Lucius LuciApro Aprocitentan 12.5mg

Product Information

• Product name: LuciApro Aprocitentan 12.5mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Aprocitentan
• Current strength: 12.5mg
• SKU: LU-ITEM-23
• Site category: hypertension, other cancer

Product Summary

LuciApro Aprocitentan 12.5mg 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

Aprocitentan is the active ingredient used for this product page. Public prescribing information for Aprocitentan 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

Aprocitentan is an ERA that inhibits the binding of endothelin (ET)-1 to ET A and ET B receptors. ET-1, via its receptors (ET A and ET B ), mediates a variety of deleterious effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation.

Reference Indications

Aprocitentan, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with Aprocitentan. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve BP goals.

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 dosage of Aprocitentan is 12. with or without food.

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 Aprocitentan is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore in patients who can become pregnant, exclude pregnancy prior to initiation of Aprocitentan. Advise use of effective contraception before the start of Aprocitentan, during treatment and for one month after stopping treatment. When pregnancy is detected, discontinue Aprocitentan as soon as possible . WARNING: EMBRYO–FETAL TOXICITY See for complete boxed warning. Based on animal data Aprocitentan may cause fetal harm if used by pregnant patients and is contraindicated in pregnancy. ( 4.1 , 5.1 , 8.1 ) For patients who can become pregnant, exclude pregnancy prior to initiation of treatment with Aprocitentan.

Common Adverse Reactions and Monitoring

The safety of Aprocitentan was evaluated in a placebo-controlled phase 3 clinical study (PRECISION, NCT03541174) in adults with uncontrolled BP (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medications.

Drug Interactions and Special Populations

Lactation: Advise not to breastfeed. Available data from post-marketing reports and published literature over decades of use with endothelin receptor antagonists in the same class as Aprocitentan have not identified an increased risk of fetal harm; however, these data are limited. Methodological limitations of these post-marketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug 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. Administration of macitentan, where approximately ≥50% of total exposure was to aprocitentan, was teratogenic in rats and rabbits at all doses tested (see Data ).

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: TRYVIO 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.