Ibandronic acid

Ibandronic acid
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Ibandronic acid is a bone density conservation agent that is FDA approved for the prophylaxis of osteoporosis. Common adverse reactions include hypertension,abdominal pain, diarrhea, indigestion, nausea, back ache, pain in limb, headache, bronchitis, upper respiratory infection.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Treatment and Prevention of Postmenopausal Osteoporosis

• BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Important Limitations of Use

• The optimal duration of use has not been determined. The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
• Dosing information:

• The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ibandronic acid in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibandronic acid in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ibandronic acid FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ibandronic acid in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibandronic acid in pediatric patients.

Contraindications

BONIVA is contraindicated in patients with the following conditions:

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 60 minutes.
• Hypocalcemia.
• Known hypersensitivity to BONIVA or to any of its excipients. Cases of anaphylaxis have been reported.

Warnings

There is limited information regarding Ibandronic acid Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ibandronic acid Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ibandronic acid Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ibandronic acid Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ibandronic acid in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ibandronic acid in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ibandronic acid during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ibandronic acid in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ibandronic acid in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ibandronic acid in geriatric settings.

Gender

There is no FDA guidance on the use of Ibandronic acid with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ibandronic acid with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ibandronic acid in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ibandronic acid in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ibandronic acid in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ibandronic acid in patients who are immunocompromised.

Administration and Monitoring

Administration

Dosage Information

• The dose of BONIVA is one 150 mg tablet taken once monthly on the same date each month.

Important Administration Instructions

Instruct Patients to do the following:

• Take BONIVA 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 BONIVA 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 BONIVA. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration.
• Do not eat, drink anything except plain water, or take other medications for at least 60 minutes after taking BONIVA.

Recommendations for Calcium and Vitamin D Supplementation

• Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Avoid the use of calcium supplements within 60 minutes of BONVIA administration because co-administration of BONIVA and calcium may interfere with the absorption of ibandronate sodium.

Administration Instructions for Missed Once-Monthly Doses

• If the once-monthly dose is missed, instruct patients to do the following:

• If the next scheduled BONIVA day is more than 7 days away, take one BONIVA 150 mg tablet in the morning following the date that it is remembered.
• If the next scheduled BONIVA day is only 1 to 7 days away, wait until the subsequent month's scheduled BONIVA day to take their tablet.

• For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one BONIVA 150 mg tablet every month on their previous chosen day.

DOSAGE FORMS AND STRENGTHS

• BONIVA 150 mg tablets: white, oblong, engraved with "BNVA" on one side and "150" on the other side.

Monitoring

There is limited information regarding Ibandronic acid Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ibandronic acid and IV administrations.

Overdosage

There is limited information regarding Ibandronic acid overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ibandronic acid Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ibandronic acid Mechanism of Action in the drug label.

Structure

There is limited information regarding Ibandronic acid Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ibandronic acid Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ibandronic acid Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ibandronic acid Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ibandronic acid Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ibandronic acid How Supplied in the drug label.

Storage

There is limited information regarding Ibandronic acid Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Ibandronic acid Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ibandronic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ibandronic acid Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ibandronic acid Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.