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Apelix is an oral phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor, which belongs to the kinase inhibitor class. By specifically inhibiting the activity of PI3Kα, Apelvis can block abnormal activation of the PI3K/Akt signaling pathway, thereby reducing excessive cell proliferation and abnormal tissue growth caused by PIK3CA gene mutations.
1. Generic name : Alpelisib (Alpelisib)
2. Trade name : VIJOICE®
3. Dosage form :Oral film-coated tablets (50mg/125mg/200mg) and oral granules (50mg/pack)
4. Main ingredients :Each tablet/contains apelix (active ingredient) and excipients (hypromellose, magnesium stearate, microcrystalline cellulose, etc.).
PIK3CA-related overgrowth spectrum (PROS) : It is used to treat PROS patients 2 years old and above with severe manifestations and require systemic treatment. This indication is based on accelerated approval and requires further verification of clinical benefit.
1. Tablet :
50mg: light yellow round tablet, engraved with “C7” and “N” VR";
125mg: dark yellow oval tablets, engraved with "Y7" and "NVR";
200mg: light yellow oval tablets, engraved with "CL7" and "NVR".
2. Granules :
50mg/pack, a mixture of white powder and granules.
1. Adult : 250mg once a day, take with food;
2. Children (2 to <18 years old) :< /b>Initially 50mg once a day, and can be increased to 125mg after 24 weeks for those aged ≥6 years;
3. How to take : Swallow the whole tablet or prepare an oral suspension (tablet); the granules can be swallowed directly or mixed with soft food.
4. Treatment of missed doses of : You can take the missed dose within 9 hours, skip the timeout; no need to take the missed dose after vomiting.
1. Reduce the dose of for adults: to 125mg for the first time and to 50mg for the second time;
2 , Reduction of for children: 125 mg to 50 mg;
3. Adjustment basis : Adjust according to the grade of adverse reactions such as hyperglycemia, rash, diarrhea, etc.
1. Hyperglycemia monitoring : Regularly detect fasting blood glucose and HbA1c before and during treatment;
2. Skin reactions :Permanent discontinuation is required if severe rash (such as SJS) occurs;
3. Risk of infection : 17% of patients develop ≥ grade 3 infection;
4. Diet : Avoid grapefruit juice and need to be taken with meals.
1. Pregnant women : Disabled (animal experiments show embryotoxicity);
2. Lactation : Breastfeeding is prohibited during treatment and within 1 week of drug withdrawal;
3. Liver insufficiency : Moderate to severe injuries require caution.
1. Common (≥10%) : diarrhea (16%), stomatitis (16%), hyperglycemia (12%);
2. Severe reactions : pneumonia (14%), neutropenia (16%).
It is contraindicated for those who are severely allergic to apelis or excipients.
1. Strong CYP3A4 inducer (such as rifampicin) : Avoid combined use;
2. BCRP inhibitor : may increase the exposure of apelix.
Save at room temperature (20-25°C), away from light and moisture.
Note : If you experience severe allergies, high blood sugar, or difficulty breathing, seek medical attention immediately. Blood sugar and liver function need to be monitored regularly during treatment.