VANRAFIA is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly. It is not known if VANRAFIA is safe and effective in children.

VANRAFIA is approved based on a reduction of proteinuria. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval may require results from an ongoing study to determine whether VANRAFIA slows decline in kidney function.

VANRAFIA is designed to target the endothelin A (ET_A) pathway. By blocking the ET_A receptor, VANRAFIA is thought to block some effects of ET-1 in IgAN.

VANRAFIA was studied in adults with IgAN as an add-on to their current blood pressure medication*

Who was studied? 

A total of 340 people with biopsy-proven IgAN who:

• had total urine protein ≥1 g/day 

• were on a stable dose of maximally tolerated blood pressure medication, like ACEi or ARB 

The initial results were based on the first 270 people who reached the 9-month visit who:

• had an average age of 45 years (19 to 77 years)

• were: 59% male and 41% female, 57% Asian, 36% White, and 2% Black or African American

What was studied? 

Of the 270 adults who reached the 9-month visit:

• 135 adults received 0.75 mg of VANRAFIA once daily in addition to blood pressure medication*

compared to

• 135 adults who received placebo (sugar pill) in addition to blood pressure medication*

How was the study done?

Change in protein in urine (proteinuria) were assessed using the urine protein-to-creatinine ratio (UPCR) test in urine samples collected over 24 hours at study initiation and through 9 months of treatment. 

What were the results?

• VANRAFIA substantially reduced proteinuria through 9 months

  • In the clinical study at 9 months, 135 adults taking VANRAFIA plus a stable and maximally tolerated dose of a blood pressure medication, like ACEi or ARB had a 38% reduction in proteinuria versus a 3% reduction in proteinuria for 135 adults taking a placebo (sugar pill) plus a stable and maximally tolerated dose of a blood pressure medication, like ACEi or ARB.

• Rapid and sustained reduction of proteinuria through 9 months of treatment 

  • Reductions in proteinuria in this clinical study were seen as soon as the first visit at 6 weeks and continued through the 9-month study

See the full results of the clinical study here.

*Participants were on a stable and maximally tolerated dose of a blood pressure medication, like ACEi or ARB.

VANRAFIA is only available through select specialty pharmacies that will deliver to your door each month:

When your insurance coverage is confirmed, the specialty pharmacy will contact you to schedule delivery or leave a message. The specialty pharmacy may call from a different number than their main number, so please be ready to pick up the phone or call them back.

The specialty pharmacy cannot ship you VANRAFIA until they have spoken with you on a live call. If you have not heard anything regarding your prescription and would like an update on your prescription, you can also contact your doctor.

Once you’ve been prescribed VANRAFIA, you or your loved one can sign up for Novartis Patient Support. It's a comprehensive program with a dedicated team in your corner.

If you need help with insurance, Novartis Patient Support can: 

• Help you navigate the insurance process 

• Work with your health care provider to manage insurance forms 

• Assist you if there are changes to your health plan

If you're looking for financial support: 

• If eligible, Co-Pay Plus may help you pay for your VANRAFIA, including refills. Co-Pay Plus is not health insurance but can help cover out-of-pocket expenses related to your prescription

• If you don't have insurance, there may be options available to you

To learn more about financial support options or the Novartis Patient Support program, visit the Savings & Support page.

Denial of benefits may occur, but this can be appealed. An appeal is a request for your insurance company to reconsider its decision about denying coverage of your medication. Your doctor can submit an appeal letter to your insurer, usually along with important details about your condition. 

You can also write a letter to go along with your doctor’s appeal letter to explain why your claim should be accepted.

You may be able to start your treatment while the insurance company reviews your appeal. 

If eligible, the Bridge Program^† can help you receive your medication when coverage is delayed or denied. The Bridge Program will end once your coverage is approved. Once you receive the approval, you can start using your VANRAFIA $0 Co-Pay Plus* Offer to help cover your out-of-pocket costs.

