Vanrafia

Pronunciation: Van-rah-fee-ah
Generic name: atrasentan
Dosage form: tablet (0.75 mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Apr 7, 2025.

What is Vanrafia?

Vanrafia (atrasentan) is a once-a-day non-steroidal tablet used for primary immunoglobulin A nephropathy (IgAN) to reduce proteinuria (protein in urine) in adults, it is used in patients who are at risk of rapid disease progression. Vanrafia is a selective endothelin A (ETA) receptor antagonist.

Vanrafia FDA approval was granted to Novartis on April 2, 2025, after positive results from the Phase III ALIGN study. 

Vanrafia was granted an accelerated FDA approval. This means continued approval depends on results from the ongoing Phase III ALIGN study and whether it demonstrates a clinical benefit of slowing disease progression which will be measured by estimated glomerular filtration rate (eGFR)  reduction at week 136 of the trial. 

What is immunoglobulin A nephropathy?

IgAN is a rare autoimmune kidney disease where the immune system attacks the kidneys, causing inflammation and kidney damage, which may progress to kidney failure over time. The damage is caused by IgA  (Immunoglobulin A), a protein from your immune system that builds up in the kidney which causes blood and protein to leak into the urine. Over time some patients with ongoing proteinuria risk progressing to kidney failure which may need maintenance dialysis or kidney transplantation.

How does Vanrafia work?

Endothelin Type A Receptor (ETAR) is a protein on cells within the kidney that when activated causes blood vessels to constrict, inflammation scarring, and other effects that contribute to IgAN.  Vanrafia works (mechanism of action) by selectively blocking the ETA receptor to help protect the kidneys and reduce proteinuria in patients with IgAN. Vanrafia is from the class of medicines called an ETA receptor antagonist. 

How well does Vanrafia work?

Results from the Phase III ALIGN clinical trial (NCT04573478) demonstrated when Vanrafia was used together with a RAS inhibitor* there was a clinically meaningful and statistically significant: 

• 36.1% reduction in proteinuria.
• Improvement in proteinuria was seen as early as week 6 and lasted through to week 36.

When Vanrafia was used in combination with a RAS inhibitor and an SGLT2 inhibitor** there was a  

• 37.4% reduction in urine protein-to-creatinine ratio (UPCR).

*RAS inhibitor  = renin-angiotensin system (RAS) inhibitor

**SGLT2 inhibitor = sodium-glucose cotransporter 2 inhibitor 

Vanrafia side effects

 Common Vanrafia side effects

The most common Vanrafia side effects are:

• Swelling of feet, hands, or extremities, edema 10% (placebo  7%)
• Low iron levels, anemia 6% (placebo 1%)
• Increase in liver enzyme 2% (placebo 1%).

These common side effects occurred in 2% or more of IgAN patients with treated with Vanrafia and higher than placebo patients in the ALIGN clinical trial.

Serious Vanrafia side effects

Liver problems. Medicines like Vanrafia can cause liver problems, including liver failure. It can increase liver enzymes in your blood. Your healthcare provider will do blood tests to check your liver enzymes before starting treatment and if needed during treatment. Your healthcare provider may temporarily stop or permanently stop treatment with Vanrafia if your liver enzymes increase or if you develop symptoms of liver problems. 

Tell your healthcare provider if you develop any of the following symptoms of liver problems during treatment with this medicine.

• Nausea or vomiting
• Pain in the upper right stomach
• Tiredness
• Loss of appetite
• Yellowing of your skin or whites of your eyes
• Dark urine
• Fever 
• Itchy skin

Fluid retention. This medicine can cause your body to hold too much water. Tell your healthcare provider if you develop symptoms of fluid retention including 

• any unusual weight gain
• trouble breathing or 
• swelling of your ankles or legs during treatment. 

Your healthcare provider may prescribe other medicines (diuretics) and may temporarily stop Vanrafia if you develop fluid retention.

Decreased sperm count. This medicine may cause a decrease in sperm counts in males and may affect the ability to father a child. Tell your healthcare provider if being able to have children is important to you.

Embryo-fetal Toxicity

Vanrafia can cause serious birth defects if taken during pregnancy. 

Females should not take Vanrafia if they are pregnant, or have become pregnant and they should not get pregnant for two weeks after stopping treatment with this medicine.

• Females who can become pregnant should have a negative pregnancy test before starting treatment.
• Females who can become pregnant should use effective birth control before starting treatment with Vanrafia, during treatment, and for 2 weeks after stopping this medicine because the medicine may still be in your body.
• Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with this medicine.
• If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another effective form of birth control.
• Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.

Females who can become pregnant are those who:

• have entered puberty, even if they have not started their menstrual period, and
• have a uterus, and
• have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.

Females who cannot become pregnant are those who:

• have not yet entered puberty, or
• do not have a uterus, or
• have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
• are infertile for any other medical reason and this infertility is permanent and cannot be reversed.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What to avoid

Do not take this medicine if you are allergic the the active ingredient, atrasentan, or any of the inactive ingredients.

Before taking this medicine  

Before taking this medicine tell your healthcare provider about all your medical conditions including if you: 

• have liver problems. 
• are pregnant or plan to become pregnant during treatment with Vanrafia as it can cause serious birth defects. Do not take Vanrafia in or before pregnancy. See "Serious Vanrafia side effects” for more information
• are breastfeeding or planning to breastfeed as it is not known if this medicine passes into your breast milk. Do not breastfeed during treatment with Vanrafia. Talk with your healthcare provider about the best way to feed your baby if you take this medicine.

How should I take Vanrafia?

• Vanrafia tablet is taken once daily, with or without food. 
• Tablet should be swallowed whole, do not crush or chew tablets
• If a dose or doses are missed, take the prescribed dose at the next scheduled time. Do not double the dose to make up for a missed dose.

Vanrafia dosing information

The recommended Vanrafia dose is 0.75 mg tablet once daily with or without food.

What other drugs will affect this medicine?

Other drugs may interact with Vanrafia, including prescription and over-the-counter medicines, vitamins, and herbal products.

Strong or Moderate CYP3A Inducers Avoid use with a strong or moderate CYP3A inducer as it is expected to decrease atrasentan levels which may reduce Vanrafia efficacy. Atrasentan is a CYP3A substrate

OATP1B1/1B3 Inhibitors Avoid use with organic anion transporting polypeptides 1B1/1B3 (OATP1B1/1B3) inhibitors as using these medicine together increases atrasentan levels which may increase the risk of Vanrafia side effects.

Not all possible drug interactions are listed here.

Storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C). 
• Store in the original container. 
• The bottle has a child-resistant cap and contains a desiccant to help keep the tablets dry.

Ingredients

Active ingredient: atrasentan 

Inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, L-cysteine hydrochloride monohydrate, polyethylene glycol, and silicon dioxide.

Company 

Vanrafia Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer