ZOMETA Rx

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ZOMETA

Cytoprotective and supportive care agents
Leukemias, lymphomas, and other hematologic cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Zoledronic acid 4mg/5mL concentrated soln for IV infusion after dilution; 4mg/100mL ready-to-use soln for IV infusion.

Select therapeutic use:

Indications for ZOMETA:

Hypercalcemia of malignancy.

Limitations Of use:

Not established for use in hyperparathyroidism or nontumor-related hypercalcemia.

Adult:

Give by IV infusion over at least 15 minutes. Albumin-corrected serum calcium ≥12mg/dL: max 4mg; allow at least 7 days before retreating.

Children:

Not recommended.

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 0.5 mg/dL from a normal pre-treatment level, or by 1 mg/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 dental surgery (do preventative dental work before therapy). Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

Avoid concomitant other bisphosphonates. Additive hypocalcemic effect with aminoglycosides, loop diuretics. Caution with other nephrotoxic drugs, calcitonin.

Pharmacological Class:

Bisphosphonate.

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.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Single-use vial, ready-to-use bottle—1

ZOMETA 5ml of 4mg/5ml vials (Qty:1)

appx. price $933.00

Indications for ZOMETA:

Adjunct in multiple myeloma and bone metastases of solid tumors.

Limitations Of use:

Not established for use in hyperparathyroidism or nontumor-related hypercalcemia.

Adult:

Give by IV infusion over at least 15 minutes. 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 recommended.

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 0.5 mg/dL from a normal pre-treatment level, or by 1 mg/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 dental surgery (do preventative dental work before therapy). Elderly. Pregnancy (Cat.D). Nursing mothers: not recommended.

Interactions:

Avoid concomitant other bisphosphonates. Additive hypocalcemic effect with aminoglycosides, loop diuretics. Caution with other nephrotoxic drugs, calcitonin.

Pharmacological Class:

Bisphosphonate.

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.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Single-use vial, ready-to-use bottle—1

ZOMETA 5ml of 4mg/5ml vials (Qty:1)

appx. price $933.00