Lucius LuciSuni Suninitib Sunitinib 12.5mg

Product Information

• Product name: LuciSuni Suninitib Sunitinib 12.5mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Sunitinib
• Current strength: 12.5mg
• SKU: LU-ITEM-112
• Site category: gastrointestinal stromal tumors, kidney cancer, other cancer

Product Summary

LuciSuni Suninitib Sunitinib 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

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

Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer.

Reference Indications

Sunitinib is a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. treatment of adult patients with advanced renal cell carcinoma (RCC). adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

Reference Dosage and Administration

Recommended dosage is 50 mg orally once daily for the first 4 weeks of each 6-week cycle (Schedule 4/2). taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity.

With this 12.5mg product, that corresponds to 4 x 12.5mg 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

WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue Sunitinib capsules as recommended . WARNING: HEPATOTOXICITY See for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue Sunitinib capsules as recommended . Hepatotoxicity : Fatal liver failure has been observed. Monitor liver function tests at baseline, during each cycle, and as clinically indicated. Interrupt Sunitinib for Grade 3 hepatotoxicity until resolution to Grade ≤1 or baseline and resume Sunitinib at a reduced dose; discontinue if no resolution.

Common Adverse Reactions and Monitoring

Gastrointestinal Stromal Tumor The safety of Sunitinib was evaluated in Study 1, a randomized, double-blind, placebo-controlled trial in which previously treated patients with GIST received Sunitinib 50 mg daily on Schedule 4/2 (n = 202) or placebo (n = 102). Median duration of blinded study treatment was 2 cycles for patients on Sunitinib (mean: 3.0; range: 1 to 9) and 1 cycle (mean; 1.8; range: 1 to 6) for patients on placebo at the time of the interim analysis. Permanent discontinuation due to an adverse reaction occurred in 7% of patients in the Sunitinib arm. Dose reductions occurred in 11% and dose interruptions occurred in 29% of patients who received Sunitinib.

Drug Interactions and Special Populations

CYP3A4 Inhibitors : Consider dose reduction of Sunitinib when administered with strong CYP3A4 inhibitors. CYP3A4 Inducers : Consider dose increase of Sunitinib when administered with strong CYP3A4 inducers. Select an alternate concomitant medication with no or minimal enzyme inhibition potential. Consider a dose reduction for Sunitinib when it is co‑administered with strong CYP3A4 inhibitors . Strong CYP3A4 Inducers Co-administration with strong CYP3A4 inducers may decrease sunitinib plasma concentrations . Select an alternate concomitant medication with no or minimal enzyme induction potential. Consider a dose increase for Sunitinib when it must be co‑administered with CYP3A4 inducers . Monitor the QT interval with ECGs more frequently in patients who require treatment with concomitant medications known to prolong the QT interval.

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: Sunitinib Malate 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.