Metastatic Bone Lesions from Solid Tumors and Multiple Myeloma—Including Breast, Prostate, and Lung Cancer

Recommended ZOMETA dosage

	Bone Health Nurses Program Creatinine Clearance Calculator Infusion Instructions

The recommended dose of ZOMETA in patients with multiple myeloma and in patients with metastatic bone lesions from solid tumors—including breast, lung, prostate and other solid tumors―is 4 mg infused over no less than 15 minutes every three or four weeks.[1] View Dosing and Administration or Infusion Instructions.

Duration of bisphosphonate therapy

In 2003, the American Society of Clinical Oncology (ASCO) updated the 2000 guidelines on the role of bisphosphonates in women with breast cancer.[2] The panel suggests that once initiated, intravenous bisphosphonates be continued until there is evidence of substantial decline in a patient’s general performance status.[2]

The optimal duration of therapy is not known. Clinical study data was analyzed at 24 months for prostate cancer, 12 months for breast cancer and multiple myeloma, and 9 months for other solid tumors.

Hypercalcemia of Malignancy

The maximum dose of ZOMETA in hypercalcemia of malignancy is 4 mg, given as a single intravenous infusion over no less than 15 minutes.[1] View Dosing and Administration or Infusion Instructions.

Hypercalcemia of malignancy is defined as albumin-corrected serum calcium ≥ 12 mg/dL (3.0 mmol/L).

Serum creatinine should be measured before each ZOMETA dose and treatment should be withheld for renal deterioration

Because ZOMETA, like other bisphosphonates, has been associated with deterioration of renal function, it is imperative to check creatinine levels in your patients for whom you prescribe ZOMETA. Withhold treatment if renal deterioration occurs, defined as follows:

• normal baseline creatinine (<1.4 mg/mL) - increase ≥ 0.5 mg/dL
• abnormal baseline creatinine (≥1.4mg/mL) - increase ≥ 1.0 mg/dL

Reinitiate treatment at the same dose received prior to treatment interruption when serum creatinine returns to within 10% of baseline.

Our infusion log can help you manage and track infusions in your patients. To access the ZOMETA Infusion log, click here.

Current dosing recommendations for patients with reduced baseline renal function

ZOMETA should be administered over no less than 15 minutes every 3 or 4 weeks as follows:

[†]Doses calculated assuming target AUC of .66(mg • nh/L) (CLcr=75 mL/min).

Upon initiation of ZOMETA therapy, apply the following guidelines:

• For patients with creatinine clearance >60 mL/min, the recommended dose remains 4 mg
• For patients with reduced creatinine clearance, dosing is calculated to achieve the same AUC as in patients with creatinine clearance of
  75 mL/min[†*]

Use our convenient creatinine clearance calculator.

Withhold treatment if renal deterioration occurs.[‡]

Re-initiate treatment at the same dose received prior to treatment interruption when serum creatinine returns to within 10% of baseline.

Patients should receive daily oral calcium 500 mg and a multiple vitamin containing 400 IU vitamin D.

[†]Doses calculated assuming target AUC of 0.66 (mg•hr/L) (CrCl)=75 mL/min).

*Creatinine clearance calculated using Cockcroft-Gault formula, below.

[‡]Defined as an increase of 0.5 mg/dL for patients with normal baseline creatinine (<1.4 mg/dL) or an increase of 1.0 mg/dL for patients with abnormal baseline creatinine (≥1.4 mg/dL).

1. ZOMETA full prescribing information. Novartis Pharmaceuticals Corporation, 2002.
   
2. Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 Update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003; 21:4042-4057. Accessed September 22, 2005 at: http://www.jco.org/cgi/content/full/21/21/4042.