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Ibandronate Sodium

Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: [1-Hydroxy-3-(methylpentylamino)propylidene]diphosphonate trihydrogen sodium monohydrate
Molecular Formula: C9H22NNaO7
CAS Number: 138926-19-9
Brands: Boniva


Synthetic bisphosphonate; bone resorption inhibitor.1 4

Uses for Ibandronate Sodium


Prevention of osteoporosis in postmenopausal women.1 Risk factors include premature ovarian failure, family history of osteoporosis, endocrine disorders (e.g., thyrotoxicosis, hyperparathyroidism, Cushing’s syndrome, hyperprolactinemia, insulin-dependent diabetes mellitus), early menopause, previous fracture, high bone turnover, reduced bone mineral density (≥1 standard deviation below premenopausal mean), thin body frame, low body weight, white or Asian race, excessive alcohol intake, treatment with certain drugs (e.g., corticosteroids), low dietary calcium or vitamin D intake, sedentary lifestyle, and cigarette smoking.5 6 8 18 42 43

Treatment of osteoporosis in postmenopausal women.1 3 7

Ibandronate Sodium Dosage and Administration


  • Oral: Provide supplemental calcium and vitamin D1 7 if dietary intake is inadequate.1 18

  • IV: Supplemental calcium and vitamin D required regardless of the adequacy of dietary intake of calcium and vitamin D.7 18


Oral Administration

Administer orally with a full glass (180–240 mL) of plain water ≥60 minutes prior to the first food, beverage (other than plain water), or other orally administered drug or supplement (including vitamins, antacids, and calcium) of the day.1 4 5 16 (See Food under Pharmacokinetics.)

Avoid lying down for ≥60 minutes following administration.1 5

Do not to suck or chew tablets; potential for oropharyngeal ulceration.1 5 (See Upper GI Effects under Cautions.)

If a morning daily oral dose is missed, do not take missed dose later that same day.5 Resume the regular schedule the next day.1 5

When administered monthly, take tablets in the morning on the same day each month.1 5 If a monthly dose is missed and the next scheduled dose is more than 7 days away, take the missed dose the next morning after it is remembered and resume the regular schedule.1 5 If the next scheduled dose is 1–7 days away, maintain the regular schedule;1 do not take more than one 150-mg tablet within the same week.1 5

IV Administration

Administer by IV injection once every 3 months by a health-care professional.7

Injection must only be administered IV.1 7 18 Safety and efficacy of IV injection administered by other routes not established.7

If a dose is missed, reschedule administration with a health-care professional as soon as possible.7 8 Schedule subsequent injections at 3-month intervals; should not be administered more often than once every 3 months.7 8

Administration Risks

Take care to avoid intra-arterial or paravenous injection as such administration could result in tissue damage.7

Rate of Administration

Administer IV over a period of 15–30 seconds.7 8


Available as ibandronate sodium (as the monosodium monohydrate); dosage expressed in terms of ibandronate.1 7


Prevention in Postmenopausal Women

2.5 mg once daily.1 Alternatively, a dosage of 150 mg once monthly may be considered.1

Treatment in Postmenopausal Women

2.5 mg once daily or 150 mg once monthly.1

Optimal duration of treatment not established.1 28 Safety and efficacy based on data supporting fracture reduction over 3 years of treatment.1 28 Reevaluate need for continued therapy periodically in all patients receiving bisphosphonates.1 28


3 mg once every 3 months.7

Optimal duration of treatment not established.7 28 Safety and efficacy of IV ibandronate based on data supporting fracture reduction over 1 year of treatment.7 Reevaluate need for continued therapy periodically in all patients receiving bisphosphonates.7 28

Special Populations

Hepatic Impairment

Dosage adjustments not necessary.1 7

Renal Impairment


Dosage adjustments not necessary in patients with mild to moderate renal impairment (Clcr ≥30 mL/minute); use not recommended in patients with severe renal impairment (Clcr <30 mL/minute).1 4 18


