司帕生坦(Sparsentan)的不良反应和副作用

Regular monitoring is required during treatment with sparsentan, including monthly follow-up before treatment and for the first 12 months, and then every 3 months, including routine blood tests and urine tests to assess efficacy and risk of adverse reactions.

Sparsentan has side effects that require immediate medical attention

Sparsentan may cause side effects while exerting its therapeutic effect. If serious adverse reactions occur, timely medical attention is required.

1. Common side effects

During treatment with Sparsentan, patients may experience swelling of the face, arms, hands, calves or feet; blurred vision; chills; confusion; postural hypotension (from supine/sitting position) dizziness, fainting); cardiac arrhythmia; nausea and vomiting; anxiety; numbness of limbs (hands/feet/lips); pale skin; sudden weight gain; excessive sweating; tingling in extremities; difficulty breathing; abnormal bleeding or bruising; persistent fatigue; abnormal weight fluctuations; weakness and heaviness of lower limbs.

2. Less common side effects

During treatment with sparsentan, patients may experience stirring-like movements; disturbance of consciousness (coma/drowsiness); decreased urine output; depression with hostility; persistent headache; increased nerve excitability; muscle twitching; and edema of the face, ankles, or hands.

3. Side effects of unknown incidence

Dark urine; loss of appetite; severe stomach pain; yellow eyes or skin. Although the incidence of the above-mentioned side effects is unknown, they may also occur while taking sparsentan.

Sparsentan's side effects for medical personnel's reference

1. Cardiovascular

Very common (10% or more): peripheral edema (14%), hypotension (14%).

2. Blood

(1) Very common 10% or more): decreased hemoglobin (11%).

(2) Common (1%-10%): Anemia, a decrease in hemoglobin greater than 2 g/dL from baseline and below the lower limit of normal, occurs more commonly with this drug; hemodilution may be a contributing factor. There were no discontinuations of treatment due to anemia or hemoglobinemia.

3. Hepatotoxicity

Common (1%-10%): elevated transaminases. Transaminase elevations occurred in 2.5% of patients and were reported as adverse events when greater than 3 times the upper limit of normal (3xULN). No cases of liver failure or elevated bilirubin (greater than 2xULN) were observed with this drug.

4. Metabolism

(1) Very common (10% or more): hyperkalemia (13%).

(2) Patients with end-stage renal disease who are taking potassium-increasing drugs or using potassium-containing salts are at a higher risk of developing hyperkalemia.

5. Nervous system

Very common (10% or more): dizziness (13%).

6. Nephrotoxicity

(1) Common (1%-10%): acute kidney injury

(2) Unreported frequency: reduced estimated glomerular filtration rate. Patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, volume depletion, or whose renal function may depend in part on activity of the renin-angiotensin system may be at increased risk for acute kidney injury.