ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Pamidronate: Pediatric drug information

Pamidronate: Pediatric drug information
(For additional information see "Pamidronate: Drug information" and see "Pamidronate: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • Pamidronate Disodium Omega;
  • PMS-Pamidronate
Therapeutic Category
  • Antidote, Hypercalcemia;
  • Bisphosphonate Derivative
Dosing: Neonatal
Osteogenesis imperfecta

Osteogenesis imperfecta: Limited data available: Full-term neonates, PNA ≥14 days: IV: Initial: 0.25 mg/kg once on day 1, then 0.5 mg/kg/dose daily days 2 and 3 of the first cycle, then 0.5 mg/kg/dose once daily for 3 days for subsequent cycles; cycles are repeated every 2 months for a total yearly dose of 9 mg/kg (Ref)

Dosing: Pediatric

Note: Due to increased risk of nephrotoxicity, single doses should not exceed 90 mg.

Hypercalcemia

Hypercalcemia: Limited data available: Children and Adolescents: Dosing based on several case reports and retrospective studies for treatment of hypercalcemia due to malignancy and/or immobility. Administer as a single infusion. Retreatment may be necessary if serum calcium does not return to normal or does not remain normal after initial treatment; reported interval for multiple doses is ≥24 hours.

Initial treatment: IV: 0.5 to 1 mg/kg; maximum dose: 90 mg (Ref)

Severe, life-threatening: IV: 1.5 to 2 mg/kg; maximum dose: 90 mg; in one case report, a higher dose of 4 mg/kg was used to treat a serum calcium concentration of 18.9 mg/dL associated with bone metastases in a 4-year old child with non-Hodgkin lymphoma (Ref)

Osteogenesis imperfecta

Osteogenesis imperfecta: Limited data available: Note: Reported dosing regimens variable (ie, weight-directed vs BSA-directed); duration of treatment has not been established; however, the most benefit has been shown to occur in the first 2 to 4 years of treatment (Ref).

Weight-directed dosing (Ref):

Infants and Children <2 years: IV: Initial: 0.25 mg/kg once on day 1, then 0.5 mg/kg/dose daily days 2 and 3 of the first cycle, then 0.5 mg/kg/dose once daily for 3 days for subsequent cycles; cycles are repeated every 2 months for a total yearly dose of 9 mg/kg

Children 2 to 3 years: IV: Initial: 0.38 mg/kg once on day 1, then 0.75 mg/kg/dose daily days 2 and 3 of the first cycle, then 0.75 mg/kg/dose once daily for 3 days for subsequent cycles; cycles are repeated every 3 months for a total yearly dose of 9 mg/kg

Children >3 years and Adolescents: IV: Initial: 0.5 mg/kg once on day 1, then 1 mg/kg/dose daily days 2 and 3 of the first cycle, then 1 mg/kg/dose once daily for 3 days for subsequent cycles; cycles are repeated every 4 months for a total yearly dose of 9 mg/kg

BSA-directed dosing: Infants, Children, and Adolescents: IV: Initial: 10 mg/m2/dose once a month for 3 months, then increase to 20 mg/m2/dose once a month for 3 months, then increase to 30 mg/m2/dose once a month for subsequent doses; maximum dose: 40 mg/m2/dose was used in six patients after 1-2 years due to skeletal pain and less bone mineral gain; improvements in mobility and vertebral height was noted in patients who received this regimen for 3 to 6 years (n=11, median age at initiation of therapy: 3.6 months, range: 3 to 13 months) (Ref); another study used the same dosing in 14 prepubescent patients with mild disease (Ref)

Osteopenia associated with cerebral palsy

Osteopenia associated with cerebral palsy (nonambulatory): Limited data available; dosing regimens variable: Children and Adolescents: IV: Initial: 1 mg/kg/dose daily for 3 days; administer every 3 to 4 months; minimum dose: 15 mg; maximum dose: 35 mg. Dosing based on two trials; the first included 14 pediatric patients (age range: 6 to 16 years, treatment group: n=7), and reported an increase in bone mineral density; therapy was used in combination with calcium and vitamin D supplementation (Ref). In the other trial (n=25, age range: 3 to 19 years), a decreased incidence of fractures was noted after 1 year of therapy (Ref). A lower dose was used in a trial of 23 pediatric patients (age range: 4 to 17 years); the initial dose was 0.37 mg/kg on day 1, followed by 0.75 mg/kg on day 2, then 0.75 mg/kg/dose once daily for 2 days was used for subsequent cycles; cycles were repeated every 4 months for 1 year; maximum single dose: 45 mg (Ref).

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific recommendations; based on experience in adult patients, dosing adjustment suggested for baseline or renal impairment during therapy.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations. Based on experience in adult patients, no dosing adjustment recommended for mild to moderate hepatic impairment and for severe impairment, there are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Adult

(For additional information see "Pamidronate: Drug information")

Breast cancer, osteolytic bone metastases

Breast cancer, osteolytic bone metastases: IV: 90 mg over at least 2 hours once every 3 or 4 weeks (maximum: 90 mg per dose) (Ref).

Hypercalcemia of malignancy

Hypercalcemia of malignancy (albumin-corrected serum calcium ≥12 mg/dL [≥3 mmol/L]) (alternative agent):

Note: May also be used at the same doses for treatment of hypercalcemia due to excessive bone resorption from other causes (eg, granulomatous diseases, hyperparathyroidism, vitamin D intoxication) (Ref). Asymptomatic or mildly symptomatic patients with chronic hypercalcemia may not require immediate treatment unless albumin-corrected serum calcium level is >14 mg/dL (>3.5 mmol/L) (Ref).

Albumin-corrected serum calcium level 12 to 13.5 mg/dL (3 to 3.4 mmol/L) and symptomatic: IV: 60 to 90 mg as a single dose over 2 to 24 hours (maximum: 90 mg per dose).

Albumin-corrected serum calcium level >13.5 mg/dL (>3.4 mmol/L): IV: 90 mg as a single dose over 2 to 24 hours (maximum: 90 mg per dose).

Re-treatment: IV: May re-treat at the same dose 7 days after the initial treatment if serum calcium does not return to normal or does not remain normal.

Hyperparathyroidism

Hyperparathyroidism (off-label use): IV: 15 to 90 mg as a single dose (maximum: 90 mg per dose) (Ref); may be repeated every 1 to 2 months or when hypercalcemia recurs (Ref). The treatment period in clinical trials was up to 1 year (Ref).

Multiple myeloma, osteolytic bone lesions

Multiple myeloma, osteolytic bone lesions: IV: 90 mg over 4 hours once monthly:

Lytic bone disease: American Society of Clinical Oncology (ASCO) guidelines: 90 mg over at least 2 hours once every 3 to 4 weeks for up to 2 years (maximum: 90 mg per dose); less frequent dosing (eg, once every 3 months) may be considered in patients with stable/responsive disease (patients with no active disease and are on maintenance therapy); discontinue after 2 years in patients with responsive and/or stable disease; resume therapy upon relapse with new-onset skeletal-related events (Ref).

