Apilis is an oral phosphatidylinositol-3-kinase alpha (PI3K alpha) inhibitor, belonging to the kinase inhibitor class.

1、 Drug name

1. Common name: Apilis

2. Product Name: VIJOICE

3. English name: Alpelisib

2、 Indications

Used to treat patients with severe manifestations of PIK3CA related overgrowth spectrum (PROS) in adults and children aged 2 years and above who require systemic treatment.

3、 Specifications and characteristics

Tablets: 50mg, 150mg

4、 Main components

1. Active ingredient: Apilis

2. Accessories include hydroxypropyl methylcellulose, magnesium stearate, mannitol, microcrystalline cellulose, starch sodium hydroxide, etc.

5、 Usage and dosage

1. Adults: The recommended dosage is 250mg, once daily, taken with meals.

2. Children (2 to<18 years old): The initial dose is 50mg, taken once daily with meals.

3. Children aged 6 and above may consider increasing to 125mg once daily after 24 weeks of treatment.

4. After reaching the age of 18, the dosage can gradually increase to adult doses.

6、 Dose adjustment

1. When serious skin reactions, high blood sugar, pneumonia, diarrhea/colitis, pancreatitis and other adverse reactions occur, medication should be interrupted, reduced or permanently discontinued.

2. The adult dose can be gradually reduced to 125mg and 50mg; The dosage for children can be reduced to 50mg.

3. If unable to tolerate 50mg daily, the medication should be permanently discontinued.

7、 Medication precautions

1. Take with meals, take medication at a fixed time every day.

2. Omission treatment: If it has not exceeded 9 hours, it can be supplemented; If it exceeds 9 hours, skip it and take it normally the next day.

3. No need to take additional medication after vomiting, take the medication on time the next day.

4. Tablets can be swallowed whole or made into oral suspensions.

8、 Medication for special populations

1. Pregnant women: There is a risk to the fetus, and effective contraception is required during the medication period and one week after discontinuation.

2. Breastfeeding period: Breastfeeding is prohibited during the medication period and within one week after the last dose.

3. Children: Safety has not been established for children under 2 years old.

4. Elderly people: Data is limited and should be used with caution.

9、 Adverse reactions

1. Common adverse reactions include diarrhea, stomatitis, and hyperglycemia.

2. Serious adverse reactions include severe allergies, severe skin reactions, high blood sugar, pneumonia, diarrhea/colitis, pancreatitis, etc.

10、 Contraindications

Prohibited for individuals with a history of severe allergies to Apilis or any of its ingredients.

11、 Drug interactions

1. Avoid co administration with strong CYP3A4 inducers such as rifampicin.

2. Avoid co administration with BCRP inhibitors.

3. When used in combination with CYP2C9 substrates, close monitoring should be conducted as it may reduce their blood drug concentration.

12、 Storage method

Stored at 20 ° C to 25 ° C, allowing for short distance transportation between 15 ° C and 30 ° C.

Alpelisibinformation