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zoledronic acid (Rx)Brand and Other Names:Reclast, Zometa

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV injectable solution

  • 4mg/5mL (5mL)
  • 5mg/100mL
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Hypercalcemia of Malignancy

Zometa: No more than 4 mg IV (infused over >15 minutes) once; may be repeated in 7 days

Monitor serum calcium, and wait at least 7 days before considering retreatment

Multiple Myeloma; Bone Metastases From Solid Tumors

Zometa: 4 mg IV (infused over >15 minutes) every 3-4 weeks

Osteoporosis

Reduction in incidence of fractures (hip, vertebral, and nonvertebral osteoporosis-related fractures)

Prevention in postmenopausal women

  • Reclast: 5 mg IV over >5 minutes every 2 years

Treatment in men and postmenopausal women

  • Reclast: 5 mg IV over >15 minutes every year

Glucocorticoid-Induced Osteoporosis

Treatment and prevention

Reclast: 5 mg IV over >15 minutes every year; supplemented with elemental calcium and vitamin D

Paget Disease

Reclast: 5 mg IV over >15 minutes once; supplemented with elemental calcium and vitamin D

Complex Regional Pain Syndrome (Orphan)

Orphan designation for treatment of complex regional pain syndrome (CRPS)

Sponsors

  • Axsome Therapeutics, Inc.; 45 Rockefeller Plaza, Suite 2000; New York, NY 10111
  • Thar Pharmaceuticals; 150 Gamma Drive; Pittsburgh, PA 15238

Dosing Modifications

Renal impairment (Zometa)

  • CrCl >60 mL/min: 4 mg
  • CrCl 50-60 mL/min: 3.5 mg
  • CrCl 40-49 mL/min: 3.3 mg
  • CrCl 30-39 mL/min: 3 mg
  • CrCl <30 mL/min: Not recommended

Renal impairment (Reclast)

  • CrCl >35 mL/min: No adjustment needed
  • CrCl <35 mL/min: Contraindicated

Hepatic impairment

  • Safety and efficacy not established

Safety and efficacy not established

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Interactions

Interaction Checker

zoledronic acid 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%

            Bone pain (55%)

            Nausea (29-46%)

            Fever (32-44%)

            Fatigue (39%)

            Anemia (22-33%)

            Vomiting (14-32%)

            Constipation (27-31%)

            Dyspnea (22-27%)

            Diarrhea (17-24%)

            Anorexia (9-22%)

            Arthralgia (5-21%)

            Headache (5-19%)

            Dizziness (18%)

            Insomnia (15-16%)

            Urinary tract infection (UTI; 12-14%)

            Anxiety (11-14%)

            Hypophosphatemia (5-14%)

            Hypokalemia (12%)

            Hypotension (11%)

            Hypomagnesemia (11%)

            Rash (11%)

            Frequency Not Defined

            Ocular inflammation (eg, uveitis, scleritis, episcleritis, conjunctivitis, iritis, orbital inflammation)

            Postmarketing Reports

            Ocular: Uveitis, scleritis, episcleritis, conjunctivitis, iritis, blurred vision, orbital inflammation (including orbital edema)

            CNS: Taste disturbance, hyperesthesia, tremor

            GI: Dry mouth

            Skin: Increased sweating

            Musculoskeletal: Muscle cramps, osteonecrosis of jaw, pain, atypical subtrochanteric and diaphyseal femoral fractures

            Osteonecrosis of other bones including femur, hip, knee, ankle, wrist and humerus

            Cardiovascular: Hypertension, bradycardia, hypotension (associated with syncope or circulatory collapse, primarily in patients with underlying risk factors)

            Acute-phase reaction (≤3 days after administration) with symptoms including pyrexia, fatigue, bone pain or arthralgias, myalgias, chills, flulike illness, arthritis with subsequent joint swelling

            Hypersensitivity: Bronchoconstriction or bronchospasm, interstitial lung disease, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis

            Renal: Hematuria, proteinuria

            General disorders and administration site: Weight increase, flulike illness (pyrexia, asthenia, fatigue or malaise) persisting for >30 days

            Laboratory abnormalities: Hyperkalemia, hypernatremia

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            Warnings

            Contraindications

            Pregnancy

            All indications: Hypersensitivity, including rare cases of urticaria, angioedema, and anaphylactic reaction or shock

            Nononcologic uses: Hypocalcemia, severe renal impairment (CrCl <35 mL/min or evidence of acute renal impairment)

            Cautions

            Assess renal function before and after treatment; if renal function is decreased after treatment, withhold additional treatment until it returns to within 10% of baseline

            Before each Reclast dose, calculate CrCl on basis of actual body weight, using Cockcroft-Gault formula

            Other risks for renal impairment include coadministration of zoledronic acid with nephrotoxic or diuretic medications, severe dehydration before or after zoledronic acid administration, and advanced age

            Previous renal insufficiency (serum creatinine >3 mg/dL [265 mmol/L]), hepatic insufficiency, musculoskeletal pain

            Infuse over ≥15 minutes; faster infusion increases renal toxicity

            May cause significant risk of hypocalcemia (seizures, tetany, and numbness); hypocalcemia must be corrected before initiation of therapy; adequately supplement patients with calcium and vitamin D; monitor serum calcium closely with concomitant administration of other drugs known to cause hypocalcemia to avoid severe or life-threatening hypocalcemia

            Use with caution in aspirin-sensitive asthma; may cause bronchoconstriction

            Increased risk of osteonecrosis of jaw (advise patients against dental work); reported predominantly in cancer patients treated with IV bisphosphonates, including zoledronic acid; many patients were also receiving chemotherapy and corticosteroids which may be risk factors; risk may increase with duration of exposure to bisphosphonates; perform preventive dental exams before initiating therapy; avoid invasive dental procedures; monitor diabetic patients carefully

            Risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

            Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years

            If patients are receiving Zometa, they should not receive Reclast

            Severe bone, joint, and muscle pain may occur; withhold future doses of zoledronic acid if severe symptoms occur

            Rehydrate patients with hypercalcemia of malignancy prior to administration of zoledronic acid injection and monitor electrolytes during treatment

            Women of childbearing age should be advised of potential hazard to fetus and avoid becoming pregnant

            Femur Fractures reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture

            Severe bone, joint, and muscle pain may occur; withhold future doses of reclast if severe symptoms occur

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            Pregnancy & Lactation

            Pregnancy category: D

            Lactation: Unknown whether drug crosses into breast milk; avoid using

            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; inhibits bone resorption via actions on osteoclast activity, leading to indirect increase in bone density

            Absorption

            Onset: Hypercalcemia of malignancy, 4-7 days; osteolytic bone metastases, 1 week

            Duration: 32 days

            Distribution

            Protein bound: 28-53%

            Metabolism

            Not metabolized

            Elimination

            Half-life: 146 hr (terminal)

            Renal clearance: 66 mL/min

            Total body clearance: 5.6 L/hr

            Excretion: Urine (39% as unchanged drug) within 24 hr, feces (<3%)

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            Administration

            IV Incompatibilities

            Calcium-containing solutions

            IV Preparation

            Zometa: Reconstitute powder with 5 mL SWI; once powder is fully dissolved, dilute further in 100 mL NS or D5W before administering

            Infusion of solution must be completed within 24 hours of initial reconstitution

            IV Administration

            Zometa: Infuse over ≥15 minutes, in line separate from other medications

            Reclast: Infuse over ≥15 minutes, using ready-to-use infusion solution

            Ensure appropriate hydration, especially in patients on diuretics

            Storage

            Zometa: Before dilution, store vials at 25°C (77°F); after final dilution, use solution immediately or store at 2-8°C (36-46°F)

            Reclast: Store at 25°C (77°F)

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            Images

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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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