Pamidronate Disodium

Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: (3-Amino-1-hydroxypropylidene)bisphosphonic acid disodium salt pentahydrate
Molecular Formula: C₃H_9NNa₂O₇P₂•5H₂O
CAS Number: 109552-15-0
Brands: Aredia

Special Alerts:

[Posted 10/13/2010] ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including alendronate (Fosamax), alendronate with cholecalciferol (Fosamax Plus D), risedronate (Actonel and Atelvia), risedronate with calcium carbonate (Actonel with Calcium), ibandronate (Boniva), tiludronate (Skelid), and zoledronic acid (Reclast) and their generic products. A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.

BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.

RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. For more information visit the FDA website at: and .

[Posted 03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.

FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.

Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. For more information visit the FDA website at: and .

[Posted 11/12/2008] FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. For more information visit the FDA website at: , and .

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

[Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: and .

[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: and .

Introduction

Synthetic bisphosphonate; bone resorption inhibitor.^{1 3 4 5}

Uses for Pamidronate Disodium

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Hypercalcemia Associated with Malignancy

Used in conjunction with achievement and maintenance of adequate hydration for the treatment of moderate to severe hypercalcemia associated with malignant neoplasms, with or without bone metastases^{1 3 4 5}

Retreatment may be considered in patients with recurrent or refractory disease.¹

Paget’s Disease of Bone

Treatment of moderate to severe Paget’s disease of bone (osteitis deformans)^{1 6 7 8 9 11 13 15 16 25 26 40 15} in symptomatic patients with multiple bone involvement [polyostotic] and elevated concentrations of serum alkaline phosphatase and urinary hydroxyproline.^{7 8 13 20}

May prevent or slow progression of complications (e.g., deformities, arthritis, fractures, neurologic manifestations, spinal cord compression, heart failure) in patients with Paget’s Disease.^{11 26 40} May not reverse established complications (e.g., severe deformities, deafness).^{11 26 40}

Treatment in patients refractory to calcitonin or etidronate disodium.^{8 9 11 13 16}

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

Decreases the incidence and delays the development of bone-related complications (e.g., fractures or spinal cord compression, bone deterioration requiring radiotherapy or orthopedic surgery), and reduces bone pain and the need for supplemental analgesic therapy in patients with osteolytic metastases associated with breast cancer^{1 23 24 27} and in patients with osteolytic lesions of multiple myeloma.^{1 29}

Used as an adjunct to antineoplastic therapy for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.^{1 20 29}

Pamidronate Disodium Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Monitor standard laboratory and clinical parameters of renal function (including serum creatinine) and complete blood counts with differential and hematocrit and hemoglobin.¹

  
  


• 
  

  Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.¹

  
  

Hypercalcemia Associated with Malignancy

• 
  

  Adequately hydrate patients prior to treatment initiation and throughout treatment.¹ Avoid overhydration, especially in patients at risk for the development of cardiac failure.¹ Attempt to restore urine output to 2L/day throughout treatment.¹

  
  


• 
  

  Corticosteroid therapy may prove beneficial.¹

  
  

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

• 
  

  Adequately hydrate patients with osteolytic lesions of multiple myeloma and marked Bence-Jones proteinuria with 0.9% sodium chloride prior to treatment initiation.^{1 39}

  
  

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

IV Administration

Administer by IV infusion.^{1 3 4 5 8 11 14 16 20 23 24 26 27 29 40}

Reconstitution

Reconstitute vial containing 30 or 90 mg of pamidronate disodium with 10 mL of sterile water for injection to provide a solution containing 3 or 9 mg /mL, respectively.¹

Allow the contents of the vials to dissolve completely before withdrawing a dose.¹

Dilution

Hypercalcemia Associated with Malignancy

Dilute the recommended daily dose in 1 L of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Paget’s Disease of Bone

Dilute 30 mg in 500 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Osteolytic Bone Metastases of Breast Cancer

Dilute 90 mg in 250 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Osteolytic Lesions of Multiple Myeloma

Dilute 90 mg in 500 mL of 0.45 or 0.9% sodium chloride injection or 5% dextrose injection.¹

Rate of Administration

Infuse slowly (i.e., >2 hours) to decrease the risk of adverse effects (e.g., infusion site reactions, renal impairment).^{6 17} (See Renal Effects under Cautions.)