Newly diagnosed, symptomatic (off-label dose): 30 mg over 2.5 hours once monthly for at least 3 years (Ref).

Paget disease

Paget disease (moderate to severe): IV: 30 mg over 4 hours once daily for 3 consecutive days (total dose = 90 mg); may re-treat at initial dose if clinically indicated.

Prostate cancer, bone loss associated with androgen deprivation therapy, prevention

Prostate cancer, bone loss associated with androgen deprivation therapy, prevention (alternative agent) (off-label use):

Note: For use in patients without bone metastases treated long-term with androgen deprivation therapy who are at elevated risk of osteoporotic fractures (according to a risk assessment tool) (Ref).

IV: 60 mg over 2 hours once every 3 months (Ref). The optimal duration of therapy has not been established (Ref).

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: There are only limited pharmacokinetic data in patients with CrCl <30 mL/minute.

Dosing adjustment in patients with kidney impairment prior to initiating pamidronate treatment:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute or SCr >3 mg/dL:

Breast cancer, osteolytic bone metastases: Use is not recommended (Ref).

Multiple myeloma (and extensive bone disease): 90 mg (or consider a reduced initial dose) over 4 to 6 hours (Ref) once every 3 to 4 weeks.

Other indications: Clinical judgement should determine whether the potential benefit outweighs the potential risk (Ref).

Hemodialysis, intermittent (thrice weekly): Avoid use; consider alternative agents. Limited data suggests that reduced pamidronate doses (30 to 60 mg) with slower infusion rates (over 4 to 6 hours) may be considered when other agents are not available (Ref); use with caution and only when potential benefits outweigh risks.

Peritoneal dialysis: Avoid use; consider alternative agents. Limited data suggests that reduced pamidronate doses (30 to 60 mg) (Ref) may be considered when other agents are not available. Prolonged infusion (over 4 to 6 hours) should be considered as well (Ref). Monitor closely; nephrotoxicity is a concern as this patient population often has residual kidney function (Ref). Use with caution and only if potential benefit outweighs the potential risk (Ref).

Dosing adjustment in patients who develop renal toxicity during pamidronate therapy:

Osteolytic bone lesions/metastases (Ref): Treatment should be withheld for deterioration in renal function (increase of SCr ≥0.5 mg/dL in patients with normal baseline [SCr <1.4 mg/dL] or ≥1 mg/dL in patients with abnormal baseline [SCr ≥1.4 mg/dL]). Resumption of therapy may be considered when serum creatinine returns to within 10% of baseline.

Multiple myeloma: American Society of Clinical Oncology (ASCO) guidelines (Ref):

Renal deterioration without an apparent cause: Withhold therapy; may resume at the prior dose when renal function returns to within 10% of baseline.

Unexplained albuminuria >500 mg/24 hours: Withhold dose until returns to baseline, then recheck every 3 to 4 weeks; consider reinitiating at a dose not to exceed 90 mg every 4 weeks and with a longer infusion time of at least 4 hours.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Fatigue (osteolytic bone metastases: 32% to 40%; hypercalcemia of malignancy: ≤12%), headache (24% to 27%; Paget disease: ≥10%), insomnia (osteolytic bone metastases: 25%; hypercalcemia of malignancy: ≤1%), anxiety (osteolytic bone metastases: 18%), pain (≤13%)

Endocrine & metabolic: Hypophosphatemia (9% to 18%), hypokalemia (4% to 18%), hypocalcemia (1% to 17%), hypomagnesemia (4% to 12%)

Gastrointestinal: Nausea (osteolytic bone metastases: 64%; hypercalcemia of malignancy: ≤18%; Paget disease: ≥5%), vomiting (osteolytic bone metastases: 36% to 46%; hypercalcemia of malignancy: ≤4%), anorexia (osteolytic bone metastases: 31%; hypercalcemia of malignancy: ≤12%), abdominal pain (osteolytic bone metastases: 20% to 24%; hypercalcemia of malignancy: ≤1%), dyspepsia (osteolytic bone metastases: 18%; hypercalcemia of malignancy: ≤4%)

Genitourinary: Urinary tract infection (16% to 20%)

Hematologic & oncologic: Anemia (osteolytic bone metastases: 40% to 48%; hypercalcemia of malignancy: ≤6%), metastases (osteolytic bone metastases: 31%), granulocytopenia (osteolytic bone metastases: 20%)

Local: Infusion site reaction (hypercalcemia of malignancy: ≤18%; includes erythema, induration, pain, and swelling)

Neuromuscular & skeletal: Myalgia (osteolytic bone metastases: 26%; hypercalcemia of malignancy: ≤1%), weakness (osteolytic bone metastases: 26%), ostealgia (5% to ≥15%), arthralgia (osteolytic bone metastases: 11% to 15%)

Renal: Increased serum creatinine (osteolytic bone metastases: 19%; mild)

Respiratory: Dyspnea (osteolytic bone metastases: 22% to 35%; other indications: <1%), upper respiratory tract infection (osteolytic bone metastases: 32%; hypercalcemia of malignancy: ≤3%), cough (osteolytic bone metastases: 25%), sinusitis (osteolytic bone metastases: 16%), pleural effusion (osteolytic bone metastases: 15%)

Miscellaneous: Fever (18% to 39%; may be transient, includes temperature increase of ≥1° C within 24 to 48 hours after treatment; Paget disease, includes temperature increase of ≥1° C within 48 hours after treatment, transient: ≤21%)

1% to 10%:

Cardiovascular: Atrial fibrillation (hypercalcemia of malignancy: ≤6%), hypertension (6%; Paget disease: ≥10%), syncope (hypercalcemia of malignancy: ≤6%), tachycardia (hypercalcemia of malignancy: ≤6%), atrial flutter (hypercalcemia of malignancy: ≤1%), cardiac failure (hypercalcemia of malignancy: ≤1%), edema (hypercalcemia of malignancy: ≤1%)

Central nervous system: Drowsiness (hypercalcemia of malignancy: ≤6%), psychosis (hypercalcemia of malignancy: ≤4%)

Endocrine & metabolic: Hypothyroidism (hypercalcemia of malignancy: ≤6%)

Gastrointestinal: Constipation (hypercalcemia of malignancy: ≤6%), gastrointestinal hemorrhage (hypercalcemia of malignancy: ≤6%), diarrhea (hypercalcemia of malignancy: ≤1%), stomatitis (hypercalcemia of malignancy: ≤1%)

Genitourinary: Uremia (hypercalcemia of malignancy: ≤4%)

Hematologic & oncologic: Leukopenia (hypercalcemia of malignancy: ≤4%), neutropenia (hypercalcemia of malignancy: ≤1%), thrombocytopenia (hypercalcemia of malignancy: ≤1%)

