Zoltero 4

Zoltero 4

zoledronic acid

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Osteolytic, osteoblastic & mixed bone metastases of solid tumours & osteolytic lesions of multiple myeloma in conjunction w/ standard antineoplastic therapy. Hypercalcaemia of malignancy (HCM).
Dosage/Direction for Use
IV Bone metastases & osteolytic lesions in conjunction w/ standard antineoplastic therapy Adult & elderly 4 mg infusion every 3-4 wk. Give oral Ca supplement 500 mg & vit D 400 IU daily. Mild to moderate renal impairment: CrCl >60 mL/min 4 mg. CrCl 50-60 mL/min 3.5 mg. CrCl 40-49 mL/min 3.3 mg. CrCl 30-39 mL/min 3 mg. HCM 4 mg single infusion.
Contraindications
Hypersensitivity to zoledronic acid or other bisphosphonates. Pregnancy & lactation.
Special Precautions
Adequately hydrate patients w/ mild to moderate renal impairment prior to administration. Avoid overhydration in patients at risk of cardiac failure. Carefully monitor albumin-corrected serum levels of Ca, phosphate, Mg & serum creatinine after initiating therapy. Consider monitoring renal function of untreated hypercalcaemia patients. Do not administer concomitantly w/ other zoledronic acid-containing medications, & w/ other bisphosphonates. Bronchoconstriction in acetylsalicylic acid sensitive asthmatic patients. Osteonecrosis of the jaw (ONJ); avoid invasive dental procedures if possible. Osteonecrosis of other anatomical sites including hip, femur & external auditory canal. Atypical subtrochanteric & diaphyseal femoral fractures, primarily in patients receiving long-term osteoporosis treatment. Potential severe & occasional incapacitating bone, joint &/or muscle pain. Co-administration w/ other hypocalcaemia-causing drugs. Measure serum Ca & correct hypocalcaemia prior to initiating therapy. Adequate supplementation Ca & vit D. Not recommended for patients w/ severe renal impairment prior to initiation of therapy. Severe hepatic insufficiency. Women of childbearing potential.
Adverse Reactions
Hypophosphataemia. Anaemia; headache, paraesthesia; sleep disorder; conjunctivitis; nausea, vomiting, decreased appetite, constipation; hyperhidrosis; myalgia, arthralgia, bone & generalised body pain, joint stiffness; HTN; renal impairment; acute phase reaction, pyrexia, flu-like illness (including fatigue, chills, malaise & flushing), peripheral edema, asthenia; increased blood creatinine & urea levels, hypocalcaemia.
Drug Interactions
May have additive effect w/ aminoglycosides, calcitonin, loop diuretics. Concomitant use w/ other potentially nephrotoxic drugs. Increased incidence of ONJ w/ anti-angiogenic drugs.
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
Zoltero 4 conc for infusion 4 mg/5mL
Packing/Price
1's
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