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IMPORTANT SAFETY INFORMATION

BEQALZI can cause serious side effects, including:

  1. Tumor Lysis Syndrome (TLS)
    1. TLS has occurred in patients treated with BEQALZI. TLS is caused by the fast breakdown of cancer cells, which can cause kidney failure, the need for dialysis treatment, and can be life-threatening. TLS can happen when you first start treatment, with dose increases, or if treatment is restarted.
    2. Before starting BEQALZI, your healthcare provider will assess your risk for TLS. You will receive other medicines and be advised to drink plenty of fluids during your treatment course. Some patients may need hospitalization for IV fluids and closer monitoring. Blood tests will be done before and during treatment. Keep all scheduled appointments.
    3. Tell your healthcare provider right away if you develop symptoms such as nausea; vomiting; diarrhea; muscle cramps, weakness, or twitches; fatigue; decreased urination; swelling in your legs, ankles, or feet; numbness or tingling, especially around your mouth or in your hands and feet; confusion or difficulty staying alert; irregular or fast heart rate; or seizures.
    4. Drink 6 to 8 glasses (about 1.5 to 2 liters or 51-68 ounces) of water each day starting 1 to 2 days before your first dose, on the day of your first dose, during dose increases, and if treatment is restarted.

  2. Serious infections. BEQALZI can cause death or serious infections. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop a fever or any signs of an infection.

  3. Decreased white blood cell count (neutropenia), which can be serious or severe and increase the risk of infection. Your healthcare provider will check your blood counts during treatment and may decrease your dose, temporarily stop, or completely stop treatment if you get certain side effects.

Do not take BEQALZI with certain medicines called strong CYP3A inhibitors when starting treatment and while your dose is being increased because this may increase the risk of TLS. Other medicines, including moderate CYP3A inhibitors, may require dose changes. Tell your healthcare provider about all the medicines you take, and do not start new medicines during treatment without talking to your healthcare provider. Avoid grapefruit products, Seville oranges (often used in marmalades), and star fruit. These can increase the amount of BEQALZI in your blood.

Before taking BEQALZI, tell your healthcare provider about all of your medical conditions, including if you have kidney problems, problems with body salts or electrolytes (such as potassium, phosphorus, or calcium), or a history of high uric acid or gout. Also tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed. BEQALZI may affect male and female fertility. If you receive BEQALZI while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment and you should use effective birth control (contraception) during treatment and for 1 week after the last dose. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment and for 1 week after your last dose. Do not breastfeed during treatment and for 1 week after the last dose. If you are a male with a female partner who can become pregnant, use effective birth control (contraception) during treatment and for 1 week after the last dose.

The most common side effects of BEQALZI include pneumonia and tiredness. The most common abnormal blood tests with BEQALZI are decreased white blood cell counts.

If you have side effects, your healthcare provider may tell you to stop taking BEQALZI for a period of time. Do not restart BEQALZI on your own. Call your healthcare provider before you start taking BEQALZI again.

These are not all the possible side effects of BEQALZI. Call your healthcare provider for medical advice about side effects. You may report side effects to BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see Medication Guide.

What is BEQALZI?

BEQALZI™ (sonrotoclax) is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) that has come back or did not respond to previous treatment, and who have already received 2 treatments for their cancer, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was approved based on patient response data. Studies are ongoing to confirm the clinical benefit of BEQALZI. It is not known if BEQALZI is safe and effective in children.