Safety
WARNING EMBRYO-FETAL TOXICITY
VANRAFIA is contraindicated for use in pregnant patients; it may cause major birth defects, based on animal data. Exclude pregnancy prior to initiation of treatment with VANRAFIA. Advise use of effective contraception before the initiation of treatment, during treatment, and for 2 weeks after discontinuation of treatment with VANRAFIA. Stop VANRAFIA as soon as possible if the patient becomes pregnant.
Contraindications
Use of VANRAFIA is contraindicated in patients who are pregnant and patients with hypersensitivity.
Safety profile of VANRAFIA in ALIGN1
Adverse reactions reported in ≥2% of adult patients with IgAN treated with VANRAFIA and higher than placebo in ALIGN*,†
aIncludes related terms.
bElevations in ALT or AST >3-fold ULN.
*The safety analysis was based on patients from both cohorts (n=403) for the duration that they received VANRAFIA.
†The median duration of treatment was 47 weeks (range: 0 to 128 weeks).
Fluid retention may occur with VANRAFIA. If clinically significant fluid retention develops, consider initiating or increasing diuretic treatment and interrupting treatment with VANRAFIA
Advise patients about contraception
Do not initiate VANRAFIA if a patient is pregnant. Advise patients to use effective contraception prior to and during treatment, and for 2 weeks following discontinuation of VANRAFIA
Stop VANRAFIA as soon as possible if your patient becomes pregnant
Counsel patients about fertility
Similar to other endothelin receptor antagonists, VANRAFIA may have a reversible adverse effect on sperm count. Counsel patients about potential effects on fertility
– A decrease in sperm count in some patients with diabetic kidney disease has been observed with VANRAFIA
– Patient sperm counts returned to normal levels within ~3 months after drug discontinuation
– This effect has not yet been studied in patients with IgAN
First ETA receptor antagonist in IgAN without a REMS program
Use of VANRAFIA is contraindicated in patients who are pregnant and patients with hypersensitivity. Serious warnings associated with VANRAFIA include embryo-fetal toxicity, hepatotoxicity, fluid retention, and decreased sperm counts. Most common adverse reactions (incidence ≥5%) were peripheral edema and anemia. Please see additional Important Safety Information below
Add once-daily VANRAFIA
Start your patients on VANRAFIA