The launch of Venacula provides a new treatment option for patients with hematological malignancies, especially in the treatment of acute myeloid leukemia, filling a gap in related fields in China.

1、 Drug name

1. Common name: Venetoclax

2. Product Name: VENCLEXTA ™

2、 Indications

Used to treat adult patients with chronic lymphocytic leukemia (CLL) who have 17p deficiency and have received at least one previous treatment.

3、 Specifications and characteristics

100mg tablets

4、 Main components

1. Active ingredient: Venetoclax

2. Auxiliary materials: copolymer ketone, colloidal silica, polysorbate 80, sodium stearoyl fumarate, etc. 10/100mg contains iron oxide yellow, 50mg contains iron oxide yellow/red/black.

5、 Usage and dosage

1. Initial treatment: 20mg once daily for 7 consecutive days; Subsequently, the dosage was increased weekly to 400mg once daily (50mg in week 2, 100mg in week 3, 200mg in week 4, and 400mg starting from week 5).

2. Medication method: Take the whole tablet orally with meals, do not chew, crush or break it.

3. Course of treatment: Continue medication until disease progression or intolerable toxicity occurs.

6、 Dose adjustment

1. Toxicity adjustment: Suspend or reduce toxicity based on neutropenia, TLS, etc. (such as reducing 400mg to 300mg, 300mg to 200mg, etc.).

2. Drug interactions:

Strong CYP3A inhibitors (such as ketoconazole) should be discontinued in the initial stage and reduced by 75% during the stable period.

Intermediate acting CYP3A or P-gp inhibitors (such as erythromycin) need to be reduced by 50%.

7、 Medication precautions

1. Dietary requirements: Must be taken with meals and avoid grapefruit, Seville orange, or starfruit.

2. Omission treatment: Take the missed medication within 8 hours, skip if it exceeds 8 hours, and take the medication normally the next day.

3. Vomiting treatment: No need to take additional medication after vomiting, take the medication according to the original plan the next day.

8、 Medication for special populations

1. Pregnancy/lactation: may cause fetal harm, contraception should be used until 30 days after discontinuation of medication; Prohibited during lactation.

2. Liver and kidney dysfunction: mild to moderate dose adjustment is not necessary, but toxicity needs to be closely monitored; There is no recommended dosage for severe cases.

3. Elderly: Patients aged 65 and above have similar safety profile.

9、 Adverse reactions

1. Common (≥ 20%) conditions include: neutropenia, diarrhea, nausea, anemia, upper respiratory tract infections, thrombocytopenia, and fatigue.

2. Serious adverse reactions include: TLS (6%), neutropenia with fever (5%), etc.

10、 Contraindications

Strong CYP3A inhibitors (such as ketoconazole) are contraindicated during the initial and dose escalation periods.

11、 Drug interactions

1. Avoid using strong/medium acting CYP3A inducers (such as rifampicin) in combination.

2. Narrow therapeutic window P-gp substrates (such as digoxin) need to be taken 6 hours before Vinaccra.

12、 Storage method

Store below 30 ℃ and keep the original packaging for the first 4 weeks.

Venetoclaxinformation