Seratinib, as one of the important drugs for the treatment of ALK positive non-small cell lung cancer, has been widely used and recognized worldwide.

1、 Drug name

1. Common name: Ceritinib

2. Product Name: ZYKADIA ®

2、 Indications

Used to treat adult patients with metastatic non-small cell lung cancer (NSCLC) confirmed as ALK positive by FDA approved testing methods.

3、 Specifications and characteristics

1. Capsule: 150mg, opaque blue cap and white body, printed with "LDK150MG" and "NVR".

2. Tablets: 150mg, light blue film coating, circular double convex, printed with "NVR" and "ZY1".

4、 Main components

Active ingredient: Ceritinib.

5、 Usage and dosage

1. Recommended dosage: 450mg orally, once daily, taken with food.

2. Missed medication: If it is more than 12 hours before the next medication, it can be taken again, otherwise it will be skipped.

3. Vomiting: No need for supplementation, take the next dose according to the original plan.

6、 Dose adjustment

1. First reduction: 300mg/day; Secondary reduction: 150mg/day; Discontinue medication if intolerable.

2. Situation that needs to be adjusted:

Severe gastrointestinal reactions (such as diarrhea and vomiting);

Hepatotoxicity (ALT/AST elevation>5-fold ULN);

QTc interval prolongation>500ms;

High blood sugar>250mg/dL;

Pancreatitis (amylase/lipase>2-fold ULN).

7、 Medication precautions

1. Take with food:

Reduce gastrointestinal adverse reactions.

2. Drug interactions:

Avoid using strong CYP3A inhibitors/inducers in combination (such as ketoconazole, rifampicin);

Avoid using sensitive CYP3A substrates (such as midazolam) or CYP2C9 substrates (such as warfarin) in combination.

3. Monitoring requirements:

Liver function (monthly), electrocardiogram (QT interval), fasting blood glucose, pancreatic enzymes (amylase/lipase).

8、 Medication for special populations

1. Pregnant women: may cause fetal harm and require contraception (during treatment and 6 months after discontinuation of medication for women, and 3 months after discontinuation of medication for men).

2. Breastfeeding period: Breastfeeding is prohibited.

3. Liver injury: Child Pugh C patients need to reduce their dosage by 1/3.

9、 Adverse reactions

1. Common (≥ 25%):

Diarrhea, nausea, vomiting, abdominal pain, fatigue.

2. Serious adverse reactions:

Hepatotoxicity (28% elevated ALT), ILD/pneumonia (2.4%), QT prolongation, hyperglycemia (13% grade 3-4), pancreatitis.

10、 Contraindications

There are no absolute contraindications, but caution should be exercised when used in patients with QT prolongation, bradycardia, and severe liver injury.

11、 Drug interactions

1. CYP3A inhibitors/inducers: Adjust dosage or avoid combination therapy.

2. QT prolonging drugs: such as antiarrhythmic drugs, need to be closely monitored.

3. Bradycardia drugs, such as beta blockers, should be avoided in combination.

12、 Storage method

Not explicitly stated, it is recommended to refer to the instruction manual and store it in its original packaging, away from light and moisture.

Ceritinibinformation