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pamidronate (Rx)Brand and Other Names:Aredia

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

powder for reconstitution

  • 30mg

pamidronate injection solution as disodium

  • 3mg/mL
  • 6mg/mL
  • 9mg/mL
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Hypercalcemia of Malignancy

Moderate hypercalcemia (ie, corrected serum calcium 12-13.5 mg/dL): 60-90 mg single-dose IV infusion over 2-24 hours

Severe hypercalcemia (ie, corrected serum calcium > 13.5 mg/dL): 90 mg single-dose IV infusion over 2-24 hours

Other information

  • Longer infusions (ie, >2 hours) may decrease renal toxicity risk, especially with pre-existing renal insufficiency
  • May repeat after at least 7 days in patients showing partial or complete response if serum calcium does not remain in normal range

Paget's Disease

30 mg IV infused over 4 hours qDay for 3 consecutive days (ie, total cumulative dose 90 mg)

Limited patients have received >1 treatment in clinical trials; may consider retreatment when clinically indicated

Osteolytic Bone Metastases of Breast Cancer

90 mg IV infusion over 2 hours q3-4Weeks

Osteolytic Bone Lesions of Multiple Myeloma

90 mg IV infusion over 4 hours qMonth

Prevention of Androgen Deprivation-induced Osteoporosis (Off-label)

60 mg IV infusion over 2 hours every 3 months or 90 mg administered once over 3-4 hours

Other Indications & Uses

Hypercalcemia of malignancy

Off-label: spondyloarthropathy

Safety & efficacy not established

Hypercalcemia of malignancy

Moderate hypercalcemia (ie, corrected serum calcium 12-13.5 mg/dL): 60-90 mg single-dose IV infusion over 2-24 hours

Severe hypercalcemia (ie, corrected serum calcium > 13.5 mg/dL): 90 mg single-dose IV infusion over 2-24 hours

Longer infusions (ie, >2 hours) may decrease renal toxicity risk, especially with pre-existing renal insufficiency

May repeat after at least 7 days in patients showing partial or complete response if serum calcium does not remain in normal range

Paget's disease

30 mg IV infused over 4 hours qDay for 3 consecutive days (ie, total cumulative dose 90 mg)Limited patients have received >1 treatment in clinical trials; may consider retreatment when clinically indicated

Osteolytic bone metastases of breast cancer

90 mg IV infusion over 2 hours q3-4Weeks

Osteolytic bone lesions of multiple myeloma

90 mg IV infusion over 4 hours qMonth

Prevention of androgen deprivation-induced osteoporosis (off-label)

60 mg IV infusion over 2 hours every 3 months or 90 mg administered once over 3-4 hours

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Interactions

Interaction Checker

pamidronate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Anemia (42.5%)

            Urinary tract infectious disease (18.5%)

            Hypokalemia (18%)

            Hypophosphatemia (18%)

            Hypocalcemia (12%)

            Hypomagnesemia (12%)

            1-10%

            Seizure (2%)

            Frequency Not Defined

            Common

            • HTN
            • Fever
            • Abdominal pain, appetite loss, dyspepsia, nausea, vomiting
            • Injection site reaction
            • Bone pain
            • Cough. dyspnea, URI, sinusitis

            Serious

            • Osteonecrosis (primarily involving the jaw) reported predominantly in pts w/ cancer
            • Focal segmental glomerulosclerosis

            Postmarketing Reports

            General: reactivation of Herpes simplex and Herpes zoster, influenza-like symptoms

            CNS: confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance

            Skin: rash, pruritus

            Special senses: conjunctivitis, orbital inflammation

            Renal and urinary disorders: Renal tubular disorders (RTD); tubulointerstitial nephritis, focal segmental glomerulosclerosis including the collapsing variant, nephrotic syndrome

            Laboratory abnormalities: hyperkalemia, hypernatremia, hematuria

            Allergy: Rare instances of allergic manifestations have been reported, including hypotension, dyspnea, or angioedema, and, very rarely, anaphylactic shock

            Osteonecrosis (primarily involving the jaw) reported predominantly in cancer patients treated with IV bisphosphonates; many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ

            Respiratory, thoracic and mediastinal disorders: ARDS, interstitial lung disease

            Musculoskeletal and connective tissue disorders: Severe and occasionally incapacitating bone, joint, and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures

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            Warnings

            Contraindications

            Pregnancy

            Hypersensitivity

            Cautions

            Associated with renal toxicity, including potential renal failure (do not exceed single dose of 90 mg)

            Severe renal impairment, musculoskeletal pain

            Electrolyte abnormalities and myelosuppression may occur

            Increased risk of osteonecrosis of the jaw (advise patients against dental work during IV bisphosphonate treatment)

            Atypical subtrochanteric and diaphyseal femoral fractures reported with bisphosphonates; may present as thigh/groin pain in absence of trauma

            May cause fetal harm when administered to pregnant women; bisphosphonates are incorporated into the bone matrix and gradually released over periods of weeks to years

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if crosses in to breast milk, avoid

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Bisphosphonate which inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone density

            Pharmacokinetics

            Half-Life: 21-35 hours

            Duration: hypercalcemia of malignancy (IV): 2 wk to 2 mth

            Bioavailability: Poor; pharmacokinetic studies not available

            Metabolism: None

            Renal clearance: 49 mL/min

            Excretion: Urine

            Onset

            • Hypercalcemia of malignancy: Initial effect 1-2 days; max effect 5-7 days (IV)
            • Paget's disease: 1-3 months (maximum effect IV)
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            Administration

            IV Incompatibilities

            Calcium-containing diluents such as LR

            IV Preparation

            Reconstitute by adding 10 mL of SWI to a vial

            May be further diluted in 250-1000 mL of 1/2NS, NS or D5W

            IV Administration

            Slowly infuse over 2-24 hours

            Longer infusion may reduce risk of nephrotoxicity

            Storage

            Do not store powder for reconstitution above 30°C (86°F)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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