Lucius LuciMaci Macitentan 10mg

Product Information

• Product name: LuciMaci Macitentan 10mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Macitentan
• Current strength: 10mg
• SKU: LU-ITEM-74
• Site category: pulmonary hypertension, other cancer

Product Summary

LuciMaci Macitentan 10mg 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

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

Endothelin (ET)-1 and its receptors (ET A and ET B ) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. Macitentan is an endothelin receptor antagonist that inhibits the binding of ET-1 to both ET A and ET B receptors. Macitentan displays high affinity and sustained occupancy of the ET receptors in human pulmonary arterial smooth muscle cells. One of the metabolites of macitentan is also pharmacologically active at the ET receptors and is estimated to be about 20% as potent as the parent drug in vitro .

Reference Indications

Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH . Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II–III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) .

Reference Dosage and Administration

Recommended dosage of Macitentan is 10 mg once daily for oral administration.

With this 10mg product, that corresponds to 1 x 10mg tablet when that reference dose is clinically appropriate.

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 Macitentan is contraindicated for use during pregnancy because it may cause fetal harm based on animal data . Therefore, for females of reproductive potential, exclude pregnancy before the start of treatment with Macitentan. Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with Macitentan . When pregnancy is detected, discontinue Macitentan as soon as possible . WARNING: EMBRYO-FETAL TOXICITY See for complete boxed warning. Based on animal data, Macitentan may cause fetal harm if used during pregnancy ( 4.1 , 5.1 , 8.1 ). Females of reproductive potential: exclude pregnancy before start of treatment.

Common Adverse Reactions and Monitoring

The exposure to Macitentan in this trial was up to 3.6 years with a median exposure of about 2 years (N=542 for 1 year; N=429 for 2 years; and N=98 for more than 3 years). The overall incidence of treatment discontinuations because of adverse events was similar across Macitentan 10 mg and placebo treatment groups (approximately 11%). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Drug Interactions and Special Populations

Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan: avoid co-administration with Macitentan ( 7.1 , 12.3 ). Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with Macitentan ( 7.2 , 12.3 ) . Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with Macitentan ( 7.3 , 12.3 ). Concomitant use of Macitentan with strong CYP3A4 inducers should be avoided . Many HIV drugs like ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of Macitentan with strong CYP3A4 inhibitors . Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment .

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: OPSUMIT 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.