Lupkynis, also known as voclosporin, is a medication that was approved by the U.S. Food and Drug Administration (FDA) in January 2021 for the treatment of lupus nephritis. Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE) that can lead to kidney damage and failure if left untreated. Lupkynis works by inhibiting calcineurin, a protein that plays a key role in the immune response that causes inflammation in the kidneys.
Since its approval, there have been updates to the labeling of Lupkynis to include long-term data on its efficacy and safety, as well as recommendations for renal function monitoring. These updates are important for healthcare providers who are prescribing Lupkynis to patients with lupus nephritis.
The long-term data on Lupkynis show that it is effective in reducing proteinuria, a key marker of kidney damage in lupus nephritis. In clinical trials, patients treated with Lupkynis experienced a significant reduction in proteinuria compared to those who received a placebo. This reduction in proteinuria was sustained over the long term, indicating that Lupkynis can help to slow the progression of kidney damage in patients with lupus nephritis.
In addition to its efficacy, Lupkynis has also been shown to be safe for long-term use. The most common side effects of Lupkynis include diarrhea, headache, and hypertension, but these side effects are generally mild and manageable. There have been no reports of serious adverse events associated with the use of Lupkynis in clinical trials.
One important aspect of the updated labeling for Lupkynis is the recommendation for renal function monitoring in patients with lupus nephritis. Renal function monitoring involves regular testing of kidney function, including measurements of serum creatinine and urine protein levels. This monitoring is important for detecting any changes in kidney function that may occur during treatment with Lupkynis.
Overall, the updates to the labeling of Lupkynis provide important information for healthcare providers who are treating patients with lupus nephritis. The long-term data on its efficacy and safety, as well as the recommendations for renal function monitoring, can help to ensure that patients receive the best possible care and achieve the best possible outcomes with this new treatment option.
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- Source: Plato Data Intelligence.
- Source: https://renal.platohealth.ai/long-term-data-renal-function-monitoring-update-added-to-lupkynis-labeling-renal-and-urology-news/