Pamidronate Disodium
Generic Name: pamidronate disodium
Brand Names:
Pamidronate Disodium
11 DESCRIPTION Pamidronate Disodium Injection is a bisphosphonate available in 30 mg and 90 mg vials for intravenous administration. Each mL of the 30 mg/10 mL vial contains 3 mg pamidronate disodium, 47 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. Each mL of the 90 mg/10 mL vial contains, 9 mg pamidronate disodium, 37.5 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0.
Overview
11 DESCRIPTION Pamidronate Disodium Injection is a bisphosphonate available in 30 mg and 90 mg vials for intravenous administration. Each mL of the 30 mg/10 mL vial contains 3 mg pamidronate disodium, 47 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. Each mL of the 90 mg/10 mL vial contains, 9 mg pamidronate disodium, 37.5 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0.
Uses
1 INDICATIONS AND USAGE Pamidronate disodium is a bisphosphonate indicated for the treatment of: • moderate or severe hypercalcemia associated with malignancy, with or without bone metastases ( 1.1 ) • patients with moderate to severe Paget’s disease of bone ( 1.2 ) • osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy ( 1.3 ) Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
Dosage
2 DOSAGE AND ADMINISTRATION • Hypercalcemia of malignancy: 60 mg to 90 mg pamidronate disodium as a single dose infused over 2 hours to 24 hours for moderate hypercalcemia, or 90 mg as a single dose infused over 2 hours to 24 hours for severe hypercalcemia. If warranted, retreat after a minimum of 7 days. ( 2.1 ) • Paget’s disease of bone: 30 mg pamidronate disodium daily as a 4-hour infusion on 3 consecutive days. ( 2.2 ) • Osteolytic Bone Metastases of Breast Cancer: 90 mg pamidronate disodium as a 2-hour infusion every 3 to 4 weeks. Retreat after recovery of renal function. ( 2.3 ) • Osteolytic Bone Lesions of Multiple Myeloma: 90 mg pamidronate disodium as a 4-hour infusion once every four weeks. Retreat after recovery of renal function.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Deterioration in renal function [see Warnings and Precautions (5.1) ] - Electrolyte disorders [see Warnings and Precautions (5.3) ] - Osteonecrosis of the jaw [see Warnings and Precautions (5.4) ] - Atypical fractures of the femur [see Warnings and Precautions (5.5) ] Most common adverse reactions per indication: • Hypercalcemia of malignancy (≥ 15%): Fever, nausea, infusion site reactions, hypocalcemia, hypophosphatemia ( 6.1 ) • Paget’s disease (≥ 10%): Temperature increase, hypertension, arthrosis, bone pain, headache ( 6.1 ) • Osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma (≥ 30%): Skeletal pain, nausea, anemia, fever, fatigue, v...
Interactions
7 DRUG INTERACTIONS • Nephrotoxic drugs: Use with caution. ( 7.1 ) • Thalidomide: Increased risk of renal dysfunction in patients with multiple myeloma. ( 7.2 ) 7.1 Nephrotoxic Drugs Caution is indicated when pamidronate disodium is used with other potentially nephrotoxic drugs. 7.2 Thalidomide In multiple myeloma patients, the risk of renal deterioration may be increased when pamidronate disodium is used in combination with thalidomide. 7.3 Loop Diuretics Concomitant administration of a loop diuretic had no effect on the calcium-lowering action of pamidronate disodium.
Warnings
5 WARNINGS AND PRECAUTIONS • Renal failure: Do not exceed single doses of 90 mg pamidronate disodium. Assess renal function before each treatment. In patients with bone metastases with severe renal impairment, use of pamidronate disodium is not recommended. ( 5.1 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) • Electrolyte disorders (e.g., hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia): Monitor phosphorus, potassium, magnesium, calcium and vitamin D and adequately supplement as appropriate. ( 5.3 ) • Osteonecrosis of the jaw: Perform preventive dental procedures prior to initiating pamidronate disodium. 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. Hypersensitivity to pamidronate, other bisphosphonates, or mannitol ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , pamidronate disodium can cause fetal harm when administered to a pregnant woman. Available data from case reports with pamidronate disodium use in pregnant women are insufficient to inform a drug-associated risk. Administration of pamidronate to pregnant rats and rabbits resulted in maternal toxicity and embryo-fetal effects (see Data ) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Pamidronate Disodium Injection is available as follows: 30 mg/10 mL (3 mg/mL) single-dose vial as a clear-colorless solution containing 30 mg of pamidronate disodium and 470 mg of mannitol in 10 mL water for injection.
Frequently Asked Questions
What is Pamidronate Disodium used for?▼
1 INDICATIONS AND USAGE Pamidronate disodium is a bisphosphonate indicated for the treatment of: • moderate or severe hypercalcemia associated with malignancy, with or without bone metastases ( 1.1 ) • patients with moderate to severe Paget’s disease of bone ( 1.2 ) • osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy ( 1.3 ) Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
What are the side effects of Pamidronate Disodium?▼
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Deterioration in renal function [see Warnings and Precautions (5.1) ] - Electrolyte disorders [see Warnings and Precautions (5.3) ] - Osteonecrosis of the jaw [see Warnings and Precautions (5.4) ] - Atypical fractures of the femur [see Warnings and Precautions (5.5) ] Most common adverse reactions per indication: • Hypercalcemia of malignancy (≥ 15%): Fever, nausea, infusion site reactions, hypocalcemia, hypophosphatemia ( 6.1 ) • Paget’s disease (≥ 10%): Temperature increase, hypertension, arthrosis, bone pain, headache ( 6.1 ) • Osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma (≥ 30%): Skeletal pain, nausea, anemia, fever, fatigue, v...
Can I take Pamidronate Disodium during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , pamidronate disodium can cause fetal harm when administered to a pregnant woman. Available data from case reports with pamidronate disodium use in pregnant women are insufficient to inform a drug-associated risk. Administration of pamidronate to pregnant rats and rabbits resulted in maternal toxicity and embryo-fetal effects (see Data ) .
What are the important warnings for Pamidronate Disodium?▼
5 WARNINGS AND PRECAUTIONS • Renal failure: Do not exceed single doses of 90 mg pamidronate disodium. Assess renal function before each treatment. In patients with bone metastases with severe renal impairment, use of pamidronate disodium is not recommended. ( 5.1 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) • Electrolyte disorders (e.g., hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia): Monitor phosphorus, potassium, magnesium, calcium and vitamin D and adequately supplement as appropriate. ( 5.3 ) • Osteonecrosis of the jaw: Perform preventive dental procedures prior to initiating pamidronate disodium. 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. Hypersensitivity to pamidronate, other bisphosphonates, or mannitol ( 4 )
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Dosage form: INJECTION, SOLUTION. Route: PERCUTANEOUS. Active ingredients: AMBROSIA TRIFIDA POLLEN (.05 g/mL). Category: BLA.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.