Infection: Candidiasis (hypercalcemia of malignancy: ≤6%)

Neuromuscular & skeletal: Arthropathy (Paget disease: ≥5%), back pain (Paget disease: ≥5%)

Renal: Renal insufficiency (osteolytic bone metastases, patients with normal baseline serum creatinine: 8%)

Respiratory: Rales (hypercalcemia of malignancy: ≤6%), rhinitis (hypercalcemia of malignancy: ≤6%)

Frequency not defined: Endocrine & metabolic: Hypervolemia (hypercalcemia of malignancy)

<1%, postmarketing, and/or case reports: Adult respiratory distress syndrome, anaphylactic shock, angioedema, confusion, conjunctivitis, electrolyte disturbance, episcleritis, femur fracture (subtrochanteric and diaphyseal), flu-like symptoms, focal segmental glomerulosclerosis (including collapsing variant), glomerulopathy, hematuria, herpes simplex infection (reactivation), herpes zoster (reactivation), hyperkalemia, hypernatremia, hypersensitivity reaction, hypotension, interstitial pulmonary disease, iritis, local inflammation (orbital), malaise, mineral abnormalities, nephrotic syndrome, osteonecrosis (primarily of the jaw), paresthesia, pruritus, renal failure, renal tubular disease, scleritis, skin rash, tetany, uveitis, visual hallucination

Contraindications

Clinically significant hypersensitivity to pamidronate, other bisphosphonates, or any component of the formulation

Canadian labeling: Additional contraindications (not in the US labeling): Pregnancy; breastfeeding

Warnings/Precautions

Concerns related to adverse effects:

• Bone fractures: Atypical femur fractures (AFF) have been reported in patients receiving bisphosphonates. The fractures include subtrochanteric femur (bone just below the hip joint) and diaphyseal femur (long segment of the thigh bone). Some patients experience prodromal pain weeks or months before the fracture occurs. It is unclear if bisphosphonate therapy is the cause for these fractures; atypical femur fractures have also been reported in patients not taking bisphosphonates, and in patients receiving glucocorticoids. Patients receiving long-term (>3 to 5 years) bisphosphonate therapy may be at an increased risk (Adler 2016; NOF [Cosman 2014]). Patients presenting with thigh or groin pain with a history of receiving bisphosphonates should be evaluated for femur fracture. Consider interrupting bisphosphonate therapy in patients who develop a femoral shaft fracture; assess for fracture in the contralateral limb.

• Musculoskeletal pain: Infrequently, severe (and occasionally debilitating) bone, joint, and/or muscle pain have been reported during bisphosphonate treatment. The onset of pain ranged from a single day to several months. Consider discontinuing therapy in patients who experience severe symptoms; symptoms usually resolve upon discontinuation. Some patients experienced recurrence when rechallenged with same drug or another bisphosphonate; avoid use in patients with a history of these symptoms in association with bisphosphonate therapy.

• Electrolyte abnormalities: Use has been associated with asymptomatic electrolyte abnormalities (including hypophosphatemia, hypokalemia, hypomagnesemia, and hypocalcemia). Rare cases of symptomatic hypocalcemia, including tetany, have been reported.

• Myelosuppression: Patients with preexisting anemia, leukopenia, or thrombocytopenia should be closely monitored during the first 2 weeks of treatment.

• Osteonecrosis of the jaw: Osteonecrosis of the jaw (ONJ), also referred to as medication-related osteonecrosis of the jaw (MRONJ), has been reported in patients receiving bisphosphonates. Known risk factors for MRONJ include invasive dental procedures (eg, tooth extraction, dental implants, boney surgery), cancer diagnosis, concomitant therapy (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, ill-fitting dentures, and comorbid disorders (anemia, coagulopathy, infection, preexisting dental or periodontal disease). Risk may increase with increased duration of bisphosphonate use and/or may be reported at a greater frequency based on tumor type (eg, advanced breast cancer, multiple myeloma). According to a position paper by the American Association of Maxillofacial Surgeons (AAOMS), MRONJ has been associated with bisphosphonates and other antiresorptive agents (denosumab), and antiangiogenic agents (eg, bevacizumab, sunitinib) used for the treatment of osteoporosis or malignancy; risk is significantly higher in cancer patients receiving antiresorptive therapy compared to patients receiving osteoporosis treatment (regardless of medication used or dosing schedule). MRONJ risk is also increased with monthly IV antiresorptive therapy compared to the minimal risk associated with oral bisphosphonate use, although risk appears to increase with oral bisphosphonates when duration of therapy exceeds 4 years. The AAOMS suggests that if medically permissible, initiation of IV bisphosphonates for cancer therapy should be delayed until optimal dental health is attained (if extractions are required, antiresorptive therapy should delayed until the extraction site has mucosalized or until after adequate osseous healing). Once IV bisphosphonate therapy is initiated for oncologic disease, procedures that involve direct osseous injury and placement of dental implants should be avoided. Patients developing ONJ during therapy should receive care by an oral surgeon (AAOMS [Ruggiero 2014]).

• Renal deterioration: Single pamidronate doses should not exceed 90 mg. Initial or single doses have been associated with renal deterioration, progressing to renal failure and dialysis. Glomerulosclerosis (focal segmental) with or without nephrotic syndrome has also been reported. Longer infusion times (>2 hours) may reduce the risk for renal toxicity, especially in patients with pre-existing renal insufficiency. Withhold pamidronate treatment (until renal function returns to baseline) in patients with evidence of renal deterioration.

Disease-related concerns:

• Breast cancer (metastatic): The American Society of Clinical Oncology (ASCO)/Cancer Care Ontario (CCO) updated guidelines on the role of bone-modifying agents (BMAs) in metastatic breast cancer patients (ASCO/CCO [Van Poznak 2017]). The guidelines recommend initiating a BMA (denosumab, pamidronate, zoledronic acid) in patients with metastatic breast cancer to the bone. One BMA is not recommended over another (evidence supporting one BMA over another is insufficient). The optimal duration of BMA therapy is not defined; however, the guidelines recommend continuing BMA therapy indefinitely. The analgesic effect of BMAs is modest and BMAs should not be used alone for pain management; supportive care, analgesics, adjunctive therapies, radiation therapy, surgery, and/or systemic anticancer therapy should be utilized. The ASCO/CCO guidelines are in alignment with prescribing information for dosing, renal dose adjustments, infusion times, prevention and management of osteonecrosis of the jaw, and monitoring of laboratory parameter recommendations.

• Hypoparathyroidism: Use caution with a history of thyroid surgery; patients may have relative hypoparathyroidism, predisposing them to pamidronate-related hypocalcemia.

• Multiple myeloma: Patients with Bence-Jones proteinuria and dehydration should be adequately hydrated prior to therapy. The American Society of Clinical Oncology (ASCO) has updated guidelines on bone-modifying agents (BMAs) in multiple myeloma (ASCO [Anderson 2018]). Bisphosphonate (pamidronate or zoledronic acid) therapy should be initiated in patients with radiographic or imaging evidence of lytic bone disease. Bisphosphonates may also be considered in patients with pain secondary to osteolytic disease and as adjunct therapy in patients receiving other interventions for fractures or impending fractures. The guidelines support utilizing IV bisphosphonates in patients with multiple myeloma and osteopenia (osteoporosis) but no radiographic evidence of lytic bone disease. Bisphosphonates are not recommended in patients with solitary plasmacytoma, smoldering (asymptomatic) or indolent myeloma with osteopenia in the absence of lytic bone disease. Bisphosphonates are also not recommended in monoclonal gammopathy of undetermined significance, unless osteopenia (osteoporosis) also is present. The guidelines recommend monthly treatment for a period of up to 2 years (less frequent dosing may be considered in patients with stable/responsive disease). After 2 years, consider discontinuing in responsive and stable patients, and reinitiate upon relapse if a new-onset skeletal-related event occurs. The ASCO guidelines are in alignment with the prescribing information for dosing, renal dose adjustments, infusion times, prevention and management of osteonecrosis of the jaw, and monitoring of laboratory parameter recommendations. According to the guidelines, in patients with extensive bone disease with existing severe renal disease (a serum creatinine >3 mg/dL or CrCl <30 mL/minute) pamidronate at a dose of 90 mg over 4 to 6 hours should be used (unless preexisting renal disease in which case a reduced initial dose should be considered). Monitor for albuminuria every 3 to 6 months; in patients with unexplained albuminuria >500 mg/24 hours, withhold the dose until level returns to baseline, then recheck every 3 to 4 weeks. Pamidronate may be reinitiated at a dose not to exceed 90 mg every 4 weeks with a longer infusion time of at least 4 hours.

• Renal impairment: Patients with serum creatinine >3 mg/dL were not studied in clinical trials; limited data are available in patients with CrCl <30 mL/minute. Evaluate serum creatinine prior to each treatment. For the treatment of bone metastases, use is not recommended in patients with severe renal impairment. With indications other than bone metastases, use clinical judgment to determine if benefits outweigh potential risks in patients with renal impairment.

Warnings: Additional Pediatric Considerations

Maintain adequate hydration with therapy (pediatric patients: 2 to 3 L/m2 [Kerdudo, 2005]) and urinary output during treatment; use with caution with other potentially nephrotoxic drugs.

Bisphosphonate therapy may not be appropriate for patients with mild osteogenesis imperfect; risk:benefit has not been established. Potential adverse effects in growing children include infusion reactions and effects on bone growth. Influenza-like reactions are common after the first dose occurring at 12 to 36 hours after the infusion and may include fever, rash, and vomiting; treatment with standard antipyretic therapy is usually adequate and symptoms do not generally recur after later doses. Increased height has been reported and theoretical effects of diminishing bone remodeling in a growing child may result in bone malformation or delayed recovery after fractures (Rauch, 2004).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous, as disodium:

Generic: 30 mg/10 mL (10 mL); 90 mg/10 mL (10 mL)

Solution, Intravenous, as disodium [preservative free]:

Generic: 6 mg/mL (10 mL)

Solution Reconstituted, Intravenous, as disodium:

Generic: 30 mg (1 ea [DSC]); 90 mg (1 ea [DSC])

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Pamidronate Disodium Intravenous)

6 mg/mL (per mL): $4.50

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as disodium:

Generic: 3 mg/mL (10 mL); 30 mg/10 mL (10 mL); 6 mg/mL (10 mL); 9 mg/mL (10 mL); 90 mg/10 mL (10 mL)

Solution Reconstituted, Intravenous:

Generic: 15 mg (1 ea)

Administration: Pediatric

Parenteral: IV: Infusion rate varies by indication; longer infusion times (>2 hours) may reduce the risk for renal toxicity, especially in patients with preexisting renal insufficiency. In pediatric trials, infusion times were 4 hours for osteogenesis imperfecta, 3 to 4 hours for osteopenia from immobility, and 4 to 6 hours for hypercalcemia; a 24-hour infusion has also been used (Ref).

Administration: Adult

IV: Infusion rate varies by indication. Longer infusion times (>2 hours) may reduce the risk for renal toxicity, especially in patients with preexisting renal insufficiency. The manufacturer recommends infusing over 2 to 24 hours for hypercalcemia of malignancy; over 2 hours for osteolytic bone lesions with metastatic breast cancer; and over 4 hours for Paget disease and for osteolytic bone lesions with multiple myeloma. ASCO guidelines for bisphosphonate use in multiple myeloma recommend infusing pamidronate over at least 2 hours; if therapy is withheld due to renal toxicity, infuse over at least 4 hours upon reintroduction of treatment after renal recovery; infuse over 4 to 6 hours in patients with preexisting severe renal impairment and extensive bone disease (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Vials, lyophilized powder for reconstitution: Store at 20°C to 25°C (68°F to 77°F). The reconstituted solution is stable for 24 hours stored under refrigeration at 2°C to 8°C (36°F to 46°F). The diluted solution for infusion is stable in D5W or NS at room temperature for up to 24 hours.

Vials, in solution: Store at 20°C to 25°C (68°F to 77°F). The diluted solution for infusion is stable in D5W or NS at room temperature for up to 24 hours.

Use

Treatment of moderate or severe hypercalcemia associated with malignancy with or without bone metastases (in conjunction with adequate hydration); treatment of osteolytic bone lesions associated with multiple myeloma or metastatic breast cancer; treatment of moderate to severe Paget's disease of bone (All indications: FDA approved in adults); has also been used in the treatment of osteogenesis imperfecta and osteopenia in cerebral palsy patients

Medication Safety Issues
Sound-alike/look-alike issues:

Aredia may be confused with Adriamycin

Pamidronate may be confused with papaverine

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: May enhance the hypocalcemic effect of Bisphosphonate Derivatives. Aminoglycosides may enhance the nephrotoxic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Angiogenesis Inhibitors (Systemic): May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy

Capecitabine: Bisphosphonate Derivatives may enhance the nephrotoxic effect of Capecitabine. Risk C: Monitor therapy

Deferasirox: Bisphosphonate Derivatives may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Inhibitors of the Proton Pump (PPIs and PCABs): May diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy

Thalidomide: May enhance the nephrotoxic effect of Pamidronate. Risk C: Monitor therapy

Dietary Considerations

Multiple myeloma or metastatic bone lesions from solid tumors or Paget disease: Take adequate daily calcium and vitamin D supplement (if patient is not hypercalcemic).

Reproductive Considerations

Bisphosphonates are incorporated into the bone matrix and gradually released over time. Because exposure prior to pregnancy may theoretically increase the risk of fetal harm, most sources recommend discontinuing bisphosphonate therapy in females of reproductive potential as early as possible prior to a planned pregnancy. Use in premenopausal females should be reserved for special circumstances when rapid bone loss is occurring; a bisphosphonate with the shortest half-life should then be used (Bhalla 2010; Pereira 2012; Stathopoulos 2011).

