Zolchoice

Zolchoice

zoledronic acid

Manufacturer:

Getwell Pharma

Distributor:

Pharma 518

Marketer:

Ambica
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Hypercalcemia of malignancy. Prevention of skeletal events in patients w/ advanced bone malignancies. Treatment of Paget's disease of bone & for osteoporosis in postmenopausal women.
Dosage/Direction for Use
IV Infuse over not <15 min. Single doses should not exceed 4 mg. Hypercalcemia of malignancy 4 mg [albumin corrected serum Ca ≥12 mg/dL (3 mmol/L)] as a single dose. Multiple myeloma & metastatic bone lesions of solid tumors Patient w/ CrCl >60 mL/min 4 mg every 3-4 wk, 50-60 mL/min 3.5 mg, 40-49 mL/min 3.3 mg, 30-39 mL/min 3 mg.
Contraindications
Lactation.
Special Precautions
Discontinue use if severe symptoms of incapacitating bone, joint &/or muscle pain develops. Osteonecrosis of the jaw has been reported. Perform preventive dental exam before starting treatment. Avoid invasive dental procedures while on treatment. Adequately rehydrate patients w/ hypercalcemia of malignancy prior to administration of treatment & monitor electrolytes during treatment. Patients must be adequately supplemented w/ Ca & vit D. Aspirin-sensitive patients may have bronchoconstriction. Factors predisposing to renal deterioration eg, dehydration or use of nephrotoxic drugs should be identified & managed if possible. Carefully monitor the standard hypercalcemia-related metabolic parameters eg, serum levels of Ca, phosphate & Mg as well as serum creatinine following therapy initiation. Short-term supplementary therapy may be necessary if hypocalcemia, hypophosphatemia or hypomagnesemia occur. Monitor serum creatinine before each dose. Do not use loop diuretics until patient is adequately rehydrated. Caution w/ nephrotoxic drugs. Renal toxicity may be greater in patients w/ renal impairment. Not recommended in patients w/ bone metastases w/ severe renal impairment. Patients w/ hepatic insufficiency. Women of childbearing potential should be advised of the potential hazard to the fetus & to avoid becoming pregnant. Not to be used during pregnancy as it can cause fetal harm.
Adverse Reactions
Nausea, fatigue, anemia, bone pain, constipation, fever, vomiting & dyspnea.
Drug Interactions
Additive effect to lower serum Ca level for prolonged periods w/ aminoglycosides. Increased risk of hypocalcemia w/ loop diuretics. Caution should be taken w/ other potentially nephrotoxic drugs. May increase risk of renal dysfunction in multiple myeloma patients w/ thalidomide.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Zolchoice lyo powd for IV infusion 4 mg/5 mL
Packing/Price
1's