Voclosporin label carries boxed warning for malignancies

By Hipa.ai Research · August 25, 2026

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 31, 2026.

On August 25, 2026, the FDA-listed label for LUPKYNIS (voclosporin) carried a boxed warning about malignancies and serious infections. The warning states that treatment with LUPKYNIS or other immunosuppressants may increase these risks and that the resulting events may lead to hospitalization or death.

Background

Voclosporin is identified in the supplied labeling record by the brand name LUPKYNIS. The available data concern a label revision and do not provide additional information about the drug’s class, mechanism, approved indication, dosing, or treatment setting.

What changed

The label included the heading “WARNING: MALIGNANCIES AND SERIOUS INFECTIONS”. Its warning language described an increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants. It also stated that these serious events may lead to hospitalization or death.

The label directed readers to the Warnings and Precautions sections identified as 5.1 and 5.2. The supplied data do not specify when the warning was first added, describe a change from an earlier label, identify particular malignancies or infections, or provide event rates, comparative risks, or patient-level findings.

What this means

For clinicians and patients reviewing the LUPKYNIS label, the boxed warning highlights malignancies and serious infections as risks associated with LUPKYNIS or other immunosuppressants. The warning states that these events can be severe enough to require hospitalization or can result in death.

The available record does not establish the frequency of either risk, identify factors that increase susceptibility, or provide recommendations beyond directing readers to the cited Warnings and Precautions sections. It also does not report a new indication, a contraindication, clinical-trial results, or a comparison between voclosporin and another treatment.

Source

Source: FDA, DailyMed drug-label document for LUPKYNIS (voclosporin), with the label event effective August 25, 2026. The document is available through dailymed.nlm.nih.gov at dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9f489295-1156-52c7-5fd0-5c4c52f9b813.