Pregnancy Considerations

It is not known if bisphosphonates cross the placenta, but based on their lower molecular weight, fetal exposure is expected (Djokanovic 2008; Stathopoulos 2011).

Information related to the use of pamidronate in pregnancy is available from case reports and small retrospective studies (Baretić 2014; Green 2014; Koren 2018; Levy 2009; Stathopoulos 2011).

Bisphosphonates are incorporated into the bone matrix and gradually released over time. The amount available in the systemic circulation varies by drug, dose, and duration of therapy. Theoretically, there may be a risk of fetal harm when pregnancy follows the completion of therapy (hypocalcemia, low birth weight, and decreased gestation have been observed in some case reports); however, available data have not shown that exposure to bisphosphonates during pregnancy significantly increases the risk of adverse fetal events (Djokanovic 2008; Green 2014; Levy 2009; Machairiotis 2019; Sokal 2019; Stathopoulos 2011). Exposed infants should be monitored for hypocalcemia after birth (Djokanovic 2008; Stathopoulos 2011).

Monitoring Parameters

Monitor serum creatinine prior to each dose; monitor serum calcium, phosphate, potassium, and magnesium; monitor for hypocalcemia for at least 2 weeks after therapy; patients with pre-existing anemia, leukopenia, or thrombocytopenia should have hemoglobin, hematocrit, and CBC with differential monitored closely, particularly in the first 2 weeks following treatment; dental exam and preventative dentistry prior to therapy for patients at risk for osteonecrosis

Additional indication-specific monitoring:

Multiple myeloma: Urine albumin every 3-6 months

Osteogenesis imperfecta: In pediatric trials, motor milestones, ambulation assessment, total body length, sitting height, and arm span were recorded every 6 months. Bone density was measured every 6 months. Conventional x-rays were obtained once yearly (Heino, 2011). Urinary excretion of calcium, alkaline phosphatase, and other bone-related chemistries were also monitored.

Osteopenia associated with cerebral palsy: In pediatric trials, bone mineral density, number and location of fractures, conventional x-rays, serum vitamin D concentrations, alkaline phosphatase, and other bone related chemistries were monitored (Bachrach, 2010; Henderson, 2002; Plotkin, 2006)

Paget's disease: Monitor serum alkaline phosphatase and urinary hydroxyproline excretion

Mechanism of Action

Pamidronate is a nitrogen-containing bisphosphonate; it inhibits bone resorption by disrupting osteoclast activity (Rogers 2011).

Pharmacokinetics (Adult Data Unless Noted)

Onset of action:

Hypercalcemia of malignancy (HCM): Reduction of albumin-corrected serum calcium: Children: ~48 hours (Kerdudo 2005); Adults: ≤24 hours for decrease in albumin-corrected serum calcium; maximum effect: ≤7 days.

Paget disease: ~1 month for ≥50% decrease in serum alkaline phosphatase.

Maximum effect: Hypercalcemia of malignancy: ≤7 days.

Duration: HCM: 7 to 14 days; Paget disease: 1 to 372 days.

Absorption: Poorly from the GI tract.

Distribution: Binds to hydroxyapatite crystals in bone; distribution to bone is incompletely understood (Cremers 2019; manufacturer's labeling).

Metabolism: Not metabolized.

Half-life elimination: 28 ± 7 hours (plasma elimination); rate of elimination from bone has not been determined.

