Safety

Cubicin (daptomycin) for injection

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

November 2014

Summary View

WARNINGS AND PRECAUTIONS

Potential Nervous System and/or Muscular System Effects in Pediatric Patients Younger than 12 Months
  • Avoid use of CUBICIN in pediatric patients younger than 12 months due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs with intravenous daptomycin
     

 

November 2013

Summary View

ADVERSE REACTIONS

Post-Marketing Experience – Immune System Disorders
  • angioedema and drug rash with eosinophilia and systemic symptoms (DRESS)

 

May 2012

Summary View

8 USE IN SPECIFIC POPULATIONS

8.3 Nursing Mothers
  • Daptomycin is present in human milk but is poorly bioavailable orally. In a single case study, CUBICIN was administered daily for 28 days to a nursing mother at an IV dose of 6.7 mg/kg/day, and samples of the patient’s breast milk were collected over a 24-hour period on day 27.  ... Caution should be exercised when CUBICIN is administered to a nursing woman. 

 

December 2010

Summary View

ADVERSE REACTIONS

Post-Marketing Experience
  • Infections and Infestations: Clostridium difficile-associated diarrhea

 

August 2010

Summary View 

WARNINGS

Eosinophilic pneumonia
  • Eosinophilic pneumonia has been reported in patients receiving Cubicin. In reported cases, patients developed fever, shortness of breath with increased oxygen requirement, and progressive pulmonary infiltrates. In general, patients developed eosinophilic pneumonia 2-4 weeks after starting Cubicin and improved when Cubicin was discontinued and steroid therapy was initiated. In cases where patients were rechallenged with Cubicin, eosinophilic pneumonia recurred. Patients developing these signs and symptoms on Cubicin should undergo prompt medical evaluation and Cubicin should be discontinued immediately. Treatment with systemic steroids should be considered if clinically indicated. 

ADVERSE REACTIONS

Post-Marketing Experience
  • Respiratory, thoracic and mediastinal disorders: Eosinophilic pneumonia

 

Page Last Updated: 12/11/2014
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