Filspare (sparsentan)
- Drug Name: Filspare
- API: Sparsentan
- Dosage Forms and Strengths: Tablet form, 200 mg and 400 mg
- Manufactured by: Travere Therapeutics
FILSPARI is an antagonist for endothelin and angiotensin II receptors, indicated for the reduction of proteinuria in adults diagnosed with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Typically, this pertains to patients with a urine protein-to-creatinine ratio (UPCR) of ≥1.5 g/g. It’s important to note that this indication is granted under accelerated approval, primarily based on the reduction of proteinuria. It has not been conclusively determined whether FILSPARI slows the decline in kidney function in patients with IgAN. Continued approval for this indication may rely on the verification and description of clinical benefits in a confirmatory clinical trial.
Dosage And administration:
- Before starting FILSPARI, discontinue the use of renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), or aliskiren.
- Commence FILSPARI treatment with 200 mg orally once daily. After 14 days, increase the dose to the recommended 400 mg once daily, as tolerated. In cases of resuming treatment after an interruption, consider titration, beginning with 200 mg once daily and increasing to 400 mg once daily after 14 days.
- Instruct patients to swallow the tablets whole with water before their morning or evening meal.
- Hepatotoxicity: Patients with hepatotoxicity symptoms should discontinue FILSPARI, and treatment should be interrupted for abnormal aminotransferase levels. Reinitiate only when levels return to normal without clinical symptoms.
- Embryo-Fetal Toxicity: FILSPARI can harm fetuses, making it contraindicated during pregnancy. Pregnancy tests are essential, and effective contraception is necessary for patients of childbearing potential.
- FILSPARI REMS: Due to hepatotoxicity and embryo-fetal toxicity risks, FILSPARI is accessible through a restricted program. Prescribers must be certified, patients must enroll, and monitoring is mandatory.
- Hypotension: Some patients may experience hypotension. Adjust other antihypertensive drugs and volume status as needed, with dose reduction or interruption if necessary.
- Acute Kidney Injury: Monitor kidney function, especially in patients reliant on the renin-angiotensin system.
- Hyperkalemia: Regularly monitor serum potassium, particularly in high-risk patients.
- Fluid Retention: In cases of significant fluid retention, evaluate and consider diuretic adjustments or FILSPARI dosing modifications.
If you are considering the import of Filspare (sparsentan) to India, please be aware that Elahere can be imported by patients or government hospitals solely in the name of the patients. The following documentation is essential for the successful import of this medication:
- Required Documentation for Import:
- A valid prescription from a qualified medical practitioner.
- Diagnostic reports of the patient.
- Government-issued identification proof for the patient, as recognized by the Government of India.
Order Confirmation Process:
The order for Elahere will be confirmed upon the receipt of the following documents:
- A valid prescription from a qualified doctor.
- An import permit, if applicable.
Availability of Filspare (sparsentan) in India:
Filspare (sparsentan) is classified as a prescription pharmaceutical drug. Consequently, it legally requires a medical prescription to be dispensed. Indian Pharma Network (IPN) specializes in facilitating the import of cancer medicines through named patient supply (NPS), ensuring transparency and authenticity by sourcing from reputable suppliers in the USA, Canada, Europe, and Australia.
Filspare (sparsentan) can be made accessible to patients, doctors, and hospitals in various cities across India, including but not limited to Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow, and Pune. To confirm an order, a valid prescription from a doctor and an import permit will be required.
IPN (Indian Pharma Network) is dedicated to facilitating the supply of Filspare (prescription medicines) to locations both within India and worldwide, while adhering to relevant legal requirements.
Our commitment lies in assuring quality and timely delivery to meet the healthcare needs of patients and medical professionals across the globe.
Indian Pharma Network is proficient in sourcing Filspare (sparsentan) from around the world and ensuring efficient delivery to patients. We provide worldwide access to the best available treatments and expedite prescription dispensing and delivery, with all prescriptions being dispensed and scrutinized by registered pharmacists before dispatching them to the patient’s address, exclusively from New Delhi, India.
Is sparsentan FDA-approved?
The FDA granted accelerated approval to sparsentan on 17 Feb,2023
What category is sparsentan?
Sparsentan is a dual endothelin and angiotensin II receptor antagonist.
What is the brand name of Filspari?
Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy.
Can I take FILSPARI if I’m pregnant or planning to become pregnant?
No, FILSPARI is contraindicated during pregnancy due to the risk of harming the developing fetus. If you can become pregnant, you must use effective contraception before, during, and for one month after discontinuing FILSPARI. Pregnancy testing is also required before and during treatment.
What are the main safety concerns with FILSPARI?
FILSPARI comes with significant safety considerations, including the risk of hepatotoxicity (liver issues) and embryo-fetal toxicity (potential harm to a developing fetus during pregnancy). These risks necessitate careful monitoring, and the medication is only available through a restricted program due to these concerns.
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