Pamidronate Disodium

PAMIDRONATE DISODIUM- pamidronate disodium injection, solution
Teva Parenteral Medicines, Inc.

1 INDICATIONS AND USAGE

1.1 Hypercalcemia of Malignancy

Pamidronate disodium injection is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

1.2 Paget’s Disease

Pamidronate disodium injection is indicated for the treatment of patients with moderate to severe Paget’s disease of bone.

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

Pamidronate disodium injection is indicated in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma [see Clinical Studies (14.3)].

1.4 Limitations of Use

The safety and efficacy of pamidronate disodium injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Hypercalcemia of Malignancy

Vigorous saline hydration, should be initiated promptly along with pamidronate therapy and if possible the urine output should be about 2 L/day throughout treatment [see Warnings and Precautions (5.2)].

Patients who receive pamidronate disodium injection should have serum creatinine assessed prior to each treatment [see Warnings and Precautions (5.1)]. Treatment should be withheld for renal deterioration.

Moderate Hypercalcemia

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

Severe Hypercalcemia

The recommended dose of pamidronate disodium injection 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., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency/impairment.

*Albumin-corrected serum calcium = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).

Retreatment

Retreatment with pamidronate disodium injection 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. A minimum of 7 days between treatments is recommended to allow for full response to the initial dose. The dose and manner of retreatment is identical to that of the initial therapy.

2.2 Paget’s Disease

The recommended dose of pamidronate disodium injection 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. When clinically indicated, patients should be retreated at the dose of initial therapy.

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

Osteolytic Bone Metastases of Breast Cancer

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

In a clinical study, renal deterioration was defined as follows:

With normal baseline creatinine, an increase of 0.5 mg/dL.
With abnormal baseline creatinine, an increase of 1 mg/dL.

In this clinical study, pamidronate disodium 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 Studies (14.3)].

Osteolytic Bone Lesions of Multiple Myeloma

The recommended dose of pamidronate disodium injection in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion administered every four weeks.

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

Limited information is available on the use of pamidronate disodium injection in multiple myeloma patients with a serum creatinine greater than or equal to 3 mg/dL.

Patients who receive pamidronate disodium injection 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:

With normal baseline creatinine, an increase of 0.5 mg/dL.
With abnormal baseline creatinine, an increase of 1 mg/dL.

In this clinical study, pamidronate disodium 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 a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits [see Clinical Studies (14.3)].

2.5 Dilution for Administration

Hypercalcemia of Malignancy

The daily dose must be administered as an intravenous infusion over at least 2 hours and up 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 injection or 5% dextrose injection. 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 injection, or 5% dextrose injection and administered over a 4-hour period daily 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 injection or 5% dextrose injection and administered over a 2-hour period once every 3 to 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 injection, or 5% dextrose injection, and administered over a 4-hour period every four weeks.

2.6 Incompatibilities, Inspection before Use

Pamidronate disodium injection must not be mixed with calcium-containing infusion solutions such as Ringer’s solution. Administer as a single intravenous solution and infuse using an intravenous line reserved for pamidronate alone.

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

3 DOSAGE FORMS AND STRENGTHS

Injection: 30 mg/10 mL solution in single-use vial

Injection: 90 mg/10 mL solution in single-use vial

4 CONTRAINDICATIONS

Pamidronate disodium is contraindicated in patients with hypersensitivity to pamidronate disodium, other bisphosphonates, or mannitol. Reactions to pamidronate disodium injection and to mannitol have included anaphylaxis.

5 WARNINGS AND PRECAUTIONS

5.1 Deterioration in Renal Function, Use in Patients with Renal Impairment

Bisphosphonates, such as pamidronate disodium, have been associated with renal toxicity, including focal segmental glomerulosclerosis. This toxicity has been manifested as nephritic syndrome, deterioration of renal function, and renal failure. Renal failure has been reported in patients after a single dose of pamidronate disodium. Some patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Do not administer single doses of pamidronate disodium in excess of 90 mg due to the risk of clinically significant deterioration in renal function, [see Dosage and Administration (2.5)] .

Assess serum creatinine prior to each treatment. Withhold treatment until renal function returns to baseline in patients who show evidence of deterioration in renal function. Do not administer pamidronate in patients with severe renal impairment for the treatment of bone metastases [see Dosage and Administration (2.1, 2.2, 2.3)].

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