ZOMETA ® - Zoledronic acid

ZOMETA ® is a drug based on anhydrous zoledronic acid

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ZOMETA ® - Zoledronic acid

ZOMETA® is indicated in the treatment of hypercalcaemia neoplastic and bone fractures associated with bone metastases.

Mechanism of action ZOMETA ® - Zoledronic acid

The bisphosphonates, a pharmaceutical category to which zoledronic acid belongs, have long been used in the treatment of bone diseases with the aim of preventing fractures that are more frequently observed in pathological conditions such as osteoporosis or bone metastases.

Although the precise mechanism of action is not yet clear, these drugs seem to predominantly concentrate in the bone, and more precisely in the areas of active reabsorption, selectively inhibiting the processes of osteoclastic differentiation and bone resorption, without affecting in any way the osteodepented activity of osteoblasts.

The aforementioned biological mechanism therefore guarantees a modulation of bone metabolism favoring remineralization and at the same time lowering blood calcium concentrations.

Recent studies also, although still in an experimental phase, show how zoledronic acid can also present a modest antitumor activity, inhibiting the on-site proliferation of neoplastic cells.

Studies carried out and clinical efficacy

1. ZOLEDRONIC ACID AND RISK OF VERTEBRAL FRACTURES

A long-standing clinical trial that demonstrates that patients at high risk of vertebral fractures can benefit significantly from the uninterrupted intake of zoledronic acid.

2. ZOLEDRONIC ACID AND BONE MESTHASIS

Work that denies the various studies present in the literature concerning the efficacy of zoledronic acid in reducing tumor progression in patients with bone metastases from breast cancer.

3. ZOLEDRONIC ACID AND PROSTATIC CARCINOMA

Japanese study that shows how treatment with zoledronic acid in patients with bone metastases from prostate cancer can significantly reduce both bone pain and PSA blood concentrations, improving the patient's quality of life.

Method of use and dosage

ZOMETA ®

Powder and solvent for solution for infusion, 4 mg vial of zoledronic acid:

the need to administer ZOMETA ® intravenously and the high degree of specialization of this advanced therapy of bone disorders associated with cancer pathologies, requires the supervision of a specialist doctor and hospitalization during hospital treatment.

Dosages and timing of intake will be decided by the doctor based on the patient's clinical picture.

Warnings ZOMETA ® - Zoledronic acid

Zoledronic acid should be administered under close medical supervision and in a hospital setting.

Periodic monitoring of electrolyte concentrations and renal function is necessary in order to avoid the appearance of imbalances and disorders so serious as to seriously compromise the patient's state of health.

The aforementioned monitoring should also extend to cardiac and hepatic function in order to avoid unpleasant side effects.

In patients without hypercalcemia contextual supplementation with Vitamin D and Calcium could prove useful in safeguarding the blood concentrations of this element and avoiding the onset of pathological conditions such as tetany or paresthesia.

Treatment with bisphosphonates, especially when prolonged over time, could be associated with the increased risk of osteonecrosis of the jaw, thus becoming a potentially dangerous condition for any dental treatment.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials and studies capable of demonstrating the safety of the intake of zoledronic acid in pregnancy for fetal health, makes it possible to extend the contraindications also to the period of pregnancy and breastfeeding.

Interactions

The simultaneous administration of zoledronic acid and other anticancer drugs or analgesics does not seem to determine the appearance of clinically relevant side effects nor of significant pharmacokinetic variations.

Particular attention should instead be paid following the possible simultaneous intake of drugs active on bone metabolism and responsible for hypocalcemia.

Contraindications ZOMETA ® - Zoledronic acid

ZOMETA ® is contraindicated in case of pregnancy, lactation and hypersensitivity to the active substance or to one of its excipients.

Undesirable effects - Side effects

Intravenous administration of zoledronic acid may be responsible for: anemia, headache, visual disturbances, conjunctivitis, nausea, vomiting, weight loss, bone pain, arthralgia, myalgia, reduced kidney function, fever and flu-like symptoms, hypophosphatemia, hypocalcemia, hypercrateninemia pancytopenia.

Like other bisphosphonates, the intake of zoledronic acid may also be responsible for osteonecrosis of the jaw and jaw.