Zolepex

Zolepex

zoledronic acid

Manufacturer:

Siam Bioscience

Distributor:

Zuellig Pharma

Marketer:

Apexcela
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Bone metastases from solid tumors as osteolytic &/or osteoblastic. Osteolytic lesions of multiple myeloma in combination w/ antineoplastic therapy. Reduction of bone damage in patients w/ advanced malignancies involving bone. Hypercalcemia of malignancy (HCM).
Dosage/Direction for Use
IV infusion Infuse over not <15 min. Adjunct to antineoplastic therapy for bone metastases of solid tumors & osteolytic lesions of multiple myeloma, & reduction of bone damage in patients w/ advanced malignancies involving bone 4 mg as single dose once every 3-4 wk. Administer supplemental Ca 500 mg & vit D 400 IU daily. HCM 4 mg as single dose. Mild to moderate renal impairment w/ CrCl 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 or any other bisphosphonates. Patients w/ hypocalcemia condition. Not to be mixed or diluted w/ Ca or other divalent containing soln eg, lactated Ringer's soln. Pregnancy & lactation.
Special Precautions
Avoid overhydration in patients at risk of cardiac failure. Severe jaw, muscle or joint pain. Patients who develop osteonecrosis of the jaw while on therapy. HCM patients w/ >1 course of retreatment. Hydrate patient appropriately prior to treatment. Maintain urinary output of 2 L daily throughout therapy; good oral hygiene & have a dental exam w/ preventive prior to treatment. Monitor patient for hypercalcemia-related metabolic parameters including serum conc of Ca, phosphate, Mg & creatinine prior to each administration & throughout treatment; renal function before treatment & withhold for renal deterioration. Investigate patients having hypercalcemia associated w/ malignancy after post-treatment evaluation at least 7 days after drug initiation. Short-term supplemental therapy if hypocalcemia, hypophosphatemia or hypomagnesemia occur. Not to be mixed or diluted w/ Ca-containing soln or other Ca-containing drug or product. Concomitant use w/ bisphosphonates, nephrotoxic drugs or shorter than recommended duration of IV infusion. Not recommended in severe renal impairment w/ CrCl <30 mL/min. Pregnancy. Lactating woman should not breastfeed during & after treatment. Not indicated for use in childn.
Adverse Reactions
Hypophosphatemia. Anemia; headache; anxiety, insomnia; conjunctivitis; nausea, vomiting, anorexia; myalgia, arthralgia, bone, back & skeletal pain; renal deterioration; fever, flu-like syndrome (including fatigue, rigors, malaise & flushing); increased blood creatinine & urea, hypocalcemia.
Drug Interactions
Lowered serum Ca conc w/ aminoglycosides. Increased risk of hypocalcemia w/ loop diuretics. Hypomagnesemia & increased risk of renal dysfunction w/ nephrotoxic agents. Potentiated risk of renal dysfunction 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
Zolepex conc for soln for infusion 4 mg/5 mL
Packing/Price
1's
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