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Generic Name: Pamidronate Disodium
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: (3-Amino-1-hydroxypropylidene)bisphosphonic acid disodium salt pentahydrate
Molecular Formula: C3H9NNa2O7P2•5H2O
CAS Number: 109552-15-0

Introduction

Synthetic bisphosphonate; bone resorption inhibitor.1 3 4 5 52 53

Uses for Aredia

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 52 53

More conservative measures (e.g., hydration alone or combined with loop diuretics) generally used for treatment of mild or asymptomatic hypercalcemia.1 5 31 32 33 39 52 53 Corticosteroid therapy may be beneficial in hypercalcemia associated with hematological malignancies.1 52 53

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Consider retreatment in patients with recurrent or refractory disease.1 52 53

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 52 53 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 of bone.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

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 52 53

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.1 23 24 27 52 53

Aredia Dosage and Administration

General

  • Monitor standard laboratory and clinical parameters of renal function (including Scr) prior to each treatment and closely monitor CBC with differential and hematocrit and hemoglobin.1 52 53

  • Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium).1 52 53

Hypercalcemia Associated with Malignancy

  • Adequately hydrate patients prior to treatment initiation and throughout treatment.1 52 53 Avoid overhydration, especially in patients with potential for cardiac failure.1 52 53 Attempt to restore urine output to 2 L/day throughout treatment.1 52 53

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 who are dehydrated prior to treatment initiation.1 39 52 53

  • In the absence of hypercalcemia, give oral calcium and vitamin D supplementation to minimize the risk of hypocalcemia in patients with predominantly lytic bone metastases or multiple myeloma who are at risk for calcium or vitamin D deficiency.1 52 53

Paget’s Disease of Bone

  • In the absence of hypercalcemia, give oral calcium and vitamin D supplementation to minimize the risk of hypocalcemia.1 52 53

Administration

IV Administration

Administer by IV infusion.1 3 4 5 8 11 14 16 20 23 24 26 27 29 40 52 53

Available as a lyophilized powder for injection1 53 and as an injection concentrate.52 53

Reconstitution

Reconstitute vial containing 30 or 90 mg of lyophilized pamidronate disodium with 10 mL of sterile water for injection to provide a solution containing 3 or 9 mg/mL, respectively.1 53

Allow the contents of the vial to dissolve completely before withdrawing dose.1 53

Dilution

Dilute reconstituted lyophilized drug or injection concentrate prior to administration.1 52 53

For treatment of 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 52 53

For treatment of 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 52 53

For treatment of 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 52 53

For treatment of 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 52 53

Rate of Administration

Longer infusions (i.e., >2 hours) may decrease the risk of adverse effects (e.g., infusion site reactions, renal impairment).1 6 17 52 53 (See Renal Effects under Cautions.)

For treatment of hypercalcemia associated with malignancy, infuse over 2–24 hours.1 52 53

For treatment of Paget’s disease of bone, infuse over a 4-hour period once daily for 3 consecutive days.1 52 53

For treatment of osteolytic bone metastases of breast cancer, infuse over a 2-hour period once every 3–4 weeks.1 52 53

For treatment of osteolytic lesions of multiple myeloma, infuse over a 4-hour period once monthly.1 52 53

Dosage

Available as pamidronate disodium; dosage is expressed in terms of the salt.1 52 53

Adults

Hypercalcemia Associated with Malignancy
Moderate Hypercalcemia
IV

60–90 mg as a single dose over 2–24 hours in those with albumin-corrected serum calcium concentration approximately 12–13.5 mg/dL.1 52 53

Consider retreatment if serum calcium concentrations do not return to normal or do not remain normal.1 52 53 In order to allow for full response to the initial dose, repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose.1 52 53

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 52 53

Consider retreatment if serum calcium concentrations do not return to normal or remain normal.1 52 53 In order to allow for full response to the initial dose, repeat the dose appropriate for the degree of hypercalcemia no sooner than 7 days after the initial dose.1 52 53

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 52 53

Monitor periodically for recurrence of disease (e.g., increased serum alkaline phosphatase concentrations and urinary hydroxyproline); individualize the need for retreatment based on patient response.7 8 9 11 13 17 25 40 When clinically indicated, retreat with the same dosage that was required for initial treatment.1 52 53

Osteolytic Bone Metastases of Breast Cancer
IV

Initially, 90 mg, administered as a 2-hour infusion, given once every 3–4 weeks.1 52 53 Optimum duration of such therapy is not known, but has been used for up to at least 24 months in clinical studies.1 52 53

