Safety

Caverject Impulse Dual Chamber System (alprostadil for injection)

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

May 2016

Summary View

WARNINGS AND PRECAUTIONS

Needle Breakage
  • Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalization and surgical removal…

PATIENT COUNSELING INFORMATION

Dosing and Self-Administration

When self-administering the patient should be instructed to:

  • Do not use a bent needle. If the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.

PATIENT INFORMATION

What are the possible side effects of CAVERJECT IMPULSE?

CAVERJECT IMPULSE may cause serious side effects, including:

  • Needle breakage.
  • needle properly... If the needle is bent at any time, do not attempt to straighten it and do not use it. A bent and re-straightened needle is predisposed to breakage. Remove the needle from the syringe, discard, and attach a new, unused sterile needle to the syringe… If the needle…

 

June 2014

Summary View

PRECAUTIONS

General Precautions
  • Benzyl alcohol: The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.

 

December 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Device malfunction/failure

 

Page Last Updated: 06/10/2016
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