Your first 90 days
Your first 90 days on Vanrafia for IgA nephropathy
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Vanrafia has one of the simpler starts among the IgA nephropathy pills. There is no REMS, no dose step and no scheduled blood test that holds up a refill. It is added to the blood pressure pill you already take. What it does have is a boxed warning about pregnancy, a liver test before day 1, and a specialty pharmacy. This page lays out those first 3 months from the FDA label, Novartis's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Vanrafia has no REMS, but it ships from a specialty pharmacy and plans often want a prior authorization. The first bottle waits on paperwork and 2 tests, not a pharmacy counter. These are the 6 things in the way, in order.
A liver blood test
The label says to check liver enzymes before starting Vanrafia, because some drugs in its class have harmed the liver. It also says not to start Vanrafia in severe liver impairment. The Medication Guide says liver enzymes are checked before starting and, if needed, during treatment.FDA label
A pregnancy test, and a birth control plan
For anyone who can become pregnant, the label requires ruling out pregnancy before the first dose. Effective birth control is required before starting, during treatment and for 2 weeks after stopping. The Medication Guide suggests talking with your doctor or a gynecologist about which methods count.FDA label
No REMS to enroll in
Filspari, the other endothelin blocker for IgAN, is dispensed under a REMS. The FDA's risk review, completed in March 2025, concluded that Vanrafia did not need one, and Novartis says there is no REMS enrollment when starting. The safety rules live in the label and Medication Guide instead.FDA REMS review
The Start Form and Novartis Patient Support
Your nephrologist's office sends a Vanrafia Start Form to Novartis Patient Support by fax or through the CoverMyMeds portal. It carries the prescription, your insurance details and your choice of specialty pharmacy. Novartis warns that an incomplete form can delay the start.Start Form guide
One of 2 specialty pharmacies
Novartis says the prescription goes to CareMed or Biologics, its 2 limited network specialty pharmacies, which ship each month to your door. Novartis says it does not recommend or require a particular one. Someone from the pharmacy calls you directly, so check missed calls and messages.Getting started
The insurance approval
Plans often require prior authorization, and the Cigna policy below does. Novartis Patient Support works with your doctor's office on the forms, and for commercial insurance its Bridge Program can supply Vanrafia free while the plan decides. The usual criteria are further down this page, so you can tell a paperwork delay from a real gap.Novartis Patient Support
The days that matter
Counted from the first dose, with the monthly refill from a 30-tablet bottle and the swelling the label asks you to report. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Start Form sent, tests drawn
The office sends the Start Form and orders the liver enzyme test and, where it applies, the pregnancy test. The prior authorization goes in alongside them.
The specialty pharmacy calls
Someone from CareMed or Biologics reaches out directly with the delivery details. Novartis says to watch for that call, and to ask your doctor for an update if it never comes.
First dose, one 0.75mg tablet
One tablet a day, with or without food, swallowed whole and never cut, crushed or chewed. Your ACE inhibitor or ARB continues alongside it unless your nephrologist says otherwise. A bottle holds 30 tablets.
One week in, swelling is worth noting
The label says the drug reaches a steady level in the blood within about 7 days. Swelling of the ankles or legs, or unusual weight gain, is what the fluid retention warning is about, so report it rather than waiting.
Refill, then every 30 days
A 30-tablet bottle runs out here, and the specialty pharmacy ships each month. The Start Form also allows a 90-tablet supply, so ask which one your prescription is written for.
