Aklasta

Description overdue on 04.10.2012

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Highly bisphosphonate . The active ingredient is inhibitor of bone resorption . The main ingredient - zoledronic acid . Drug substance acts selectively on bone. The principle effects of the drug Aklasta based on suppression of activity osteoclasts With the medicament does not adversely affect the mechanical properties, mineralization and bone formation. Due to the high affinity of bisphosphonates and mineralized tissue   provided the selective effect of the drug in the skeletal system. The exact molecular mechanism by which inhibition of osteoclast activity is still not fully understood. When bone metastases zoledronic acid exerts direct anti-tumor effects . The mechanism of action is directed to induction of apoptosis, inhibition of proliferation, which is effectively used in   Breast Cancer , Myeloma. The drug reduces the   risk of metastasis . Record the analgesic, anti-angiogenic activity. The drug inhibits osteoclastic bone resorption, which alters the microenvironment of the bone marrow and reduces the growth of tumor cells. Also noted suppression cell proliferation   human endothelium. Zoledronic acid reduces the level of calcium in blood serum hypercalcemia induced by cancer process. Aklasta produced as a lyophilisate, concentrate for preparing a solution, as a final solution.

Indications:

Aklasta used in osteoskleroticheskih, osteolytic, mixed metastases in the skeletal system (solid tumors), in the presence of osteolytic lesions in the multiple myeloma   (complex therapy). The drug is prescribed for postmenopausal osteoporosis   to increase bone mineralization, to reduce the risk of non-vertebral fractures and fractures of the vertebrae and femurs. The use of medication can prevent new osteoporotic fractures in patients, male and female with fractures of the proximal femur in history. The drug is prescribed for Paget's disease .

Contraindications:

Aklasta does not apply in case of intolerance bisphosphonate, zoledronic acid in patients with chronic renal failure, breastfeeding, pregnancy, children and adolescents.

Side effect:

Water and electrolyte metabolism:   hypernatremia, hypokalemia , Metabolic disorders of potassium, hypomagnesemia, hypocalcemia, hypophosphatemia . Bodies of blood:   leukopenia, pancytopenia , Anemia, thrombocytopenia. Digestive:   dryness of mouth, stomatitis , Constipation, disturbances of appetite, diarrhea, toothache, esophagitis , Dyspepsia, vomiting, nausea. Nervous system:   sleep disorders, anxiety, tremors, hyperesthesia, hypoesthesia, paresthesia , Weakness, dizziness, headache, confusion, vertigo , Fainting. Senses:   conjunctivitis, disorders of taste perception, pain in the eyes, episcleritis , Decreased visual acuity, uveitis, iritis. Urinary system:   proteinuria, hematuria , Acute renal failure, renal disorders in the system. Respiratory system:   cough, dyspnea (especially Paget's disease), hypercreatininemia . Skin: rash, itching, sweating. Musculoskeletal system:   osteonecrosis of the jaw, swelling of joints, muscle cramps, pain in the limbs and back arthralgia , Myalgia, ossalgia. Local reactions:   the formation of infiltration at the injection site, swelling, irritation, pain.   Allergic reactions : Angionervotichesky swelling, skin rashes, itching. It is also noted shivering, flu-like symptoms, fever, pain, asthenia, fatigue, bradycardia , Anorexia, chest pain, weight gain, peripheral edema .

Mode of application:

Aklasta injected intravenously, the injection time - 15 minutes. If hypercalcemia of malignancy in the background: the recommended dose of 4 mg (determined by the level of albumin). When cancer zaboelvaniya, with osteolytic lesions of multiple myeloma in the background, for bone metastases is administered 4 mg every 3-4 weeks. Infusion is performed only when adequate hydration   patient. With the deterioration of state after the registered distinct effect is carried out repeated drug administration: every 15 minutes for 8 mg. To assess the effectiveness of the drug is administered at intervals of not less than 1 week. In most cases, the achieved result is observed for 30 days after infusion of 4 mg, and for 40 days after infusion of 8 mg. In patients with moderate and mild renal failure   does not require correction dosing regimen of the drug Aklasta. Before the re-introduction of zoledronic acid is necessary to determine the level of creatinine. Prevention of fractures in postmenopausal osteoporosis are administered 5 mg 1 time per year. It is recommended to take additional vitamin D and calcium supplements. The drug can be administered no earlier than 2 weeks after surgery. Paget's disease:   single dose of 5 mg in combination with vitamin D, calcium preparations. Zoledronic acid solution was prepared immediately prior to administration under aseptic conditions: 5 ml of water was dissolved 4 mg, gently shaken until complete dissolution. The mixed solution was diluted in 50 ml sodium chloride or dextrose. Before introducing the solution was warmed to room temperature.

Special instructions:

It is necessary to assess the level of hydration of the patient before the infusion, it is recommended to avoid overhydration   because of the possible complications of the cardiovascular system. After injection requires regular monitoring of creatinine Phosphorus, magnesium, calcium in the blood. There bronchospasm   in patients with asthma and hypersensitivity to acetylsalicylic acid . In the treatment of patients with malignant neoplasms there are cases of bisphosphonate osteonecrosis of the mandible . Among the risk factors can be noted chemotherapy, cancer, poor oral hygiene, the use of glucocorticosteroids . Concomitant use different vzaimonezamenyaemyh drugs. When diagnosing hypocalcemia   before the treatment is carried out compulsory treatment with adequate doses of vitamin D and calcium.

Drug Interactions:

It must not be used as a solvent solution which contains calcium ions, including Ringer . Aklasta pharmaceutically incompatible with other drugs, which makes it impossible to mix products in the same syringe. Clinically significant interactions are not registered, while the use of antibiotics,   diuretics , Analgesics, anticancer medicines . The risk of hypomagnesemia, hypocalcemia increases while the appointment aminoglycosides , Bisphosphonates because unidirectional effect on the calcium ion concentration in serum.