Osteolytic Bone Lesions of Multiple Myeloma
IV

Initially, 90 mg, administered as a 4-hour infusion, given once monthly.1 52 53 Optimum duration of therapy currently is not known, but monthly doses have been administered for up to at least 21 months in clinical studies.1 52 53

Prescribing Limits

Adults

IV

Maximum 90 mg as a single dose.1 52 53

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 52 53

Renal Impairment

Withhold therapy in patients with bone metastases associated with solid tumors or with osteolytic lesions associated with multiple myeloma if renal function deteriorates (defined as an increase in Scr of at least 0.5 or 1 mg/dL in patients with normal [<1.4 mg/dL] or elevated [≥1.4 mg/dL] baseline Scr, respectively) during therapy; in clinical trials, pamidronate therapy was not resumed until Scr had returned to within 10% of baseline levels.1 52 53

Geriatric Patients

No specific dosage recommendations; however, select dosage cautiously, usually starting at the lower end of the dosage range, because of possible age-related decreases in hepatic, renal, or cardiac function and concomitant diseases and drug therapy.1 52 53

Cautions for Aredia

Contraindications

  • Known hypersensitivity to pamidronate or other bisphosphonates.1 52 53

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity

May cause fetal harm; use not recommended in pregnant women, and women of childbearing potential should avoid conception during therapy.1 52 53 If patient becomes pregnant, apprise of potential fetal hazard.1 52 53

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function, progression to renal failure and dialysis); may occur after initial or single dose of pamidronate.1 52 53

Focal segmental glomerulosclerosis (including collapsing variant) with or without nephrotic syndrome reported, particularly in patients with multiple myeloma or breast cancer; gradual improvement in some patients following drug discontinuance.1 52 53

Risk of renal toxicity may be greater in patients with impaired renal function.1 52 53

Monitor Scr prior to each treatment.1 52 53

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 52 53

General Precautions

Metabolic Effects

Asymptomatic hypophosphatemia,1 3 30 31 33 52 53 hypokalemia,1 52 53 hypomagnesemia,1 33 38 52 53 and hypocalcemia reported.1 3 9 11 30 33 52 53 Rarely, symptomatic hypocalcemia, including tetany, reported.1 52 53

Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.1 52 53 Institute short-term calcium and/or vitamin D therapy if hypocalcemia occurs.1 17 19 52 53

Adequately hydrate patients with hypercalcemia of malignancy throughout treatment.1 52 53 Avoid overhydration, especially in patients with potential for cardiac failure.1 52 53 Attempt to restore urine output to 2 L/day throughout treatment.1 52 53

Musculoskeletal Effects

Osteonecrosis and osteomyelitis of the jaw reported in cancer patients receiving bisphosphonates.1 41 42 43 44 45 46 47 52 53 Most patients were receiving IV bisphosphonates and concurrent chemotherapy, head and neck radiation therapy, and corticosteroids.1 46 47 52 53 Postmarketing experience and literature reports suggest greater frequency of cases associated with tumor type (advanced breast cancer, multiple myeloma) and dental status (e.g., tooth extraction, periodontal disease, poorly fitting dentures).41 42 43 44 45 46 53

Good oral hygiene and a dental examination (panoramic jaw radiograph) with appropriate preventive dentistry recommended prior to treatment with bisphosphonates in patients with cancer.1 41 42 43 46 47 52 53 Avoid invasive dental procedures in such patients if possible during therapy.1 42 43 46 47 52 53

Severe, occasionally incapacitating bone, joint, and/or muscle pain reported infrequently.1 42 48 49 51 52 53 Time to onset of symptoms varied from 1 day to years after treatment initiation.1 42 48 51 52 53 Such pain generally improves following discontinuance of the drug but has recurred upon subsequent rechallenge in some patients.1 42 48 49 50 51 52 53

Hematologic Effects

Anemia, leukopenia, neutropenia, and thrombocytopenia reported.1 52 53 Monitor complete blood counts with differential and hematocrit and hemoglobin.1 52 53 Carefully monitor patients with preexisting anemia, leukopenia, or thrombocytopenia for the first 2 weeks after treatment initiation.1 52 53

Specific Populations

Pregnancy

Category D.1 52 53 (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Not known if pamidronate is distributed into milk.1 52 53 Use with caution in nursing women.1 52 53

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 2 52 53

Geriatric Use

No substantial differences in safety and efficacy relative to younger patients, but increased sensitivity cannot be ruled out.1 52 53 (See Geriatric Use under Dosage and Administration.)

