What is Sparsentan?
Sparsentan can be used to reduce the amount of protein in urine (proteinuria) in adults who have a kidney condition called primary immunoglobulin-A nephropathy.
Sparsentan can only be purchased from a pharmacy that is certified under a special program. Registering for the program is required. You also need to understand the risks and advantages of sparsentan. Sparsentan can be used in other ways not mentioned in this guide.
Side effects of Sparsentan
If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: difficulty breathing, hives, swelling in your lips, face, throat, or tongue.
Sparsentan can cause serious liver problems. Call your doctor immediately if you experience nausea, vomiting, or a loss of appetite. You may also notice fatigue, weight loss, jaundice, and dark urine.
Sparsentan may cause serious side effects. Contact your doctor immediately if:
- Feeling lightheadedness as though they could pass out.
- Kidney problems: swelling, decreased urination, fatigue, or feeling short of breath.
- High blood potassium—nausea and weakness, tingly feelings, chest pains, irregular heartbeats, or loss of mobility;
- Fluid accumulation—shortness of breath even when lying down, swelling, and rapid weight gain.
Some of the common side effects associated with sparsentan include:
- Dizziness;
- Swelling of the hands, legs, and ankles;
- Anemia (low red cell count)
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Warnings
Do not use it if you are pregnant. Use effective birth control. Inform your doctor of all the other medications you are taking. Certain drugs should not contain sparsentan. Sparsentan can cause serious liver problems. Call your doctor immediately if you experience nausea, vomiting, or a loss of appetite. You may also notice fatigue, weight loss, dark urine, and jaundice. Sparsentan can only be obtained through a special program. The program requires that you register and fully understand the risks and advantages of the medicine.
Before you take this drug
Certain drugs should not be taken with sparsentan. The treatment plan you receive may change if:
- Aliskiren;
- Medicines to treat high pressure in the lungs: bosentan, ambrisentan, and others
- Heart or blood pressure medication: enalapril, candesartan, lisinopril, irbesartan, losartan, olmesartan, valsartan, and telmisartan.
Tell your doctor about any of the following:
- High blood pressure
- Heart problems
- Liver or kidney disease
May cause birth defects. Use effective birth control during sparsentan use and for 1 month following your last dose. Inform your physician immediately if you become pregnant. Consult your doctor for the best method of contraception to use while using sparsentan.
Before starting this treatment, you will need a negative pregnancy result. You must take a test for pregnancy during and after sparsentan treatment. Do not breastfeed.
How to take Sparsentan?
Read all the instructions or guides that come with your medication and follow the directions. Sometimes, your doctor will change the dose. Your medication must be taken exactly as directed. Sparsentan can be taken up to once a day. Do not forget to follow your doctor's instructions.
Before eating, take one tablet with water. Each time, take it in the same manner. Take sparsentan with plenty of fluids. You may worsen your condition if you suddenly stop taking sparsentan. Before stopping the medication, consult your doctor. Even if you don't have any symptoms, you may still need to undergo frequent medical testing.
Your liver function will be tested frequently, and the next dose you receive may be affected by the results. Store sparsentan at room temperature, away from moisture and heat. Sparsentan should be stored in its original container.
Details on dosage
Adult dose for primary immunoglobulin A nephropathy:
Initial dose: 200 mg orally, once daily for 14 days
Maintenance dose: Increase to 400 mg once daily, orally, after the initial dose.
Comments:
Consider dose titration if you are resuming your treatment after an interruption. Start with the initial dose and continue for 14 days. Then increase it to the recommended maintenance dose.
Use: To reduce proteinuria in adults at risk of primary immunoglobulin A nephropathy who are at high risk of rapid disease progression (with urine protein-to-creatinine ratio of 1.5 or higher); indication is determined based on clinical assessment. On accelerated approval, and continued approval may be contingent on a confirmatory clinical trial.
What happens if I miss the dose?
Do not take the missed dose. Use your next dose as usual. Do not take two doses in one go.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention. What should I avoid when taking sparsentan?
You should not use potassium supplements or salt substitutes unless you have been told to by your doctor. Grapefruit can interact with sparsentan, causing side effects. Avoid consuming grapefruit products.
Interaction with other drug
It is sometimes not safe to take certain medications at the same time. Some medications may interact with or modify the blood levels of other drugs that you are taking, possibly leading to side effects or making them less effective. Avoid taking antacids within 2 hours of taking sparsentan.
Inform your physician of all medications you are currently taking. Sparsentan can be affected by many drugs, including:
- Blood pressure or heart medication
- A diuretic (or "water pill") that can increase potassium in the blood, such as triamterene or spironolactone;
- Nsaids are nonsteroidal anti-inflammatory medications (nonsteroidal analgesic drugs), such as aspirin, naproxen, celecoxib (Aleve), diclofenac (indomethacin), meloxicam, and others.
This list is incomplete. Sparsentan may interact with other drugs, including vitamins, herbal products, prescription medicines, and over-the-counter medicines. This list does not include all possible drug interactions.