Should not be administered to patients with severe renal impairment (Clcr <30 mL/minute, Scr >2.3 mg/dL).7 18

Geriatric Patients

Dosage adjustments not necessary.1 7

Cautions for Ibandronate Sodium


  • Oral: Esophageal abnormalities that delay esophageal emptying (e.g., stricture, achalasia).1 5

  • Oral and IV: Uncorrected hypocalcemia.1 5 7 8

    Oral and IV: Known hypersensitivity to ibandronate or any ingredient in the formulation.1 5 7 8

  • Oral: Inability to stand or sit upright for ≥60 minutes.1 5



Upper GI Effects

Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation).1 2 (See Oral Administration under Dosage and Administration.) Monitor for any manifestations and discontinue if dysphagia, odynophagia, new or worsening heartburn, or retrosternal pain occurs.1

Use with caution in patients with history of upper GI disease (e.g., Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers).1 Gastric and duodenal ulcers (some severe and with complications) reported during postmarketing experience.1

Route of Administration

Injection must be administered IV by a health-care professional; do not administer by non-IV (e.g., intra-arterial) routes.7 (See Administration Risks under Dosage and Administration.)

Like other bisphosphonates, may cause transient decrease in serum calcium concentrations when given IV.7

General Precautions

Metabolic Effects

Correct hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before initiating therapy.1 7 8 18

Oral: If daily intake inadequate, administer supplemental calcium and vitamin D.1 5 18

IV: Supplemental calcium and vitamin D required regardless of the adequacy of dietary intake of calcium and vitamin D.7 18

Musculoskeletal Effects

Osteonecrosis and osteomyelitis of the jaw reported in patients receiving bisphosphonates, usually when given IV.1 7 13 Associated mostly with dental procedures (e.g., tooth extraction) in cancer patients, but some cases occurred in patients with postmenopausal osteoporosis or other diagnoses.1 7 13 Known risk factors include cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, preexisting dental disease, anemia, coagulopathy, and infection.1 7

If osteonecrosis of the jaw develops, consult an oral surgeon for treatment.1 7 Dental surgery may exacerbate condition.1 7

In patients requiring dental procedures, no data are available to suggest whether discontinuance of therapy prior to procedure reduces the risk of osteonecrosis of the jaw.1 7 Base management of patients requiring dental treatment on an individual assessment of risks and benefits.1 7

Severe and occasionally incapacitating bone, joint, and/or muscle pain reported infrequently with bisphosphonate therapy.1 5 7 8 18 Time to onset varied from 1 day to years (mean onset about 3 months) after treatment initiation.1 7 8 20 If severe symptoms occur, consider discontinuing drug.1 Such pain generally improves following discontinuance, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.1 5 7 8 18

Atypical (subtrochanteric or diaphyseal) femur fractures reported rarely with long-term use (>3 years) of bisphosphonates, mostly in patients receiving these drugs for osteoporosis.28 29 30 31 Often occurs with minimal or no trauma, and may be bilateral.26 27 28 30 33 Causality not established; atypical fractures also occur in osteoporotic patients not receiving bisphosphonates.28 29 30 31 Risk may be increased with concomitant use of glucocorticoid, estrogen, and proton-pump inhibitor therapy.30 32 33 35

Evaluate patients who present with new thigh or groin pain for possibility of an atypical femoral fracture; include assessment of the contralateral limb.26 27 28 30 Consider interruption of bisphosphonate therapy in patients with manifestations of possible femoral fracture; weigh risks versus benefits of continued treatment.26 27 30 Discontinue if a femoral shaft fracture is confirmed.28 29 30

Atrial Fibrillation

Although data are conflicting, possible increased risk of atrial fibrillation with use of bisphosphonates.21 22 23 24 FDA analysis of data from long-term (6 months to 3 years) controlled trials identified a higher rate of atrial fibrillation in patients receiving bisphosphonates (alendronate, ibandronate, risedronate, or zoledronic acid) versus placebo; however, only a few events reported in each study.23 FDA is continuing to monitor this safety concern.23

