Acidron^®

Acidron^® is the preparation of Zoledronic Acid which 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 Acidron® is rapidly distributed to bone. The main molecular target of Acidron® in the osteoclast is the enzyme farnesyl pyrophosphate synthase, but this does not exclude other mechanisms. There was no accumulation of the active substance in plasma after multiple doses given every 28 days. Acidron® is not metabolized and is excreted unchanged via the kidney.

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Acidron^® is indicated for-

- Treatment of hypercalcemia of malignancy.
- Acidron^® is indicated for the treatment & prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone.
- Treatment of multiple myeloma and bone metastases of solid tumors.
- Acidron^® is indicated for the treatment of patients with multiple myeloma and patients with bone metastases from solid tumors (breast cancer, prostate cancer, lung cancer, and other solid tumors) in conjunction with standard anti-neoplastic therapy.

Hypercalcemia of malignancy
The maximum recommended dose of Acidron^® in hypercalcemia of malignancy (serum calcium 12 mg/di or 3.0 mmol/1) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion. Dose adjustment of Acidron® is not necessary in treating patients for hypercalcemia of malignancy presenting with mild-to-moderate renal impairment. Re-treatment with Acidron^® may be considered if serum calcium does not return to normal after initial treatment. It is recommended that a minimum of 7 days elapse before re-treatment, to allow for full response to the initial dose.
Multiple myeloma and bone metastases of solid tumors
The recommended dose of Acidron^® in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused every 3-4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU of vitamin-D daily.
Patients with renal impairment: The use of Acidron^® 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-

Use in pregnancy and lactation
Zoledronic acid is contraindicated during pregnancy and in breast-feeding women.

Use in children and adolescents
It is not recommended for use in pediatric patients.

Patients must be appropriately hydrated prior to administration of 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.

The most common side effects of zoledronic acid are headache, nausea, anorexia, fatigue, osteonecrosis of jaw, anemia, bone pain, constipation, fever, vomiting, flu-like syndrome, hypocalcemia, myalgia, arthralgia and hypophosphatemia.

Zoledronic acid is contraindicated in patients with known hypersensitivity to zoledronic acid or any of its components. It is also contraindicated in patients with severe renal impairment (creatinine clearance< 30 ml/min), pregnancy and lactation.

Drug interaction with medication: Specific drug-drug interaction studies have not been conducted with zoledronic acid. Zoledronic acid is eliminated by renal excretion. Caution is indicated when zoledronic acid is administered in conjunction with drugs that can significantly impact renal function (e.g., aminoglycosides or diuretics that may cause dehydration).
Drug interaction with food and others: Not applicable.

Clinical experience with acute over dosage is limited. Patients who have received doses higher than those recommended should be carefully monitored. In the event of overdose leading to clinically significant hypocalcemia, reversal may be achieved with supplemental oral calcium and/or an infusion of calcium.

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 2-8°C for not more than 24 hours. If refrigerated, the solution must be allowed to reach room temperature before administration.
Acidron^® 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.

Store in a cool (below 30°C) and dry place protected from light. Keep away from the reach of children.

Acidron^® concentrated solution for IV infusion: Each vial contains Zoledronic Acid INN 4mg/5ml.

Acidron^® concentrated solution for IV infusion: Each pack contains a 5 ml glass vial.