*Co-Pay Plus: Limitations apply. Valid only for those with private insurance. The Program includes the Co-Pay Plus offer, Plus Card (if applicable), and Rebate, with a combined annual limit up to $15,000. Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

^†Bridge Program: The Bridge Program applies to VANRAFIA only. Eligible patients must have private insurance and a valid prescription for VANRAFIA, and a prior authorization or an initial denial of coverage. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment to remain eligible. Program provides VANRAFIA for free to eligible patients for up to 12 months, or until they receive insurance coverage approval, whichever occurs earlier. A valid prescription consistent with FDA-approved labeling is required. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Additional Limitations may apply. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice.

If you have government insurance and have questions about financial assistance or are not covered by health insurance, Novartis Patient Support can help by connecting you with the Novartis Patient Assistance Foundation (NPAF). NPAF is an independent 501(c)(3) non-profit organization that provides Novartis medications free of cost to eligible patients who have limited or no prescription insurance coverage and cannot afford the cost of their medication.

To be eligible, you must:

• Reside in the United States or a US territory 

• Be treated by a licensed US health care provider on an outpatient basis 

• Meet income and insurance guidelines

For additional information, please visit PAP.Novartis.com or call NPAF at 1-800-277-2253. To check eligibility and enroll in the NPAF, please ask your doctor to submit a Start Form to Novartis Patient Support.

Take VANRAFIA exactly as your doctor tells you. Do not change your dose or stop taking VANRAFIA unless your doctor tells you to.

• Take VANRAFIA once a day with or without food.

• Swallow the tablets whole.

• Do not cut, crush, or chew.

If you take too much VANRAFIA, call your doctor right away or go to the nearest hospital or emergency room.

If a dose or doses are missed, take the prescribed dose at the next scheduled time. The dose should not be doubled to make up for a missed dose. If you take too much VANRAFIA, call your doctor right away or go to the nearest hospital or emergency room.

Take VANRAFIA exactly as your doctor tells you. VANRAFIA can be taken as an add-on to blood pressure medications. Blood pressure medications include ACEi and ARB. VANRAFIA can also be added to your high blood sugar treatment, like an SGLT2 inhibitor.

For female patients with reproductive potential

VANRAFIA can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking VANRAFIA, become pregnant during treatment, or for 2 weeks after stopping treatment. Females who can become pregnant should have a negative pregnancy test before starting VANRAFIA.

Do not take VANRAFIA if you are pregnant, plan to become pregnant, or become pregnant during treatment with VANRAFIA. VANRAFIA can cause serious birth defects. Do not take VANRAFIA if you are allergic to atrasentan or any of the ingredients in VANRAFIA.

• Talk to your health care provider or gynecologist (a health care provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and for two weeks after treatment with VANRAFIA.

• Do not breastfeed during treatment with VANRAFIA.

For male patients with reproductive potential

VANRAFIA, and other medicines like VANRAFIA, may cause decreased sperm counts in some men during treatment. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.

• Decreased sperm counts were observed in some patients with diabetic kidney disease taking 0.75 mg of VANRAFIA once daily. These returned to normal levels within about 3 months after stopping the treatment. This effect has not been studied in people with IgAN

These are not all the possible side effects of VANRAFIA. Talk to your doctor about all possible side effects.

Please see Important Safety Information below. Please also see the Medication Guide, including serious side effects.

The most common side effects of VANRAFIA include:

• swelling of hands, legs, ankles, and feet – 10%

• low red blood cells – 6%

• increased levels of liver enzyme – 2%

These are not all the possible side effects of VANRAFIA. Talk to your doctor about all possible side effects.

Do not take VANRAFIA if you are pregnant, plan to become pregnant, or become pregnant during treatment with VANRAFIA. VANRAFIA can cause serious birth defects. Do not take VANRAFIA if you are allergic to atrasentan or any of the ingredients in VANRAFIA.

Please see Important Safety Information below. Please also see the Medication Guide, including serious side effects.