Prescribing companion
Vanrafia (atrasentan)Baseline testing, contraception, interactions and prior authorization criteria, without a REMSFor prescribers and their offices treating IgA nephropathy: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS. Baseline liver enzymes, a negative pregnancy test where it applies, the Start Form to Novartis Patient Support, and the prescription routed to a specialty pharmacy (CareMed or Biologics, or the plan's own).
Example PA threshold
Cigna example: biopsy, proteinuria 0.5g a day or more or UPCR 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, 3 months of supportive care, eGFR 30 or higher, no concurrent Fabhalta or Filspari.
Monitoring
Liver enzymes at baseline, then as clinically indicated (consider periodic tests if baseline aminotransferases are above 3 times ULN); watch for fluid retention, hemoglobin decline and pregnancy.
Support line
Novartis Patient Support, 844-4VANRAF (844-482-6723), Start Form fax 877-682-6723, Co-Pay Plus to $0 up to $15,000 a year for private plans, Bridge Program free drug up to 12 months while a private plan decides.
Give your patient their plan
A one-page handout for starting Vanrafia, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/vanrafiaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| No REMS certification | The FDA's REMS review concluded a REMS was not necessary to manage embryo-fetal toxicity or hepatotoxicity; the risks are communicated through the prescribing information and Medication Guide. No prescriber, pharmacy or patient enrollment is required. | FDA REMS review |
| Baseline labs | Liver enzymes before initiation; do not initiate in severe hepatic impairment. Exclude pregnancy in patients who can become pregnant. | FDA label |
| Counsel on contraception | Effective contraception before initiation, during treatment and for 2 weeks after discontinuation. The label also asks prescribers to counsel on emergency contraception and to review any change of method. | FDA label |
| Keep the ACEi or ARB | ALIGN enrolled patients on a stable, maximally tolerated RAS inhibitor and continued it throughout. | FDA label |
| Submit the Start Form | Online through CoverMyMeds or by fax to 877-6VANRAF (877-682-6723). Required fields include the primary diagnosis code (N02.B listed), preferred specialty pharmacy (the form notes the plan may dictate one) and the prescription; Novartis says an incomplete form may delay the start. Do not fax medical records. | Start Form guide |
| Route to a specialty pharmacy | Novartis names 2 limited network specialty pharmacies, CareMed (1-877-227-3405) and Biologics (1-800-850-4306), and says it does not recommend or require a particular pharmacy. | Getting started |
| Bridge for the PA | For private insurance with a PA requirement or initial denial, the Bridge Program supplies Vanrafia free for up to 12 months or until approval, if the PA or appeal is submitted within 45 days of enrollment. Not available where Medicare, Medicaid, TRICARE or another government program pays. | Novartis Patient Support |
Prior authorization criteria and what to document
One public policy as the example: Cigna, June 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | Primary IgA nephropathy confirmed by biopsy, age 18 or older | Pathology report with date (documentation required) | Cigna policy |
| Proteinuria | 0.5g a day or more, or UPCR 1.5g/g or higher | 24-hour urine protein or UPCR result with date (documentation required) | Cigna policy |
| RAS blockade | At least 12 weeks at the maximum or maximally tolerated dose of an ACE inhibitor or ARB before starting | Agent, dose, start date | Cigna policy |
| Supportive care | At least 3 months of optimized supportive care: blood pressure, lifestyle and cardiovascular risk | Prescriber attestation ("according to the provider"; no documentation flag in the policy) | Cigna policy |
| Kidney function | eGFR 30 or higher, at initiation and renewal | Creatinine and eGFR with date | Cigna policy |
| No combination | Not used concurrently with another IgAN drug such as Fabhalta or Filspari | Medication list, with stop dates if switching | Cigna policy |
| Prescriber | Prescribed by or in consultation with a nephrologist | Specialty on the request, or the consult note | Cigna policy |
| Renewal | Prescriber-reported response, such as reduced UPCR or proteinuria from baseline; approvals are 1 year at a time | Baseline and current UPCR | Cigna policy |
Vanrafia dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 0.75mg orally once daily, with or without food. Swallow whole; do not cut, crush or chew. No titration. A bottle holds 30 tablets; the Start Form offers 30 or 90 tablets, with 11 refills or another number written in. | FDA label |
| Missed dose | Take the prescribed dose at the next scheduled time; do not double. The Medication Guide tells patients to skip the missed dose. | FDA label |
| Hepatic impairment | No adjustment in mild or moderate impairment; do not initiate in severe (Child-Pugh C) impairment. | FDA label |
| Renal impairment | No clinically significant pharmacokinetic difference for eGFR 15 to 90; effect of end-stage kidney disease unknown. | FDA label |
| Hepatotoxicity | Discontinue for clinically relevant aminotransferase elevations, elevations with bilirubin above 2 times ULN, or clinical symptoms of hepatotoxicity. Consider re-initiation when enzymes normalize in patients without symptoms or jaundice. | FDA label |
