Lucius LuciAtras Atrasentan 75mg

Product Information

• Product name: LuciAtras Atrasentan 75mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Atrasentan
• Current strength: 75mg
• SKU: LU-ITEM-138
• Site category: proteinuria, other cancer

Product Summary

LuciAtras Atrasentan 75mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Atrasentan is the active ingredient used for this product page. Public prescribing information for Atrasentan was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Atrasentan is an ET A receptor antagonist (Ki = 0.034 nM) with >1800-fold selectivity for the ET A receptor compared to the endothelin type B receptor (Ki = 63.3 nM). Endothelin (ET)-1 is thought to contribute to the pathogenesis of IgAN via the ET A R.

Reference Indications

Atrasentan 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 . It has not been established whether Atrasentan slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. Atrasentan is an endothelin receptor antagonist 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.

Reference Dosage and Administration

The public label should be checked for the indication-specific recommended dosage. Available administration instructions note that the medicine may be taken recommended dose of Atrasentan is 0. with or without food 2.

Dose conversion must be confirmed by a physician because the reference dose may vary by indication, organ function, toxicity, or interacting medicines.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY Atrasentan 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 Atrasentan. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with Atrasentan. Stop Atrasentan as soon as possible if the patient becomes pregnant . WARNING: EMBRYO-FETAL TOXICITY See for complete boxed warning. Atrasentan 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 Atrasentan if pregnancy occurs.

Common Adverse Reactions and Monitoring

The safety of Atrasentan was evaluated in ALIGN (NCT04573478), a randomized, double-blind, placebo controlled clinical study in 403 adults with IgAN . The median duration of treatment was 47 weeks (range: 0 to 128 weeks). The incidence of a hemoglobin decrease > 2 g/dL compared to baseline and below the lower limit of normal was greater for the Atrasentan 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.

Drug Interactions and Special Populations

Strong or moderate CYP3A inducers: Avoid concomitant use. OATP1B1/1B3 inhibitors: Avoid concomitant use. Atrasentan is a CYP3A substrate . Concomitant use with a strong and moderate CYP3A inducer is expected to decrease atrasentan exposure , which may reduce Atrasentan efficacy. OATP1B1/1B3 Inhibitors Avoid concomitant use with organic anion transporting polypeptides 1B1/1B3 (OATP1B1/1B3) inhibitors. Atrasentan is a OATP1B1/1B3 substrate . Lactation: Advise not to breastfeed. There are no available data on Atrasentan use in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: VANRAFIA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.