Label Changes for:
Cubicin (daptomycin for injection)
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Addition of the following adverse reactions:
- Blood and lymphatic system disorders: anemia
- General and administration site conditions: pyrexia
- Renal and urinary disorders: acute kidney injury, renal insufficiency, and renal failure
- Skin and Subcutaneous Tissue Disorders: acute generalized exanthematous pustulosis
- …Special Senses: visual disturbances
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
Post-Marketing Experience – Immune System Disorders
- angioedema and drug rash with eosinophilia and systemic symptoms (DRESS)
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.
- Infections and Infestations: Clostridium difficile-associated diarrhea
- 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.
- Respiratory, thoracic and mediastinal disorders: Eosinophilic pneumonia