Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma

Zometa(R):
4 mg IV over no less than 15 minutes, every 3 to 4 weeks

Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.

Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors

Zometa(R):
4 mg IV over no less than 15 minutes, every 3 to 4 weeks

Comments: Oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily are recommended.

Uses: Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy

Usual Adult Dose for Hypercalcemia of Malignancy

Zometa(R):

• Maximum dose: Single dose of 4 mg IV infusion over no less than 15 minutes

Comments: If serum calcium does not return to normal, retreatment should be considered after a minimum of 7 elapsed days.

Use: Treatment of hypercalcemia of malignancy (albumin-corrected calcium equal 12 mg/dL or grater)

Usual Adult Dose for Paget's Disease

Reclast(R):
5 mg IV infusion, at a constant infusion rate, over no less than 15 minutes

Calcium and vitamin D supplementation:

• Calcium: 750 mg elemental calcium orally twice a day, or 500 mg orally three times a day
• Vitamin D: 800 international units orally daily, especially in the 2 weeks following drug administration

Comments: Retreatment may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase or failure to achieve normalization of serum alkaline phosphatase.

Uses: Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than upper limit of age- specific normal reference range

Usual Adult Dose for Osteoporosis

Reclast(R):
5 mg IV infusion over no less than 15 minutes, once a year

Comments: An average of at least 1200 mg calcium and 800 to 1000 international units vitamin D daily is recommended.

Uses:

• Osteoporosis in postmenopausal women, diagnosed by bone mineral density or prevalent vertebral fracture (this drug reduces the incidence of fractures).
• To increase bone mass in men with osteoporosis.
• Treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Usual Adult Dose for Prevention of Osteoporosis

Reclast(R):
5 mg IV infusion over no less than 15 minutes, every 2 years

Uses:

• Prevention of osteoporosis in postmenopausal women.
• Prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months.

Renal Dose Adjustments

Zometa(R):
Hypercalcemia of Malignancy:

• Mild to moderate renal dysfunction: No adjustment recommended.
• Severe renal dysfunction: Dose adjustment may be required; however, no specific guidelines have been suggested.

Multiple myeloma and metastatic bone lesions of solid tumors:

• CrCl 50 to 60 mL/min: 3.5 mg IV infusion
• CrCl 40 to 49 mL/min: 3.3 mg IV infusion
• CrCl 30 to 39 mL/min: 3 mg IV infusion
• CrCl 29 mL/min or less: Not recommended

Reclast(R):

• CrCl 35 mL/min or greater: No adjustment recommended.
• CrCl less than 35 mL/min: Contraindicated

Comments:

• During treatment, serum creatinine should be measured before each dose of this drug and treatment should be withheld if renal deterioration occurs.
• Renal deterioration was defined as follows: An increase of 0.5 mg/dL for patients with normal serum creatinine baseline, and an increase of 1 mg/dL for patients with abnormal serum creatinine baseline.
• Treatment with this drug should be resumed only when the creatinine return to within 10% of the baseline value; and the reinitiating dosage should be the same as before treatment interruption.

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• IV Infusion time should not be less than 15 minutes given over a constant infusion rate.
• The IV infusion should be followed by a 10 mL normal saline flush of the intravenous line.
• Solution for infusion should not be allowed to come in contact with any calcium or other divalent cation-containing solutions, such as lactated ringers, and should be administered as a single intravenous solution through a separate vented infusion line.
• Patients should be appropriately hydrated prior to administration of this drug.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
• Administration of acetaminophen following administration of this drug may reduce the incidence of acute-phase reaction symptoms.

General:

• Patients being treated with Zometa(R) should not be treated with brands Reclast(R), Aclasta(R), or any other bisphosphonate.
• Patients on bisphosphonate therapy should reevaluate continuation of the therapy on a periodic basis.
• Acute phase reaction commonly occurs within the first three days following the administration of this drug and may include fever, flu-like symptoms, myalgia, arthralgia and headache.

Monitoring:

• Metabolic: Serum calcium, electrolytes, phosphate, magnesium
• Hematologic: CBC, hematocrit/hemoglobin
• Renal: Serum creatinine/creatinine clearance before, during, and after treatment

Patient advice:

• Patients should tell their doctor if they have kidney problems before starting treatment with this drug.
• Patients should have a dental examination prior to treatment with this drug and should avoid invasive dental procedures during treatment.
• Additional oral daily calcium and vitamin supplementation are important during treatment with this drug.