Renal Impairment

Safety and efficacy not established in patients with severe renal impairment (Scr >3 mg/dL).1 52 53 Not recommended for use in patients with severe renal impairment and bone metastases.1 52 53 Carefully weigh possible benefits and risks of therapy in other patients with severe renal impairment.1 52 53 (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 52 53

Paget’s disease of bone: Arthrosis, bone pain, hypertension, headache.1 52 53

Osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma: Skeletal pain, nausea, anemia, fever, fatigue, vomiting, constipation, dyspnea, diarrhea, headache, anorexia, myalgia, coughing, dyspepsia, abdominal pain.1 52 53

Interactions for Aredia

Nephrotoxic Agents

Potential for increased risk of nephrotoxicity.1 52 53 Use concomitantly with caution.1 52 53

Specific Drugs

Drug

Interaction

Comments

Diuretics, loop

No effect on calcium-lowering effect of pamidronate1 52 53

Thalidomide

Increased risk of nephrotoxicity with concurrent use in patients with multiple myeloma1 52 53

Aredia Pharmacokinetics

Absorption

Onset

Hypercalcemia associated with malignancy: Reduction of serum calcium concentration usually is apparent within 1–3 days3 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 52 53 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 (90-mg dose).1 52 53 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.20

Duration

Hypercalcemia associated with malignancy: Normocalcemia persists for about 6–14 days following a single dose.1 3 30 33 38 52 53

Paget’s disease of bone: Reduction in marker of bone formation (decrease of serum alkaline phosphatase concentrations) persist from 1–372 days.1 9 11 13 14 15 16 40 53

Special Populations

In patients with hepatic impairment, increased mean AUC and peak plasma concentrations.1 53

Distribution

Extent

Distributed mainly to bones, liver, spleen, teeth, and tracheal cartilage in rats.1 52 53 Protracted binding of the drug to the bone mineral matrix.1 4 15 20 22 26 52 53

Pamidronate crosses the placenta in rats; not known whether distributed into human milk.1 52 53

Elimination

Metabolism

No evidence of metabolism.1 4 15 20 22 26 52 53

Elimination Route

Urinary excretion is the sole means of elimination.1 52 53

Half-life

Averages 28 hours.1 52 53 Rate of elimination from bone not determined.1 52 53

Special Populations

In cancer patients with renal impairment, decreased clearance compared with cancer patients without renal impairment.1 52 53 Accumulation of pamidronate not anticipated when recommended dose is repeated on a monthly basis;1 52 53 however, limited pharmacokinetic data exist in patients with Clcr <30 mL/minute.1 52 53

In patients with hepatic impairment, decreased plasma clearance.1 52 53 Not thought to be clinically relevant.1 52 53

Stability

Storage

Parenteral

Powder for Injection

≤30°C or 20–25°C depending on manufacturer; consult manufacturers’ labelings.1 53

Store vials of reconstituted solution at 2–8°C for up to 24 hours.1 53

Injection Concentrate

20–25°C or below 25°C depending on manufacturer; consult manufacturers’ labelings.52 53

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Do not mix with other drugs.1 52 53

Solution Compatibility1 52 53

Compatible

Dextrose 5% in water

Sodium chloride 0.45 or 0.9%

Incompatible

Ringer’s injection, lactated

Actions

  • Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption.19 40 53

  • 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 52 53

Advice to Patients

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 52 53 Advise women to avoid pregnancy during therapy.1 52 53 If patient becomes pregnant, apprise of potential fetal hazard.1 52 53

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 52 53

  • Importance of advising patients of other important precautionary information.1 52 53 (See Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pamidronate Disodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion

30 mg*

Aredia

Novartis

Pamidronate Disodium for Injection

90 mg*

Aredia

Novartis

Pamidronate Disodium for Injection

Injection, for IV infusion

30 mg*

Pamidronate Disodium Injection

60 mg*

Pamidronate Disodium Injection

90 mg*

Pamidronate Disodium Injection

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 2, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceutical Corporation. Aredia (pamidronate disodium) for injection for intravenous infusion prescribing information. East Hanover, NJ: 2008 Nov.

