Mobotinib (mobosetinib) 2024 latest version instructions

Indications:

Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy.

Mechanism of action:

Mobotinib can specifically recognize and bind to the ATP binding site of EGFR 20 exon insertion mutation. After it binds to EGFR, it can inhibit the abnormal EGFR signaling pathway caused by EGFR ex20ins mutations. By inhibiting the abnormal EGFR signaling pathway, mobotinib can block the growth and reproduction of tumor cells and delay the development of tumors.

Medication method:

Daily oral administration160mg (usually 4 capsules)

Side effects:

1.Gastrointestinal reactions: Nausea and vomiting are common side effects of mobotinib, which may be related to the irritation of the gastrointestinal tract by the drug. In addition, diarrhea is also a problem that many patients will encounter after using mobotinib. Data show that up to 93% of patients will experience diarrhea.

2. Loss of appetite: After taking mobotinib, some patients may experience loss of appetite, which may be related to the effect of the drug on the gastrointestinal tract.

3. Stomatitis: Stomatitis is also a common side effect of mobotinib, which manifests as inflammation or ulceration of the oral mucosa.

4.Other adverse reactions: In addition to the above side effects, Mobotinib may also cause adverse reactions such as increased serum creatinine, decreased lymphocytes, paronychia, dry skin, fatigue, hypomagnesemia, hypokalemia, decreased platelet count, and increased liver enzymes. These reactions may have an impact on the patient's physical condition and require close attention.

Warnings and precautions:

1.QTcInterval prolongation and torsade de pointes:

Mobotinib may prolong the QTc interval, which may lead to torsade de pointes, a potentially fatal arrhythmia. Therefore, patients' baseline QTc interval and electrolyte levels should be assessed before using mobotinib and monitored periodically during treatment. If signs or symptoms of QTc prolongation occur, mobotinib may need to be suspended, dose reduced, or permanently discontinued.

2.Interstitial lung disease (ILD)/Pneumonia:

Patients should be closely monitored for new or worsening pulmonary symptoms while taking mobotinib. If ILD/pneumonia is suspected, medication should be stopped immediately and relevant examinations should be conducted. If ILD/pneumonia is diagnosed, mobotinib needs to be permanently discontinued.

3.Cardiotoxicity:

Mobotinib may cause cardiotoxicity, including reduced ejection fraction, cardiomyopathy, etc. Therefore, cardiac function, especially left ventricular ejection fraction, should be monitored during treatment.

Drug interactions:

1.Interaction with CYP3A4 inhibitors: Mobotinib mainly passes through liver cytochrome P450 (CYP) 3A4 metabolism. When coadministered with strong CYP3A4 inhibitors (such as itraconazole), the plasma concentration of mobotinib will be significantly increased, which may increase the risk of adverse reactions. Therefore, concomitant use with strong CYP3A4 inhibitors should be avoided or dosage adjustments should be made as needed.

2. Interactions with drugs that prolong the QTc interval: Mobotinib itself may cause prolongation of the QTc interval. The risk of arrhythmia may be increased when combined with other drugs known to prolong the QTc interval (such as antiarrhythmic drugs, antihistamines, etc.). Therefore, concomitant use of these drugs should be avoided or close ECG monitoring should be performed if necessary.

Medication for special populations:

Pregnant and lactating women, those with liver and kidney dysfunction, and the elderly should use this medication with caution.