pharmacopeia

Ibandronate

Bone Surface InteractionsBone Resorption InhibitionUS-FDASourced from openFDA
GET
/api/v1/drug/ibandronate
2D structure
[1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl]phosphonic acid
SMILES CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
InChIKey MPBVHIBUJCELCL-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover.

Indications

Sourced from openFDA
  • Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ).ICD-10: M81.0

Contraindications

Sourced from openFDA
  • Ibandronate sodium tablets are contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see Warnings and Precautions [5.1] ) Inability to stand or sit upright for at least 60 minutes ( see Dosage and Administration [2.2] , and Warnings and Precautions [5.1] ) Hypocalcemia ( see Warnings and Precautions [5.2 ] ) Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported ( see Adverse Reactions [6.2] ).contraindicated

Dosage & administration

Sourced from openFDA

Take one 150 mg tablet once monthly on the same day each month ( 2.1 ) Instruct patient to: ( 2.2 ) Swallow whole tablet with 6 to 8 oz of plain water only, at least 60 minutes before the first food, beverage, or medication of day. Avoid lying down for at least 60 minutes after taking ibandronate sodium tablets. Do not eat, drink (except for water), or take other medication for 60 minutes after taking ibandronate sodium tablets. Take supplemental calcium and vitamin D if dietary intake inadequate ( 2.3 ) 2.1 Dosage Information The dose of ibandronate sodium tablet is one 150 mg tablet taken once monthly on the same date each month. 2.2 Important Administration Instructions Instruct Patients to do the following: Take ibandronate sodium tablets at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, (see DRUG INTERACTIONS [7.1] ) . Avoid the use of water with supplements including mineral water because they may have a higher concentration of calcium. Swallow ibandronate sodium tablets whole with a full glass of plain water (6 to 8 oz) while standing or sitting in an upright position to reduce the potential for esophageal irritation. Avoid lying down for 60 minutes after taking ibandronate sodium tablets (see WARNINGS AND PRECAUTIONS [5.1] ). Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.

Warnings & precautions

Sourced from openFDA

Upper gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions and discontinue use if new or worsening symptoms occur. ( 5.1 ) Hypocalcemia may worsen during treatment. Correct hypocalcemia before use. ( 5.2 ) Severe Bone, Joint, and Muscle Pain may occur. Consider discontinuing use if symptoms develop. ( 5.3 ) Osteonecrosis of the Jaw has been reported. ( 5.4 ) Atypical Fractures including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered. ( 5.5 ) 5.1 Upper Gastrointestinal Adverse Reactions Ibandronate sodium tablets, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when ibandronate sodium tablets are given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse drug reactions are described elsewhere in the labeling: Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.1 )] Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.2 )] Musculoskeletal [see Warnings and Precautions ( 5.3 )] Jaw Osteonecrosis [see Warnings and Precautions ( 5.4 )] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.5 )] Severe Renal Impairment [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (greater than 5%) are back pain, dyspepsia, pain in extremity, diarrhea, headache, and myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment and Prevention of Postmenopausal Osteoporosis Daily Dosing The safety of ibandronate sodium tablets 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 – 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to ibandronate sodium tablets 2.5 mg.

Use in specific populations

Sourced from openFDA

Ibandronate sodium tablets are not recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min). ( 5.6 , 8.6 ) 8.1 Pregnancy Risk Summary Ibandronate sodium tablets is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium caused post-implantation loss and obstruction of labor with maternal and fetal periparturient mortality at greater than or equal to 3 times human exposure at the recommended 2.5 mg daily oral dose, or at greater than or equal to 1 times human exposure at the recommended 150 mg once-monthly oral dose. In pregnant rats, kidney developmental toxicity occurred in offspring at greater than or equal to 30 times the daily 2.5 mg human dose or at greater than or equal to 9 times the once-monthly 150 mg human dose. In rat reproductive studies, impaired pup neuromuscular development was observed at 45 times the daily 2.5 mg dose and 13 times the once-monthly 150 mg dose. In reproductive studies in the rabbit, ibandronate sodium caused maternal mortality at greater than or equal to 8 times the daily 2.5 mg dose and greater than or equal to 4 times the once-monthly 150 mg dose ( see Data ).

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The absorption of oral ibandronate occurs in the upper gastrointestinal tract. Plasma concentrations increase in a dose-linear manner up to 50 mg oral intake and increases nonlinearly above this dose.

Overdosage

Sourced from openFDA

No specific information is available on the treatment of overdosage of ibandronate sodium tablets. However, based on knowledge of this class of compounds, oral overdosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, dyspepsia, esophagitis, gastritis, or ulcer. Milk or antacids should be given to bind ibandronate sodium tablets. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain fully upright. Dialysis would not be beneficial.

Approval history

Sourced from openFDA
  • Mar 19, 2012ANDAANDA078948Apotex Inc
  • Mar 19, 2012ANDAANDA078998Orbion Pharms
  • Apr 30, 2012ANDAANDA078997Dr Reddys Labs Ltd
  • Feb 14, 2014ANDAANDA090853Sun Pharm
  • Aug 19, 2015ANDAANDA205332Eugia Pharma
  • Oct 16, 2015ANDAANDA204222Apotex
  • Mar 11, 2016ANDAANDA204502Aurobindo Pharma
  • Oct 31, 2017ANDAANDA206887Macleods Pharms Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,004 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Arthralgia2508.3%
  2. 2Diarrhoea2387.9%
  3. 3Nausea2277.6%
  4. 4Femur Fracture2187.3%
  5. 5Headache2056.8%
  6. 6Fatigue2006.7%
  7. 7Fall1705.7%
  8. 8Dizziness1695.6%
  9. 9Pain1645.5%
  10. 10Asthenia1555.2%
  11. 11Drug Ineffective1454.8%
  12. 12Myalgia1424.7%
  13. 13Dyspnoea1414.7%
  14. 14Pain In Extremity1414.7%
  15. 15Vomiting1394.6%

Literature

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Recent PubMed references pinned to Ibandronate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Ibandronate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ibandronate work?
The action of ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover.
What is Ibandronate used for?
According to FDA labeling, Ibandronate carries indications including: Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ibandronate?
Ibandronate is classified as Bone Surface Interactions, Bone Resorption Inhibition.
What are the brand names for Ibandronate?
Ibandronate is marketed under brand names including Boniva.
What are the contraindications for Ibandronate?
Ibandronate labeling lists contraindications including: Ibandronate sodium tablets are contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see Warnings and Precautions [5.1] ) Inability to stand or sit upright for at least 60 minutes ( see Dosage and Administration [2.2] , and Warnings and Precautions [5.1] ) Hypocalcemia ( see Warnings and Precautions [5.2 ] ) Known hypersensitivity to ibandronate sodium tablets or to any of its excipients. Cases of anaphylaxis have been reported ( see Adverse Reactions [6.2] ).. Always consult the full prescribing information and a clinician.
Note. Data for ibandronate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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