Excretion: Urine (exclusive route of elimination; 30% to 62% of dose as unchanged drug within 120 hours [remainder of dose retained in the body]; lower in patients with renal dysfunction).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Aredia;
  • (AR) Argentina: Aminomux | Fada pamidronato | Pamdosa | Pamidronato servycal;
  • (AT) Austria: Aredia | Dinatrium Pamidronat | Ebedronat | Pamidro Cell | Pamidronat Dinatrium Alternova;
  • (AU) Australia: Aredia | Disodium pamidront | Pamidronate | Pamidronate agila | Pamisol;
  • (BE) Belgium: Pamidrin | Pamidronaat | Pamidronate;
  • (BG) Bulgaria: Aredia;
  • (BR) Brazil: Aredia | Melidronato | Pamidrom | Pamidron | Pamidronato dissodico | Pamired;
  • (CH) Switzerland: Pamidronat Mepha | Pamidronat Teva | Pamifos;
  • (CL) Chile: Aredia | Pamifos;
  • (CN) China: Aredia | Bonin | Pu ke ding;
  • (CO) Colombia: Aredia | Pamidronato disodico;
  • (CZ) Czech Republic: Aredia | Pamidronate medac;
  • (DE) Germany: Aredia | Axidronat | Pamidronat Gry | Pamidronat onkovis | Pamifos | Ribodronat;
  • (DO) Dominican Republic: Pamidria;
  • (EC) Ecuador: Aredia;
  • (EE) Estonia: Aredia | Biodronate;
  • (EG) Egypt: Aredia;
  • (ES) Spain: Aredia | Linoten | Pamidronato disodico Combino pharm | Pamidronato Stada | Pamidronato Teva | Pamifos;
  • (FI) Finland: Aredia | Pamidronat Meda | Pamidronatdinatr m | Pamifos;
  • (FR) France: Aredia | Pamidronate de sodium merck generiques | Pamidronate de sodium ratiopharm | Paminject;
  • (GB) United Kingdom: Aredia | Pamidronate;
  • (GR) Greece: Aredia | Pamerit;
  • (HK) Hong Kong: Aredia;
  • (HR) Croatia: Aredia;
  • (HU) Hungary: Aredia;
  • (ID) Indonesia: Aredia | Pamired;
  • (IE) Ireland: Aredia;
  • (IL) Israel: Aredia;
  • (IN) India: Aredronet | Biodronate | Bonapam | Pamidria | Pamifos | Pamired;
  • (IT) Italy: Aredia | Pamidronato | Pamidronato Bin | Pamidronato ratiopharm | Texpami;
  • (JO) Jordan: Aredia | Pamidronate;
  • (JP) Japan: Aredia;
  • (KR) Korea, Republic of: Aredia | Pamiron | Panorin;
  • (KW) Kuwait: Aredia;
  • (LB) Lebanon: Aredia;
  • (LT) Lithuania: Aredia | Pamidronat disodium hospira;
  • (LU) Luxembourg: Aredia;
  • (LV) Latvia: Aredia;
  • (MX) Mexico: Aredia | Pamisol;
  • (MY) Malaysia: Aredia | Biodronate | Pamifos | Pamisol;
  • (NL) Netherlands: Pamidronaatdinatrium PCH;
  • (NO) Norway: Aredia | Pamidronatdinatrium hospira | Pamidronatdinatrium Mayne | Pamidronatdinatrium Pfizer | Pamifos;
  • (NZ) New Zealand: Aredia | Pamisol;
  • (PE) Peru: Hipotic;
  • (PH) Philippines: Aredia | Hospira pamidronate | Pamisol;
  • (PK) Pakistan: Aminomux | Aredia;
  • (PL) Poland: Aredia | Pamidia | Pamidronat Medac | Pamifos;
  • (PR) Puerto Rico: Aredia | Pamidronate;
  • (PT) Portugal: Aredia | Pamidran | Pamidronato Azevedos | Pamidronato Hikma | Pamidronato medinfar;
  • (PY) Paraguay: Aminomux | Fada pamidronato | Pamidronato fusa | Pamidronato imedic;
  • (RO) Romania: Aredia | Pamidronate hospira;
  • (RU) Russian Federation: Aredia | Pamidronate medac | Pomegara;
  • (SE) Sweden: Pamidronat Teva | Pamifos;
  • (SG) Singapore: Aredia;
  • (SI) Slovenia: Aredia;
  • (SK) Slovakia: Aredia | Pamifos;
  • (TH) Thailand: Aredia | Pamisol;
  • (TN) Tunisia: Axidronat | Ostepam | Pamidos | Pamidronate mylan;
  • (TR) Turkey: Aredia | Pamidem | Pamidria | Pamidronat Disodyum DBL;
  • (TW) Taiwan: Aredia | Pamisol;
  • (UA) Ukraine: Aredia | Pamidria | Pamifos | Pamiredin | Pomegara | Stopklastal;
  • (UY) Uruguay: Aminomux | Aredia | Pamdosa | Pamidronato disodico;
  • (VE) Venezuela, Bolivarian Republic of: Aminomux | Aredia;
  • (VN) Viet Nam: Padurone;
  • (ZA) South Africa: Aredia
  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Adler RA, El-Hajj Fuleihan G, Bauer DC, et al. Managing osteoporosis in patients on long-term bisphosphonate treatment: report of a Task Force of the American Society for Bone and Mineral Research [published correction appears in J Bone Miner Res. 2016;31(10):1910]. J Bone Miner Res. 2016;31(1):16-35. doi: 10.1002/jbmr.2708. [PubMed 26350171]
  3. Alibhai SMH, Zukotynski K, Walker-Dilks C, et al; Cancer Care Ontario Genitourinary Cancer Disease Site Group. Bone health and bone-targeted therapies for prostate cancer: a programme in evidence-based care - Cancer Care Ontario clinical practice guideline. Clin Oncol (R Coll Radiol). 2017;29(6):348-355. doi:10.1016/j.clon.2017.01.007 [PubMed 28169118]
  4. American Dental Association Council on Scientific Affairs, “Dental Management of Patients Receiving Oral Bisphosphonate Therapy,” JADA, 2006, 137(8):1144-50. Available at http://jada.ada.org/article/S0002-8177(14)64960-6/pdf [PubMed 16873332]
  5. Ammann P, Herter-Clavel C, Lubrano A, Rizzoli R. A single bisphosphonate infusion is associated with improved functional capacity in elderly subjects with primary hyperparathyroidism. Aging Clin Exp Res. 2003;15(6):500-504. [PubMed 14959954]
  6. Anderson K, Ismaila N, Flynn PJ, et al. Role of bone-modifying agents in multiple myeloma: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2018;36(8):812-818. doi: 10.1200/JCO.2017.76.6402. [PubMed 29341831]
  7. Aredia (pamidronate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2012.
  8. Aström E, Jorulf H, Söderhäll S. Intravenous pamidronate treatment of infants with severe osteogenesis imperfecta. Arch Dis Child. 2007; 92(4):332-3388. [PubMed 17114205]
  9. Auron A, Tal L, Srivastava T, et.al. Reversal of hypercalcemic acute kidney injury by treatment with intravenous bisphosphonates. Pediatric Nephrology. 2009; 24:613-617. [PubMed 18839218]
  10. Bachrach SJ, Kecskemethy HH, Harcke HT, et al. Decreased fracture incidence after 1 year of pamidronate treatment in children with spastic quadriplegic cerebral palsy. Dev Med Child Neurol. 2010;52(9):837-842. [PubMed 20573180]
  11. Bamias A, Kastritis E, Bamia C, et al, “Osteonecrosis of the Jaw in Cancer After Treatment With Bisphosphonates: Incidence and Risk Factors,” J Clin Oncol, 2005, 23(34):8580-7. [PubMed 16314620]
  12. Baretić M, Tomić Brzac H, Dobrenić M, Jakovčević A. Parathyroid carcinoma in pregnancy. World J Clin Cases. 2014;2(5):151-156. [PubMed 24868516]
  13. Bhalla AK, "Management of Osteoporosis in a Pre-menopausal Woman," Best Pract Res Clin Rheumatol, 2010, 24(3):313-27. [PubMed 20534366]
  14. Cianferotti L, Bertoldo F, Carini M, et al. The prevention of fragility fractures in patients with non-metastatic prostate cancer: a position statement by the international osteoporosis foundation. Oncotarget. 2017;8(43):75646-75663. doi: 10.18632/oncotarget.17980. [PubMed 29088899]
