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Filspari is a brand name for Sparsentan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥ 0.75 g/g, see section 5.1). 3
Verbatim from this product's EMA label. Tap a section to expand.
Posology Sparsentan treatment should be initiated at a dose of 200 mg once daily for 14 days and then increased to a maintenance dose of 400 mg once daily, dependent upon tolerability. For titration from the initial dose of 200 mg once daily to the maintenance dose of 400 mg once daily, 200 mg and 400 mg film-coated tablets are available to achieve the maintenance dose.
1). When resuming treatment with sparsentan after interruption, repeating the initial dosing schedule may be considered. 4). Missed dose If a dose is missed, the dose should be skipped and the next dose is to be taken at the regularly scheduled time.
Double or extra doses should not be taken. 2). In elderly patients sparsentan treatment should be initiated at a dose of 200 mg once daily for 14 days. 4). 2). There is limited clinical experience with moderate hepatic impairment. 4). Sparsentan has not been studied in patients with severe hepatic impairment (Child-Pugh C classification) and is therefore not recommended for use in these patients.
There is limited clinical experience with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) values more than two times the upper limit of the normal range (ULN). 4). 73 m2) kidney disease. 2). 4). Sparsentan has not been studied in patients who have received a kidney transplant, therefore sparsentan should be used with caution is these patients.
Sparsentan has not been studied in patients undergoing dialysis. Initiation of sparsentan is not recommended in these patients. 4 Paediatric population The safety and efficacy of Filspari in children below the age of 18 years with IgAN have not yet been established.
No data are available. Method of administration Oral use. It is recommended to swallow the tablets whole with water to avoid bitter taste. Sparsentan can be taken with or without food.
4 %). 9 %). Tabulated list of adverse reactions The adverse reactions reported in the active-controlled phase 2 and phase 3 clinical trials in patients exposed to sparsentan in chronic kidney disease population including IgAN and FSGS (N=446) are listed in the table below by MedDRA system organ class and frequency convention: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1 000 to < 1/100); rare (> 1/10 000 to < 1/1000); very rare (< 1/10 000).
Table 1:
Adverse drug reactions observed during clinical trials System organ class Very common Common Uncommon Blood and lymphatic system disorders - Anaemia Metabolism and nutrition disorders Hyperkalaemia - Nervous system disorders Dizziness Headache - Vascular disorders Hypotension Orthostatic hypotension - Renal and urinary disorders Renal impairment Acute kidney injury - General disorders and administration site conditions Oedema peripheral Fatigue - Investigations Blood creatinine increased Elevated transaminasea - a Elevated transaminase includes preferred terms of alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, and hepatic enzyme increased.
Description of selected adverse reactions Haemoglobin decrease In PROTECT, anaemia or decreased haemoglobin was reported as an ADR in 2 ( 1 %) subjects treated with sparsentan compared to 4 (2 %) irbesartan-treated subjects. Overall, haemoglobin ≤ 9 g/dL was reported at any time post treatment in 7 (3 %) subjects in the sparsentan treatment arm and 4 (2 %) subjects in the irbesartan treatment arm.
This decrease is thought to be in part due to haemodilution. There were no treatment discontinuations due to anaemia. Hepatic associated adverse events In PROTECT, a total of 6 (3 %) subjects in the sparsentan group and 4 (2 %) subjects in the irbesartan group had elevation of liver transaminases exceeding 3 times upper-limit-of-normal without elevation of total bilirubin, after receiving study medication for 168 to 407 days, respectively.
6). Hypotension Hypotension has been associated with the use of renin-angiotensin-aldosterone system (RAAS) inhibitors, including sparsentan. 8). In patients at risk for hypotension, eliminating or adjusting other antihypertensive medicinal products and maintaining appropriate volume status should be considered.
If hypotension develops despite elimination or reduction of other antihypertensive medicinal products, dose reduction or dose interruption of sparsentan should be considered. A transient hypotensive response is not a contraindication to further dosing of sparsentan; treatment can be resumed once blood pressure has stabilised.
