To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
AMJEVITA (ADALIMUMAB-ATTO) - The Package Insert (PI) was updated to include use in the treatment of hidradenitis suppurativa (HS) and surrounding clinical trial details. The Use in Specific Populations section was also updated detailing inclusion and exclusion criteria for pediatric patients
EVKEEZA (EVINACUMAB-DGNB) – The Warnings and Precautions section of the PI was updated to include anaphylaxis as a potential outcome. Clinical trial data was updated to include additional study details in adults and pediatric patients. Fatigue was also added as a adverse reaction noted in pediatric patients.
FOLLISTIM AQ (FOLLITROPIN ALFA/BETA) – The Warnings and Precautions section of the PI was updated adding abnormal ovarian enlargement and ovarian neoplasms as adverse reactions. The Use in Specific Populations section was updated stating use in pregnant women is contraindicated and offers no benefit. Additional details were updated to use in lactation.
KEYTRUDA (PEMBROLIZUMAB) – The Adverse Reactions/Clinical Trials Experience sections were updated to include Urothelial Carcinoma and supporting trial data. The Use In Specific Populations section was updated to include additional reactions noted in pediatric patients at 10% or greater rate when compared to adults
PREGNYL (GONADOTROPIN, CHORIONIC) – The following additions were made to the Contraindications section of the PI: prior hypersensitivity reactions to human gonadotropins, high serum FSH indicating primary gonadal failure in women, the presence of uncontrolled non-gonadal endocrinopathies, tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males, malformations of the reproductive organs incompatible with pregnancy, fibroid tumors of the uterus incompatible with pregnancy, and abnormal vaginal bleeding of undetermined origin. The Use in Specific Populations section was also updated detailing lactation.
STELARA (USTEKINUMAB) – The Warnings and Precautions section of the PI was updated to include details surrounding One case of reversible posterior leukoencephalopathy syndrome (RPLS) observed in clinical studies.
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.