Amivantamab Label Adds Boxed Warning for Cardiomyopathy, Toxicity

The label for Amivantamab (Rybrevant) was revised by the FDA on 2026-05-29 to include a new boxed warning. This warning highlights serious risks including cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity.

What this means

The addition of a boxed warning to Amivantamab's label signifies that healthcare providers should be aware of these serious risks when prescribing or administering the drug. Boxed warnings, also known as black box warnings, are the strongest warnings the FDA requires for prescription drugs and medical devices when there is reasonable evidence of a serious hazard.

The warning for cardiomyopathy indicates a potential for serious cardiac adverse events, including heart muscle dysfunction. This typically necessitates careful baseline cardiac function assessment and ongoing monitoring, such as echocardiograms or MUGA scans, throughout treatment with Amivantamab. Patients should be advised to report any symptoms of heart failure, such as shortness of breath or swelling.

The warning for embryo-fetal toxicity highlights the significant risk of harm to a developing fetus if Amivantamab is administered during pregnancy. This usually requires pregnancy testing for females of reproductive potential prior to initiating treatment and advising effective contraception during treatment and for a specified period after the last dose.

Furthermore, the warning for pulmonary toxicity points to the risk of severe or life-threatening lung-related adverse events, such as interstitial lung disease or pneumonitis. Clinicians should monitor patients for new or worsening respiratory symptoms, including cough, dyspnea, or fever, and consider interrupting or discontinuing treatment if such events occur.

Clinicians should carefully review the full prescribing information to understand the complete details of these warnings and to implement appropriate monitoring and risk mitigation strategies for patients receiving Amivantamab.

Source

The information regarding this label revision was obtained from the FDA via DailyMed. The label update for Amivantamab was effective 2026-05-29, as detailed on dailymed.nlm.nih.gov.