Applies to sparsentan: oral tablet.
Warning
Oral route (Tablet)
Warning: Hepatotoxicity and Embryo-Fetal ToxicityBecause of the risks of hepatotoxicity and birth defects, sparsentan is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program.HepatotoxicitySome endothelin receptor antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferase (ALT or AST) of at least 3-times the upper limit normal (ULN) have been observed in up to 2.5% of sparsentan-treated patients, including cases confirmed with rechallenge.Measure transaminases and bilirubin before initiating treatment and monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN.Sparsentan should generally be avoided in patients with elevated aminotransferases (greater than 3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be increased risk for serious hepatotoxicity.Embryo-Fetal ToxicitySparsentan can cause major birth defects if used by pregnant patients based on animal data. Therefore, pregnancy testing is required before the initiation of treatment, during treatment, and one month after discontinuation of treatment with sparsentan. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after discontinuation of treatment sparsentan.
Serious side effects of Sparsentan
Along with its needed effects, sparsentan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sparsentan:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chills
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular heartbeat
- nausea or vomiting
- nervousness
- numbness or tingling in the hands, feet, or lips
- pale skin
- rapid weight gain
- sweating
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness or heaviness of the legs
Less common
- Agitation
- coma
- decreased urine output
- depression
- headache
- hostility
- irritability
- lethargy
- muscle twitching
- stupor
- swelling of the face, ankles, or hands
Incidence not known
- Dark urine
- loss of appetite
- stomach pain, severe
- yellow eyes or skin
For Healthcare Professionals
Applies to sparsentan: oral tablet.
General
The most common adverse reactions occurring in 5% of patients or more included peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.[Ref]
Cardiovascular
Very common (10% or more): Peripheral edema (14%), hypotension (14%)[Ref]
Hematologic
-Decreases in hemoglobin greater than 2 g/dL compared to baseline and below the lower limit of normal occurred more commonly with this drug; hemodilution may be a contributing factor.
-No treatment discontinuations occurred due to anemia or hemoglobinemia.[Ref]
Very common (10% or more): Decreased hemoglobin (11%)
Common (1% to 10%): Anemia[Ref]
Hepatic
Common (1% to 10%): Transaminase elevations[Ref]
-Transaminase elevations occurred in 2.5% of patients and were reported as adverse events when greater than 3 times the upper limit of normal (3 x ULN).
-No cases of liver failure or elevations in bilirubin (greater than 2 x ULN) were observed with this drug.[Ref]
Metabolic
-Patients who have advanced kidney disease, or take concomitant potassium-increasing drugs, or use potassium-containing salts are at higher risk for developing hyperkalemia.[Ref]
Very common (10% or more): Hyperkalemia (13%)[Ref]
Nervous system
Very common (10% or more): Dizziness (13%)[Ref]
Renal
Common (1% to 10%): Acute kidney injury
Frequency not reported: Decreased estimated glomerular filtration rate[Ref]
-Patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, volume depletion, or those whose kidney function may depend in part on the activity of the renin-angiotensin system may be at higher risk of developing acute kidney injury.
-Small decreases in estimated glomerular filtration rate occurred during the first 4 weeks of initiating therapy with this drug, and then stabilized.[Ref]
