To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
CALDOLOR (IBUPROFEN IV) - The Adverse Reactions and Use in Specific Populations sections of the Package Insert (PI) were updated to detail clinical study reports for pediatric use.
COSENTYX (SECUKINUMAB) - The Warnings and Precautions section of the PI was updated to detail pen and prefilled syringe caps contain natural rubber. Additional guidance was included for the use in pediatric patients.
TECENTRIQ (ATEZOLIZUMAB) - The Adverse Reactions section of the PI was updated to detail reports of pericarditis, pericardial effusion, and cardiac tamponade in post marketing reports.
DOCETAXEL (DOCETAXEL) - The Drug Interactions section of the PI was updated as well as the Patient Counseling Information, Patient Information and Medication Guide detailing that docetaxel can cause fetal harm when administered during pregnancy and information regarding embryo-fetal toxicity.
OMEGAVEN (FISH OIL TRIGLYCERIDES) - The Warnings and Precautions section of the PI was updated detailing clinical decompensation with rapid infusion in neonates and infants. Serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion. Hypertriglyceridemia was also commonly reported. Guidance was provided to strictly adhere to recommended total daily dosage; and that the hourly infusion rate should not exceed 1.5 mL/kg/hour. Additional routine monitoring guidance was updated including the ability to interfere with certain laboratory tests including Vitamin K contained in Omegaven; which can counteract anticoagulation activity.
LIBTAYO (CEMIPLIMAB-RWLC) - The Medication Guide was revised throughout including Dosing and Administration frequency and infusion rate and Warnings and Precautions for Immune-Mediated and Infusion Related Reactions.
HYRIMOZ (ADALIMUMAB-ADAZ) The Medication Guide was revised throughout including Dosing and Administration for Hidradenitis Suppurativa.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with Coram.