ZOLEDRONIC ACID
(zo-le-dron'ic)
Zometa
Classifications: bisphosphonate; regulator, bone metabolism
Prototype: Etidronate Disodium
Pregnancy Category: D

Availability

4 mg vial

Actions

Zoledronic acid inhibits bone resorption by inhibiting osteoclastic activity and inducing osteoclast apoptosis. Zoledronic acid also blocks osteoclastic resorption of bone and cartilage. It inhibits various stimulatory factors of osteoclastic activity by bone tumors.

Therapeutic Effects

Zoledronic acid inhibits osteoclastic activity and sketetal calcium release induced by various stimulatory factors released by bone tumors.

Uses

Treatment of hypercalcemia of malignancy, multiple myeloma, and bony metastases from solid tumors.

Unlabeled Uses

Paget's disease.

Contraindications

Hypersensitivity to zoledronic acid or other bisphosphonates; preexisting hypocalcemia; serum creatinine of 0.5 mg/dL; pregnancy (category D).

Cautious Use

Lactation, renal, and/or hepatic impairment; dental work; concurrent administration of aminoglycosides, or loop diuretics; older adults. Safety and effectiveness of zoledronic acid in pediatric patients have not been established.

Route & Dosage

Hypercalcemia of Malignancy
Adult: IV 4 mg over a minimum of 15 min. May consider retreatment if serum calcium has not returned to normal, may repeat after 7 d

Multiple Myeloma and Bony Metastases from Solid Tumors
Adult: IV 4 mg over a minimum of 15 min q 3–4 wk

Paget's Disease
Adult: IV A single dose of 200 mcg or 400 mcg

Renal Impairment
Dose in renal insufficiency: Cl_cr >60 mL/min = 4 mg; Cl_cr 50–60 mL/min = 3.5 mg; Cl_cr 40–49 mL/min = 3.3 mg; Cl_cr 30–39 mL/min = 3.0 mg

Administration

Intravenous

Do not administer to anyone who is dehydrated or suspected of being dehydrated. Consult physician.
Do not administer zoledronic acid unless patient is adequately rehydrated.
Do not administer until serum creatinine values have been evaluated by the physician.

PREPARE: IV Infusion: Reconstitute by adding 5 mL of sterile water for injection to each vial. Withdraw the entire contents of the vial (4 mg) and further dilute in 100 mL of D5W or NS. Do not use Lactated Ringer's solution. If not used immediately, refrigerate. The total time between reconstitution and end of infusion must not exceed 24 h.

ADMINISTER: IV Infusion: Infuse 4 mg or less (NEVER MORE) over NO LESS than 15 min.

INCOMPATIBILITIES Solution/additive and Y-site: Do not mix or infuse with calcium-containing solutions (e.g., Ringer's Lactate).

Store at 2°–8° C (36°–46° F) follow reconstitution. Must be completely infused within 24 h of reconstitution.

Adverse Effects (1%)

Body as a Whole: Fever, flu-like syndrome, redness and swelling at injection site, asthenia, chest apin, leg edema, mucositis, rigors. CNS: Insomnia, anxiety, confusion, agitation, headache, somnolence. CV: Hypotension. GI: Nausea, vomiting, constipation, abdominal pain, anorexia, dysphagia. Hematologic: Anemia, granulocytopenia, thrombocytopenia, pancytopenia. Metabolic: Hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia, dehydration. Musculoskeletal: Skeletal pain, arthralgias, osteonecrosis of the jaw in cancer patients. Respiratory: Dyspnea, cough, pleural effusion. Skin: Alopecia, dermatitis. Urogenital: Renal deterioration [increase in serum creatinine (SCr)].

Interactions

Drug: loop diuretics may increase risk of hypocalcemia; thalidomide and other nephrotoxic drugs may increase risk of renal toxicity.

Pharmacokinetics

Onset: 4–10 d. Duration: 3–4 wk. Metabolism: Not metabolized. Elimination: Excreted in urine. Half-Life: 146 h.

Nursing Implications

Assessment & Drug Effects

Lab tests: Baseline renal function tests prior to each dose and periodically thereafter; periodic ionized calcium or corrected serum calcium (CSC) levels, serum phosphate and magnesium, electrolytes, CBC with differential, Hct and Hgb.
Notify physician immediately of deteriorating renal function as indicated by rising serum creatinine levels over baseline value.
Withhold subsequent doses of zoledronic acid if serum creatinine is not within 10% of the baseline value. Consult physician.
Monitor closely patient's hydration status. Note that loop diuretics should be used with caution due to the risk of hypocalcemia.
Monitor for S&S of bronchospasm in aspirin-sensitive asthma patients; notify physician immediately.

Patient & Family Education

Maintain adequate daily fluid intake. Consult with physician for guidelines.
Report unexplained weakness, tiredness, irritation, muscle pain, insomnia, or flu-like symptoms.
Do not breast feed without consulting physician.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug