In non clinical studies, alectinib can block ALK phosphorylation and the activation of downstream signaling proteins such as STAT3 and AKT, thereby inhibiting tumor cell proliferation.

1、 Drug name

1. Common name: Aletinib

2. Product Name: ALECENSA

3. English name: Alectinib

2、 Indications

Used to treat patients with metastatic non-small cell lung cancer (NSCLC) who are positive for anaplastic lymphoma kinase (ALK) and have disease progression or intolerance to crizotinib after treatment.

3、 Specifications and characteristics

1. Specification: 150mg/capsule

2. Appearance: Capsule.

4、 Main components

1. Active ingredient: Aletinib (present in the form of Aletinib Hydrochloride, each pill is equivalent to 161.33 milligrams of Aletinib Hydrochloride)

5、 Usage and dosage

1. The recommended dosage is 600 milligrams per dose (i.e. 4 capsules of 150 milligrams), taken twice daily with meals.

2. Medication should be continued until disease progression or intolerable toxicity occurs.

6、 Dose adjustment

1. Depending on the severity of adverse reactions, dosage adjustments may be necessary. The dose adjustment is divided into three levels: the initial dose is 600 milligrams twice a day; The initial reduction is 450 milligrams twice daily; The second reduction is 300 milligrams twice a day.

2. If the patient cannot tolerate 300 milligrams twice a day, the medication should be permanently discontinued. Specific adjustment criteria include elevated liver enzymes, elevated bilirubin, interstitial lung disease, symptomatic bradycardia, elevated creatine kinase, and other conditions.

7、 Medication precautions

1. It should be taken with meals to increase drug absorption.

2. Capsules should be swallowed whole and should not be opened or dissolved.

3. If one dose is missed, there is no need to take it again, and the next dose should be taken at the scheduled time.

4. If vomiting occurs after taking the medication, there is no need to take the next dose as scheduled.

8、 Medication for special populations

1. Pregnant women: May cause harm to the fetus, effective contraception should be used during medication and within one week after the last dose.

2. Breastfeeding period: It is not recommended to breastfeed during the medication period and within one week after the last dose.

3. Male partners with fertility: Effective contraception should be used during the medication period and within 3 months after the last dose.

4. Children: Safety and efficacy have not yet been established.

5. Elderly: Insufficient clinical research data.

6. Liver and kidney dysfunction: Mild to moderate liver dysfunction or complete mild to moderate kidney dysfunction requiring dose adjustment; The safety of patients with moderate to severe liver dysfunction or severe renal dysfunction has not been studied.

9、 Adverse reactions

1. Common adverse reactions (incidence ≥ 20%) include fatigue, constipation, edema, and muscle pain.

2. Other common reactions include coughing, rash, nausea, headache, diarrhea, difficulty breathing, etc.

3. Laboratory abnormalities commonly include elevated liver enzymes, elevated creatine kinase, anemia, etc.

4. Serious adverse reactions include liver toxicity, interstitial lung disease, bradycardia, severe muscle pain, etc.

10、 Contraindications

There are no known contraindications.

11、 Drug interactions

1. Currently, no pharmacokinetic interactions requiring dose adjustment have been identified.

2. Aletinib and its metabolites do not inhibit major CYP enzymes, but may inhibit P-glycoprotein and breast cancer resistant protein.

12、 Storage method

Store at a temperature not exceeding 30 ° C (86 ° F), in its original packaging, away from light and moisture.

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