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Mobocertinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
1. Chinese name: mobotinib
2. English name: mobocortinib
3. Trade name: EXKI VITY
1. For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) diagnosed with epidermal growth factor receptor (EGFR) exon 20 insertion mutations by FDA-approved testing methods.
2. Suitable for patients with disease progression after platinum-based chemotherapy.
Capsule dosage form, Each capsule contains 40mg of Mobotinib (equivalent to 48.06mg of Mobotinib succinate).
1. Active ingredient: Mobotinib succinate
2. Excipients: The capsule shell contains gelatin and titanium dioxide, and the printing ink contains shellac, alcohol, etc.
1. Recommended dose: 160 mg orally, once a day, with or without food.
2. How to take: Swallow the capsule whole. Do not open, chew or dissolve the contents of the capsule.
3. Treatment of missed doses: If you have not taken the dose for more than 6 hours, skip the dose and take the medicine at the original planned time the next day.
4. Treatment of vomiting: If you vomit after taking the medicine, there is no need to take a supplement, and you can continue taking it at the original dose the next day.
1. QT interval prolongation : Suspension of administration when ≥481ms occurs for the first time, and the original dose or reduction (120mg → 80mg) after recovery; permanent discontinuation when recurrence or ≥501ms.
2. Interstitial lung disease : If suspected, the drug will be suspended; if confirmed, the drug will be permanently discontinued.
3. Diarrhea : Suspension for grade ≥ 2, and then reduce the dose after recovery; for grade 4, reduce the dose for the first time, and permanently discontinue the drug if it recurs.
4. Cardiotoxicity : Suspension for grade 2, original dose or reduction after recovery; permanent discontinuation for grade ≥3.
5. Combined use of with CYP3A inhibitors: When combined use is necessary, the dose should be halved (such as 160mg → 80mg).
1. Diet affects : Food does not affect absorption, but avoid grapefruit/juice (which may increase blood concentration).
2. Monitoring requirements : Electrocardiogram, electrolytes, heart function and pulmonary symptoms need to be monitored regularly before and during medication.
3. Contraceptive requirements : Women of childbearing age need to use non-hormonal contraception (drugs may affect the hormonal contraceptive effect), during the medication and within 1 month (females)/1 week (males) after stopping the medication.
1. Hepatic/renal insufficiency : No adjustment is required for mild to moderate, and there is no clear recommended dose for severe cases.
2. Elderly : Patients over 65 years old have a higher incidence of adverse reactions and require close monitoring.
3. Pregnant women : Disabled, may cause fetal damage.
4. Lactation : Breastfeeding is prohibited during medication and within 1 week of stopping the medication.
1. Common reactions (>20%) : Diarrhea (92%), rash (78%), Nausea (37%), stomatitis (46%), vomiting (40%), decreased appetite (39%), paronychia (39%), fatigue (29%), dry skin (32%), musculoskeletal pain (34%).
2. Severe reactions : QT interval prolongation (1.2%>500ms), interstitial lung disease (4.3%), heart failure (2.7%), severe diarrhea (20% grade 3).
There are no absolute contraindications, but patients with QTc>470ms are not included in clinical studies.
1. CYP3A inhibitor : Avoid combined use of strong/moderate inhibitors (such as itraconazole), otherwise the dose needs to be reduced and electrocardiogram monitoring strengthened.
2. CYP3A inducer : Avoid the combined use of strong/moderate inducers (such as rifampicin), which may reduce the efficacy.
3. QT prolonging drug : Avoid combined use with amiodarone, etc., which may increase the risk of arrhythmia.
1. Store at room temperature (20°C-25°C), allowing short periods of 15°C-30°C.
2. Keep dry and away from light.