For treatment of hypercalcemia associated with malignancy, infuse over at least 2–24 hours.¹

For treatment of Paget’s disease of bone, infuse over a 4-hour period once daily for 3 consecutive days.¹

For treatment of osteolytic bone metastases, infuse over a 2-hour period once every 3–4 weeks.¹

For treatment of osteolytic lesions of multiple myeloma, infuse over a 4-hour period once monthly.¹

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Dosage of pamidronate disodium is expressed in terms of the salt.¹

Adults

Hypercalcemia Associated with Malignancy

Moderate Hypercalcemia

IV

60–90 mg as a single dose over at least 2–24 hours in those with albumin-corrected serum calcium concentration approximately 12–13.5 mg/dL.¹

Consider retreatment if serum calcium concentrations do not return to normal or remain normal.¹ Repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose in order to allow full response to the initial dose.¹

Severe Hypercalcemia

IV

90-mg as a single dose over 2–24 hours in those with albumin-corrected serum calcium concentration >13.5 mg/dL.¹

Consider retreatment if serum calcium concentrations do not return to normal or remain normal.¹ Repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose in order to allow full response to the initial dose.¹

Paget’s Disease of Bone

IV

Initially, 30 mg, administered as a 4-hour infusion, once daily on 3 consecutive days (total cumulative dose 90 mg for the course).¹

Individualize the need for retreatment and base on patient response (e.g., increased serum alkaline phosphatase concentrations and urinary hydroxyproline).¹¹ When clinically indicated, retreat with the same dosage that was required for initial treatment.¹

Osteolytic Bone Metastases of Breast Cancer

IV

Initially, 90 mg, administered as a 2-hour infusion, given once every 3–4 weeks.¹ Optimum duration of such therapy is not known, but has been used at these intervals for 24 months.¹

Osteolytic Bone Lesions of Multiple Myeloma

IV

Initially, 90 mg, administered as a 4-hour infusion, given once monthly.¹ Optimum duration of therapy currently is not known, but monthly doses have been administered for 21 months.¹

Prescribing Limits

Adults

IV

Maximum 90 mg as a single dose.¹ Duration of IV infusion should be no less than 2 hours.¹

Special Populations

Hepatic Impairment

No dosage adjustment required in patients with mild to moderate hepatic impairment; not studied in patients with severe hepatic impairment.¹

Renal Impairment

Withhold therapy in patients with bone metastases associated with solid tumors or with osteolytic lesions associated wtih multiple myeloma if renal function deteriorates (defined as an increase in serum creatinine concentration of at least 0.5 or 1 mg/dL in patients with normal [<1.4 mg/dL] or elevated [≥1.4 mg/dL] baseline serum creatinine concentrations, respectively) during therapy until serum creatinine concentrations return to within 10% of baseline levels.¹

Cautions for Pamidronate Disodium

Contraindications

• 
  

  Known hypersensitivity to pamidronate or other bisphosphonates.¹

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Fetal/Neonatal Morbidity

May cause fetal harm; use not recommended in pregnant women, and women of childbearing potential should avoid conception during therapy.¹ If patient becomes pregnant, apprise of potential fetal hazard.¹

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function and potential renal failure).¹ Risk may be greater in patients with impaired renal function.¹ Monitor standard laboratory and clinical parameters of renal function (including serum creatinine) prior to each treatment.¹

May reduce the risk for renal toxicity by using the recommended duration of infusion (i.e., >2 hours), particularly in patients with preexisting renal insufficiency.¹

