To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE (various strengths) The Warnings and Precautions section of the Package Inserts (PI) were updated stating “To avoid life-threatening hyperkalemia, do not administer Potassium Chloride in Dextrose and Sodium Chloride Injections USP as an intravenous push (i.e., intravenous injection manually with a syringe connected to the intravenous access, without a quantitative infusion device).”
ZYVOX (LINEZOLID) The Warnings and Precautions section of the PI was updated in regard to myelosuppression; specifically, thrombocytopenia being reported more often in patients with severe renal impairment, whether or not on dialysis, and in patients with moderate to severe hepatic impairment.
DIFLUCAN (FLUCONAZOLE) The Drug Interactions section of the PI was updated detailing use with HMG-CoA reductase inhibitors stating “dose reduction of statins may be needed. Refer to the statin-specific prescribing information for details.” Additional information was provided when administered with Ivacaftor and Lurasidone.
LEQEMBI (LECANEMAB-IRMB) Major updates were made to the Boxed Warnings, Indications and Usage, Dose and Administration, Contraindications and Warnings and Precautions sections of the PI. Contraindications include patients with serious hypersensitivity to the medication or any of the excipients. Reactions have included angioedema and anaphylaxis. Warnings and precautions include details regarding Amyloid Related Imaging Abnormalities, Hypersensitivity Reactions, Infusion-Related Reactions and Adverse Reactions. Use in Specific Populations was updated stating “No overall differences in safety or effectiveness of LEQEMBI have been observed between patients 65 years of age and older and younger adult patients.” Additional clinical trial experience was included in the PI as well as patient counseling information.
TEPEZZA (TEPROTUMUMAB-TRBW) The Warnings and Precautions section of the PI was updated detailing hearing impairment including hearing loss. These details were also added to the post marketing subsection as well as the patient counseling information.
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% The Warnings and Precautions section of the PI was updated throughout detailing heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT). Details regarding heparin resistance were added and hypersensitivity reactions were updated to include chills, fever, urticaria, asthma, rhinitis, lacrimation, and anaphylactoid reactions. New subsections were added detailing hyperkalemia and elevation of serum aminotransferases. Additional adverse reactions were included from post marketing experience. The drug interactions section was updates to include NSAIDS, thienopyridines, and glycoprotein IIv/IIa antagonists.
HADLIMA (ADALIMUMAB-BWWD) The Warnings and Precautions section of the PI was updated detailing additional malignancies and rates noted with TNF blockers.
CYLTEZO (ADALIMUMAB-ADBM) The Warnings and Precautions section of the PI was updated detailing additional malignancies. Details were added regarding liver enzyme elevation as well as clinical study safety profile in patients treated for uveitis.
AMJEVITA (ADALIMUMAB-ATTO) The Warnings and Precautions section of the PI was updated detailing additional malignancies. Details were added regarding liver enzyme elevation as well as clinical study safety profile in patients treated for uveitis.
DOCETAXEL (DOCETAXEL) The Use in Specific Populations section of the PI was updated detailing male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose, based on findings in animal reproduction studies. Additional patient information was included regarding low white blood cell counts occurring during treatment, having the potential to cause serious infections that may lead to death.
JEVTANA (CABAZITAXEL) The Use in Specific Populations section of the PI was updated detailing the potential for fetal harm when administered to pregnant women. Additional information was included regarding pregnancy testing and contraception.
LEQVIO (INCLISIRAN SODIUM) – Extensive changes were made to the Clinical Trials Experience section of the PI. Additional information was added to the Pregnancy and Geriatric subsection of Use in Specific Populations.
VEKLURY (REMDESIVIR) The Use in Specific Populations section of the PI was updated detailing use in Pediatric Patients with Renal Impairment. Additional clinical trial data was added to the Renal Impairment Subsection.
HUMALOG (INSULIN LISPRO RECOMBINANT) The Clinical Trials Experience section of the PI was update defining common adverse reactions. Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMALOG. Extensive changes were made to the Drug Interactions section. The risk summary was updated when used in Lactation. The Safety and Effectiveness when used in Pediatric Patients was also updated to include clinical trial data and results. Additional patient counseling information was updated detailing instructions for patients using continuous subcutaneous insulin pumps.
COSENTYX (SECUKINUMAB) The Warnings and Precautions section of the PI was updated to include hypersensitivity reactions and Eczematous Eruptions. Adverse reactions were updated to include Inflammatory Bowel Disease. The Clinical Trials Experience section was divided to age-group related results. Pediatric and Geriatric Use sections were updated with safety and effectiveness as well as clinical trial data. Additional details were added to the Patient Counseling Information.
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.