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Aklasta – the drug inhibiting a bone resorption.
Dosage form of drug of Aklast – solution for infusions: transparent, colourless liquid (in polyethylene bottles on 100 ml, on 1 bottle in a cardboard pack).
Is a part of 1 bottle (100 ml):
Relative, Aklasta is used with care in the presence of the following diseases / states:
Aklasta's solution is entered in the form of intravenous infusion, using for this purpose the valve infusional system providing constant rate of administering of solution for not less than 15 minutes.
Before performing infusion it is necessary to provide adequate hydration of an organism. In particular it is important for elderly patients (≥65 years), and also for the patients receiving diuretics.
The recommended scheme of use:
At clearance of creatinine of ≥35 ml/min., functional disturbances of a liver and to elderly patients dose adjustment is not required.
Aklasta should not be mixed or entered together with any other medicines. It is impossible to allow contact with solutions, calciferous or any other bivalent cations.
For Aklasta's introduction it is always necessary to use separate system for infusions.
It is desirable to use solution right after opening of a bottle. If solution is cooled, before introduction he is recommended to be stood indoors before achievement of room temperature.
The undesirable phenomena at treatment of osteoporosis at men, postmenopauzny osteoporosis at women, a bone disease of Pedzhet, prevention of the subsequent changes at patients with changes of proximal department of a femur, treatment and prevention of the osteoporosis connected using glucocorticosteroids, as a rule, carry poorly or moderately expressed character.
Development of disturbances lasting not longer 3 days in the form of fever, mialgiya, a grippopodobny syndrome, an arthralgia and a headache was most often noted. At repeated introduction of Aklasta expressiveness of side reactions considerably decreased.
Frequency of development of disturbances can be estimated on a scale: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1 000, <1/100); seldom (≥1/10 000, <1/1 000); very seldom (<1/10 000); with an unknown frequency (according to separate messages from clinical practice).
Disturbances, perhaps connected (according to attending physicians) with Aklasta's introduction at treatment of a bone disease of Pedzhet, different types of osteoporosis, prevention of new changes at patients with changes of proximal department of a femur:
When carrying out separate researches the following undesirable phenomena which emergence frequency in Aklasta's group was lower, than at the patients who were not receiving drug were recorded: a hypocalcemia, reactions in an injection site, reddening of eyes, gastritis, increase in content of S-reactive protein, a dentagra, a dysgeusia, feeling of heartbeat.
At Aklasta's use for women with postmenopauzny osteoporosis development of fibrillation of auricles was noted (this disturbance is not confirmed with other clinical trials of zoledronovy acid).
The general profile of safety at Aklasta's use at postmenopauzny osteoporosis (with the preventive purpose) is comparable with that at treatment of postmenopauzny osteoporosis, except the side reactions which are observed within 3 days after infusion (in the form of pain, fever, a fever, a mialgiya, nausea, a headache, increased fatigue, an arthralgia) which frequency was higher at the patients using drug for prevention. Most often these side reactions were easy or average degree of manifestation and took place independently within 3 days after emergence. At repeated use of Aklasta expressiveness of these undesirable phenomena considerably decreased.
Side reactions, perhaps connected using Aklasta for prevention of postmenopauzny osteoporosis (according to attending physicians):
At postmenopauzny osteoporosis against the background of performing therapy cases of decrease in concentration of calcium in blood serum without clinical signs of a hypocalcemia were noted. At treatment of a bone disease of Pedzhet approximately in 1% of cases development of the passing hypocalcemia which is followed by clinical manifestations was noted.
During use of zoledronovy acid cases of renal failures with increase in concentration of creatinine of blood which sometimes were followed by an acute renal failure were noted (it is necessary to be careful at Aklasta's use for patients with the accompanying oncological diseases and chemotherapy).
Cases of emergence of an osteonecrosis (in the majority of episodes – jaws) generally took place at oncological patients after extraction of tooth or other dental manipulations. As a rule, they observed symptoms of local infectious and inflammatory process, including osteomyelitis.
Also during therapy the following undesirable phenomena were noted (relationship of cause and effect using Aklasta is not established): hypersensitivity reactions, including in rare instances urticaria, a bronkhokonstriktion, a Quincke's disease, anaphylactic reactions / shock.
In some cases in clinical practice development of functional disturbances of kidneys, including a renal failure at which carrying out a hemodialysis, or cases of a lethal outcome, in particular was required from patients with existence of accessory factors of risk (for example, the accompanying therapy by diuretics and nephrotoxic drugs, advanced age or heavy dehydration) or renal pathology in the anamnesis was noted.
Patients need to know the main manifestations of a hypocalcemia. Behind a condition of the patients entering into risk group regular medical observation has to be established.
To patients with a bone disease of Pedzhet only qualified specialists with experience of treatment of this disease have to appoint therapy.
To reduce the frequency of development of the side reactions arising within 3 days after Aklasta's introduction use of paracetamol or an ibuprofen shortly after infusion is possible.
At a hypocalcemia prior to use of drug it is necessary to carry out treatment by adequate doses of calcium and vitamin D. At other disturbances of mineral exchange (for example, the operations which developed after carrying out on parathyroid and thyroid glands, at a hypoparathyrosis or decrease in absorption of calcium in intestines) it is also necessary to carry out therapy.
To reduce probability of emergence of renal failures, it is necessary to observe the following instructions:
Oncological diseases, the accompanying therapy (for example, radiation therapy, chemotherapy, treatment by glucocorticosteroids) and existence of other accompanying diseases belong to risk factors of emergence of an osteonecrosis (for example, infections, anemia, coagulopathies, diseases of teeth in the anamnesis). Before Aklasta's introduction it is necessary to conduct dental examination and, with risk factors, to perform necessary preventive procedures in advance.
Patients have data on cases of atypical diaphyseal and subtrochanterian fractures of femur, is long receiving bisfosfonata. These changes, as a rule, develop spontaneously or after an insignificant injury and can be followed by bad accretion. The doctor to accept the decision on cancellation of use of Aklasta for patients with suspicion of atypical fractures of a femur individually on the basis of assessment of a ratio of advantage and risk.
It is necessary to be careful when performing potentially dangerous types of works as during use of drug development of dizzinesses is possible.
Special researches on studying of interaction of zoledronovy acid with other medicines were not conducted.
It is necessary to be careful at the combined use of Aklasta with the medicinal means / substances which are significantly influencing function of kidneys.
At functional disturbances of kidneys Aklasta's combination with drugs which are removed preferential by kidneys can lead to increase in systemic action of these medicines.
Aklasta's solution is incompatible with solutions which contain calcium or other bivalent cations (for example, in one system for intravenously drop introduction).
To store in the place, unavailable to children, at a temperature up to 25 °C.
Period of validity – 3 years.
Solution after opening of a bottle keeps stability for 24 hours at its storage at a temperature of 2-8 °C.
Name of drug
Aklasta solution for infusions 5mg/100ml 1 pieces
Aklasta solution for инф 5 mg фл 100 ml, Novartis Pharma
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