Aclasta 5mg solution 100ml

Composition

Solution Aclasta for infusion transparent, colorless. 
1 bottle (100 ml) contains 5 mg of zoledronic acid monohydrate,
1 bottle per pack.

Mechanism of action

Aclasta - an inhibitor of bone tissue resorption, a representative of bisphosphonates. Zoledronic acid belongs to the class of aminobisphosphonates, acts primarily on bone, inhibits the activity of osteoclasts and bone resorption. The selective effect of bisphosphonates on bone tissue is based on a high affinity for mineralized bone tissue. After the on / in the introduction of Aclasta quickly redistributed to the bone and, like other bisphosphonates, is localized mainly in the remodeling of bone tissue. The main molecular target of Aclasta in the osteoclast is the enzyme Farnesyl pyrophosphate synthetase (FPS), while the possibility of other mechanisms of drug action is not excluded. The long period of action of Aklasty is determined by the high affinity for the active center of the FPS and a pronounced affinity for mineralized bone tissue.

Experimental models of accelerated osteoresorption have shown that Aclasta significantly inhibits bone resorption without undesirable effects on the formation, mineralization and mechanical properties of bone,dose-dependently reduces the activity of osteoclasts and the frequency of activation of new foci of remodeling in both trabecular and cortical (Gaversovoy) bone, without causing the formation of fibrous bone and aberrant osteoid accumulation.

Indications and usage

- postmenopausal osteoporosis (to reduce the risk of fractures of the femur, vertebrae and non-vertebral fractures, to increase bone mineral density);
- prevention of subsequent (new) osteoporotic fractures in men and women with fractures of the proximal femur;
- Pedzhet's bone disease.

Aklast's drug is administered in the form of iv infusion. Before the introduction of Aklasty should ensure adequate hydration of the body. This is especially important for patients over the age of 65, as well as for patients receiving diuretic therapy.

For treatment, the recommended dose of Aklasty is 5 mg (1 bottle - 100 ml of solution) in / in 1 time per year. If the intake of Calcium and vitamin D with food is not enough, patients with osteoporosis should also be given calcium and vitamin D drugs.

Adverse reactions

The following adverse events were most often observed with a duration of usually no more than 3 days after administration of the drug Aklast: fever (18.1%), myalgia (9.4%), flu-like syndrome (7.8%), arthralgia (6.8%), headache (6.5%). Most of these reactions were mild or moderate.With repeated administration of the drug Aclasta patients with postmenopausal osteoporosis, the severity of adverse events was significantly reduced.

Contraindications

- severe violations of mineral metabolism, including hypocalcemia;
- pregnancy;
- lactation period (breastfeeding);
- children and adolescents up to 18 years of age (since the safety and efficacy of using Aklasts in this category of patients has not been studied);
- Hypersensitivity to zoledronic acid, or to any other component of the drug, or to any bisphosphonates.

Aclasta is not recommended for use in patients with severely impaired renal function (CC and <30 ml / min).

Special notes

The physician should inform patients of the main manifestations of hypocalcemia and ensure regular monitoring of patients at risk.
Aklast's therapy in patients with Paget's disease of the bone should be performed only by qualified doctors with experience in treating this
diseases.
Before the appointment of the drug Aclasta should determine the level of creatinine in serum.
In the presence of hypocalcemia, before using Aclasta, treatment with adequate doses of calcium and vitamin D should be carried out. Other existing disorders of mineral metabolism should also be treated (for example, hypoparathyroidism, reduction of calcium absorption in the intestine) and regular monitoring of patients with hypocalcemia should be provided. 
To reduce the frequency of adverse events that occurred within 3 days after drug administration, you can assign Paracetamol or Ibuprofen immediately after the infusion of Aclasta. 
Risk factors for osteonecrosis are cancer, concomitant therapy (for example, Chemotherapy, radiation therapy, treatment of GCS), and the presence of other comorbidities (for example, anemia, coagulopathy, infections, and a history of dental diseases).

Keep out of reach of children at a temperature not exceeding 25 ° C. After opening the vial, Aklast's solution is stable at a temperature of 2 ° -8 ° C for 24 hours.

 - 3 years.