The standard dosage of Ensartinib is 225 mg orally once daily, with or without food, swallowed whole at a fixed time every day. Treatment does not start at 100 mg. Whether to make up a missed dose depends on the time remaining until the next scheduled dose, and no additional dose should be taken if vomiting occurs.
Standard Dosage and Administration
Recommended Dosage
225 mg orally once daily.
May be taken on an empty stomach or with food, but it is recommended to take it at the same time every day.
Method of Administration
Swallow whole; do not chew, crush, or open/break open capsules.
Avoid consuming grapefruit, sour limes (Seville oranges), and their products during treatment to prevent increasing plasma concentration and side effects.
Storage Conditions
Protect from light, seal tightly, and store below 25°C.
Management of Missed Doses and Vomiting
Missed Doses
Time until next dose ≥ 12 hours: You may take the missed dose.
Time until next dose < 12 hours: Skip the missed dose and take the next dose at the regularly scheduled time the following day.
Do not take a double dose at one time.
Vomiting
If vomiting occurs after taking a dose, do not take an additional dose. Take the next dose at the regularly scheduled time.
Principles of Dose Modification
Must Be Determined by a Physician
Do not increase, decrease, or stop the medication on your own.
If adverse reactions occur, your physician will temporarily withhold administration, reduce the dosage, or permanently discontinue the drug based on the situation.
Common Dose Reduction Steps
225 mg once daily → 200 mg once daily → 150 mg once daily.
If the treatment remains intolerable after dose reduction, permanent discontinuation may be necessary.
Signs Requiring Immediate Medical Attention
Severe rash or skin ulceration/breakdown.
Significant liver injury, eye pain, or visual disturbances.
Shortness of breath (dyspnea), worsening dry cough, bradycardia (slow heart rate), etc.
Drug Interactions and Precautions
Avoid Concomitant Use with Strong CYP3A4 Inhibitors/Inducers
Such as clarithromycin, itraconazole, rifampin, carbamazepine, etc.
If concomitant use is necessary, a physician must evaluate whether to adjust the Ensartinib dose.
Special Populations
Contraindicated during pregnancy and breastfeeding.
Effective contraception must be used during treatment and for a period of time after stopping the medication.
Fatigue and dizziness may occur; exercise caution when driving or operating machinery.
Ensartinib is mainly indicated for ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Specific dosing regimens and dose modifications must strictly follow the guidance of a specialist physician.
