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Aclasta (Zoledronic Acid) 5 mg lowers the amount of calcium loss from bone. It is used to treat too much calcium in your blood from cancer. It is also used to prevent complications of cancer that has spread to the bone.

Aclasta, also known as zoledronate, is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, and Paget’s disease of bone. It is given by injection into a vein.

Pharmacology:

Aclasta / Zoledronic acid belongs to the class of nitrogen-containing bisphosphonates and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption.

The action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered Zoledronic acid is rapidly distributed to bone.

The main molecular target of Zoledronic acid in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms.

Clinical studies in tumour-induced hypercalcemia demonstrated that the effect of Aclasta / Zoledronic acid is characterized by decreases in serum calcium and urinary calcium excretion.

In addition to its inhibitory activity against bone resorption, Zoledronic acid also possesses anti-tumour activity, anti-angiogenic activity, anti-pain activity, cytostatic and pro-apoptotic activity on tumour cells and synergistic cytostatic effect with other anti-cancer drugs.

There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Zoledronic acid is not metabolized and is excreted unchanged via the kidney.

Dosage:

Hypercalcemia of malignancy: The maximum recommended dose of Aclasta / Zoledronic Acid in hypercalcemia of malignancy (serum calcium 12 mg/dl or 3.0 mmol/l) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion.

Dose adjustment of Zoledronic Acid is not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment. Re-treatment with Zoledronic Acid may be considered if serum calcium does not return to normal after initial treatment.

Multiple myeloma and bone metastases of solid tumors: The recommended dose of Zoledronic Acid in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused every 3-4 weeks.

Administration:

Prior to administration, the required amount of concentrate from one vial must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).

The duration of infusion must not be less than 15 minutes. After addition of the solution to the infusion media, the infusion solution should be used as soon as possible. If storage of the infusion solution is necessary, hold at 2-8º C for not more than 24 hours.

Aclasta / Zoledronic Acid must not be mixed with calcium or other divalent cation-containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs.

Interaction:

In clinical studies, Aclasta / Zoledronic acid has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without interactions.

Caution is advised when Zoledronic acid are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods.

In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid is used in combination with thalidomide.

Concomitant use of loop diuretics with Aclasta / Zoledronic acid increases the risk of hypocalcemia. Caution is indicated when Zoledronic acid is used with other potentially nephrotoxic drugs.

Contraindications:

The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates; severe renal impairment (Creatinine clearance <30 ml/min); pregnancy and lactation.

Side Effects:

The post-dose side-effects are headache, nausea, anorexia, fatigue, osteonecrosis of jaw, anemia, bone pain, constipation, fever, vomiting, flu-like syndrome, hypocalcemia, myalgia, arthralgia and hypophosphataemia.

Pregnancy & Lactation:

Aclasta / Zoledronic acid is contraindicated during pregnancy and in breast-feeding women. It is also not recommended for use in children and adolescents below 18 years of age.

Precautions & Warnings:

Patients must be appropriately hydrated prior to administration of Aclasta / Zoledronic Acid. This is especially important in the elderly and for patients receiving diuretic therapy.

Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion.

Serum levels of calcium, phosphate, magnesium and potassium, as well as serum creatinine should be carefully monitored after initiating Zoledronic Acid therapy.

If hypocalcemia, hypophosphatemia or hypomagnesemia occurs, short-term supplemental therapy may be necessary. Moreover, careful renal function monitoring should be considered.

Use in Special Populations:

Patients with renal impairment: The use of Aclasta / Zoledronic Acid is not recommended in patients with severe renal impairment (Creatinine clearance <30 ml/min).

No dose adjustment is necessary in patients with creatinine clearance >60 ml/min. Based on creatinine clearance the following dose should be used in patient with impaired renal function:

Overdose Effects:

Clinical experience with acute over dosage is limited. Over dosage may cause hypocalcemia, hypophosphatemia, and hypomagnesemia.

In such case, reduction in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate and magnesium sulfate respectively.

Reconstitution:

Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.

Storage Conditions:

Store below 30° C prior to opening. Protect from moisture and light. Zoledronic Acid must be kept out of the reach and sight of children.