Refill, number 2
The 3-month visit
The label sets no scheduled liver test after the first one and says to repeat it as clinically indicated. Whether and when to recheck liver enzymes, blood count or urine protein is your nephrologist's call.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Vanrafia label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated June 12, 2026, read from the FDA's label database today. FDA label
- June 2026
The current DailyMed version carries this date. Its prescribing information and Medication Guide text match the April 2025 approval, so nothing about the dose, warnings or tests changed.FDA label
- October 2025
The FDA approved a bottle label change adding the instruction to store and dispense Vanrafia in its original container. It was a packaging change, not a safety one.FDA letter
- April 2025
Accelerated approval to reduce urine protein in adults with primary IgA nephropathy at risk of rapid progression, generally a ratio of 1.5g/g or more. Novartis must confirm the benefit in a further trial. The approval carried no REMS.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Once a day, whole, with or without food
The label says one 0.75mg tablet once a day, with or without food. Swallow it whole, and never cut, crush or chew it. A high-fat meal did not change how much is absorbed.FDA label
- If you miss a dose
The Medication Guide says to skip the missed dose and take the next one at the usual time. It says never to take 2 doses at once to make up for one.FDA label
- It adds to your blood pressure pill
Vanrafia was studied on top of a stable, maximally tolerated ACE inhibitor or ARB, which continued through the trial. Novartis describes it as an add-on to that medicine. This differs from Filspari, which replaces it.Getting started
- Medicines that do not mix
The label says to avoid strong or moderate CYP3A inducers, such as rifampin, which can make Vanrafia less effective. It also says to avoid OATP1B1/1B3 inhibitors such as cyclosporine, which raise the drug level. Tell the pharmacist everything you take, including supplements.FDA label
- Pregnancy, birth control and breastfeeding
Vanrafia must not be taken during pregnancy. For anyone who can become pregnant, the label calls for effective birth control before, during and for 2 weeks after treatment. It asks you to call the prescriber at once if a period is late. It also advises against breastfeeding.FDA label
- Unprotected sex or a failed method
The Medication Guide says to talk to your doctor or pharmacist right away after unprotected sex or a birth control failure. Your doctor may discuss emergency birth control. Ask before switching methods, so the new one still counts as effective.FDA label
- Sperm count
The label says Vanrafia may lower sperm counts. In some patients with diabetic kidney disease, counts returned to normal within about 3 months of stopping. Tell your nephrologist if fathering a child matters to you.FDA label
- Storage
Room temperature, 68°F to 77°F (20°C to 25°C), in the original bottle with its drying packet. The label says to store and dispense it only in that container.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs the label ties to the liver
Nausea or vomiting, pain in the upper right belly, tiredness, loss of appetite, yellow skin or eyes, dark urine, fever or itching. The label asks you to report these to your doctor. It says the drug is stopped if liver enzymes rise in a meaningful way or with these symptoms.FDA label
Swelling and weight gain
Swelling of the hands, legs, ankles or feet occurred in 10% of patients on Vanrafia against 7% on placebo in the ALIGN trial. The Medication Guide also lists unusual weight gain and trouble breathing. Your doctor may add a water pill or pause Vanrafia.FDA label
Low red blood cells
Anemia occurred in 6% on Vanrafia against 1% on placebo. The label says the drop in hemoglobin is thought to be partly from extra fluid. No one in the trial stopped the drug for it. It shows up on a blood test rather than as a symptom.FDA label
A possible pregnancy
The label says to contact the prescriber right away about a late period or any chance of pregnancy. The label says the drug is stopped as soon as possible if pregnancy is confirmed.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- The prescription went to a retail pharmacyVanrafia is dispensed through specialty pharmacies, and the Start Form lists CareMed and Biologics. The prescriber's office resends it, and the form notes your plan may dictate a specific specialty pharmacy. This is a routing problem, not a denial.Start Form guide
- The Start Form is incompleteNovartis says an incomplete Start Form can delay treatment. The office can check it with Novartis Patient Support at 844-482-6723 and refax it to 877-682-6723.Start Form guide
- Prior authorization pending or deniedPlans ask for criteria like those below, such as the biopsy, a protein level, 12 weeks on an ACE inhibitor or ARB, and a nephrologist. For commercial insurance the Bridge Program supplies Vanrafia free for up to 12 months. The authorization or appeal must be filed within 45 days of enrolling.Novartis Patient Support
- The plan sees another IgAN drug on your recordThe Cigna policy below does not cover Vanrafia taken together with Fabhalta or Filspari. If you are switching, the prescriber's records showing the stop date usually settle it.Cigna policy
- A copay you cannot payCommercial insurance: Co-Pay Plus, as little as $0 up to $15,000 a year. Medicare, Medicaid, TRICARE, VA and other government plans are excluded by its terms. Novartis points people with limited or no prescription coverage to the Novartis Patient Assistance Foundation, an independent nonprofit, at 1-800-277-2254, and our help paying page lists charity funds.Novartis Patient Support
Cigna prior authorization policy, June 15, 2026
- Age 18 or older, with IgA nephropathy confirmed by biopsy
- Protein in the urine of 0.5g a day or more, or a urine protein-to-creatinine ratio of 1.5g/g or higher
- At least 12 weeks on the highest or highest tolerated dose of an ACE inhibitor or an ARB before starting
- At least 3 months of supportive care, meaning blood pressure control, lifestyle and heart risk measures
- Kidney function (eGFR) of 30 or higher
- Prescribed by or with a nephrologist
- Not taken together with another IgA nephropathy drug such as Fabhalta or Filspari
Approval length. A year at a time, renewed if the prescriber reports a response such as lower urine protein and the eGFR is still 30 or higher.
