【Drug Name】

Name: Venetoclax Tablets

Product Name:VECLADX

【Specification】

100mg

【Indications】

VECLADX is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion, who have received at least one prior treatment. 

It is not known if VECLADX is safe and effective in children.

【Recommended Dosage】

• Take VECLADX exactly as your doctor tells you to take it. Do not change your dose of VECLADX or stop taking VECLADX unless your doctor tells you to. 

• When you first take VECLADX: o You may need to take VECLADX at the hospital or clinic to monitor for TLS. 

o Your doctor will start VECLADX at a low dose. Your dose will be slowly increased weekly over 5 weeks up to the full dose. Read the Quick Start Guide that comes with VECLADX before your first dose. 

• Follow the instructions about drinking water described in the section of this Medication Guide. 

• Take VECLADX 1 time a day with a meal and water at about the same time each day. 

• Swallow VECLADX tablets whole. Do not chew, crush, or break the tablets. 

• If you miss a dose of VECLADX and it has been less than 8 hours, take your dose as soon as possible. If you miss a dose of VECLADX and it has been more than 8 hours, skip the missed dose and take the next dose at your usual time. 

• If you vomit after taking VECLADX, do not take an extra dose. Take the next dose at your usual time the next day.

【Side Effects】

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your doctor will do tests to check your risk of getting TLS before you start taking VECLADX. You will receive other medicines before starting and during treatment with VECLADX to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your doctor will do blood tests in your first 5 weeks of treatment to check you for TLS during treatment with VECLADX. It is important to keep your appointments for blood tests. Tell your doctor right away if you have any symptoms of TLS during treatment with VECLADX, including: 

• fever 

• chills 

• nausea 

• vomiting 

• confusion 

• shortness of breath 

• seizures 

• irregular heartbeat 

• dark or cloudy urine 

• unusual tiredness 

• muscle or joint pain Drink plenty of water when taking VECLADX to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VECLADX, and each time your dose is increased. Your doctor may delay, decrease your dose, or stop treatment with VECLADX if you have side effects.

• Low white blood cell count (neutropenia). Low white blood cell counts are common with VECLADX, but can also be severe. Your doctor will do blood tests to check your blood counts during treatment with VECLADX. Tell your doctor right away if you have a fever or any signs of an infection while taking VECLADX. The most common side effects of VECLADX include: 

• diarrhea 

• nausea 

• low red blood cell count 

• upper respiratory tract infection

• low platelet count 

• feeling tired VECLADX may cause fertility problems in males. This may affect your ability to father a child. Talk to your doctor if you have concerns about fertility. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VECLADX. For more information, ask your doctor or pharmacist.

【Storage】

• Store VECLADX at or below 86°F (30°C). 

• Keep VECLADX tablets in the original package during the first 4 weeks of treatment. 

Do not transfer the tablets to a pillbox or other container. 

Keep VECLADX and all medicines out of reach of children.