What are the precautions for taking Dacomitinib?

In the clinical study of Dacomitinib (Dacomitinib), warnings and precautions such as interstitial lung disease, diarrhea, skin adverse reactions , embryo-fetal toxicity have emerged. Doctors will adjust the drug dose according to the severity of the disease, such as reducing, interrupting, or permanently discontinuing dacomitinib.

1. Interstitial lung disease (ILD)/pneumonitis: Severe and fatalILD/pneumonitis occurred in patients treated with dacomitinib. Monitor patients for pulmonary symptoms of ILD/pneumonitis. Discontinue dacomitinib and immediately investigate ILD in patients who experience worsening of respiratory symptoms that may be indicative of ILD (eg, dyspnea, cough, and fever). If ILD is confirmed, permanently discontinue dacomitinib.

2. Diarrhea: Including severe and fatal diarrhea, for grade 2 or more severe diarrhea, discontinue dacomitinib until recovery to a severity less than or equal to grade 1, and then resume dacomitinib at the same or reduced dose according to the severity of the diarrhea. For diarrhea, initiate antidiarrheal treatment (loperamide or diphenoxylate hydrochloride plus atropine sulfate) immediately.

3. Adverse skin reactions: In clinical studies, patients treated with dacomitinib may experience rashes and skin exfoliation reactions, including any degree of illness. Withhold dacomitinib for persistent Grade 2 or any Grade 3 or 4 dermatological adverse reaction until recovery to grade ≤ 1 severity, then resume dacomitinib at the same or reduced dose based on the severity of the dermatological adverse reaction. The incidence and severity of rashes and exfoliative skin reactions may increase with sun exposure. When starting dacomitinib, begin using a moisturizer and take appropriate measures to limit sun exposure. Once grade 1 rash occurs, treatment with topical antibiotics and topical steroids is initiated. For grade 2 or more severe dermatologic adverse reactions, initiate oral antibiotics.

4. Embryo-Fetal Toxicity: Based on the results of animal studies and its mechanism of action, Dacomitinib can cause harm to the fetus when administered to pregnant women. In animal reproduction studies, oral administration of dacomitinib to pregnant rats during organogenesis resulted in an increased incidence of postimplantation loss and reduced fetal body weight at doses that resulted in exposures approaching the 45 mg human dose. Loss of EGFR signaling has been shown to cause embryonic and postnatal death in animals. Inform pregnant women of potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment with dacomitinib and for at least 17 days after the final dose.

DacomitinibThe original drug has been launched in China and has entered the scope of Class B medical insurance. The price of the common specification 15mg*30 tablets per box may be more than 1,000 yuan; the European version of dacominiboriginal drug sold overseas, the specification 45mg*30 tablets may be more than 20,000 yuan per box (the price may fluctuate due to exchange rates). Currently, there are cheaper generic drugs of dacomitinib sold overseas. Their pharmaceutical ingredients are basically the same as those of the original drugs sold domestically and abroad. For example, the price of 45mg*30 tablets produced by a Lao pharmaceutical factory may be around a few hundred yuan per box (the price may fluctuate due to exchange rate effects).