Potential Risk of Esophageal Cancer

Some evidence (from postmarketing experience and observational studies) suggests a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer.25 36 37 However, because of conflicting data,37 38 39 additional study needed to confirm such findings.36

FDA states that benefits of oral bisphosphonates continue to outweigh their potential risks in patients with osteoporosis; it is important to consider that esophageal cancer is rare, especially in women.36 37

Avoidance of oral bisphosphonates in patients with Barrett’s esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.25

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function and, rarely, renal failure) with bisphosphonates.7 12 Risk may be greater in patients with coexisting conditions associated with renal impairment, concomitant therapy with other nephrotoxic drugs, preexisting renal disease, dehydration, dosage, infusion volume and rate, and multiple cycles of treatment.4 7 8 9 10 11

Use not recommended in patients with severe renal impairment (Scr >2.3 mg/dL or Clcr <30 mL/minute).1 7

Assess risk factors predisposing patients to renal deterioration.7 8 Measure Scr prior to each IV dose.7 Withhold treatment if deterioration of renal function occurs.7

Specific Populations


Category C. 1 7


Distributed into milk in rats; not known whether distributed into human milk.1 7 Use caution.1 7

Pediatric Use

Safety and efficacy not established in children.1 7 18 Not indicated for use in children.18

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 7 Consider age-related decreases in renal function.18

Renal Impairment

Oral: Use not recommended in patients with severe renal impairment (CLcr <30 mL/minute).1 18

IV: Do not administer in patients with severe renal impairment (Clcr <30 mL/minute, Scr >2.3 mg/dL).7 18

Common Adverse Effects

Oral: Upper respiratory infection,1 back pain,1 dyspepsia,1 2 5 bronchitis,1 pain in the extremities,1 5 abdominal pain,1 diarrhea,1 5 headache,1 hypertension,1 pneumonia,1 myalgia,1 arthralgia,1 urinary tract infection,1 nausea.1

IV: Arthralgia,7 8 16 17 back pain,7 hypertension,7 abdominal pain.7

Interactions for Ibandronate Sodium

Does not induce or inhibit CYP isoenzymes (i.e., CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, or 3A4)4 7 and is not metabolized.1 4 7

Antacids or Mineral Supplements Containing Divalent Cations

Pharmacokinetic interaction (decreased absorption of ibandronate) when tablets are used concomitantly with antacids or mineral supplements containing divalent cations (e.g., aluminum, calcium, magnesium, iron).1 5 44 Administer tablets ≥60 minutes prior to such drugs or supplements.1 5

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely.1

Drugs Excreted through Renal Tubular Transport

Based on limited data in animals, not excreted through renal tubular transport.1 4 7 Pharmacokinetic interaction unlikely.1 4

Nephrotoxic Agents

Potential pharmacologic interaction (increased risk of renal toxicity). 4 7 8 9 10 11 12 Assess patients taking concomitant nephrotoxic agents.1 7 (See Renal Effects under Cautions.)

Specific Drugs and Tests




Bone-imaging agents

Potential to interfere with use of bone-imaging agents1 7

Histamine H2-receptor antagonists

Increased oral bioavailability of ibandronate1 4 44

No evidence of increased adverse upper GI effects1 18

Not considered clinically important1 4


Pharmacokinetic interaction unlikely with IV ibandronate7


No evidence of increased adverse upper GI effects1

Use concomitantly with caution1


Pharmacokinetic interaction unlikely with IV ibandronate7


Pharmacokinetic interaction unlikely with IV ibandronate1 7

Ibandronate Sodium Pharmacokinetics



Absolute (compared with IV administration) oral bioavailability about 0.6%.1 4 16


Reduction in bone turnover evident within 1–3 months of treatment initiation; maximal effects observed at 6 months.1 7 44


