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Label Changes for:

Pamidronate Disodium (pamidronate disodium injection) Solution for Intravenous Infusion

October 2008

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

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

  • Deterioration in Renal Function

PRECAUTIONS

  • General
    • Patients with a history of thyroid surgery may have relative hypoparathyroidism that may predispose to hypocalcemia with
      pamidronate disodium.
  • Renal Insufficiency
    • In clinical trials, patients with real impairment (serum creatinine >3 mg/dL) have not been studied. Limited pharmacokinetic data exist
      in patients with creatinine clearance <30 mL/min...
  • Drug Interactions
    • In multiple myeloma patients, the risk of renal dysfunction may be increased when pamidronate disodium is used in combination with thalidomide.
  • Geriatric Use (new )

ADVERSE REACTIONS

  • Postmarketing Experience
    • General
      • reactivation of Herpes simplex and Herpes zoster, influenza-like symptoms
    • CNS
      • confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance
    • Skin
      • rash, pruritus
    • Special Senses
      • conjunctivitis
    • Renal
      • focal segmental glomerulosclerosis including the collapsing variant, nephrotic syndrome
    • Laboratory Abnormalities
      • hyperkalemia, hypernatremia, hematuria

WARNINGS

Deterioration in Renal Function:

Renal deterioration, progression to renal failure, and dialysis have been reported in patients after the initial or a single dose of pamidronate disodium.

Focal segmental glomerulosclerosis (including the collapsing variant) with or without nephritic syndrome, which may lead to renal failure, has been reported in pamidronate disodium-treated patients, particularly in the setting of multiple myeloma and breast cancer. Some of these patients had gradual improvement in renal status after pamidronate disodium was discontinued.

Label approved 10/17/2008 not available on this site

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