What is FILSPARI prescribed for?
FILSPARI is prescribed to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.
What is the name of the drug and what does it do?
FILSPARI (generic name: sparsentan), pronounced “fil spah’ ree,” is a medicine that helps adults with a kidney condition called primary immunoglobulin A (IgA) nephropathy.
It’s used to lower the amount of protein in the urine for those at risk of their kidney disease getting worse quickly, usually when their urine protein-to-creatinine ratio is 1.5 g/g or higher.
How does it work?
FILSPARI works by blocking certain receptors in the body that are linked to kidney problems.
By doing this, FILSPARI helps reduce the amount of protein in the urine for adults with a kidney condition called primary immunoglobulin A (IgA) nephropathy.
This can be especially helpful for those at risk of their kidney disease getting worse quickly.
By lowering the protein in the urine, FILSPARI can improve how the kidneys work and slow down the kidney disease from getting worse.
What did the research discover?
The FDA granted accelerated approval to FILSPARI after studying patients with IgA nephropathy, a kidney disease where the immune system damages the kidneys.
In the clinical trial PROTECT, patients with IgA nephropathy were given FILSPARI or irbesartan, a medication that helps lower blood pressure and protect the kidneys.
The study assessed the effectiveness and safety of FILSPARI in 281 patients who reached Week 36, with 141 on FILSPARI and 140 on irbesartan.
Safety was analyzed in 404 patients who received at least one dose of either drug.
The main aim was to see the change in urine protein levels at Week 36 compared to the start.
FILSPARI showed a 45% reduction in urine protein, while irbesartan showed a 15% reduction.
This accelerated approval gives patients early access to FILSPARI while further studies confirm its benefits.
What are some of the side effects?
The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.
- Peripheral edema
- Hypotension (including orthostatic hypotension)
- Dizziness
- Hyperkalemia
- Anemia
What are the dosage recommendations and how should I take it?
FILSPARI is an oral tablet (200mg or 400mg) that is taken once daily.
Source:
Drug Trials Snapshots: FILSPARI [Internet]. U.S. Food and Drug Administration. 2023 [cited 2024 Jul 1]. Available from: https://www.fda.gov/drugs/drug-trials-snapshots-filspari
