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Aredia

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Aredia

Indications
Dosage
How Supplied

INDICATIONS

Hypercalcemia of Malignancy

Aredia, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with Aredia. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of Aredia in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

Paget's Disease

Aredia is indicated for the treatment of patients with moderate to severe Paget's disease of bone. The effectiveness of Aredia was demonstrated primarily in patients with serum alkaline phosphatase ≥ 3 times the upper limit of normal. Aredia therapy in patients with Paget's disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥ 50% in at least 50% of patients, and by ≥ 30% in at least 80% of patients. Aredia therapy has also been effective in reducing these biochemical markers in patients with Paget's disease who failed to respond, or no longer responded to other treatments.

Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma

Aredia is indicated, in conjunction with standard antineoplastic therapy, for the treatment of Osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. The Aredia treatment effect appeared to be smaller in the study of breast cancer patients receiving hormonal therapy than in the study of those receiving chemotherapy, however, overall evidence of clinical benefit has been demonstrated (see CLINICAL PHARMACOLOGY, Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma, Clinical Trials section).

DOSAGE AND ADMINISTRATION

Hypercalcemia of Malignancy

Consideration should be given to the severity of as well as the symptoms of hypercalcemia. Vigorous saline hydration alone may be sufficient for treating mild, asymptomatic hypercalcemia. Overhydration should be avoided in patients who have potential for cardiac failure. In hypercalcemia associated with hematologic malignancies, the use of glucocorticoid therapy may be helpful.

Moderate Hypercalcemia

The recommended dose of Aredia in moderate hypercalcemia (corrected serum calcium* of approximately 12-13.5 mg/dL) is 60 to 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., > 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.

Severe Hypercalcemia

The recommended dose of Aredia in severe hypercalcemia (corrected serum calcium* > 13.5 mg/dL) is 90 mg given as a SINGLE-DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., > 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.

Retreatment

A limited number of patients have received more than one treatment with Aredia for hypercalcemia. Retreatment with Aredia, in patients who show complete or partial response initially, may be carried out if serum calcium does not return to normal or remain normal after initial treatment. It is recommended that a minimum of 7 days elapse before retreatment, to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.

Paget's Disease

The recommended dose of Aredia in patients with moderate to severe Paget's disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.

Retreatment

A limited number of patients with Paget's disease have received more than one treatment of Aredia in clinical trials. When clinically indicated, patients should be retreated at the dose of initial therapy.

Osteolytic Bone Lesions of Multiple Myeloma

The recommended dose of Aredia in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.

Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to Aredia infusion.

Limited information is available on the use of Aredia in multiple myeloma patients with a serum creatinine > 3.0 mg/dL.

Patients who receive Aredia should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:

  • For patients with normal baseline creatinine, increase of 0.5 mg/dL.
  • For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.

In this clinical study, Aredia treatment was resumed only when the creatinine returned to within 10% of the baseline value.

The optimal duration of therapy is not yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials section).

Osteolytic Bone Metastases of Breast Cancer

The recommended dose of Aredia in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3-4 weeks.

Aredia has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megesterol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide.

Patients who receive Aredia should have serum creatinine assessed prior to each treatment. Treatment should be withheld for renal deterioration. In a clinical study, renal deterioration was defined as follows:

  • For patients with normal baseline creatinine, increase of 0.5 mg/dL.
  • For patients with abnormal baseline creatinine, increase of 1.0 mg/dL.

In this clinical study, Aredia treatment was resumed only when the creatinine returned to within 10% of the baseline value.

The optimal duration of therapy is not known, however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits (see Clinical Trials section).

Calcium and Vitamin D Supplementation

In the absence of hypercalcemia, patients with predominantly lytic bone metastases or multiple myeloma, who are at risk of calcium or vitamin D deficiency, and patients with Paget's disease of the bone, should be given oral calcium and vitamin D supplementation in order to minimize the risk of hypocalcemia.

Preparation of Solution

Reconstitution

Aredia is reconstituted by adding 10 mL of Sterile Water for Injection, USP, to each vial, resulting in a solution of 30 mg/10 mL or 90 mg/10 mL. The pH of the reconstituted solution is 6.0-7.4. The drug should be completely dissolved before the solution is withdrawn.

Method of Administration

DUE TO THE RISK OF CLINICALLY SIGNIFICANT DETERIORATION IN RENAL FUNCTION, WHICH MAY PROGRESS TO RENAL FAILURE, SINGLE DOSES OF AREDIA SHOULD NOT EXCEED 90 MG. (SEE WARNINGS.)

There must be strict adherence to the intravenous administration recommendations for Aredia in order to decrease the risk of deterioration in renal function.

Hypercalcemia of Malignancy

The daily dose must be administered as an intravenous infusion over at least 2 to 24 hours for the 60-mg and 90-mg doses. The recommended dose should be diluted in 1000 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP. This infusion solution is stable for up to 24 hours at room temperature.

Paget's Disease

The recommended daily dose of 30 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period for 3 consecutive days.

Osteolytic Bone Metastases of Breast Cancer

The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 2-hour period every 3-4 weeks.

Osteolytic Bone Lesions of Multiple Myeloma

The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% Sodium Chloride, USP, or 5% Dextrose Injection, USP, and administered over a 4-hour period on a monthly basis.

Aredia must not be mixed with calcium-containing infusion solutions, such as Ringer's solution, and should be given in a single intravenous solution and line separate from all other drugs.

Note: Parenteral drug products should be inspected visually for participate matter and discoloration prior to administration, whenever solution and container permit.

Aredia reconstituted with Sterile Water for Injection may be stored under refrigeration at 2°C-8°C (36°F-46°F) for up to 24 hours.

*Albumin-corrected serum calcium (CCa,mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).

HOW SUPPLIED

Vials -30 mg - each contains 30 mg of sterile, lyophilized pamidronate disodium and 470 mg of mannitol, USP.

Carton of 4 vials..........................................................NDC 0078-0463-91

Vials - 90 mg - each contains 90 mg of sterile, lyophilized pamidronate disodium and 375 mg of mannitol, USP.

Carton of 1 vial...........................................................NDC 0078-0464-61

Do not store above 30°C (86°F).

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: 05/2012

Last reviewed on RxList: 6/21/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
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How Supplied
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