  15. Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-2381. doi: 10.1007/s00198-014-2794-2. [PubMed 25182228]
  16. Cremers S, Drake MT, Ebetino FH, Bilezikian JP, Russell RGG. Pharmacology of bisphosphonates. Br J Clin Pharmacol. 2019;85(6):1052-1062. doi:10.1111/bcp.13867 [PubMed 30650219]
  17. Davenport A, Goel S, Mackenzie JC. Treatment of hypercalcaemia with pamidronate in patients with end stage renal failure. Scand J Urol Nephrol. 1993;27(4):447-451. doi:10.3109/00365599309182276 [PubMed 8159916]
  18. Diamond TH, Winters J, Smith A, et al, “The Antiosteoporotic Efficacy of Intravenous Pamidronate in Men With Prostate Carcinoma Receiving Combined Androgen Blockade: A Double Blind, Randomized, Placebo-Controlled Crossover Study,” Cancer, 2001, 92(6):1444-50. [PubMed 11745221]
  19. Djokanovic N, Klieger-Grossmann C, and Koren G, "Does Treatment With Bisphosphonates Endanger the Human Pregnancy?" J Obstet Gynaecol Can, 2008, 30(12):1146-8. [PubMed 19175968]
  20. Durie BG, Katz M, and Crowley J, “Osteonecrosis of the Jaw and Bisphosphonate,” N Engl J Med, 2005, 353(1):99-102. [PubMed 16000365]
  21. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  22. Fitton A and McTavish D, “Pamidronate: A Review of Its Pharmacological Properties and Therapeutic Efficacy in Resorptive Bone Disease,” Drugs, 1991, 41(2):289-318. [PubMed 1709854]
  23. French AE, Kaplan N, Lishner M, et al, “Taking Bisphosphonates During Pregnancy,” Can Fam Physician, 2003, 49:1281-2. [PubMed 14594094]
  24. Gimsing P, Carlson K, Turesson I, et al, “Effect of Pamidronate 30 mg Versus 90 mg on Physical Function in Patients With Newly Diagnosed Multiple Myeloma (Nordic Myeloma Study Group): A Double-Blind, Randomised Controlled Trial,” Lancet Oncol, 2010, 11(10):973-82. [PubMed 20863761]
  25. Glorieux FH, Bishop NH, Plotkin H, et al, “Cyclic Administration of Pamidronate in Children With Severe Osteogenesis Imperfecta,” N Engl J Med, 1998, 339(14):947-52. [PubMed 9753709]
  26. Green SB, Pappas AL. Effects of maternal bisphosphonate use on fetal and neonatal outcomes. Am J Health Syst Pharm. 2014;71(23):2029-2036. [PubMed 25404594]
  27. Heino T, Astrom E, Laurencikas E, et al. Intravenous pamidronate treatment improves growth in prepubertal osteogenesis imperfecta patients. Horm Res Paediatr. 2011;75:354-61. [PubMed 21304249]
  28. Hellstein JW, Adler RA, Edwards B, et al, "Managing the Care of Patients Receiving Antiresorptive Therapy for Prevention and Treatment of Osteoporosis: Executive Summary of Recommendations From the American Dental Association Council on Scientific Affairs," J Am Dent Assoc, 2011, 142(11):1243-51. [PubMed 22041409]
  29. Hellstein JW, Adler RA, Edwards B, et al, "Managing the Care of Patients Receiving Antiresorptive Therapy for Prevention and Treatment of Osteoporosis: Recommendations From the American Dental Association Council on Scientific Affairs," 2011, Available at http://www.ada.org/sections/professionalResources/pdfs/topics_ARONJ_report.pdf. Accessed February 2013.
  30. Henderson RC, Lark RK, Kecskemethy HH, et al, “Bisphosphonates to Treat Osteopenia in Children With Quadriplegic Cerebral Palsy: A Randomized, Placebo-Controlled Clinical Trial,” J Pediatr, 2002, 141(5):644-51. [PubMed 12410192]
  31. Hillner BE, Ingel JN, Chlebowski RT, et al, “American Society of Clinical Oncology 2003 Update on the Role of Bisphosphonates and Bone Health Issues in Women With Breast Cancer,” J Clin Oncol, 2003, 21(21):4042-57. [PubMed 12963702]
  32. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  33. Jansson S, Morgan E. Biochemical effects from treatment with bisphosphonate and surgery in patients with primary hyperparathyroidism. World J Surg. 2004;28(12):1293-1297. [PubMed 15517486]
  34. Jansson S, Tisell LE, Lindstedt G, Lundberg PA. Disodium pamidronate in the preoperative treatment of hypercalcemia in patients with primary hyperparathyroidism. Surgery. 1991;110(3):480-486. [PubMed 1845370]
  35. Kellihan MJ and Mangino PD, “Pamidronate,” Ann Pharmacother, 1992, 26(10):1262-9. [PubMed 1421653]
  36. Kerdudo C, Aerts I, Fattet S, et al. Hypercalcemia and childhood cancer: a 7-year experience. J Pediatr Hematol Oncol. 2005;27(1):23-27. [PubMed 15654274]
  37. Khan AA, Morrison A, Hanley DA, et al. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res. 2015; 30(1):3-23. [PubMed 25414052]
  38. Koren R, Neeman O, Koren S, Benbassat CA. Humoral hypercalcemia of pregnancy treated with bisphosphonates. Arch Endocrinol Metab. 2018;62(1):125-128. [PubMed 29694631]
  39. Kutluk MT, Hazar V, Akyuz C, et.al. Childhood cancer and hypercalcemia: report of a case treated with pamidronate. Journal of Pediatrics. 1997;130(5):828-831. [PubMed 9152297]
  40. Kutluk MT. Use of bisphosphonates in hypercalcemia associated with childhood cancer. Journal of Clinical Oncology. 1999;17(6):1960. [PubMed 10561239]
  41. Kyle RA, Yee GC, Somerfield MR, et al. American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma. J Clin Oncol. 2007;25(17):2464-2472. [PubMed 17515569]
  42. Levy S, Fayez I, Taguchi N, et al, "Pregnancy Outcome Following in utero Exposure to Bisphosphonates," Bone, 2009, 44(3):428-30. [PubMed 19059370]
  43. Lteif AN and Zimmerman D, “Bisphosphonates for Treatment of Childhood Hypercalcemia,” Pediatrics, 1998, 102(4 Pt 1):990-3. [PubMed 9755274]
  44. Lu KC, Yeung LK, Lin SH, Lin YF, Chu P. Acute effect of pamidronate on PTH secretion in postmenopausal hemodialysis patients with secondary hyperparathyroidism. Am J Kidney Dis. 2003;42(6):1221-1227. [PubMed 14655194]
  45. Machairiotis N, Ntali G, Kouroutou P, Michala L. Clinical evidence of the effect of bisphosphonates on pregnancy and the infant. Horm Mol Biol Clin Investig. 2019;40(2). doi:10.1515/hmbci-2019-0021 [PubMed 31539355]
  46. Maerevoet M, Martin C, and Duck L, “Osteonecrosis of the Jaw and Bisphosphonates,” N Engl J Med, 2005, 353(1):99-102. [PubMed 16003838]
  47. Mahmoud S, Mitwally H, El Zeer HS, El Madhoun I, Khatib M. Use of pamidronate to treat hypercalcemia in an oncology dialysis patient: a case report. Am J Case Rep. 2018;19:1087-1089. doi:10.12659/AJCR.908605 [PubMed 30209247]
  48. Major P, Lortholary A, Hon J, et al, "Zoledronic Acid Is Superior to Pamidronate in the Treatment of Hypercalcemia of Malignancy: A Pooled Analysis of Two Randomized, Controlled Clinical Trials," J Clin Oncol, 2001, 19(2):558-67. [PubMed 11208851]
