Dacomitinib Tablets PHODACO 45mg/15mg

[Drug Name] Dacomitinib Tablets

[Other Names] Dacomitinib / Duozerun / VIZIMPRO

[English Name] Dacomitinib Tablets

[Specification] 15 mg × 30 tablets/box; 45 mg × 30 tablets/box

[Manufacturer] State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

[Overview]

Dacomitinib is a pan-HER inhibitor that demonstrates good penetration into the brain. Its targets include not only EGFR (HER1) but also HER2 and HER4; it is believed to exhibit superior efficacy—possibly due to its ability to inhibit multiple proteins within the HER family. Similar to 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) whose tumors have been identified as having epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

[Dosage and Administration]

1. Administer 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.

[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) for short-term transport.

[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. Women of reproductive potential are advised 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 lead to severe or life-threatening toxicity.

[Special Populations]

Lactation: Breastfeeding is not recommended.

[Manufacturer Introduction]

Pharmaceutical Factory No. 2 of the Lao People's Democratic Republic (PHARMA 2 VIENTIANE)—hereinafter referred to as "Lao Pharma 2"—is a state-owned pharmaceutical enterprise in Laos, operating directly under the supervision of the Lao Ministry of Health. Established in the 1970s, Lao Pharma 2 boasts a history spanning over 40 years. It stands as the largest, oldest, and most comprehensive pharmaceutical manufacturer in Laos in terms of the variety of medicines produced.

Each year, Lao Pharma 2 supplies patients with a wide range of medications—totaling over 160 different products—including intravenous solutions, injectables, oral tablets, oral capsules, oral syrups, and ointments. Keeping pace with the times, Lao Pharma 2 actively explores new frontiers, continuously introducing advanced foreign technologies and seeking breakthroughs in manufacturing processes and pharmaceutical R&D to ensure that its own research, development, and production capabilities remain aligned with international standards. Currently, Lao Pharma 2 holds ISO 9001:2008 certification for its manufacturing processes. The mission of Lao Pharma 2 is to provide high-quality, internationally benchmarked pharmaceutical services to an ever-growing number of customers and patients through continuous progress and active exploration.

[Product Specifications]

Product Name: Dacomitinib Tablets 15 mg / 45 mg (30 tablets per box)