alendronate (Rx)

Brand and Other Names:Fosamax, Binosto, more...Fosamax Plus D
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg (generic)
  • 10mg (generic)
  • 35mg (generic)
  • 40mg (generic)
  • 70mg (generic, Fosamax)

tablet, effervescent

  • 70mg (generic, Binosto)

solution, oral

  • 70mg/75mL (generic, Fosamax)

Osteoporosis

Postmenopausal women

  • Indicated for treatment and prevention of osteoporosis in postmenopausal women
  • Prevention
    • Fosamax: 5 mg PO qDay or 35 mg PO once weekly
  • Treatment
    • Fosamax: 10 mg PO qDay or 70 mg (tablet and oral solution) once weekly
    • Binosto: 70 mg PO once weekly

Men

  • Fosamax: 10 mg PO qDay or 70 mg (tablet and oral solution) once weekly
  • Binosto: 70 mg PO once weekly

Glucocorticoid-Induced Osteoporosis

Fosamax only

Indicated for treatment of glucocorticoid-induced osteoporosis

Males and females: 5 mg PO qDay

Postmenopausal women not on hormone replacement therapy: 10 mg PO qDay

Paget Disease

Fosamax only

Indicated for treatment of Paget disease of bone

40 mg PO qDay for 6 months

Dosing Modifications

Renal impairment

  • Mild-to-moderate renal impairment (CrCl 35-60 mL/min): Dose adjustment not necessary
  • Severe renal impairment (CrCl <35 mL/min): Not recommended

Hepatic impairment

  • No dosage adjustment necessary
  • As there is evidence that alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment

Dosing Considerations

Limitation of Use

  • Optimal duration of use not determined; for patients at low-risk for fracture, consider drug discontinuation after 3-5 years of use

Safety and efficacy not established

Osteogenesis Imperfecta (Orphan)

Treatment in pediatric patients aged 4 years or older

Orphan indication sponsor

  • Merck, Sharpe & Dohme Corp; 126 East Lincoln Ave, PO Box 2000; Rahway, NJ 07065-0900

Gaucher Disease (Orphan)

Treatment of bone manifestations of disease

Orphan indication sponsor

  • Richard J Wenstrup, MD; Division of Human Genetics, Children's Hospital Research Foundation; Cincinnati, OH 45229-3039
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Interactions

Interaction Checker

and alendronate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Daily dosing

            • Abdominal pain (2.1-6.6%)
            • Musculoskeletal (bone, muscle or joint) pain (4.1%)
            • Acid regurgitation (2-4.1%)
            • Flatulence (2.6-4.1%)
            • Nausea (0.6-3.6%)
            • Dyspepsia (3.4-3.6%)
            • Constipation (1.3-3.1%)
            • Diarrhea (1.4-3.1%)
            • Headache (0.6-2.6%)
            • Esophageal ulcer (1.5%)
            • Vomiting (1%)
            • Dysphagia (1%)
            • Abdominal distention (1%)

            Weekly dosing

            • Abdominal pain (1.7-3.7%)
            • Musculoskeletal pain (2.9%)
            • Dyspepsia (1.9-2.7%)
            • Acid regurgitation (1.4-1.9%)
            • Nausea (1.4-1.9%)
            • Abdominal distention (1%)
            • Constipation (0.8%)
            • Flatulence (0.4%)
            • Gastritis (0.2%)
            • Muscle pain (0.2%)

            <1%

            Daily dosing

            • Gastroesophageal reflux disease (0.7%)
            • Senses taste perversion (0.5%)
            • Gastritis (0.5%)

            Weekly dosing

            • Musculoskeletal pain (0.8%)
            • Constipation (0.8-0.9%)
            • Flatulence (0.4%)
            • Gastritis (0.2%)
            • Muscle pain (0.2%)
            • Abdominal distention (0.2%)

            Postmarketing Reports

            Body as a whole: Hypersensitivity reactions including urticaria and angioedema; transient myalgia, malaise, asthenia, and fever; symptomatic hypocalcemia; peripheral edema

            Gastrointestinal: Esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration; gastric or duodenal ulcers

            Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing

            Musculoskeletal: Bone, joint, and/or muscle pain, occasionally severe, and incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures

            Nervous system: dizziness, vertigo

            Pulmonary: Acute asthma exacerbations

            Skin: Rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis

            Special Senses: Uveitis, scleritis, or episcleritis, cholesteatoma of the external auditory canal (focal osteonecrosis)

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            Warnings

            Contraindications

            Hypersensitivity

            Hypocalcemia

            Abnormalities of the esophagus delaying esophageal emptying such as stricture or achalasia

            Inability to stand or sit upright for 30 minutes

            Cautions

            May cause local irritation of upper GI mucosa

            Take with plain water only, not coffee, juice, or mineral water; sit or stand upright for at least 30 minutes after administration

            Hypocalcemia reported with use of bisphosphonates; correct hypocalcemia prior to therapy; ensure adequate calcium and vitamin D intake

            Conjunctivitis, uveitis, episcleritis, and scleritis reported with alendronate use; perform ophthalmic evaluation in patients with signs of ocular inflammation

            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

            Not recommended in severe renal impairment (CrCl <35 mL/min)

            In Paget disease, drug is available only through Paget's Patient Support Program with Pharma Care Specialty Pharmacy (800-238-7828 x58197) distribution system for 40-mg dosage regimen

            Risk of severe bone, joint, or muscle pain; discontinue therapy in patients who experience severe symptoms of pain; avoid use in patients with history of these symptoms in association with bisphosphonate therapy

            Possible increased risk of atypical subtrochanteric and diaphyseal femur fractures; may consider discontinuing therapy after 3-5 years in patients at low-risk for fracture; following discontinuation, re-evaluate fracture risk periodically; consider periodic reevaluation of need for continued bisphosphonate therapy, particularly if treatment lasts >5 years; patients with new thigh or groin pain should be evaluated to rule out a femoral fracture

            Use effervescent tablet with caution in sodium-restricted patients (tablet contains 603 mg sodium, equivalent to approximately 1532 of NaCl or salt)

            Drug interaction overview

            Calcium supplements/antacids
            • Coadministration with calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of alendronate
            Aspirin
            • In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of alendronate sodium greater than 10 mg and aspirin-containing products
            Nonsteroidal anti-inflammatory drugs (NSAIDs)
            • Use with caution
            • In a clinical study which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in alendronate-treated group compared to placebo
            Levothyroxine
            • Bioavailability of alendronate was slightly decreased when alendronate and levothyroxine were coadministered to healthy subjects
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            Pregnancy & Lactation

            Pregnancy

            Available data on use in pregnant women insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes; discontinue when pregnancy recognized.

            Animal data

            • In animal reproduction studies, daily oral administration to rats from before mating through end of gestation or lactation showed decreased postimplantation survival and decreased pup body weight gain starting at doses equivalent to less than half of highest recommended 40 mg clinical daily dose (based on body surface area, mg/m2)
            • Oral administration to rats during organogenesis resulted in reduced fetal ossification starting at doses 3 times clinical daily dose of 40 mg;
            • No similar fetal effects observed in pregnant rabbits dosed orally during organogenesis at doses equivalent to approximately 10 times the 40 mg clinical daily dose
            • Delayed or failed delivery of offspring, protracted parturition, and late pregnancy maternal and fetal deaths due to maternal hypocalcemia occurred in rats at oral doses as low as one tenth the 40 mg clinical daily dose
            • Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years; based on mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy
            • Impact of variables such as time between cessation of bisphosphonate therapy to conception, particular bisphosphonate used, and route of administration (intravenous versus oral) on risk not studied

            Lactation

            Not known whether drug present in human breast mild, affects milk production or has effects on infants

            Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential effects on breastfed child from drug or underlying maternal condition

            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; binds to hydroxyapatite crystals in bone and inhibits osteoclast-mediated bone resorption; decreases mineral release and collagen or matrix breakdown in bone

            Absorption

            Bioavailability (fasting): Women, 0.64%; men, 0.59%; reduced up to 60% by food

            Onset: 3 weeks

            Duration: 12-30 weeks (multiple doses)

            Distribution

            Protein bound: 78%

            Vd: 28 L (exclusive of bone)

            Metabolism

            Not metabolized

            Elimination

            Half-life: Up to 10 years in bone (terminal)

            Excretion: Urine 50%, feces (unabsorbed drug)

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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.