  49. Marrón B, Remón C, Pérez-Fontán M, Quirós P, Ortíz A. Benefits of preserving residual renal function in peritoneal dialysis. Kidney Int Suppl. 2008;(108):S42-S51. doi:10.1038/sj.ki.5002600 [PubMed 18379546]
  50. McMahon RE, Bouquot JE, Glueck CJ, et al, “Osteonecrosis: A Multifactorial Etiology,” J Oral Maxillofac Surg, 2004, 62(7):904-5. [PubMed 15244000]
  51. Minisola S, Pepe J, Piemonte S, Cipriani C. The diagnosis and management of hypercalcaemia. BMJ. 2015;350:h2723. doi:10.1136/bmj.h2723 [PubMed 26037642]
  52. Pamidronate disodium injection [prescribing information]. Lake Forest, IL: Hospira Inc; April 2021.
  53. Pamidronate disodium [prescribing information]. Georgetown, IN: Areva Pharmaceuticals Inc; July 2015.
  54. Pamidronate disodium [product monograph]. Toronto, Ontario, Canada: Fresenius Kabi Canada; March 2019.
  55. Pereira RM, Carvalho JF, Paula AP, et al, "Guidelines for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis," Rev Bras Reumatol, 2012, 52(4):580-93. [PubMed 22885424]
  56. Plotkin H, Coughlin S, Kreikemeier R, et al. Low doses of pamidronate to treat osteopenia in children with severe cerebral palsy: a pilot study. Dev Med Child Neurol. 2006;48(9):709-712. [PubMed 16904014]
  57. Plotkin H, Rauch F, Bishop NJ, et al. Pamidronate treatment of severe osteogenesis imperfecta in children under 3 years of age. J Clin Endocrinol Metab. 2000;85:1846-1850. [PubMed 10843163]
  58. Ralston SH, Corral-Gudino L, Cooper C, et al. Diagnosis and management of Paget's disease of bone in adults: a clinical guideline. J Bone Miner Res. 2019;34(4):579-604. doi: 10.1002/jbmr.3657. [PubMed 30803025]
  59. Ralston SH, Gallacher SJ, Patel U, et al, “Cancer-Associated Hypercalcemia: Morbidity and Mortality, Clinical Experience in 126 Treated Patients,” Ann Intern Med, 1990, 112(7):499-504. [PubMed 2138442]
  60. Rauch F and Glorieux FH, “Osteogenesis Imperfecta,” Lancet, 2004, 363(9418):1377-85. [PubMed 15110498]
  61. Rauch F, Plotkin H, Travers R, et al. Osteogenesis imperfecta types I, III, and IV: effect of pamidronate therapy on bone and mineral metabolism. J Clin Endocrinol Metab. 2003;88(3):986-992. [PubMed 12629073]
  62. Rauch F, Travers R, Glorieux FH. Pamidronate in children with osteogenesis imperfecta: histomorphometric effects of long-term therapy. J Clin Endocrinol Metab. 2006;91(2):511-516. [PubMed 16291701]
  63. Refer to manufacturer's labeling.
  64. Rogers MJ, Crockett JC, Coxon FP, et al, “Biochemical and Molecular Mechanisms of Action of Bisphosphonates,” Bone, 2011, 49(1):34-41. [PubMed 21111853]
  65. Ruggiero SL, Dodson TB, Fantasia J, et al; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014;72(10):1938-1956. doi: 10.1016/j.joms.2014.04.031. [PubMed 25234529]
  66. Ruggiero S, Gralow J, Marx RE, et al. Practical guidelines for the prevention, diagnosis, and treatment of osteonecrosis of the jaw in patients with cancer. J Clin Oncol. 2006;2(1):7-14. [PubMed 20871729]
  67. Saylor PJ, Rumble RB, Tagawa S, et al. Bone health and bone-targeted therapies for prostate cancer: ASCO endorsement of a Cancer Care Ontario guideline. J Clin Oncol. 2020;38(15):1736-1743. doi:10.1200/JCO.19.03148 [PubMed 31990618]
  68. Shane E. Treatment of hypercalcemia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed August 17, 2022.
  69. Siminoski K, Fitzgerald AA, Flesch G, et al, "Intravenous Pamidronate for Treatment of Reflex Sympathetic Dystrophy During Breast Feeding,"J Bone Miner Res, 2000, 15(10):2052-5. [PubMed 11028460]
  70. Singer FR, Bone HG 3rd, Hosking DJ, et al; Endocrine Society. Paget's disease of bone: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(12):4408-4422. doi:10.1210/jc.2014-2910. [PubMed 25406796]
  71. Smith MR, McGovern FJ, Zietman AL, et al, “Pamidronate to Prevent Bone Loss During Androgen-Deprivation Therapy For Prostate Cancer,” N Engl J Med, 2001, 345(13):948-55. [PubMed 11575286]
  72. Sokal A, Elefant E, Leturcq T, Beghin D, Mariette X, Seror R. Pregnancy and newborn outcomes after exposure to bisphosphonates: a case-control study. Osteoporos Int. 2019;30(1):221-229. [PubMed 30171300]
  73. Stathopoulos IP, Liakou CG, Katsalira A, et al, "The Use of Bisphosphonates in Women Prior to or During Pregnancy and Lactation," Hormones (Athens), 2011, 10(4):280-91. [PubMed 22281884]
  74. Steelman J and Zeitler P, “Treatment of Symptomatic Pediatric Osteoporosis With Cyclic Single-Day Intravenous Pamidronate Infusions,,” J Pediatr, 2003, 142(4):417-23. [PubMed 12712060]
  75. Tarassoff P and Csermak K, “Avascular Necrosis of the Jaws: Risk Factors in Metastatic Cancer Patients,” J Oral Maxillofac Surg, 2003, 61(10):1238-9. [PubMed 14586868]
  76. Torregrosa JV, Moreno A, Mas M, Ybarra J, Fuster D. Usefulness of pamidronate in severe secondary hyperparathyroidism in patients undergoing hemodialysis. Kidney Int Suppl. 2003;(85):S88-S90. [PubMed 12753274]
  77. Trimarchi H, Lombi F, Forrester M, Elizondo C, Sawinski D, Pereyra H, Freixas E. Disodium pamidronate for treating severe hypercalcemia in a hemodialysis patient. Nat Clin Pract Nephrol. 2006;2(8):459-463. doi:10.1038/ncpneph0248 [PubMed 16932480]
  78. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/. Updated September 2016. Accessed October 3, 2016.
  79. Vitale G, Fonderico F, Martignetti A, et al, “Pamidronate Improves the Quality of Life and Induces Clinical Remission of Bone Metastases in Patients With Thyroid Cancer,” Br J Cancer, 2001, 84(12):1586-90. [PubMed 11401309]
  80. Van Poznak C, Somerfield MR, Barlow WE, et al. Role of bone-modifying agents in metastatic breast cancer: an American Society of Clinical Oncology-Cancer Care Ontario focused guideline update. J Clin Oncol. 2017;35(35):3978-3986. doi: 10.1200/JCO.2017.75.4614. [PubMed 29035643]
  81. Woo KT, Chan CM. KDIGO clinical practice guidelines for bisphosphonate treatment in chronic kidney disease. Kidney Int. 2011;80(5):553-554. doi:10.1038/ki.2011.202 [PubMed 21841837]
  82. Young G, Shende A. Use of pamidronate in the management of acute cancer-related hypercalcemia in children. Med Pediatr Oncol. 1998;30(2):117-121. [PubMed 9403021]
  83. Zeitlin L, Rauch F, Plotkin H, et al. Height and weight development during long-term therapy with cyclical intravenous pamidronate in children and adolescents with osteogenesis imperfect types I, III and IV. Pediatrics. 2003;111:1030–1036. [PubMed 12728084]
Topic 12673 Version 243.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