AREDIA (pamidronate disodium) INDICATIONS AND USAGE

Hypercalcemia of Malignancy
AREDIA (pamidronate disodium), in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

Paget's Disease
AREDIA (pamidronate disodium) is indicated for the treatment of patients with moderate to severe Paget's disease of bone.

Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma
AREDIA (pamidronate disodium) is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

AREDIA (pamidronate disodium) DESCRIPTION
AREDIA, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg, 60-mg, or 90-mg vials for intravenous administration. Each 30-mg, 60-mg, and 90-mg vial contains, respectively, 30 mg, 60 mg, and 90 mg of sterile, lyophilized pamidronate disodium and 470 mg, 400 mg, and 375 mg of mannitol, USP. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. AREDIA, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt , pentahydrate, (APD).

IMPORTANT SAFETY INFORMATION

AREDIA (pamidronate disodium) is contraindicated in patients with clinically significant hypersensitivity to bisphosphonates or any of the excipients in the formulation.

Due to the risk of clinically significant deterioration in renal function, which may progress to renal failure, single doses of AREDIA (pamidronate disodium) should not exceed 90 mg and the duration of infusion should be no less than 2 hours. Risk factors for the deterioration of renal function include elevated baseline creatinine and multiple cycles of bisphosphonate treatment.

AREDIA (pamidronate disodium) is not recommended in patients with severe renal impairment. Serum creatinine should be measured before each dose and treatment should be withheld for renal deterioration. In the clinical studies, patients with serum creatinine >3.0 mg/dL were excluded, renal deterioration was defined as an increase of 0.5 mg/dL for patients t with normal baseline creatinine and an increase of 1.0 mg/dL for patients with abnormal baseline creatinine. Treatment was resumed only when the creatinine returned to within 10% of the baseline value.

AREDIA (pamidronate disodium) is excreted intact primarily via the kidney, and the risk of renal adverse reactions may be greater in patients with impaired renal function. Patients who receive AREDIA (pamidronate disodium) should have serum creatinine assessed prior to each treatment. In patients receiving AREDIA (pamidronate disodium) for bone metastases, who show evidence of deterioration in renal function, AREDIA (pamidronate disodium) treatment should be withheld until renal function returns to baseline.

Pregnancy Category D. AREDIA (pamidronate disodium) should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Osteonecrosis of the Jaw (ONJ) has been reported in patients with cancer receiving treatment including bisphosphonates, chemotherapy, and/or corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors. While on treatment, these patients should avoid invasive dental procedures if possible. No data are available as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship between bisphosphonate use and ONJ has not been established.

In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.

The most common adverse events in bone metastases clinical trials regardless of causality were as follows: Fluid overload, generalized pain, hypertension, abdominal pain, anorexia, constipation, nausea, vomiting, urinary tract infection, bone pain, fever, back pain, arthrosis, headache, anemia, hypocalcemia, arthralgias, myalgias, and dyspnea.

Caution is advised when IV bisphosphonates are administered with potentially nephrotoxic drugs.

Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Click here for full prescribing information.