Zolchoice

Zolchoice Adverse Reactions

zoledronic acid

Manufacturer:

Getwell Pharma

Distributor:

Pharma 518

Marketer:

Ambica
Full Prescribing Info
Adverse Reactions
General: The most common adverse events (>25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting and dyspnea.
Hypercalcemia of Malignancy: The safety of Zoledronic acid for injection was studied in patients with hypercalcemia of malignancy (HCM) who received either Zoledronic acid for injection 4 mg given as a 5 minute intravenous infusion (n=86) or pamidronate 90 mg given as a 2 hour intravenous infusion (n=103). The population aged between 33-84 years, 60% male and 81% Caucasian with breast, lung, head and neck and renal cancer as the most common forms of malignancy. Note: pamidronate 90 mg was given as a 2 hour intravenous infusion. The relative safety of pamidronate 90 mg given as a 2 hour intravenous infusion compared to the same dose given as a 24 hour intravenous infusion has not been adequately studied in controlled clinical trials.
Renal Toxicity: 5 minutes intravenous infusion of Zoledronic acid for Injection 4 mg has been shown to result in an increased risk of renal toxicity as measured by increase in serum creatinine which can lead to renal failure.
15 minutes intravenous infusion of Zoledronic acid for Injection 4 mg reduced the incidence of renal toxicity and renal failure. Zoledronic acid for Injection should be administered by intravenous infusion over no less than 15 minutes.
Acute Phase reaction like events: Symptoms consistent with acute phase reaction (APR) can occur with intravenous BISPHOSPHONATES use. Fever has been the most commonly associated symptom. Occasionally, a flu like syndrome consisting of fever, chills, flushing, bone pain and/or arthralgias and myalgias can be experienced by patients.
Mineral and Electrolyte Abnormalities: Electrolyte abnormalities, most commonly hypocalcemia, hypophosphatemia and hypomagnesemia can occur with BISPHOSPHONATES use.
Injection Site reactions: Local reactions such as redness or swelling may be observed infrequently at the infusion site. In most cases no specific treatment is required and the symptoms subside after 24-48 hours.
Ocular Adverse events: Ocular inflammation such as uveitis and scleritis can occur with BISPHOSPHONATES use including Zoledronic acid for Injection.