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Atrasentan

Also known as: Vanrafia

Route: Oral

1 interaction on record⛔ Black Box Warning

Atrasentan has 1 known drug interaction based on U.S. FDA drug labeling data. Notable interactions include combinations with Gemfibrozil. Patients taking Atrasentan should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 1
Moderate: 1

Moderate (1)

Atrasentan + Gemfibrozil— OATP1B1 substrate; gemfibrozil inhibition may increase atrasentan exposure, requiring dosing reduction.

Atrasentan + Gemfibrozil🟡Moderate

OATP1B1 substrate; gemfibrozil inhibition may increase atrasentan exposure, requiring dosing reduction.

⛔ FDA Black Box Warning

WARNING: EMBRYO-FETAL TOXICITY VANRAFIA is contraindicated for use in pregnant patients; it may cause major birth defects based on animal data [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)] . Exclude pregnancy prior to initiation of treatment with VANRAFIA. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with VANRAFIA. Stop VANRAFIA as soon as possible if the patient becomes pregnant [see Dosage and Administration (2.1), Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. VANRAFIA may cause major birth defects if used during pregnancy ( 4.1 , 5.1 , 8.1 ) Exclude pregnancy before start of treatment. ( 2.1 , 4.1 , 5.1 , 8.3 ) Use effective contraception before start of treatment, during treatment and two weeks after treatment. ( 4.1 , 5.1 , 8.3 ) Discontinue VANRAFIA if pregnancy occurs. ( 4.1 , 5.1 )

Contraindications

4 CONTRAINDICATIONS Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Pregnancy Use of VANRAFIA is contraindicated in patients who are pregnant [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1)] . 4.2 Hypersensitivity VANRAFIA is contraindicated in patients with a history of a hypersensitivity reaction to atrasentan or any component of the product.

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on data from animal reproductive toxicity studies, VANRAFIA may cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy [see Contraindications (4.1)] . There are no available data on VANRAFIA use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available data from published literature and post-marketing surveillance over decades of use with products in the same pharmacologic class (ERA) have not identified an increased risk of major birth defects. However, these data are limited and do not establish the presence or absence of a drug-associated risk of major birth defects. Methodological limitations of these post marketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of exposure; and missing data. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal endothelin receptor antagonist use. In animal reproduction studies, oral administration of atrasentan to pregnant rats and rabbits throughout organogenesis at doses that were below the maximum recommended human dose (MRHD) based on area under the curve (AUC) caused teratogenic effects in rats and rabbits (see Data) . Advise pregnant patients of the potential risk to the fetus [see Contraindications (4.1)] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryo-fetal development studies in pregnant rats and rabbits, teratogenicity and/or embryo

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.