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ibandronate (Rx)Brand and Other Names:Boniva

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 150mg

prefilled syringe

  • 1 mg/1 mL (3 mL)
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Osteoporosis

Indicated for treatment and prevention of osteoporosis in postmenopausal women; increases BMD and reduces vertebral fracture incidence

150 mg PO every month OR

3 mg IV every 3 months administered over 15-30 seconds (Treatment only)

Administration

Take at least 60 minutes before first food, drink or other medications; take with full glass of water, in upright position & remain upright for 60 minutes to minimize esophageal adverse events

Take with plain water only; juice or coffee can significantly reduce bioavailability

Do NOT chew or suck tablet

Not applicable

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Interactions

Interaction Checker

ibandronate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            ADRs frequency similar to placebo

            >10%

            URI (34%)

            Back pain (14%)

            Dyspepsia (12%)

            Bronchitis (10%)

            1-10% (selected)

            Asthenia

            Diarrhea

            Dizziness

            Myalgia

            Pneumonia

            Tooth disorder

            UTI

            Postmarketing Reports

            Hypersensitivity: Allergic reactions including anaphylactic reaction/shock; in some cases fatal, angioedema, bronchospasm, asthma exacerbations, Stevens-Johnson syndrome, erythema multiforme, rash, and dermatitis bullous

            Metabolic: Hypocalcemia

            Musculoskeletal: Joint, bone, or muscle pain, described as severe or incapacitating; osteonecrosis of the jaw, atypical femoral shaft fracture resulting from low-energy or low-trauma

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            Warnings

            Contraindications

            Hypersensitivity; anaphylaxis reported, including fatalities

            Uncorrected hypocalcemia

            Inability to stand or sit upright for at least 60 min

            Esophagus abnormalities that delay emptying (eg, stricture, achalasia)

            Cautions

            Potential for esophagitis, dysphagia & esophageal ulcers

            Severe esophageal risk greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water

            Do not continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation

            Food decreases bioavailability

            Ensure adequate intake of calcium, vitamin D; correct hypocalcemia before use

            Osteonecrosis of the jaw, can occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing; known risk factors include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders; risk of osteonecrosis of the jaw may increase with duration of exposure to bisphosphonates

            Risk of severe bone, joint and/or muscle pain; consider discontinuing if symptoms develop

            Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

            Not recommended in severe renal impairment (CrCl <30 mL/min)

            Avoid concomitant multivalent cation-containing drugs or food

            Esophageal cancer risk (July 21, 2011 FDA safety communication)

            • Conflicting findings exist from studies evaluating the risk of esophageal cancer with oral bisphosphonates
            • Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates (eg, sit up or stand after administration, take with full glass of water)
            • An ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus is currently being conducted by the FDA
            • The FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer
            • There are insufficient data to recommend endoscopic screening of asymptomatic patients
            • FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available
            • Instruct patients to contact their healthcare provider if they develop symptoms of esophagitis (eg, swallowing difficulties, chest pain, new or worsening heartburn, trouble or pain when swallowing)
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: unknown; use caution

            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

            Half-Life for 150 mg tablet: 37-157 hours

            Peak Plasma Time: 1 hr

            Bioavailability: 0.6% compared with IV dosing

            Protein Bound: 90-99%

            Vd: 90 L

            Metabolism: none

            Clearance

            Total body: 84-160 mL/min

            Renal: 42-80 mL/min

            Other Information

            Excretion: Urine (50-60%), feces (unabsorbed drug)

            Mechanism of Action

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

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            Administration

            IV Administration

            Direct IV injection over 15-30 seconds

            Administer over 1 hour for metastatic bond disease

            Administer over 2 hours for hypercalcemia of malignancy

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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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