Label Changes for:

Reclast (zoledronic acid) Injection

August 2011

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2011 and August 2011

 

August 2011 

 

CONTRAINDICATIONS

Renal Failure
  • Reclast is contraindicated in patients with creatinine clearance < 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3)]

 

WARNINGS AND PRECAUTIONS

Renal Impairment
  • Reclast is contraindicated in patients with creatinine clearance <35 mL/min and in those with evidence of acute renal impairment. [See Contraindications (4.2)]. If history or physical signs suggest dehydration, Reclast therapy should be withheld until normovolemic status has been achieved. [See Post-marketing Experience (6.2)]….

 

MEDICATION GUIDE

Reclast can cause serious side effects including:

 

Severe kidney problems.

Severe kidney problems may happen when you take Reclast. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:

  • already have kidney problems
  • take a diuretic or “water pill”
  • do not have enough water in your body (dehydrated) before or after you receive Reclast
  • are of advanced age since the risk increases as you get older
  • take any medicines known to harm your kidneys

You should drink at least 2 glasses of fluid within a few hours before receiving Reclast to reduce the risk of kidney problems.

 

March 2011

 

ADVERSE REACTIONS

Post-Marketing Experience
  • osteonecrosis of the jaw, ocular adverse events, and hypotension
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