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Cotellic® is a multi-kinase inhibitor that inhibits the proliferation and survival of tumor cells by selectively inhibiting the activity of MEK1 and MEK2 kinases and blocking the RAS/RAF/MEK/ERK signaling pathway.
Cobimetinib, trade name COTELLIC.
It is used to treat unresectable or metastatic melanoma positive for BRAF V600E or V600K mutation, and needs to be used in combination with vemurafenib. Not suitable for patients with wild-type BRAF melanoma.
1. Specifications : 20 mg film-coated tablets, each tablet contains 22 mg of cobimetinib fumarate (equivalent to 20 mg of cobimetinib free base).
2. Characteristics : White round tablets.
1. Active ingredient: Cobimetinib fumarate.
2. Excipients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate (tablet core); polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc (coating).
1. Usage : Take orally, once a day, 60mg each time (3 tablets of 20mg), take it continuously for 21 days and then stop taking it for 7 days (28 days is a cycle).
2. Dosage : Take it with food or on an empty stomach. There is no need to take another dose after missing a dose or vomiting, and continue taking the next dose as originally planned.
1. The first reduction of : 40mg once a day; the second reduction of : 20mg once a day; if it is still intolerable, discontinue the drug permanently.
2. Combined use of CYP3A inhibitors with : Avoid strong/moderate CYP3A inhibitors; if combined use is necessary (≤14 days), reduce the dose to 20 mg, and return to the original dose after discontinuation.
1. Diet : No special requirements.
2. Missed dose/vomiting : Skip the dose and take the next dose as planned.
3. Other :
Avoid sun exposure and use SPF≥30 sunscreen.
Monitor changes in liver function, left ventricular ejection fraction (LVEF), creatine phosphokinase (CPK) and vision during medication.
1. Pregnant women : Contraindicated as it may cause fetal malformation. Women of childbearing potential need to use contraception until 2 weeks after stopping the drug.
2. Lactation : Breastfeeding is prohibited within 2 weeks after stopping the drug.
3. Hepatic/renal insufficiency : No dosage adjustment is required for mild to moderate, and no clear recommendation for severe cases.
4. Children/Elderly : Safety has not been established.
1. Common (≥20%) : Diarrhea, photosensitivity reaction, nausea, fever, vomiting.
2. Serious adverse reactions :
3. New skin/non-skin malignant tumors (such as squamous cell carcinoma).
4. Hemorrhage (such as cerebral hemorrhage), cardiomyopathy, severe rash, retinopathy, hepatotoxicity, and rhabdomyolysis.
There are no absolute contraindications, but it is prohibited for those who are allergic to the ingredients.
1. CYP3A inhibitor (such as itraconazole): Significantly increases the plasma concentration of cobimetinib, avoid combined use.
2. CYP3A inducer (such as rifampicin): Reduce the efficacy of cobimetinib, avoid combined use.
Save at room temperature below 30°C (86°F) and keep dry.