Label Changes for:

Boniva (ibandronate sodium) Tablets

November 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS & PRECAUTIONS

  • Upper Gastrointestinal Adverse Reactions
  • Hypocalcemia and Mineral Metabolism
  • Musculoskeletal Pain

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Treatment and Prevention of Postmenopausal Osteoporosis
      • Daily Dosing
        • Initial Section
        • Gastrointestinal Adverse Events
        • Musculoskeletal Adverse Events
        • Ocular Adverse Events
      • Monthly Dosing
        • Initial Section
          • Gastrointestinal Adverse Events
          • Musculoskeletal Adverse Events
          • Acute Phase Reactions
          • Ocular Adverse Events
  • Postmarketing Experience (new subsection)

DRUG INTERACTIONS

  • Calcium Supplements/Antacids
  • H2 Blockers

USE IN SPECIFIC POPULATIONS

  • Renal Impairment (added)

PATIENT COUNSELING INFORMATION

  • Information for Patients (see highlighted prescribing information for new text)

PATIENT PACKAGE INSERT

  • What are the possible side effects of Boniva?
    • ...Rarely, patients have reported allergic and skin reactions...

WARNINGS & PRECAUTIONS

Upper Gastrointestinal Adverse Reactions:

...Advise patients to comply with the dosing instructions to minimize the risk of these effects. Discontinue use if new or worsening symptoms develop (see DOSAGE AND ADMINISTRATION [2.2], ADVERSE REACTIONS [6]).

Hypocalcemia and Mineral Metabolism:

...Adequate intake of calcium and vitamin D is important in all patients to prevent hypocalcemia (see DOSAGE AND ADMINISTRATION [2.3]). Hypocalcemia following dosing has been reported postmarketing.

Musculoskeletal Pain:

...Consider discontinuing use if severe symptoms develop.

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