Biochemical markers of bone turnover returned to baseline ≥12 months after treatment discontinuance.44


Bioavailability decreased by 90% when administered with a standard breakfast compared with administration under fasting conditions.1 Bioavailability and effect on BMD reduced when food and beverages taken <60 minutes following oral administration.1

Special Populations

In patients with renal impairment (Clcr 40–70 mL/minute), AUC is increased by 55% compared with that in patients with normal renal function (Clcr >90 mL/minute).7 Patients with severe renal impairment (Clcr <30 mL/minute) had >2-fold increase in AUC compared with exposure for healthy individuals.7 44



Widely distributed throughout the body and redistributed to bone.4 44 Subsequently, the drug is released systemically via bone turnover.1 4 Not known whether distributed into milk.7

Plasma Protein Binding

84–99.5% at therapeutic drug concentrations.1 4 7 44



No evidence of metabolism.7 16

Elimination Route

Excreted in urine (50–60% of circulating dose) as unchanged drug and in feces (unabsorbed drug).1 4 7 44


Apparent oral terminal half-life is 37–157 hours; dose-dependent.1

Apparent IV terminal half-life is 4.6–25.5 hours; dose-dependent.7

Special Populations

No race-related pharmacokinetic differences between Asians and whites; other races not studied.44 Pharmacokinetics not affected by gender.1 44

Pharmacokinetics not evaluated in pediatric patients.1 44 Pharmacokinetics in patients with hepatic impairment not studied as ibandronate is not metabolized in the liver.1





25°C (may be exposed to 15–30°C).1



25°C (may be exposed to 15–30°C).7


For information on systemic interactions resulting from concomitant use, see Interactions.


Do not admix with calcium-containing solutions or other IV drugs.7


  • Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption in a dose-dependent manner.1 4 7 44

  • Reduces biochemical markers of bone resorption in patients with postmenopausal osteoporosis.1 7 44

  • Maintains or increases BMD2 3 13 and increases bone mass in postmenopausal women.1 4 5 7

Advice to Patients

  • Importance of providing patient with a copy of the manufacturer’s patient information.1 7

  • Importance of adhering to recommended life-style modifications (e.g., exercise, calcium and vitamin D supplementation).1 5

  • Importance of correct oral administration (e.g., avoiding foods and beverages other than plain water [including mineral water] prior to administration, not lying down for ≥60 minutes following administration).1 5 18 (See GI Effects under Cautions.)

  • Importance of not taking vitamins, calcium, or antacids ≤60 minutes of taking oral ibandronate.1 5

  • Necessity of swallowing tablets whole, without chewing or sucking.1 5

  • Importance of reviewing how to resume therapy in the event of a missed dose.1 5 7

  • Importance of discontinuing oral ibandronate and informing clinician if symptoms of esophageal disease (e.g., new or worsening dysphagia, difficulty or pain on swallowing, retrosternal pain, heartburn) develop.1 5

  • Importance of informing a clinician if severe bone pain, joint pain, muscular pain, or jaw problems develop.5 8

  • Importance of women informing clinicians if they are or plan to become pregnant or to plan to breast-feed.1 5 8

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (vitamins, supplements, antacids), as well as any concomitant illnesses (e.g., preexisting dysphagia, esophageal disorders, renal impairment).1 5 8

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ibandronate Sodium


Dosage Forms


Brand Names



Tablets, film-coated

2.5 mg (of ibandronate)

Boniva (with povidone)

Roche (also promoted by GlaxoSmithKline)

150 mg (of ibandronate)

Boniva (with povidone)

Roche (also promoted by GlaxoSmithKline)

Injection, for IV use only

1 mg (of ibandronate) per mL

Boniva (available in prefilled syringe with needle and swabs)

Roche (also promoted by GlaxoSmithKline)

AHFS DI Essentials. © Copyright 2018, Selected Revisions March 14, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.


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