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U.S. Department of Health and Human Services

Safety

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Reclast (zoledronic acid) Injection


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Hypersensitivity to zoledronic acid or any components of Reclast

WARNINGS AND PRECAUTIONS

  • Hypocalcemia and Mineral Metabolism
  • Renal Impairment
  • Musculoskeletal Pain
  • Patients with Asthma

ADVERSE REACTIONS

  • Clinical Studies Experience
    • Treatment of Osteoporosis
      • Table 1
      • Renal Impairment
      • Acute Phase Reaction
      • Laboratory Findings
      • Injection Site Reactions
      • Osteonecrosis of the Jaw
      • Atrial Fibrillation
      • Ocular Adverse Events
  • Postmarketing Experience (new subsection)

DRUG INTERACTIONS

  • Initial Section
  • Nephrotoxic Drugs
    • ...such as nonsteroidal anti-inflammatory drugs.

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
  • Geriatric Use

PATIENT COUNSELING INFORMATION

  • Information for Patients

PATIENT PACKAGE INSERT

  • What is the most important information I should know about Reclast?
  • What is Reclast?
  • What should I tell my doctor before getting Reclast?
  • Tell your doctor about all the medicines you take...
  • How will I receive Reclast?
  • What are the possible side effects of Reclast?
  • What is Osteoporosis?

CONTRAINDICATIONS

Hypersensitivity to zoledronic acid or any components of Reclast

Hypersensitivity reactions including rare cases of urticaria, angioedema, and anaphylactic reaction/shock have been reported...

WARNINGS AND PRECAUTIONS

Hypocalcemia and Mineral Metabolism

...Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended...

All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels...

Renal Impairment

...Monitor serum creatinine before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider interim monitoring of serum creatinine in at-risk patients.

Musculoskeletal Pain

In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. The time to onset of symptoms varied from one day to several months after starting the drug. Consider withholding future Reclast treatment if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate...

Patients with Asthma

...Use Reclast with caution in aspirin-sensitive patients.