| Fluid retention | If clinically significant, consider initiating or increasing a diuretic and interrupting Vanrafia. Not evaluated in IgAN patients with heart failure. | FDA label |
Monitoring the Vanrafia label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Liver enzymes; pregnancy test where it applies | Required by the label before initiation; no REMS gate, so the result stays in the chart | FDA label |
| As clinically indicated | Liver enzymes | Consider periodic monitoring if baseline aminotransferases exceed 3 times ULN; ALT or AST above 3 times ULN occurred in 2% against 1% on placebo in ALIGN | FDA label |
| Any time | Symptoms of hepatic injury: nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, itching | Patients are told to report them; discontinue with clinical symptoms of hepatotoxicity | FDA label |
| First weeks onward | Edema, weight, dyspnea | Peripheral edema 10% against 7% in ALIGN; steady state is reached within 7 days | FDA label |
| No set schedule | Hemoglobin | The label sets no hemoglobin schedule; anemia 6% against 1%; mean change at week 36 of -0.7 g/dL against -0.2; a fall of more than 2 g/dL from baseline to below the lower limit of normal in 12% against 4%, thought partly hemodilution; no discontinuations | FDA label |
| Ongoing | Blood pressure | Mean change at week 36 of -4/-4 mmHg against +3/+2 on placebo; hypotension mild or moderate and rarely symptomatic | FDA label |
| Any time | Pregnancy | Test promptly if menses are delayed or pregnancy is suspected; discontinue as soon as possible if confirmed | FDA label |
Vanrafia drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Avoid | Strong or moderate CYP3A inducers, such as rifampin; rifampin reduced atrasentan Ctrough by 90%, which may reduce efficacy | FDA label |
| Avoid | OATP1B1/1B3 inhibitors, such as cyclosporine; cyclosporine raised Cmax 4.3-fold and AUC 3.8-fold, which may increase adverse reactions | FDA label |
| Noted, no instruction | Strong CYP3A inhibitors: ketoconazole raised AUC by 90%; section 7 carries no avoidance statement for this class | FDA label |
| No interaction expected | Midazolam, losartan and fexofenadine; Vanrafia is used on top of an ACEi or ARB | FDA label |
| Pregnancy and lactation | Contraindicated in pregnancy; effective contraception before, during and for 2 weeks after; breastfeeding not advised | FDA label |
| Male fertility | May impair spermatogenesis; in diabetic kidney disease patients, sperm counts recovered within about 3 months of stopping; not studied in IgAN | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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
- 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
Questions prescribers' offices ask about Vanrafia
Does Vanrafia have a REMS?
No REMS, per the June 2026 label and the FDA's March 29, 2025 REMS review, which concluded one was not necessary for embryo-fetal toxicity or hepatotoxicity; Novartis withdrew its proposed REMS on March 24, 2025. Counseling, pregnancy exclusion and contraception rest on the boxed warning, section 5.1 and the Medication Guide.
What testing is required before starting Vanrafia?
Liver enzymes and, in patients who can become pregnant, pregnancy exclusion, per the June 2026 label (sections 2.1, 5.1 and 5.2). Liver tests are then repeated as clinically indicated, with periodic monitoring to be considered when baseline aminotransferases exceed 3 times ULN.
Is the ACE inhibitor or ARB stopped before Vanrafia?
No; in ALIGN, the trial behind the June 2026 label, RAS inhibitor therapy at a stable maximally tolerated dose continued throughout. The label has no contraindication or avoidance statement for ACE inhibitors or ARBs, and losartan showed no clinically significant interaction.
Which drugs interact with Vanrafia?
Two classes to avoid, per section 7 of the June 2026 label: strong or moderate CYP3A inducers (rifampin cut atrasentan Ctrough by 90%) and OATP1B1/1B3 inhibitors (cyclosporine raised AUC 3.8-fold). Ketoconazole raised AUC by 90%, with no avoidance statement for strong CYP3A inhibitors in section 7.
What do insurers ask for to approve Vanrafia?
The Cigna policy shown on this page, effective June 15, 2026, asks for biopsy-confirmed IgAN, proteinuria of 0.5g a day or more or UPCR of 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, 3 months of supportive care, eGFR of 30 or higher and a nephrologist, and excludes concurrent Fabhalta or Filspari. It approves a year at a time.
Sources
- VANRAFIA (atrasentan) tablets, prescribing information and Medication Guide, DailyMed version 3, Novartis, via DailyMed and openFDA, 2026-06-12.
- NDA 219208 Risk Assessment and Risk Mitigation Review, Evaluation of Need for a REMS, FDA, 2025-03-29.
- NDA 219208 accelerated approval letter, FDA, 2025-04-02.
- NDA 219208/S-001 supplement approval letter, container label, FDA, 2025-10-20.
- Novartis Patient Support™ | VANRAFIA® (atrasentan), Novartis, 2026-11-07.
- Starting VANRAFIA® (atrasentan), Novartis, 2026-11-07.
- Guide to completing the VANRAFIA (atrasentan) Start Form, Novartis, 2026-11-07.
- Drug Coverage Policy IP0740, Nephrology, Vanrafia, Cigna, 2026-06-15.
- Novartis delivered sales growth in Q2 and further advanced the pipeline; Full-year guidance reaffirmed (Q2 2026 media release), Novartis, 2026-07-21.
A reference drawn from the June 12, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.