Sparsentine Detailed Instructions

1. Indications and Usage

sparsentanis an endothelin and angiotensinII receptor antagonist used to reduce primary immunoglobulinAnephropathy(IgAN) Proteinuria in adults, usually urine protein to creatinine ratio (UPCR) ≥1.5g/g. This indication received accelerated approval based on reduction in proteinuria.

It has not been established whether sparsentan slows renal function decline in patients with IgAN and continued approval for this indication may depend on verification and description of clinical benefit in confirmatory clinical trials.

2. Usage and dosage

Primary Immune GlobulinARoutine Adult Doses for Renal Disease:

Initial dose: 200mg orally once daily for 14 days.

Maintenance dose:After initial dose, increase to400 mgorally once daily as tolerated.

-Consider dose titration when resuming treatment after an interruption:Start with the initial dose for 14 days and then increase to the recommended maintenance dose.

Three. Dosage form

Tablets: 200mg and 400mg

Four. Contraindications

Pregnant.

Do not use SparsentanTake concurrently with angiotensin receptor blockers, endothelin receptor antagonists, or aliskiren.

Five. Warnings and Precautions

1.Using this drug during pregnancy can harm the fetus. If you are a woman who can become pregnant, your doctor will check to make sure you are not pregnant before starting the medication, during treatment, and 1 month after stopping the medication. Use an effective method of birth control to prevent pregnancy before starting, during treatment, and for 1 month after the last dose. If you think you are pregnant while taking this medicine, tell your doctor right away.

2.This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, severe stomach pain, or yellowing of your eyes or skin.

Contact your doctor immediately if you experience blurred vision, confusion, dizziness, weakness, or lightheadedness when you stand up suddenly from a lying or sitting position, sweat, or are unusually tired or weak. These may be symptoms of low blood pressure.

3.This medicine may cause serious kidney problems. Check with your doctor right away if you develop agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, drowsiness, muscle twitching, nausea, rapid weight gain, seizures, coma, swelling of the face, ankles, or hands, or unusual fatigue or weakness.

Check with your doctor right away if you feel confused, have an irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in your hands, feet, or lips, stomach pain, difficulty breathing, or weakness or heaviness in your legs. These may be symptoms of hyperkalemia (high levels of potassium in the blood).

4.This medicine may cause fluid retention (excess water in the body). Check with your doctor right away if you experience decreased urine output, noises, rattling, or trouble breathing, swelling of the face, hands, feet, or lower legs, or weight gain.

5.Do not take other medications unless discussed with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

6. Adverse reactions

The most common adverse reactions (≥5%) are peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.

7. Used by specific groups of people

Lactation period: Breastfeeding is not recommended.

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