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Metabolic Effects

Asymptomatic hypophosphatemia,^{1 3 30 31 33} hypokalemia,¹ hypomagnesemia,^{1 33 38} and hypocalcemia reported.^{1 3 9 11 30 33} Rarely, symptomatic hypocalcemia, including tetany reported.¹

Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.¹ Institute short-term calcium and/or vitamin D therapy if hypocalcemia occurs.^{1 17 19}

Patients should be adequately hydrated throughout treatment of hypercalcemia of malignancy.¹ Avoid overhydration, especially in patients at risk for the development of cardiac failure.¹ Attempt to restore urine output to 2L/day throughout treatment.¹

Musculoskeletal Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Osteonecrosis and osteomyelitis of the jaws have been reported in cancer patients receiving bisphosphonates.^{1 41 42 43 44 45} Most patients were receiving concurrent chemotherapy and corticosteroids,¹ and the majority of cases were associated with dental procedures (e.g., tooth extraction).^{41 42 43 44 45}

A dental examination with appropriate preventive dentistry recommended prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).^{1 41 42 43} Such patients should avoid invasive dental procedures if possible during therapy.^{1 42 43}

In the treatment of Paget’s disease of bone, monitor patients periodically (e.g., serum alkaline phosphatase concentrations and urinary hydroxyproline) for recurrence of disease.^{7 8 9 13 17 25 40}

Hematologic Effects

Anemia, leukopenia, neutropenia, and thrombocytopenia reported.¹ Monitor complete blood counts with differential and hematocrit and hemoglobin.¹ Carefully monitor patients with preexisting anemia, leukopenia, or thrombocytopenia in the first 2 weeks of treatment initiation.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Not known if pamidronate is distributed into milk.¹ Use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2}

Renal Impairment

Not studied in patients with severe renal impairment (serum creatinine concentration >5 mg/dL).¹ Not recommended for use in patients with severe renal impairment and bone metastases.¹ Carefully weigh the possible benefits and risks of therapy in other patients with severe renal impairment.¹ (See Renal Effects under Cautions.)

Common Adverse Effects

Hypercalcemia of malignancy: Infusion-site reactions (e.g., erythema, edema, induration, pain on palpation, thrombophlebitis), transient low-grade fever, hypokalemia, hypophosphatemia.^{1 3 9 10 16 20 22 30 33}

Paget’s disease of bone: Arthrosis, bone pain, hypertension, headache.¹

Osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma: Fatigue, dyspnea, anorexia, dyspepsia, abdominal pain, anemia, myalgia, headache, coughing.¹

Interactions for Pamidronate Disodium

Nephrotoxic Agents

Potential for increased risk of nephrotoxicity.¹ Use concomitantly with caution.¹

Specific Drugs

Drug	Interaction	Comments
Diuretics, loop	No effect on calcium-lowering effect of pamidronate1

Pamidronate Disodium Pharmacokinetics

Absorption

Onset

Hypercalcemia associated with malignancy: Reduction of serum calcium concentration usually is apparent within 1–3 days^{1 3 4 33 38} and generally is maximal within 5–7 days.^{3 4 38}

Paget’s disease of bone: Onset of therapeutic response usually is evident within the first week.^{1 17} Symptomatic relief of bone pain usually is evident within 0.5–3 months after therapy.^{8 13 40} The median time to appreciable therapeutic response (≥50% decrease from baseline) for serum alkaline phosphatase was approximately 1 month.¹ Plateau at 5–12 months after therapy.^{7 8 9 13 17 25 40}

Bone metastases of breast cancer: Decrease in bone pain usually is evident within 2 weeks.^{1 20}

Duration

Hypercalcemia associated with malignancy: Normocalcemia persists about 6–14 days following a single dose.^{1 3 30 33 38}

Paget’s disease of bone: Reduction in marker of bone formation (decrease of serum alkaline phosphatase concentrations) persist from 1–372 day(s).^{1 9 11 13 14 15 16 40}

