Lucius LuciNiro Nirogacestat 50mg

Product Information

• Product name: LuciNiro Nirogacestat 50mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Nirogacestat
• Current strength: 50mg
• SKU: LU-ITEM-148
• Site category: progressive fibroma, other cancer

Product Summary

LuciNiro Nirogacestat 50mg 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

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

Nirogacestat is a gamma secretase inhibitor that blocks proteolytic activation of the Notch receptor. When dysregulated, Notch can activate pathways that contribute to tumor growth.

Reference Indications

Nirogacestat is indicated for adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.

Reference Dosage and Administration

Recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity. administered orally twice daily until disease progression or unacceptable toxicity.

With this 50mg product, that corresponds to 3 x 50mg tablets 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

Diarrhea : Severe diarrhea can occur. Monitor and dose modify for Grade 3-4 diarrhea. Ovarian Toxicity : Female reproductive function and fertility may be impaired. Advise females of reproductive potential of the potential risk prior to treatment and monitor routinely. Hepatotoxicity : Elevated AST and ALT can occur. Monitor AST and ALT regularly and modify dose as recommended. Non-Melanoma Skin Cancers : Perform dermatologic examination prior to initiation of Nirogacestat and routinely during treatment. Electrolyte Abnormalities : Monitor phosphate and potassium regularly and modify dose as recommended. Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

Common Adverse Reactions and Monitoring

The most common laboratory abnormalities (≥15%) are decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium. The safety of Nirogacestat was evaluated in 69 patients enrolled in DeFi with progressing desmoid tumor . Patients received Nirogacestat 150 mg orally twice daily or placebo orally twice daily until disease progression or unacceptable toxicity. The median duration of exposure to Nirogacestat was 20.6 months (range: 0.3 to 33.6). Permanent discontinuation of Nirogacestat due to an adverse reaction occurred in 20% of patients. Dosage interruptions of Nirogacestat due to an adverse reaction occurred in 51% of patients.

Drug Interactions and Special Populations

Strong or moderate CYP3A inhibitors : Avoid concomitant use. Strong or moderate CYP3A inducers : Avoid concomitant use. Gastric acid reducing agents : Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, Nirogacestat administration can be staggered with antacids. Effects of Other Drugs on Nirogacestat Strong or Moderate CYP3A Inhibitors Prevention or Management Avoid concomitant use of Nirogacestat with strong or moderate CYP3A inhibitors including grapefruit products, Seville oranges, and starfruit. Clinical Effect Nirogacestat is a CYP3A substrate. Strong or Moderate CYP3A Inducers Prevention or Management Avoid concomitant use of Nirogacestat with strong or moderate CYP3A inducers. Clinical Effect Nirogacestat is a CYP3A substrate.

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: OGSIVEO 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.