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Label Changes for:

Clinolipid (lipid injectable emulsion)

July 2016

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

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

July 2016

ADVERSE REACTIONS

Post-marketing Experience
  • Immune System Disorders: Hypersensitivity with the manifestations of rash and dyspnea

USE IN SPECIFIC POPULATIONS

PLLR Conversion:

Pregnancy
Risk Summary
  • The limited available data on the use of CLINOLIPID in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if CLINOLIPID is used in pregnant women. Animal reproduction studies have not been conducted with lipid injectable emulsion.
  • The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and15 to 20% respectively.
Clinical Considerations
Disease-Associated Maternal and/or Embryo-Fetal Risk:
  • Severe malnutrition in a pregnant woman is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. It is not known whether the administration of CLINOLIPID to pregnant women provides adequate essential fatty acids to the developing fetus.
Lactation
Risk Summary
  • There are no data available to assess the presence of CLINOLIPID and/or its active metabolite(s) in human milk, the effects on the breastfed child or the effects on milk production The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINOLIPID and any potential adverse effects on the breastfed child from CLINOLIPID or from the underlying maternal condition.

PATIENT COUNSELING INFORMATION

Should patients self-administer CLINOLIPID at home, patients should also be instructed to:

  • Ensure that there is a 1.2 micron in-line filter in place prior to and during administration. (addition of 1.2 micron to in-line filter)
     
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