Zinvel Special Precautions

zoledronic acid


Gland Pharma




Mega Lifesciences
Full Prescribing Info
Special Precautions
Hydration and Electrolyte Monitoring: Patients with hypercalcemia of malignancy must be adequately rehydrated prior to administration of Zoledronic acid.
Loop diuretics should not be used until the patient is adequately rehydrated and should be used with caution in combination with Zoledronic acid in order to avoid hypocalcemia. Zoledronic acid should be used with caution with other nephrotoxic drugs.
Standard hypercalcemia-related metabolic parameters, such as serum levels of calcium, phosphate, and magnesium, as well as serum creatinine, should be carefully monitored following initiation of therapy with Zinvel. If hypocalcemia, hypophosphatemia, or hypomagnesemia occur, short-term supplemental therapy may be necessary.
Renal Impairment: Zoledronic acid is excreted intact primarily via the kidney, and the risk of adverse reactions, in particular renal adverse reactions, may be greater in patients with impaired renal function. Safety and pharmacokinetic data are limited in patients with severe renal impairment and the risk of renal deterioration is increased.
Preexisting renal insufficiency and multiple cycles of Zoledronic acid and other bisphosphonates are risk factors for subsequent renal deterioration with Zinvel. Factors predisposing to renal deterioration, such as dehydration or the use of other nephrotoxic drugs, should be identified and managed, if possible.
Zoledronic acid treatment in patients with hypercalcemia of malignancy with severe renal impairment should be considered only after evaluating the risks and benefits of treatment. In the clinical studies, patients with serum creatinine >400 μmol/L or >4.5 mg/dL were excluded.
Zoledronic acid treatment is not recommended in patients with bone metastases with severe renal impairment. In the clinical studies, patients with serum creatinine > 265 μmol/L or >3.0 mg/dL were excluded and there were only 8 of 564 patients treated with Zoledronic acid 4 mg by 15-minute infusion with a baseline creatinine >2 mg/dL. Limited pharmacokinetic data exists in patients with creatinine clearance <30 mL/min.
Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zoledronic acid. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Cancer patients should maintain good oral hygiene and should have a dental, examination with preventive dentistry prior to treatment with bisphosphonates.
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Musculoskeletal Pain: Discontinue use if severe symptoms develop.
Patients with Asthma: While not observed in clinical trials with Zoledronic acid, there have been reports of bronchoconstriction in aspirin sensitive patients receiving bisphosphonates.
Hepatic Impairment: Only limited clinical data are available for use of Zoledronic acid to treat hypercalcemia of malignancy in patients with hepatic insufficiency, and these data are not adequate to provide guidance on dosage selection or how to safely use Zoledronic acid in these patients.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Zoledronic acid is not indicated for use in children.
Use in the Elderly: Clinical studies of Zoledronic acid in hypercalcemia of malignancy included 34 patients who were 65 years of age or older. No significant differences in response rate or adverse reactions were seen in geriatric patients receiving Zoledronic acid as compared to younger patients. Controlled clinical studies of Zoledronic acid in the treatment of multiple myeloma and bone metastases of solid tumors in patients over age 65 revealed similar efficacy and safety in older and younger patients. Because decreased renal function occurs more commonly in the elderly, special care should be taken to monitor renal function.
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