Must-read for patients: Overview of basic information in the instructions for dacomitinib/dacomitinib

1. Generic name: Dacomitinib, Dacomitinib

Product name:Vizimpro, Dozerun

Other names: dacomitinib, piroxitinib

2. Who can take dacomitinib/dacomitinib? Indications?

Dacomitinib/Dacomitinib is indicated for patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 deletion as detected by a U.S. Food and Drug Administration (FDA) First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with L858R substitution mutations.

3. What are the side effects of Dacomitinib/Dacomitinib?

Common side effects of dacomitinib include diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, weight loss, hair loss, cough, and pruritus; serious side effects include diarrhea and interstitial lung disease.

4. How should I take dacomitinib/dacomitinib?

The recommended dose of dacomitinib is45 mg orally once daily until disease progression or unacceptable toxicity. Dacomitinib can be taken with or without food, but it must be taken at the same time every day. If the patient vomits or misses a dose, do not take another dose or make up the missed dose but continue with the next scheduled dose.

5. How to store Dacomitinib/Dacomitinib?

Dacomitinib is available as tablets and storage temperature20°C to 25°C (68°F to 77°F); offsets allowed between 15°C to 30°C (59°F to 86°F).

6. How does Dacomitinib/Dacomitinib work?

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 exon 21 L858R substitution mutation). Dacomitinib also inhibits the activities of DDR1, EPHA6, LCK, DDR2 and MNK1 at clinically relevant concentrations in vitro.

Dacomitinib showed 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 demonstrated antitumor activity in orally administered mice bearing intracranial human tumor xenografts driven by EGFR amplification.

7. What will happen if you overdose on Dacomitinib/Dacomitinib?

The maximum asymptomatic dose in rats is 50mg/kgMSDS. In animal studies, dacomitinib was shown to induce embryo-fetal toxicity, manifested by an increased incidence of post-implantation loss and reduced fetal weight at doses approaching the human dose of 45 mg after administration to rats during organogenesis. On the other hand, dacomitinib lacks mutagenic potential in bacterial reverse mutation assays, human lymphocyte chromosomal aberration assays, and in vivo clastogenic or aneuploid rat bone marrow micronucleus assays.

Dose-limiting toxicities and overdose toxicities include stomatitis, rash, palmar-plantar paresthesia syndrome, dehydration, paronychia, and diarrhea. Based on these findings, the maximum tolerated dose (defined as the dose at which dose-limiting toxicity does not exceed 33%) is 45 mg. If you take medicine, please seek medical treatment promptly.

8. Who cannot use dacomitinib/dacomitinib?

1. Women: According to the results of animal studies and its mechanism of action, dacomitinib taken by pregnant women may cause fetal damage. Therefore, it is recommended that women of childbearing potential use effective contraceptive measures during treatment and at least 17 days after the last dose; and do not breastfeed during treatment and at least 17 days after the last dose.