Sonrotoclax Brand names: Beqalzi

What is sonrotoclax used for?

From the label: indications and usage

BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) [see Clinical Studies (14.1) ]. […]

Conditions named in the indications of sonrotoclax's FDA labels, with every medicine labeled for each:

• Leukemia, lymphoma and myeloma

What does the patient leaflet for sonrotoclax say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about BEQALZI?

BEQALZI can cause serious side effects, including: 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 can be life-threatening. TLS can happen when you first start treatment with BEQALZI, when your dose is increased, or when you restart BEQALZI after stopping treatment. You will receive other medicines before starting and during treatment with BEQALZI to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check your risk for TLS before you start treatment and during treatment with BEQALZI. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with BEQALZI, including: nausea vomiting diarrhea muscle cramps, weakness, or twitching 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 seizures Drink plenty of water during treatment with BEQALZI to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 1.5 to 2 liters) of water daily: starting 1 to 2 days before your first dose, on the day of your first dose, each time your dose is increased, and if you restart BEQALZI after stopping treatment. 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. […]

From the patient leaflet: What should I avoid while taking BEQALZI?

Avoid drinking grapefruit juice and eating grapefruit products, Seville oranges (often used in marmalades), or star fruit during treatment with BEQALZI. These products may increase the amount of BEQALZI in your blood.

From the patient leaflet: How should I store BEQALZI?

Store BEQALZI at room temperature between 68°F and 77°F (20°C and 25°C). For BEQALZI blister packs, store the tablets in the original blister package. Do not transfer the tablets to a different container. Keep BEQALZI and all medicines out of the reach of children.

Is there a generic for sonrotoclax (Beqalzi)?

No generic sonrotoclax is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Beqalzi tablets: the compound patent runs to April 29, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

What else is labeled for the same conditions as sonrotoclax?

37 other medicines are given the same way (oral) and in the same FDA class as sonrotoclax or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

What next?

Check an interaction

what two or more labels say about each other