before taking the preparation in tablets. After taking the tablet, refrain from eating for at least 30 minutes. During the treatment, you can always drink water (be aware that the water does not contain higher concentrations of calcium). The tablets should be swallowed whole (they should not be chewed, sucked or crushed) with a glass of plain water (180-240 ml) when the patient is standing or sitting upright. Patients should not lie down for 60 minutes after taking the preparation.