Venetoclax

The launch of venetoclax provides new treatment options for patients with hematological tumors, especially in the treatment of acute myeloid leukemia, filling a gap in related domestic fields.

1. Drug name

1. Common name: Venetoclax (Venetoclax)

2. Trade name: VE NCLEXTA™

II. Indications for

It is used to treat adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion, and the patient must have received at least one previous treatment.

3. specifications and properties

100mg tablets

4. main ingredient

1. Active ingredient: Venetoclax

2. Excipients: Copovidone, colloidal silica, polysorbate 80, sodium stearyl fumarate, etc. 10/100mg contains iron oxide yellow, 50mg contains iron oxide yellow/red/black.

5. U200c usage and dosage

1. Initial treatment of : 20mg once a day for 7 days; then increase the dose weekly to 400mg once a day (50mg in the 2nd week, 100mg in the 3rd week, 200mg in the 4th week, and 400mg from the 5th week).

2. How to take : Take the tablet orally with food and swallow the whole tablet. Do not chew, crush or break.

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

VI. U200c dose adjustment

1. Toxicity adjustment : Suspend or reduce the dose (such as 400mg to 300mg, 300mg to 200mg, etc.) based on neutropenia, TLS and other toxicities.

2. Drug interaction :

Strong CYP3A inhibitors (such as ketoconazole) are contraindicated in the initial stage, and the dosage needs to be reduced by 75% in the stable period.

The dose of moderate CYP3A or P-gp inhibitors (such as erythromycin) needs to be reduced by 50%.

7. Precautions for using

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

2. Treatment of missed doses : Take the missed dose within 8 hours, skip it if it exceeds 8 hours, and take the medicine normally the next day.

3. Vomiting treatment : There is no need to take additional doses after vomiting. Take the medicine as originally planned the next day.

8. U200c medication for special groups

1. Pregnancy/breastfeeding : may cause harm to the fetus, contraception is required until 30 days after stopping the drug; it is contraindicated during lactation.

2. Hepatic and renal insufficiency : No dose adjustment is required for mild to moderate cases, but toxicity needs to be closely monitored; for severe cases, there is no recommended dose.

3. Elderly : The safety profile is similar in patients aged ≥65 years.

9. Adverse reactions of

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

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

10. Contraindications of

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

11. drug interactions

1. Avoid combined use of strong/moderate CYP3A inducers (such as rifampicin).

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

12. storage method

Stored below 30℃, the original packaging must be retained for the first 4 weeks.