Zometa Generic Name & Formulations
Legal Class
Rx
General Description
Zoledronic acid 4mg/5mL concentrated soln for IV infusion after dilution; 4mg/100mL ready-to-use soln for IV infusion.
Pharmacological Class
Bisphosphonate.
How Supplied
Single-use vial, ready-to-use bottle—1
Manufacturer
Generic Availability
NO
Zometa Indications
Indications
Hypercalcemia of malignancy.
Limitations of Use
Not established for use in hyperparathyroidism or nontumor-related hypercalcemia.
Zometa Dosage and Administration
Adult
Give by IV infusion over at least 15mins. Albumin-corrected serum calcium ≥12mg/dL: max 4mg; allow at least 7 days before retreating.
Children
Not indicated.
Zometa Contraindications
Not Applicable
Zometa Boxed Warnings
Not Applicable
Zometa Warnings/Precautions
Warnings/Precautions
Not recommended for use in patients with bone metastases with severe renal impairment. Renal or hepatic insufficiency. Check serum creatinine before each dose: withhold until serum creatinine is within 10% of baseline if serum creatinine increases by 0.5mg/dL from a normal pre-treatment level, or by 1mg/dL from an abnormal pre-treatment level, within 2 weeks of next dose. Assure adequate hydration when treating hypercalcemia of malignancy. Correct hypocalcemia before initiating treatment; supplement with calcium and vitamin D. Closely monitor electrolytes (esp. calcium, magnesium, phosphate), CBC/differential, hematocrit, hemoglobin. Evaluate if thigh or groin pain develops and consider discontinuing if atypical femur fracture is suspected. Aspirin-sensitive asthma. Avoid invasive dental surgery (do preventative dental work before therapy). Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and after treatment. Nursing mothers: not recommended.
Zometa Pharmacokinetics
See Literature
Zometa Interactions
Interactions
Avoid concomitant other bisphosphonates. Additive hypocalcemic effect with aminoglycosides, calcitonin, loop diuretics. Caution with other nephrotoxic drugs.
Zometa Adverse Reactions
Adverse Reactions
Nausea, fatigue, anemia, musculoskeletal pain (discontinue if severe), constipation, fever, vomiting, dyspnea, flu-like syndrome, electrolyte disturbances, hypotension, CNS effects, rigors, headache, paresthesia, renal toxicity; osteonecrosis of the jaw, atypical subtrochanteric, diaphyseal femoral fractures, severe hypocalcemia.
Zometa Clinical Trials
See Literature
Zometa Note
Not Applicable
Zometa Patient Counseling
See Literature
Zometa Generic Name & Formulations
Legal Class
Rx
General Description
Zoledronic acid 4mg/5mL concentrated soln for IV infusion after dilution; 4mg/100mL ready-to-use soln for IV infusion.
Pharmacological Class
Bisphosphonate.
How Supplied
Single-use vial, ready-to-use bottle—1
Manufacturer
Generic Availability
NO
Zometa Indications
Indications
Adjunct in multiple myeloma and bone metastases of solid tumors.
Zometa Dosage and Administration
Adult
Give by IV infusion over at least 15mins. CrCl >60mL/min: 4mg; CrCl 50–60mL/min: 3.5mg; CrCl 40–49mL/min: 3.3mg; CrCl 30–39mL/min: 3mg; CrCl <30mL/min: see full labeling; all: every 3–4 weeks (give oral multivitamin supplement with calcium 500mg + Vit. D 400 IU daily).
Children
Not indicated.
Zometa Contraindications
Not Applicable
Zometa Boxed Warnings
Not Applicable
Zometa Warnings/Precautions
Warnings/Precautions
Not recommended for use in patients with bone metastases with severe renal impairment. Renal or hepatic insufficiency. Check serum creatinine before each dose: withhold until serum creatinine is within 10% of baseline if serum creatinine increases by 0.5mg/dL from a normal pre-treatment level, or by 1mg/dL from an abnormal pre-treatment level, within 2 weeks of next dose. Assure adequate hydration when treating hypercalcemia of malignancy. Correct hypocalcemia before initiating treatment; supplement with calcium and vitamin D. Closely monitor electrolytes (esp. calcium, magnesium, phosphate), CBC/differential, hematocrit, hemoglobin. Evaluate if thigh or groin pain develops and consider discontinuing if atypical femur fracture is suspected. Aspirin-sensitive asthma. Avoid invasive dental surgery (do preventative dental work before therapy). Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and after treatment. Nursing mothers: not recommended.
Zometa Pharmacokinetics
See Literature
Zometa Interactions
Interactions
Avoid concomitant other bisphosphonates. Additive hypocalcemic effect with aminoglycosides, calcitonin, loop diuretics. Caution with other nephrotoxic drugs.
Zometa Adverse Reactions
Adverse Reactions
Nausea, fatigue, anemia, musculoskeletal pain (discontinue if severe), constipation, fever, vomiting, dyspnea, flu-like syndrome, electrolyte disturbances, hypotension, CNS effects, rigors, headache, paresthesia, renal toxicity; osteonecrosis of the jaw, atypical subtrochanteric, diaphyseal femoral fractures, severe hypocalcemia.
Zometa Clinical Trials
See Literature
Zometa Note
Not Applicable
Zometa Patient Counseling
See Literature