If hypotension persists despite elimination or reduction of antihypertensive medicinal products, sparsentan dosing should be reduced to the initial starting dose until blood pressure stabilises. Dose interruption of treatment with sparsentan should be considered if symptoms of hypotension persist after 2 weeks of dose reduction.
2). 2). Impaired kidney function A transient increase in serum creatinine has been associated with RAAS inhibitors, including sparsentan. 8). Periodic monitoring of serum creatinine and serum potassium levels should be performed in patients at risk.
Sparsentan should be used with caution in patients with bilateral renal artery stenosis. 2). Fluid retention Fluid retention has been associated with medicinal products that antagonise the endothelin type A receptor (ETAR), including sparsentan.
8). If fluid retention develops during treatment with sparsentan, treatment with diuretics is recommended, or the dose of existing diuretics should be increased before modifying the dose of sparsentan. Treatment with diuretics can be considered in patients with evidence of fluid retention before the start of treatment with sparsentan.
Sparsentan has not been studied in patients with heart failure. Therefore, sparsentan should be used with caution in patients with heart failure. 8). No concurrent elevations in bilirubin > 2 × ULN or cases of liver failure have been observed in sparsentan-treated patients.
5)
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All events were non-serious and asymptomatic, the majority were mild or moderate in intensity, all were reversible, and other reasons have been identified as potential causal factors or as potentially contributing to 10 transaminase elevations.
No clinical symptoms of hepatic injury were observed. In the sparsentan group, the study drug was discontinued in 3 subjects after positive rechallenge while in 2 subjects sparsentan treatment, was restarted with no repeated hepatic enzyme elevations.
Acute kidney injury (AKI) In PROTECT, acute kidney injury ADRs were reported in 4 (2 %) subjects in the sparsentan group and 3 (1 %) subjects in the irbesartan group. Four subjects (2 %) who received sparsentan reported serious AKI all of which were reversible.
None of the serious AKI required dialysis. In the sparsentan group, the study drug was discontinued in 3 subjects. Hyperkalaemia In PROTECT, hyperkalaemia was reported as an ADR in 20 (10 %) subjects treated with sparsentan compared to 16 (8 %) irbesartan-treated subjects.
All events were non-serious in subjects treated with sparsentan, the majority were mild to moderate in intensity and all were reversible. There were no treatment discontinuations due to hyperkalaemia. The risk of hyperkalaemia is increasing for patients with a lower eGFR.
Hypotension Hypotension was reported during treatment with sparsentan. In PROTECT, a SBP <= 100 mmHg or a reduction in SBP exceeding 30 mmHg, was reported in 12 % and 10 % of patients on sparsentan, respectively, versus 11 % and 10 % on irbesartan.
4 %) were ≥ 65 years old. Hypotension was reported in 20 (11 %) subjects < 65 years of age and in 6 (40 %) subjects 65 to 74 years of age. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Therefore, to reduce the risk of potential serious hepatotoxicity, serum aminotransferase levels and total bilirubin should be monitored prior to initiation of treatment and then continue monitoring every three months. Patients should be monitored for signs of hepatic injury.
g, jaundice), sparsentan therapy should be discontinued. Consider re-initiation of sparsentan only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients without clinical symptoms of hepatotoxicity.
2). There is limited clinical experience with moderate hepatic impairment. 2). Dual blockade of the Renin Angiotensin Aldosterone System (RAAS) There is evidence that the concomitant use of Angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. 5 mmol/l. As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with sparsentan, especially in the presence of renal impairment and/or heart failure.
Close monitoring of serum potassium in patients at risk is recommended. If patients experience clinically significant hyperkalaemia adjustment of concomitant medicinal products, or temporary down–titration or discontinuation is recommended.
5 mmol/l discontinuation should be considered. 6 Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.