This policy was last revised in April 2026 and took effect on June 15, 2026. It cites the April 2025 label, whose clinical text is unchanged in the current June 2026 version. Other plans set their own thresholds, and a full approval may change them. It is here as an example of what a plan asks for, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- A dedicated team member who reaches out from the start, with a welcome kit and your choice of texts, calls or emails
- Co-Pay Plus for private insurance, as little as $0 up to $15,000 a year, not valid under Medicare, Medicaid, TRICARE, VA, DoD or other government programs
- The Bridge Program, free Vanrafia for up to 12 months while a private plan decides, if the prior authorization or appeal is filed within 45 days of enrolling
- Help navigating the insurance process, with a team member who works with your doctor's office on insurance forms and helps if your health plan changes
- Information on the Novartis Patient Assistance Foundation, an independent nonprofit, for people with limited or no prescription coverage
Details as the drugmaker publishes them. Novartis Patient Support
Five questions for the pharmacist or the support line
- Are you CareMed, Biologics or a pharmacy my plan chose, and what number will the delivery call come from?
- Is my prescription written for 30 tablets or 90, and when will the next shipment go out?
- I take these other medicines and supplements. Are any of them CYP3A inducers or OATP1B1/1B3 inhibitors?
- Should I keep the tablets in the original bottle when I travel, or is a pill box all right?
- If my doctor adds a water pill for swelling, does anything change about how I take Vanrafia?
Questions people ask in the first weeks
Does Vanrafia have a REMS?
No. The FDA's risk review, completed in March 2025 before approval, concluded that a REMS was not needed. The pregnancy and liver rules sit in the label and Medication Guide instead. There is no program enrollment and no test that gates each refill.
What tests are needed before starting Vanrafia?
A liver enzyme test for everyone and, for anyone who can become pregnant, a negative pregnancy test. After that the label says to repeat liver tests as clinically indicated, so the schedule is your nephrologist's decision.
Do I stop my ACE inhibitor or ARB when I start Vanrafia?
Not by the label. In the ALIGN trial the ACE inhibitor or ARB continued throughout, and Novartis describes Vanrafia as an add-on to it. That is different from Filspari, where the label says to stop it first. Any change to your ACE inhibitor or ARB is your nephrologist's decision.
Can I pick up Vanrafia at my regular pharmacy?
No. Novartis says it is sent to one of 2 limited network specialty pharmacies, CareMed or Biologics, which ship it to your home each month. Your plan may name its own specialty pharmacy.
What if I miss a dose of Vanrafia?
The Medication Guide says to skip the missed dose and take the next one at the regular time. It says never to take 2 doses at once.
Why was Vanrafia denied by my insurance?
A plan like Cigna's asks for the biopsy, a protein level above its threshold, or 12 weeks on an ACE inhibitor or ARB. Some also refuse it alongside Fabhalta or Filspari. The nephrologist's records usually resolve it, and the Bridge Program can cover a commercial plan's delay.
Is Vanrafia fully approved?
Not yet. It has accelerated approval based on lowering urine protein, and the label says it is not established whether it slows kidney function decline. Novartis said on July 21, 2026 that it had filed in the US for traditional approval.
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Sources
- VANRAFIA (atrasentan) tablets, prescribing information and Medication Guide, DailyMed version 3, Novartis, via DailyMed and openFDA, June 12, 2026.
- NDA 219208 Risk Assessment and Risk Mitigation Review, Evaluation of Need for a REMS, FDA, March 29, 2025.
- NDA 219208 accelerated approval letter, FDA, April 2, 2025.
- NDA 219208/S-001 supplement approval letter, container label, FDA, October 20, 2025.
- Novartis Patient Support™ | VANRAFIA® (atrasentan), Novartis, November 7, 2026.
- Starting VANRAFIA® (atrasentan), Novartis, November 7, 2026.
- Guide to completing the VANRAFIA (atrasentan) Start Form, Novartis, November 7, 2026.
- Drug Coverage Policy IP0740, Nephrology, Vanrafia, Cigna, June 15, 2026.
- Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed (Q2 2026 media release), Novartis, July 21, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing nephrologist. Found an error? Use the report link in the footer and it will be checked against the source.