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LuciDac Dacomitinib Vizimpro
Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Description
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Product Description
Product Name: LuciDac
Chinese Name: Dacomitinib
English Name: Dacomitinib
Specifications: 15 mg/capsule, 30 capsules/bottle; 45 mg/capsule, 30 capsules/bottle
[Overview]
Dacomitinib is a pan-HER inhibitor that demonstrates good brain penetration. Its targets include not only EGFR (HER1) but also HER2 and HER4; it is likely due to its ability to inhibit multiple proteins within the HER family that it exhibits superior efficacy. Like Afatinib, it forms an irreversible bond with the EGFR kinase domain.
[Indications]
Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
[Storage]
Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
[Dosage and Administration]
1. Take orally once daily at a dose of 45 mg, continuing until disease progression or the occurrence of unacceptable toxicity.
2. May be taken with or without food.
[Adverse Reactions]
The most common adverse reactions (incidence > 20%) are diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, weight loss, alopecia, cough, and pruritus.
[Warnings and Precautions]
Interstitial Lung Disease (ILD): Permanently discontinue LuciDac if ILD is confirmed.
Diarrhea: Withhold and reduce the dose of LuciDac based on severity.
Dermatologic Adverse Reactions: Withhold and reduce the dose of LuciDac based on severity.
Embryo-Fetal Toxicity: LuciDac can cause fetal harm. Advise females of reproductive potential to use effective contraception. [Drug Interactions]
Proton Pump Inhibitors (PPIs): Avoid concomitant use with LuciDac; use locally acting antacids or H2 receptor antagonists instead; administer LuciDac at least 6 hours before or 10 hours after the H2 receptor antagonist.
CYP2D6 Substrates: Avoid concomitant use with LuciDac in cases where even a minimal increase in the concentration of the CYP2D6 substrate could result in severe or life-threatening toxicity.
[Special Populations]
Lactation: Breastfeeding is not recommended.