2. Ciba, Summit, NJ: Personal communication.

3. Gucalp R, Ritch P, Wiernik PH et al. Comparative study of pamidronate disodium and etidronate disodium in the treatment of cancer-related hypercalcemia. J Clin Oncol. 1992; 10:134-42. [PubMed 1727915]

4. Thiébaud, Jaeger P, Jacquet AF et al. Dose-response in the treatment of hypercalcemia of malignancy by a single infusion of the bisphosphonate AHPrBP. J Clin Oncol. 1988; 6:762-8. [PubMed 3367184]

5. Bilezikian JP. Management of acute hypercalcemia. N Engl J Med. 1992; 326:1196-203. [IDIS 295128] [PubMed 1532633]

6. Hosking DJ. Advances in the management of Paget’s disease of bone. Drugs. 1990; 40:829-40. [PubMed 2078998]

7. Cantrill JA, Buckler HM, Anderson DC. Low dose intravenous 3-amino-1-hydroxypropylidene-1,1-bisphosphonate (APD) for the treatment of Paget’s disease of bone. Ann Rheum Dis. 1986; 45:1012-8. [IDIS 224896] [PubMed 3813665]

8. Thiébaud D, Jaeger P, Gobelet C et al. A single infusion of the bisphosphonate AHPrBP (APD) as treatment of Paget’s disease of bone. Am J Med. 1988; 85:207-12. [IDIS 245310] [PubMed 3261129]

9. Ryan PJ, Sherry M, Gibson T et al. Treatment of Paget’s disease by weekly infusions of 3-aminohydroxypropylidene-1,1-bisphosphonate (APD). Br J Rheumatol. 1992; 31:97-101. [PubMed 1371084]

10. Fitton A, McTavish D. Pamidronate: a review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs. 1991; 41:289-318. [PubMed 1709854]

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19. Price RI, Gutteridge DH, Stuckey BGA et al. Rapid, divergent changes in spinal and forearm bone density following short-term intravenous treatment of Paget’s disease with pamidronate disodium. J Bone Miner Res. 1993; 8:209-17. [PubMed 8442439]

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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.

25. Michalsky M, Stepan JJ, Wilczek H et al. Galactosyl hydroxylysine in assessment of Paget’s bone disease. Clin Chim Acta. 1995; 234:101-8. [PubMed 7758208]

26. Fenton AJ, Gutteridge DH, Kent GN et al. Intravenous aminobisphosphonate in Paget’s disease: clinical, biochemical, histomorphometric and radiological responses. Clin Endocrinol. 1991; 34:197-204.

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.

28. Burckhardt P, Thiébaud D, Perey L et al. Treatment of tumor-induced osteolysis by APD. Recent Results Cancer Res. 1989; 116:54-66. [PubMed 2762665]

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41. Ruggiero SL, Mehrotra B, Rosenberg TJ et al. Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofacial Surg. 2004; 62:527-34.

42. Novartis. Zometa(zoledronic acid) injection prescribing information. East Hanover, NJ; 2004 Aug.

43. Hohneker JA. Dear doctor letter regarding osteonecrosis of the jaw in patients with cancer receiving bisphophonates. East Hanover, NJ: Novartis; 2004 September 24.

44. Ruggiero SL, Mehrotra B. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191.

45. Bone HG, Santora AC. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191-2.

46. Hohneker JA. Dear doctor letter regarding important drug precautions for dental health professional with patients being treated for cancer. East Hanover, NJ: Novartis; 2005 May 5. From FDA website .

47. Food and Drug Administration. Oncologic Drugs Advisory Committee meeting. Expert panel recommendation for the prevention, diagnosis, and treatment of osteonecrosis of the jaw. Bethesda, MD; Mar. 4, 2005. From FDA website .

48. Center for Drug Evaluation and Research, Food and Drug Administration. FDA Alert: Information on bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa. 2008 Jan 7. From FDA website. Accessed 2008 Oct 28.

49. Wysowski DK, Chang JT. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med. 2005; 165:346-7. [PubMed 15710802]

50. Center for Drug Evaluation and Research, Food and Drug Administration. Update of safety review follow-up to the October 1, 2007 early communication about the ongoing safety review of bisphosphonates. Bisphosphonates: alendronate (Fosamax, Fosamax plus D) etidronate (Didronel), ibandronate (Boniva), Pamidronate (Aredia), risedronate (Actonel, Actonel w/calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa). 2008 Nov 12. From the FDA website. Accessed 2008 Nov 21.

51. Procter & Gamble Pharmaceuticals. Actonel (risedronate sodium) tablets prescribing information. Cincinnati, OH; 2008 Apr.

52. Hospira Inc. Pamidronate disodium injection prescribing information. Lake Forest, IL; 2008 Apr.

53. Bedford Laboratories. Pamidronate disodium injection and pamidronate disodium for injection prescription information. Bedford,OH; 2011 Jun.

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