Zolchoice Warnings

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hydration and Electrolyte Monitoring: Prior to administration of Zoledronic acid for Injection patients with hypercalcemia of malignancy must be adequately rehydrated. Loop diuretics in combination with Zoledronic acid for Injection should be used with caution in order to avoid hypocalcemia. Loop diuretics should not be used until the patient is adequately rehydrated. Zoledronic acid for Injection 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 Zoledronic acid for Injection. If hypocalcemia, hypophosphatemia or hypomagnesemia occur, short-term supplemental therapy may be necessary.
Renal Impairment: Zoledronic acid for Injection is excreted intact primarily via the kidney. The risk of renal adverse reactions may be greater in patients with impaired renal function. Pre-existing renal insufficiency and multiple cycles of Zoledronic acid for Injection and other bisphosphonates are risk factors for subsequent renal deterioration. Factors predisposing to renal deterioration such as dehydration or the use of other nephrotoxic drugs should be identified and managed if possible. Patients who have hypercalcemia of malignancy with severe renal impairment, the treatment with Zoledronic acid for Injection should be considered only after evaluating the risks and benefits of treatment.
Zoledronic acid for Injection treatment is not recommended in patients with bone metastases with severe renal impairment. 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 for Injection. Many reports of ONJ involved patients with signs of local infection including osteomyelitis. Cancer patients prior to treatment with bisphosphonates may be required to have a dental examination with preventive dentistry and should maintain good oral hygiene. While on treatment patients should avoid invasive dental procedures if possible. Dental surgery may exacerbate the condition in patients who develop ONJ while on BISPHOSPHONATES therapy.
Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint and/or muscle pain has been reported in patients taking bisphosphonates. This category of drugs includes Zoledronic acid for Injection. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue the use of the drug if it develops severe symptoms. Most patients had relief of symptoms after stopping. The recurrence of symptoms might be possible when rechallenged with the same drug or another BISPHOSPHONATES.
Patients with Asthma: The patients receiving bisphosphonates may have bronchoconstriction in aspirin sensitive patients.
Hepatic Impairment: Only limited clinical data are available for use of Zoledronic acid for Injection 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.
Use in Pregnancy: Zoledronic acid for Injection may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.