Action

Inhibits osteoclast-mediated bone by blocking resorption of mineralized bone and cartilage, eventually causing cell death and limiting tumor growth. Also limits calcium release produced by tumor.

Availability

Concentrate for dilution for infusion (Zometa): 4 mg/5 ml single-use vial

Solution for infusion (Reclast): 5 mg/100 ml in ready-to-infuse bottles

Solution for infusion (Zometa): 4 mg/100 ml in single-use ready-to-use bottles

Indications and dosages

➣ Hypercalcemia caused by cancer

Adults: 4 mg (Zometa) I.V. as a single dose infused over 15 minutes. If albumin-corrected calcium level doesn't return to normal or stay normal, retreatment with 4 mg I.V. begins no sooner than 7 days after initial treatment. For single dose, maximum recommended dosage is 4 mg.

➣ Multiple myeloma; bone metastasis from solid tumors in conjunction with standard antineoplastic therapy

Adults: 4 mg I.V. (Zometa) as a single dose infused over 15 minutes q 3 to 4 weeks for patients with creatinine clearance greater than 60 ml/minute. Optimal duration of therapy is unknown.

➣ Paget's disease of bone

Adults: 5 mg (Reclast) I.V. as single dose in 100 ml ready-to-infuse solution infused over 15 minutes with constant infusion rate by vented infusion line

➣ Treatment of osteoporosis in men and postmenopausal women

Adults: 5 mg (Reclast) I.V. as single 5-mg infusion over 15 minutes once yearly

➣ Prevention of osteoporosis in postmenopausal women

Adults: 5 mg (Reclast) I.V. as single 5-mg infusion over 15 minutes once every 2 years

➣ Treatment and prevention of glucocorticoid-induced osteoporosis

Adults: 5 mg (Reclast) I.V. as single 5-mg infusion over 15 minutes once yearly

Dosage adjustment

• Renal impairment (Zometa)

Contraindications

• Hypersensitivity to drug or its components

• Hypocalcemia (Reclast)

• Patients with creatinine clearance less than 35 ml/minute and those with evidence of acute renal impairment (Reclast)

Precautions

Use cautiously in:

• bone metastasis with severe renal impairment (use not recommended)

• asthma, renal dysfunction, hepatic insufficiency, history of hypoparathyroidism

• pregnant patients (avoid Reclast use)

• concurrent use of nephrotoxic drugs

• breastfeeding patients

• children (use not indicated)

Administration

• Before starting therapy, make sure patient is adequately hydrated.

• Don't allow drug to come in contact with calcium-containing solutions; administer as single I.V. solution.

• Reconstitute Zometa concentrate for infusion by adding 5 ml of sterile water for injection to 4-mg vial. Dilute further by adding reconstituted drug to 100 ml of normal saline solution or dextrose 5% in water.

See To avoid inadvertent injection of undiluted Zometa concentrate for infusion, don't store undiluted drug in a syringe.

• Be aware that Zometa ready-to-use solution for infusion (for single-use only) may be administered directly without further preparation.

• To prepare reduced Zometa dosages for patients with baseline creatinine clearance of 60 ml/minute or less, see manufacturer's directions.

• Give Reclast I.V. in 100 ml ready-to-infuse solution administered by vented infusion line. Infusion time must not be less than 15 minutes, with constant infusion rate. Following infusion, flush I.V. line with 10 ml normal saline.

• Be aware that a single Reclast dose shouldn't exceed 5 mg.

See Give by I.V. infusion over no less than 15 minutes. (Faster infusion may cause renal failure.)

• Be aware that all patients must be adequately supplemented with oral calcium and vitamin D daily during treatment with this drug.

Adverse reactions

CNS: dizziness, lethargy, rigors, asthenia, headache, agitation, confusion, insomnia, anxiety, drowsiness, fatigue, paresthesia

CV: hypotension

EENT: conjunctivitis

GI: nausea, vomiting, diarrhea, constipation, dysphagia, anorexia

GU: urinary tract infection, renal toxicity

Hematologic: anemia, neutropenia

Metabolic: dehydration, hypomagnesemia, hypocalcemia, hypophosphatemia

Musculoskeletal: myalgia, joint or bone pain, osteonecrosis of jaw, atypical subtrochanteric and diaphyseal femoral fractures

Respiratory: dyspnea, cough, pleural effusion

Skin: rash

Other: flulike syndrome, pyrexia, pain, peripheral edema, infection, fever, chills, infusion site reactions, hypersensitivity reactions (including rare cases of urticaria, angioedema, and anaphylactic reaction or shock)

Interactions

Drug-drug. Aminoglycosides, loop diuretics, other nephrotoxic agents, thalidomide: increased risk of renal toxicity

Drug-diagnostic tests. Calcium, hemoglobin, magnesium, phosphorus, platelets, potassium, red blood cells, white blood cells: decreased levels

Creatinine: increased or decreased level

Patient monitoring

• Monitor electrolyte levels (especially calcium). Watch for signs and symptoms of electrolyte imbalance.

• Assess vital signs. Stay alert for hypotension, dyspnea, and pleural effusion.

See Closely monitor fluid intake and output and creatinine level. Check for signs and symptoms of renal toxicity.

• Monitor CBC with platelet count.

See Be aware that drug may cause atypical femur fractures. Evaluate patient with thigh or groin pain and consider discontinuing or interrupting therapy based on an individual benefit-risk assessment. Also, if severe incapacitating bone, joint, or muscle pain occurs, withhold drug.

Patient teaching

• Explain therapy to patient, including associated risk of renal failure and need for follow-up laboratory tests.

• Tell patient to report shortness of breath, unusual bleeding or bruising, decreased urine output, or other significant problems.

• Instruct patient to take daily oral calcium supplement and multivitamin containing vitamin D as prescribed.

• Tell patient to avoid invasive dental procedures while taking this drug.

• Advise female of childbearing age to avoid pregnancy and breastfeeding.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.