zoledronic acid (Rx)

Brand and Other Names:Reclast, Zometa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV injectable solution

  • 4mg/5mL (5mL)
  • 5mg/100mL

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

Dosage 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

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

Glioma (Orphan)

Orphan designation for treatment of glioma

Sponsor

  • Laboratorio Italiano Biochimico Farmaceutico Lisapharma SpA; Via Licinio 11; Erba (CO), Italy

Safety and efficacy not established

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Interactions

Interaction Checker

and zoledronic acid

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • human parathyroid hormone, recombinant

              zoledronic acid decreases effects of human parathyroid hormone, recombinant by Other (see comment). Contraindicated. Comment: Coadministration of bisphosphonates with rhPTH leads to reduction in rhPTH's calcium sparing effect, which can interfere with the normalization of serum calcium.

            Serious - Use Alternative (0)

              Monitor Closely (13)

              • aluminum hydroxide

                aluminum hydroxide decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • calcium acetate

                calcium acetate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium carbonate

                calcium carbonate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium chloride

                calcium chloride decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium citrate

                calcium citrate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • calcium gluconate

                calcium gluconate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

              • dichlorphenamide

                dichlorphenamide and zoledronic acid both decrease serum potassium. Use Caution/Monitor.

              • peramivir

                zoledronic acid increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

              • sodium bicarbonate

                sodium bicarbonate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium citrate/citric acid

                sodium citrate/citric acid decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of zoledronic acid by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of zoledronic acid by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • voclosporin

                voclosporin, zoledronic acid. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (17)

              • amikacin

                amikacin, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • aspirin

                aspirin decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • aspirin rectal

                aspirin rectal decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate decreases levels of zoledronic acid by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • bumetanide

                bumetanide, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • entecavir

                zoledronic acid, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

              • ethacrynic acid

                ethacrynic acid, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • foscarnet

                foscarnet increases effects of zoledronic acid by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.

              • furosemide

                furosemide, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • gentamicin

                gentamicin, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • indomethacin

                indomethacin increases levels of zoledronic acid by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • neomycin PO

                neomycin PO, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • paromomycin

                paromomycin, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • streptomycin

                streptomycin, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • teriparatide

                teriparatide, zoledronic acid. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.

              • tobramycin

                tobramycin, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

              • torsemide

                torsemide, zoledronic acid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Additive hypocalcemia.

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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

              Acqured Fanconi syndrome

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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

              Cases of osteonecrosis (primarily involving the jaw but also of other anatomical sites including hip, femur and external auditory canal) reported predominantly in cancer patients

              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

              There are no available data in pregnant women to inform the drug-associated risk

              Bisphosphonates are incorporated into bone matrix and are gradually released over periods of weeks to years; there may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy; advise pregnant women and females of reproductive potential of the potential risk to a fetus

              Verify pregnancy status of females of reproductive potential prior to initiation of therapy

              Therapy can cause fetal harm when administered to a pregnant woman; drug binds to bone long term and may be released over weeks to years; advise females of reproductive potential to use effective contraception during and after therapy

              Based on animal studies, therapy may impair fertility in females of reproductive potential

              Animal data

              • Based on findings from animal studies and its mechanism of action, drug can cause fetal harm when administered to a pregnant woman; in animal reproduction studies, administration of drug to pregnant rats during organogenesis resulted in fetal malformations and embryo-fetal lethality at maternal exposures that were greater than or equal to 2.4 times the human clinical exposure based on AUC

              Lactation

              Not known whether drug is present in human milk, or whether it affects milk production, or breastfed child; drug binds to bone long term and may be released over weeks to years

              Consider developmental and health benefits of breast-feeding along with the mother’s clinical need for therapy and any potential adverse effects on breast-fed child from drug or from 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; 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

              BRAND FORM. UNIT PRICE PILL IMAGE
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
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              4 mg/5 mL vial
              zoledronic acid intravenous
              -
              4 mg/5 mL vial
              zoledronic acid intravenous
              -
              4 mg/5 mL vial
              zoledronic acid intravenous
              -
              4 mg vial
              zoledronic acid intravenous
              -
              4 mg/5 mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              zoledronic acid intravenous

              ZOLEDRONIC ACID - INJECTION

              (ZOLE-eh-dron-ick)

              COMMON BRAND NAME(S): Zometa

              USES: This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Zoledronic acid belongs to a class of drugs known as bisphosphonates. It lowers high blood calcium levels by reducing the amount of calcium released from your bones into your blood. It also works by slowing the breakdown of your bones by cancer to prevent bone fractures.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start receiving zoledronic acid and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor, usually over at least 15 minutes. The dosage is based on your medical condition (including your kidney function) and response to treatment.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Avoid mixing zoledronic acid with IV fluids that have calcium in them (such as Ringer's solution, Hartmann's solution, parenteral nutrition-TPN/PPN). Talk to your pharmacist for more details.For the treatment of high blood calcium levels, fluids are usually given through a vein before you receive this medication. To decrease the chance of kidney problems, drink plenty of fluids during treatment unless otherwise directed by your doctor. It takes at least 7 days after a dose to get the full benefit of this drug. The dose may need to be repeated depending on your blood calcium levels.For the treatment of multiple myeloma and bone problems caused by the spread of cancer, this medication is usually given every 3 to 4 weeks or as directed by your doctor. You may also be instructed to take calcium and vitamin D supplements each day.

              SIDE EFFECTS: Dizziness, headache, tiredness, or flu-like symptoms (such as fever, chills, muscle/joint aches) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, jaw/ear pain, eye/vision problems, numbness/tingling, muscle spasms, irregular heartbeat.Get medical help right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, risedronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, dehydration, aspirin-sensitive asthma.Some people using zoledronic acid may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication may cause severe kidney problems, especially in the elderly. Consult your doctor or pharmacist for more information. To help prevent harm to your kidneys, drink plenty of fluids unless otherwise directed by your doctor. (See also How to Use section.)Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using zoledronic acid. Zoledronic acid may harm an unborn baby. Ask about reliable forms of birth control while using this medication and after stopping treatment. This medication may stay in your body for many years. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because it may harm a nursing infant, breast-feeding while using this drug and after stopping treatment is not recommended. This medication may stay in your body for many years. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.While using this medication, you should not be treated with other bisphosphonates, including other brands of zoledronic acid used to prevent or treat bone loss (osteoporosis).Some products that may interact with this drug include: calcium-containing IV fluids, "water pills" (diuretics such as bumetanide, furosemide).Also tell your doctor or pharmacist of drugs that may be harmful to your kidneys such as: aminoglycoside antibiotics (including gentamicin, tobramycin), amphotericin B, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen), tacrolimus.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: change in the amount of urine, muscle spasms, muscle weakness, mental/mood changes, irregular heartbeat, seizures.

              NOTES: Laboratory and/or medical tests (such as calcium and other blood mineral levels, kidney function tests) will be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

              STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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              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.
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              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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              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.
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              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.