What are the daily precautions for sparsentan?

The dosage of sparsentan is individualized; please use it in accordance with your doctor’s instructions or the information on the drug label.

What are the daily precautions for sparsentan?

Embryo-fetal Toxicity

Based on data from animal reproductive studies, Lucius Pharmaceuticals Sparsentan® may cause fetal harm if administered to pregnant women and is therefore contraindicated during pregnancy. Existing human data on endothelin receptor antagonists (ERAs) have not confirmed the presence of fetal harm associated with Sparsentan® use. Patients of childbearing potential should be informed of the potential fetal risks. Pregnancy must be excluded before initiating Sparsentan® treatment. It is recommended that patients of childbearing potential use effective contraceptive measures before starting treatment, during the entire course of treatment, and for two weeks after discontinuing Lucius Pharmaceuticals Sparsentan®. If pregnancy is detected, Sparsentan® should be discontinued as soon as possible.

Hypotension

Hypotension has been observed in patients receiving angiotensin receptor blocker (ARB) and ERA therapy. The incidence of hypotension-related adverse events (including dizziness, some of which are severe) is higher in patients treated with Sparsentan® compared with irbesartan. For patients at risk of hypotension, consider discontinuing or adjusting other antihypertensive medications and maintaining an adequate volume status. If hypotension persists after discontinuing or reducing other antihypertensive drugs, consider reducing the dosage of Sparsentan® or interrupting administration. A transient hypotensive response is not a contraindication for continued use of Sparsentan®, and re-administration may be attempted after blood pressure stabilizes.

Acute Kidney Injury

Monitor renal function regularly. Drugs that inhibit the renin-angiotensin system (RAS) may cause renal injury. Patients whose renal function is partially dependent on RAS activity (e.g., those with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at a particularly high risk of acute kidney injury when using Lucius Pharmaceuticals Sparsentan®. For patients with a clinically significant decline in renal function during Sparsentan® treatment, consider suspending or discontinuing therapy.

Drug Interactions

Concurrent use with some drugs is strictly prohibited, while co-administration with others may be permissible when necessary—your doctor may adjust the dosage or take other protective measures in such cases. During treatment with this drug, it is essential to inform your healthcare provider of all medications you are taking. The following is a selected list of drugs with potentially important interactions and is not exhaustive.

Drugs with Prohibited Concurrent Use

Concurrent use of this drug with any of the following medications is forbidden. Your doctor may choose to avoid prescribing this drug or replace some of your current medications:

Aliskiren, ambrisentan, azilsartan, azilsartan medoxomil, bosentan, candesartan, eprosartan, irbesartan, losartan, macitentan, olmesartan, telmisartan, valsartan.

General Usage Precautions

1. Your doctor will regularly monitor your disease progression and may conduct blood and urine tests to detect adverse drug reactions. Relevant tests must be completed before initiating treatment, and follow-up tests should be performed every 3 months during therapy.

2. Concurrent use of this drug with aliskiren or other antihypertensive agents (e.g., ARBs, ERAs) is strictly prohibited.

3. Use of this drug during pregnancy may cause fetal harm. If you are of childbearing potential, your doctor will perform a pregnancy test to confirm non-pregnancy before starting treatment. Effective contraceptive measures must be used before initiation, throughout the entire treatment period, and for 2 weeks after the last dose; consult your doctor to select a suitable contraceptive method. If you suspect pregnancy during treatment, inform your doctor immediately.