Dosing & Uses
Dosage Forms & Strengths
tablet
- 150mg
prefilled syringe
- 1 mg/1 mL (3 mL)
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- human parathyroid hormone, recombinant
ibandronate 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 (24)
- aluminum hydroxide
aluminum hydroxide decreases levels of ibandronate 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 ibandronate 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 ibandronate 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 ibandronate 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 ibandronate 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 ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.
- carbonyl iron
carbonyl iron decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- deferasirox
deferasirox, ibandronate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.
- ferric maltol
ferric maltol decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous fumarate
ferrous fumarate decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous gluconate
ferrous gluconate decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- ferrous sulfate
ferrous sulfate decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- iron dextran complex
iron dextran complex decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- iron sucrose
iron sucrose decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- magnesium supplement
magnesium supplement will decrease the level or effect of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Formation of a chelate reduces absorption of the drug through intestinal tract; administer magnesium 2hr before or 2hr after the bisphosphonate derivative
- polysaccharide iron
polysaccharide iron decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- rose hips
rose hips decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- selenium
selenium will decrease the level or effect of ibandronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Avoid administering polyvalent cations 2 hr before or 1 h after ibandronate.
- sodium bicarbonate
sodium bicarbonate decreases levels of ibandronate 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 ibandronate 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 ibandronate 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 ibandronate 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, ibandronate. 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.
- zinc
zinc will decrease the level or effect of ibandronate by cation binding in GI tract. Modify Therapy/Monitor Closely. Multivalent cation-containing products may interfere with absorption of ibandronate. Administer ibandronate at least 60 min before taking any other oral medications.
Minor (9)
- entecavir
ibandronate, 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.
- food
food decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- foscarnet
foscarnet increases effects of ibandronate by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.
- magnesium chloride
magnesium chloride decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium citrate
magnesium citrate decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium hydroxide
magnesium hydroxide decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium oxide
magnesium oxide decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium sulfate
magnesium sulfate decreases levels of ibandronate by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- teriparatide
teriparatide, ibandronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.
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; atypical femoral shaft fracture resulting from low-energy or low-trauma; osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal
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)
Pregnancy & Lactation
Pregnancy: Ibandronate is not indicated for use in women of reproductive potential; there are no data with ibandronate use in pregnant women to inform any drug-associated risks
Lactation: Ibandronate is not indicated for use in women of reproductive potential; there is no information on the presence of ibandronate in human milk, effects of ibandronate on breastfed infant, or effects of ibandronate on milk production; ibandronate is present in rat milk; clinical relevance of these data is unclear
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate oral - | 150 mg tablet |  | |
| ibandronate intravenous - | 3 mg/3 mL solution |  | |
| ibandronate intravenous - | 3 mg/3 mL solution |  | |
| ibandronate intravenous - | 3 mg/3 mL solution |  | |
| ibandronate intravenous - | 3 mg/3 mL solution |  | |
| ibandronate intravenous - | 3 mg/3 mL vial |  | |
| ibandronate intravenous - | 3 mg/3 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ibandronate oral
IBANDRONATE MONTHLY - ORAL
(eye-BAN-droe-nate)
COMMON BRAND NAME(S): Boniva
USES: Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods.This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet before starting this medication and each time you get a refill because new information may be available. Follow the instructions very closely to make sure you absorb as much of the drug as possible and reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once a month on the same date each month. Choose the day of the month that best fits your schedule. Take this medication after getting up for the day, and at least 60 minutes before taking your first food, beverage or other medication. Do not take it at bedtime or while you are still in bed.Take this medication with a full glass (6 to 8 ounces/180 to 240 milliliters) of plain water. Do not take it with any other beverages. Do not chew or suck the tablet or keep it in your mouth to melt. Swallow the tablet whole. Then stay fully upright (sitting, standing, or walking) for at least 60 minutes and do not lie down until after your first food of the day. Wait at least 60 minutes after taking ibandronate before you eat or drink anything other than plain water and before taking any other medication by mouth.Medications such as quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), sucralfate, and bismuth subsalicylate may interfere with the absorption of ibandronate. Calcium or iron supplements, vitamins with minerals, and antacids containing calcium, magnesium or aluminum, as well as foods such as dairy products (such as milk, yogurt), mineral water, and calcium-enriched juice, may also interfere with absorption. Do not take these products for at least 60 minutes after taking ibandronate.Take this medication regularly to get the most benefit from it. Remember to take it on the same day each month. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.Continue to take other medications for your condition as directed by your doctor.
SIDE EFFECTS: Stomach upset, diarrhea, pain in arms/legs, or mild flu-like symptoms (such as fatigue, muscle ache) may occur. If any of these effects last or get worse, 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 pain, vision changes.This medication may rarely cause irritation and ulcers in your stomach or esophagus. Get medical help right away if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.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 taking ibandronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (such as alendronate, etidronate, pamidronate, 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: esophagus problems (such as heartburn, narrowing of the esophagus, achalasia), low blood calcium levels (hypocalcemia), inability to sit upright or stand for 60 minutes, difficult or painful swallowing, stomach/intestinal disorders (such as ulcers), severe kidney disease.Some people taking ibandronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking 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 surgery (especially dental procedures), tell your doctor and dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking ibandronate before your surgery. Ask for specific instructions about stopping or starting this medication.Tell your doctor if you are pregnant or plan to become pregnant. Ibandronate may stay in your body for many years. You should not become pregnant while using ibandronate. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section.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.This medication may interfere with certain lab tests (such as bone-imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
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.
NOTES: Do not share this medication with others.Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements and make lifestyle changes. Consult your doctor for specific advice.Lab and/or medical tests (such as bone density tests, x-rays, height, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose and your next scheduled dose is more than 7 days away, do not take the medication later in the day. Take it the next morning after you remember. Then continue taking your monthly dose in the morning on your originally chosen day of the month. If your next scheduled dose is only 1 to 7 days away, wait until your selected day to take the medication. Do not take two tablets within the same week to catch up. Consult your doctor or pharmacist if you have any questions.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines 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 July 2023. Copyright(c) 2023 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.
Formulary
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