Big Bear DAKEDX Dacomitinib 45mg

Product Information

• Product name: DAKEDX Dacomitinib45mg Dacomitinib 45mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Dacomitinib
• Current strength: 45mg
• SKU: Product ID 3139
• Site category: general medicines

Product Summary

DAKEDX Dacomitinib45mg Dacomitinib 45mg is an AISTIKA-listed product supplied by Laos BigBear 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

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

Dacomitinib is an irreversible inhibitor of the kinase activity of the human EGFR family (EGFR/HER1, HER2, and HER4) and certain EGFR activating mutations (exon 19 deletion or the exon 21 L858R substitution mutation). Dacomitinib demonstrated dose-dependent inhibition of EGFR and HER2 autophosphorylation and tumor growth in mice bearing subcutaneously implanted human tumor xenografts driven by HER family targets including mutated EGFR. Dacomitinib also exhibited antitumor activity in orally-dosed mice bearing intracranial human tumor xenografts driven by EGFR amplifications.

Reference Indications

Dacomitinib is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test . Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

Reference Dosage and Administration

Recommended Dosage: 45 mg orally once daily with or without food.

With this 45mg product, that corresponds to 1 x 45mg 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

Interstitial Lung Disease (ILD): Permanently discontinue Dacomitinib if ILD is confirmed. Diarrhea: Withhold and reduce the dose of Dacomitinib based on the severity. ( 2.3 , 5.3 ) Embryo-Fetal Toxicity: Dacomitinib can cause fetal harm. Advise females of reproductive potential to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Interstitial Lung Disease (ILD) Severe and fatal ILD/pneumonitis occurred in patients treated with Dacomitinib and occurred in 0.5% of the 394 Dacomitinib-treated patients; 0.3% of cases were fatal. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Dacomitinib and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue Dacomitinib if ILD is confirmed .

Common Adverse Reactions and Monitoring

The median duration of exposure to Dacomitinib was 10.8 months (range 0.07–68) . The data described below reflect exposure to Dacomitinib in 227 patients with EGFR mutation-positive, metastatic NSCLC enrolled in a randomized, active-controlled trial (ARCHER 1050 ) ; 224 patients received gefitinib 250 mg orally once daily in the active control arm . Patients were excluded if they had a history of ILD, interstitial pneumonitis, or brain metastases. The median duration of exposure to Dacomitinib was 15 months (range 0.07–37). Dose interruptions occurred in 57% of patients treated with Dacomitinib. Dose reductions occurred in 66% of patients treated with Dacomitinib.

Drug Interactions and Special Populations

Proton Pump Inhibitors (PPIs): Avoid use with Dacomitinib; use locally-acting antacids or H2-receptor antagonist; administer Dacomitinib at least 6 hours before or 10 hours after H2-receptor antagonist. ( 2.4 , 7.1 ) CYP2D6 Substrates: Avoid concomitant use with Dacomitinib where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities. Avoid the concomitant use of PPIs with Dacomitinib. As an alternative to PPIs, use locally-acting antacids or an H2-receptor antagonist. Administer Dacomitinib at least 6 hours before or 10 hours after taking an H2-receptor antagonist . Avoid concomitant use of Dacomitinib with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities. Lactation: Advise not to breastfeed.

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: Vizimpro 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.