FDA Drug Warnings March 2025 | Lippincott NursingCenter

FDA Drug Warnings - March 2025

elexacaftor–tezacaftor–ivacaftor and ivacaftor

Trikafta

NEW WARNING

The FDA is requiring the prescribing information for Trikafta, a combination drug containing elexacaftor, tezacaftor, and ivacaftor, to carry a Boxed Warning regarding the increased risk of serious, and sometimes fatal, liver injury. The drug combination isn't recommended in patients with Child-Pugh class B liver impairment and shouldn't be used in patients with Child-Pugh class C liver impairment.

The warning includes that patient's prescribed Trikafta should have liver function studies assessed at baseline then monitored monthly for the first 6 months, every 3 months for the next 12 months, and then at least annually. Monitoring should be performed more frequently in patients with a history of liver impairment or elevated baseline liver function studies. Further, therapy should be interrupted for significant elevations in liver function studies or signs or symptoms of liver injury, then the patient followed closely until the abnormalities resolve. Trikafta should only be resumed if the abnormalities resolve and if the benefits of use outweigh the risk.

Patients should be advised to immediately stop Trikafta and seek medical attention for signs or symptoms of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.

Adverse effects from the use of Trikafta should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook

fezolinetant

Veozah

NEW WARNING

The FDA is requiring the prescribing information for fezolinetant to include a Boxed Warning regarding an increased risk of liver toxicity with its use. The warning requires that liver function studies be performed at baseline and that therapy not be started if either ALT or AST is 2 × the upper limit of normal (ULN) or more, or if the total bilirubin is 2 × ULN for the evaluating laboratory.

The Boxed Warning further requires that follow-up liver function studies be performed monthly for the first three months, then at 6 and 9 months after starting therapy, and more frequently if transaminase levels are greater than 3 × ULN. Therapy should be discontinued if transaminase levels are greater than 5 × ULN; or they are greater than 3 × ULN when the total bilirubin level is greater than 2 × ULN.

In addition, the Boxed Warning advises patients to immediately stop the drug and seek medical attention for signs or symptoms suggestive of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.

Adverse effects from the use of fezolinetant should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook

glatiramer acetate

Copaxone, Glatopa

NEW WARNING

The FDA is requiring that the prescribing information for glatiramer acetate products include a Boxed Warning that anaphylaxis can occur at any time during therapy, from first dose to years after the start of therapy. The warning states that the drug is contraindicated in patients with a history of hypersensitivity to glatiramer, including anaphylaxis.

Patients should be monitored for hypersensitivity reactions. If anaphylaxis occurs, the drug must be immediately discontinued and the patient treated as clinically indicated. The drug should be permanently discontinued unless a clear alternative cause of reaction is identified.

The Boxed Warning explains that patients should be aware that symptoms of anaphylaxis (widespread rash; swelling of the face, eyelids, lips, mouth, throat, or tongue; sudden shortness of breath or wheezing; convulsions; trouble swallowing or speaking; fainting, dizziness, or feeling faint) may overlap with those of immediate postinjection reactions. Further, the patient should be advised to stop glatiramer and seek immediate medical attention if anaphylaxis occurs, as prompt identification is important to avoid a delay in treatment.

Adverse effects from the use of glatiramer acetate should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook