Zoledronic Acid Fresenius Kabi

Zoledronic Acid Fresenius Kabi

zoledronic acid

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma

Marketer:

Fresenius Kabi
Concise Prescribing Info
Contents
Zoledronic acid monohydrate
Indications/Uses
Reduction of skeletal-related events (pathological fractures, spinal compression, bone radiation or surgery, or tumour-induced hypercalcemia) in adults w/ advanced bone malignancies. Adults w/ tumour-induced hypercalcemia (TIH).
Dosage/Direction for Use
IV Adult & elderly Reduction of skeletal-related events in patients w/ advanced bone malignancies 4 mg every 3-4 wk. Administer 500 mg oral Ca supplement + 400 IU vit D daily. TIH 4 mg as single dose. Mild to moderate renal impairment w/ CrCl >60 mL/min 4 mg, 50-60 mL/min 3.5 mg, 40-49 mL/min 3.3 mg, 30-39 mL/min 3 mg.
Contraindications
Hypersensitivity to zoledronic acid monohydrate or other bisphosphonates. Breastfeeding.
Special Precautions
Not to be mixed w/ Ca or other divalent cation-containing infusion soln eg, lactated Ringer's soln. Discontinue in patients w/ suspected atypical femur fracture. Withhold treatment in patients w/ renal deterioration. Osteonecrosis of the jaw (ONJ); bone, joint &/or muscle pain; signs of local infection including osteomyelitis; atypical subtrochanteric & diaphyseal femoral fractures; hypocalcaemia (severe &/or life-threatening), cardiac arrhythmias & neurologic adverse events including seizures, numbness & tetany. Patients who are smoking & w/ comorbid conditions eg, anaemia, coagulopathies, infection; w/ history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures & poorly fitting dentures. Recurrence of musculoskeletal pain when rechallenged w/ therapy or another bisphosphonate. Assess patients to ensure adequate hydration prior to administration. Determine serum creatinine & CrCl in patients w/ multiple myeloma or metastatic bone lesions from solid tumours when initiating treatment. Monitor Ca, phosphate & Mg serum levels after initiating therapy; renal function. Assess serum creatinine levels prior to each dose. Consider dental exam w/ appropriate preventive dentistry prior to treatment. Evaluate patients w/ thigh, hip or groin pain for incomplete femur fracture. Avoid overhydration in patients at risk of cardiac failure; invasive dental procedures while on treatment. Concomitant use w/ other medicines containing zoledronic acid or any other bisphosphonate; chemotherapies, RT, corticosteroids. May influence ability to drive & use machines. Not recommended in severe renal impairment (CrCl <30 mL/min). Severe hepatic insufficiency. Not to be used during pregnancy. Contraindicated in lactation. Childn 1-17 yr.
Adverse Reactions
Bone pain, fever, fatigue, arthralgia, myalgia & rigors, renal function impairment, ONJ, acute phase reaction, hypocalcemia, ocular adverse events, atrial fibrillation, anaphylaxis.
Drug Interactions
Additive effects w/ aminoglycosides. Possibility of hypomagnesaemia w/ other potentially nephrotoxic medicinal products. Increased risk of renal dysfunction w/ thalidomide. Increased incidence of ONJ w/ anti-angiogenic medicinal products.
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
Zoledronic Acid Fresenius Kabi conc for soln for infusion 4 mg/5 mL
Packing/Price
1's
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