Brand Name
Vanrafia
Generic Name
Atrasentan
View Brand Information FDA approval date: April 02, 2025
Form: Tablet
What is Vanrafia (Atrasentan)?
VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, generally a urine protein-to-creatinine ratio .
Approved To Treat
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Related Clinical Trials
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Summary: The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.
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Brand Information
VANRAFIA (atrasentan)
WARNING: EMBRYO-FETAL TOXICITY
VANRAFIA is contraindicated for use in pregnant patients; it may cause major birth defects based on animal data
1INDICATIONS AND USAGE
VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
This indication is approved under accelerated approval based on a reduction of proteinuria
2DOSAGE FORMS AND STRENGTHS
VANRAFIA 0.75 mg: film-coated, round, biconvex, white to off-white tablet debossed with “7” on one side and unmarked on the other side.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Embryo-fetal Toxicity
- Hepatotoxicity
- Fluid Retention
- Decreased Sperm Counts
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VANRAFIA was evaluated in ALIGN (NCT04573478), a randomized, double-blind, placebo controlled clinical study in 403 adults with IgAN
Laboratory Tests and Vital Signs
Hemoglobin Decrease
At Week 36, the mean change in hemoglobin from baseline for those patients receiving VANRAFIA in the ALIGN study was -0.7 g/dL compared to -0.2 g/dL for those receiving placebo. The incidence of a hemoglobin decrease > 2 g/dL compared to baseline and below the lower limit of normal was greater for the VANRAFIA arm (12%) compared to the placebo arm (4%). These decreases are thought to be in part due to hemodilution. There were no treatment discontinuations due to anemia or hemoglobin decrease in the ALIGN study.
Blood Pressure Decrease
At Week 36, the mean change from baseline in systolic and diastolic blood pressure (BP) for patients receiving VANRAFIA in the ALIGN study was -4 mmHg and -4 mmHg, respectively, compared to +3 mmHg and +2 mmHg, respectively, in patients receiving placebo. Hypotension observed in VANRAFIA treated patients was mild or moderate in severity, rarely symptomatic, and did not necessitate treatment discontinuation.
4OVERDOSAGE
There is no experience with overdose of VANRAFIA. Atrasentan has been given in a single dose up to 139.5 mg and multiple doses up to 40 mg/day in healthy volunteers. Overdose of VANRAFIA may result in headache or vasodilation. In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because atrasentan is highly protein-bound.
5DESCRIPTION
VANRAFIA contains atrasentan, an endothelin type A (ET
Atrasentan is a slightly hygroscopic white to off-white powder that is slightly soluble in water.
VANRAFIA is available as a film-coated tablet for oral administration. Each VANRAFIA tablet contains 0.75 mg atrasentan (equivalent to 0.803 mg of atrasentan hydrochloride) and contains the following excipients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, L-cysteine hydrochloride monohydrate, polyethylene glycol, and silicon dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
VANRAFIA is supplied as follows:
- 0.75 mg tablets are film-coated, round, biconvex, white to off-white tablets debossed with “7” on one side and unmarked on the other side, packaged in a high-density polyethylene (HDPE) bottle containing a desiccant, with induction seal and child-resistant cap. Each bottle contains 30 tablets (NDC 0078-1420-15).
Storage
Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide)
Embryo-Fetal Toxicity
Educate and counsel female patients of reproductive potential to use effective contraception prior to starting treatment with VANRAFIA, during treatment and for two weeks after treatment discontinuation. Patients who can become pregnant should have a negative pregnancy test prior to treatment with VANRAFIA
Patients should be instructed to immediately contact their physician if they suspect they may be pregnant. Patients should seek additional contraceptive advice as needed.
Educate and counsel patients who can become pregnant on the use of emergency contraception in the event of unprotected sex or contraceptive failure.
Advise patients to contact their healthcare provider if they want to change the form of birth control which is used to ensure that another acceptable form of birth control is selected.
Hepatotoxicity
Some members of this pharmacological class are hepatotoxic. Educate patients on signs of hepatotoxicity. Advise patients that they should contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching
Fluid Retention
Educate patients on signs of fluid retention. Advise patients that they should contact their doctor if they have unusual weight increase or swelling of the ankles or legs
Lactation
Advise patients not to breastfeed during treatment with VANRAFIA
Other Risks Associated with VANRAFIA
Instruct patients that the risks associated with VANRAFIA also include the following:
- Decreases in sperm count
Distributed by:
© 2025 Novartis
T2025-18
8PRINCIPAL DISPLAY PANEL
NDC 0078-1420-15
Rx only
VANRAFIA
(atrasentan) tablets
0.75 mg
Dispense with accompanying
Swallow tablets whole.
30 tablets
NOVARTIS
