April Adverse Events Report: FDA Labeling Changes
The adverse events report featuring FDA labeling changes for bendamustine hydrochloride, nilotinib, dinutuximab.
BENDEKA (BENDAMUSTINE HYDROCHLORIDE)
Warnings and Precautions added: skin reactions, hepatotoxicity
- Fatal and serious skin reactions have been reported with bendamustine hydrochloride injection treatment in clinical trials and postmarketing safety reports, including the toxic skin reactions Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and rash.
- Skin reaction events occurred when bendamustine hydrochloride injection was given as a single agent and in combination with other anticancer agents or allopurinol.
- Fatal and serious cases of liver injury have been reported with bendamustine hydrochloride injection. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients.
- Most cases of hepatoxicity were reported within the first 3 months of starting therapy.
Patient Counseling Information added: hepatoxicity
- Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity.
- Niolotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.
Patient Counseling Information updated:
- Patients should be advised that treatment with nilotinib can cause serious thrombocytopenia, neutropenia, and anemia; possibly life-threatening, abnormal heartbeat; an increased risk of pancreatitits, tumor lysis syndrome; and fluid retention.
- Patients should be cautioned about symptoms suggestive of these adverse events and advised to seek immediate medical attention if such symptoms occur.
- The potential for serious adverse reactions in nursing infants whose mothers are being treated with nilotinib is unknown. Because many drugs are excreted in human milk, physicians should decide whether to advise nursing mothers to discontinue nursing or stop nilotinib treatment based on the importance of the drug to the mother.
Boxed Warning revised:
- Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy.
- Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioids prior to, during, and for 2 hours following completion of dinutuximab infusion.
Warnings and Precautions added:
- Permanently discontinue dinutuximab in patients with peripheral motor neuropathy of grade 2 or greater severity.
- Urinary retention that persists for weeks to months following discontinuation of opioids has occurred in patients treated with dinutuximab; permanently discontinue the drug if retention does not resolve after opioid therapy ends.
- Transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS) have occurred in patients treated with dinutuximab. Permanently discontinue dinutuximab in patients who develop transverse myelitis and in patients with signs and symptoms of RPLS, such as severe headache, hypertension, visual changes, lethargy, or seizures.
For full details, visit the FDA’s Drug Safety Labeling Changes database.