Pamidronate
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Dosing in kidney impairment
Patients with Renal Impairment The renal clearance of pamidronate was reduced in patients with reduced creatinine clearance. Because pamidronate disodium is administered on a monthly basis, drug accumulation is not expected. No changes in pamidronate disodium dosing regimen are recommended for patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min).
Limited pharmacokinetic data exist in patients with creatinine clearance < 30 mL/min [see Warnings and Precautions and Clinical Pharmacology ] .
Dosing in liver impairment
Patients with Hepatic Impairment Patients with moderate hepatic impairment exhibited higher mean pamidronate AUC and C max . Because pamidronate disodium is administered on a monthly basis, drug accumulation is not expected. No changes in pamidronate disodium dosing regimen are recommended for patients with mild to moderate hepatic impairment.
Pamidronate disodium has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology ] .
Preparation and administration
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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.
Incompatibilities, Inspection before Use Pamidronate disodium 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.
Drug interactions
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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.
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 and lactation
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 ) . Bisphosphonates, such as pamidronate disodium, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years.
There may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In animal reproduction studies, intravenous administration of pamidronate to pregnant rats and rabbits during the period of organogenesis resulted in maternal toxicity and embryo-fetal effects at doses of 0.6 to 8.3 times the highest recommended human dose for a single intravenous infusion.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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