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Mobotinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. By selectively binding to and inhibiting the receptor of EGFR exon 20 insertion mutation, it blocks abnormal signaling pathways, inhibits the proliferation and growth of tumor cells, exerts anti-tumor effects, and provides a new treatment option for patients with non-small cell lung cancer carrying this mutation.
1. Trade name: EXKIVITY
2. Generic name: Mobocertinib
Specifications: 40mg capsules.
Characteristics: Oral capsule dosage form.
1. Active ingredient: Mobocertinib
2. Excipients: The capsule shell contains gelatin and titanium dioxide, and the printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butanol, propylene glycol, concentrated ammonia solution, black iron oxide, potassium hydroxide and purified water.
1. Recommended dosage: Take 160mg once a day, orally, with or without food.
2. Administration method: Swallow the capsule whole. Do not open, chew or dissolve the contents of the capsule.
1. Adjust the dose according to the severity of adverse reactions. Reduce the dose to 120 mg once a day for the first time and to 80 mg once a day for the second time.
2. For QTc interval prolongation, decide whether to suspend the medication, reduce the dose, or permanently discontinue the medication based on the severity.
3. For moderate CYP3A inhibitors, if co-administration is unavoidable, the dose of mobotinib needs to be reduced by approximately 50%, and the original dose must be restored after 3-5 half-lives of stopping the inhibitor.
1. Before and after meals: Mobotinib can be taken with or without food, but it needs to be taken at a fixed time every day.
2. Missed dose: If the dose is missed for more than 6 hours, the dose will be skipped and the next dose will be taken at the originally planned time the next day.
3. Vomiting: If you vomit after taking the medicine, there is no need to take an additional dose. Take the next dose according to the original plan the next day.
1. Pregnant women: Mobotinib may be harmful to the fetus and is contraindicated in pregnant women.
2. Breast-feeding women: Should not breast-feed during treatment and within 1 week after stopping the drug.
3. Women and men of reproductive potential: It is recommended that women of reproductive potential use effective non-hormonal contraceptive measures during treatment and within 1 month after stopping the drug; it is recommended that the female partners of male patients use effective contraceptive measures during treatment and within 1 week after stopping the drug.
4. Children: The safety and effectiveness of Mobotinib in children have not been established.
5. Elderly people: There is no significant difference in overall effectiveness among patients aged ≥65 years old, but the incidence of grade 3 and above adverse reactions and serious adverse reactions is higher in patients aged ≥65 years.
6. Hepatic and renal insufficiency: Patients with mild to moderate hepatic and renal insufficiency do not need to adjust the dose. The recommended dose for patients with severe hepatic and renal insufficiency has not yet been determined.
1. Common adverse reactions (>20%): Diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin and musculoskeletal pain.
2. Common (≥2%) grade 3 or 4 laboratory abnormalities: lymphopenia, increased amylase, increased lipase, decreased potassium, decreased hemoglobin, increased creatinine and decreased magnesium.
3. Serious adverse reactions: Including QTc interval prolongation with torsade de pointes, interstitial lung disease (ILD)/pneumonitis, cardiotoxicity, diarrhea, etc.
Mobotinib has no absolute contraindications.
1. CYP3A inhibitors: Avoid combination with strong or moderate CYP3A inhibitors. If it is unavoidable, the dosage needs to be reduced and QTc monitoring strengthened.
2. CYP3A inducers: Avoid combination with strong or moderate CYP3A inducers, which may reduce the efficacy of mobotinib.
3. Drugs that prolong QTc: Avoid combination with other drugs known to prolong the QTc interval to increase the risk of cardiac events.
12. Storage method
Store at 20°C to 25°C (68°F to 77°F), with an allowed temperature fluctuation range of 15°C to 30°C (59°F to 86°F).