Index of drugs

Treatment of osteoporosis in postmenopausal women with an increased risk of fractures. A reduction in the risk of vertebral fractures has been demonstrated; efficacy in preventing femoral neck fractures has not been established.

1 pre-filled syringe contains 3 ml solution of 3 mg ibandronic acid as monohydrate sodium salt.

A drug from the group of bisphosphonates acting selectively on bone tissue. It inhibits the activity of osteoclasts without directly affecting bone formation. This process does not interfere with the inflow of osteoblasts. In postmenopausal women, ibandronic acid causes a progressive increase in bone mass and a reduction in the frequency of fractures, by slowing accelerated bone turnover to pre-menopausal values. After
Initial systemic exposure, ibandronic acid is rapidly bound by bone or is excreted in the urine. The percentage of circulating dose that reaches the bone tissue is estimated at 40-50%. Plasma protein binding is around 85-87%. There is no evidence that ibandronic acid is metabolized. It is removed from the circulatory system by incorporation into the bone tissue (about 40-50% in menopausal women), while the remaining part is excreted unchanged by the kidneys. Apparent ending T_0,5 it is in the range of 10-72 hours.

Hypersensitivity to ibandronic acid or to any of the excipients. Hypocalcaemia.

Before starting treatment, the existing Calcium deficiency should be compensated. Other disturbances of bone and mineral metabolism should also be effectively treated before treatment with the preparation. All patients must receive calcium and vitamin D supplements at appropriate doses. During treatment with bisphosphonates, atypical subtrochanteric fracture and femoral shaft were reported. These fractures often occur on both sides; therefore, the bone in the other limb should be assessed in bisphosphonate treated patients who have fractured the femoral shaft. There have also been reports of poor healing of these fractures. Based on an individual benefit / risk assessment for patients suspected of atypical femur fracture, discontinuation of bisphosphonates should be considered pending evaluation. Patients should be advised to report any thigh, hip and groin pain, and each patient with such symptoms should be examined for incomplete fracture of the thigh bone. Patients with co-morbidities or other drugs that may have an adverse effect on the kidneys should undergo regular monitoring during treatment. Due to limited clinical data, ibandronic acid for injections is not recommended for patients with serum creatinine> 200 μmol / l (2.3 mg / dl) or with a creatinine clearance <30 ml / min.
Before starting treatment with bisphosphonates in patients who are also at risk for osteonecrosis of the jaw (eg cancer, chemotherapy, radiotherapy, corticosteroids, improper oral hygiene), a dental examination and appropriate prophylaxis should be considered. In this group of patients, if possible, invasive dental treatment should be avoided. In patients who develop osteonecrosis of the mandible during treatment with bisphosphonates, surgical dental procedures may exacerbate the course of the disease. In the case of patients requiring dental procedures, there are no data suggesting whether discontinuation of bisphosphonate therapy reduces the risk of osteonecrosis of the jaw. The management of each patient should be based on a clinical assessment based on an individual assessment of the benefit / risk ratio. There are no indications for use in children. Care should be taken not to administer the drug intra-arterially or Next to the vein, as it may lead to tissue damage.

Due to the lack of relevant data, the drug should not be used during pregnancy and breast-feeding (in animal studies, reproductive toxicity and low levels of ibandronic acid in milk have been demonstrated after administrationiv).

Common: headache, gastritis, indigestion, diarrhea, abdominal pain, nausea, constipation, rash, joint pain, muscle pain, back pain, musculoskeletal pain, flu-like symptoms (transient, usually associated with the first dose), fatigue. Uncommon: phlebitis, thrombophlebitis, bone pain, injection site reactions, asthenia. Rarely: hypersensitivity reactions, inflammation of the eye (uveitis, episcleritis, sclerosis), angioneurotic edema, swelling of the face, swelling, urticaria, unusual subtrochanteric and thoracic femoral fractures. Very rare: osteonecrosis of the jaw - most of the reports refer to cancer patients, but these cases have also been reported in patients being treated for osteoporosis; osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis); diagnosed cancer, chemotherapy, radiotherapy, use of corticosteroids, poor oral hygiene are also mentioned as risk factors.

Intravenously. The recommended dose is 3 mg for an injection of 15-30 s every 3 months. The optimal duration of treatment for osteoporosis with bisphosphonates has not been established. Periodically, the need to continue treatment should be assessed based on the benefits and potential risks individually for each patient, especially after 5 years or longer. If a dose is missed, the next injection should be carried out as soon as possible; subsequent injections should be planned every 3 months from the date of the last injection. Patients with mild or moderate renal impairment who have serum creatinine ≤200 μmol / l (2.3 mg / dl) or creatinine clearance (estimated or estimated) ≥30 ml / min in patients with hepatic impairment and in elderly patients, dose adjustment is not necessary.