Pamidronate Disodium (Page 8 of 8)

Osteolytic Bone Lesions of Multiple Myeloma

The recommended dose of pamidronate disodium 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 pamidronate disodium infusion.

Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine ≥3 mg/dL.

Patients who receive pamidronate disodium 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 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 yet known, however, in a study of patients with myeloma, final analysis after 21 months demonstrated overall benefits (see Clinical Trials).

Osteolytic Bone Metastases of Breast Cancer

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

Pamidronate disodium has been frequently used with doxorubicin, fluorouracil, cyclophosphamide, methotrexate, mitoxantrone, vinblastine, dexamethasone, prednisone, melphalan, vincristine, megestrol, and tamoxifen. It has been given less frequently with etoposide, cisplatin, cytarabine, paclitaxel, and aminoglutethimide. Patients who receive pamidronate disodium 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 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 Trials).

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.

Method of Administration

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

There must be strict adherence to the intravenous administration recommendations for pamidronate disodium 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 injection, or 5% dextrose injection. This infusion solution is stable for up to 24 hours of 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 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 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 on a monthly basis.

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

HOW SUPPLIED

Pamidronate Disodium Injection is supplied as follows:

30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. NDC 10139-306-10 , individually boxed.

90 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 9 mg/mL. NDC 10139-307-10 , individually boxed.

Store at 20° to 25°C (68° to77°F) [see USP controlled room temperature].

*Zometa ® is a registered trademark of Novartis Pharmaceuticals Corporation.

Manufactured for:

GeneraMedix Inc.

150 Allen Road

Liberty Corner, NJ 07938

Manufactured by:

Mustafa Nevzat İlaç Sanayii A.Ş.

Saatçi Bayırı, Prof. Dr. Bülent Tarcan Sokak, # 5/1

34349 Gayrettepe / İstanbul -Turkey

January 2009

PI30600.01

PAMIDRONATE DISODIUM
pamidronate disodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10139-306
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMIDRONATE DISODIUM (PAMIDRONIC ACID) PAMIDRONIC ACID 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 47 mg in 1 mL
WATER
PHOSPHORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-306-10 10 mL (10 MILLILITER) in 1 VIAL None
PAMIDRONATE DISODIUM
pamidronate disodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10139-307
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAMIDRONATE DISODIUM (PAMIDRONIC ACID) PAMIDRONIC ACID 9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 37.5 mg in 1 mL
WATER
PHOSPHORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-307-10 10 mL (10 MILLILITER) in 1 VIAL None
Labeler — GeneraMedix, Inc.

Revised: 02/2009 GeneraMedix, Inc.

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