Special Populations

In patients with hepatic impairment, increased mean AUC and peak plasma concentrations.¹

Distribution

Extent

Distributed mainly to bones, liver, spleen, teeth, and tracheal cartilage in rats.¹ Protracted binding of the drug to the bone mineral matrix.^{1 4 15 20 22 26}

Pamidronate crosses the placenta in rats; not known whether distributed into human milk.¹

Elimination

Metabolism

No evidence of metabolism.^{1 4 15 20 22 26}

Elimination Route

Urinary excretion is the sole means of elimination.¹

Half-life

Averages 28 hours.¹ Rate of elimination from bone not determined.¹

Special Populations

In cancer patients with renal impairment, decreased clearance compared with cancer patients without renal impairment.¹ Accumulation of pamidronate is not anticipated when recommended dose is repeated on a monthly basis.¹

In patients with hepatic impairment, decreased plasma clearance.¹ Not thought to be clinically relevant.¹

Stability

Storage

Parenteral

Powder for Injection

≤30°C.¹

Store reconstituted solution at 2–8°C for up to 24 hours.¹

ActionsActions

• 
  

  Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption.^{19 40}

  
  


• 
  

  Reduces biochemical markers of bone resorption, urinary calcium excretion, and urinary hydroxyproline in patients with breast cancer.^{10 20 28}

  
  


• 
  

  Hypocalcemic effect appears to result principally from inhibition of bone resorption and does not depend on cytotoxic activity or enhancement of renal calcium excretion.^{1 5 10 33 38}

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Advise women to avoid pregnancy during therapy.¹ If patient becomes pregnant, apprise of potential fetal hazard.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pamidronate Disodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV infusion	30 mg	Aredia (with mannitol)	Novartis
		90 mg	Aredia (with mannitol)	Novartis

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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2. Ciba, Summit, NJ: Personal communication.

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24. Theriault R, Lipton A, Leff R et al. Reduction of skeletal related complications in breast cancer patients with osteolytic bone metastases receiving hormone therapy, by monthly pamidronate sodium (Aredia) infusion. Proc Am Soc Clin Oncol. 1996; 15:122.

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27. Hortobagyi GN, Porter L Blayney D et al. Reduction of skeletal related complications in breast cancer patients with osteolytic bone metastases receiving chemotherapy (CT), by monthly pamidronate sodium (PAM) (Aredia) infusion. Proc Am Soc Clin Oncol. 1996; 15:108.

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34. Reid IR, Cundy T, Ibbertson HK et al. Osteomalacia after pamidronate for Paget’s disease. Lancet. 1994; 343:855. [IDIS 327910] [PubMed 7908098]

35. Ghose K, Waterworth R, Trolove P et al. Uveitis associated with pamidronate. Aust N Z J Med. 1994; 24:320. [PubMed 7980223]

36. Ignoffo RJ, Tseng A. Focus on pamidronate: a biphosphonate compound for the treatment of hypercalcemia of malignancy. Hosp Formul. 1991; 26:774,776-7,781,784-86.

37. Thürlimann B, Waldburger R, Senn HJ et al. Mithramycin and pamidronate (APD) in symptomatic tumour-related hypercalcaemia—a comparative randomised crossover trial. In: Bijvoet OLM, Lipton A eds. Osteoclast inhibition in the management of malignancy-related bone disorders: an international symposium held during the 15th International Cancer Congress, Hamburg, Germany, August 1990. Lewiston, NY: Hogrefe & Huber Publishers; 1991:27-32.

38. Morton A, Dodwell DJ, Howell A. Disodium pamidronate (APD) for the management of hypercalcaemia of malignancy: comparative studies of single-dose versus daily infusions and of infusion duration. In: Burckhardt P, ed. Disodium pamidronate (APD) in the treatment of malignancy-related disorders: an international symposium held during the 13th Congress of the European Society for Medical Oncology (ESMO), Lugano, Switzerland, October 1988. Toronto: Hans Huber Publishers; 1989:85-100.

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