Consumer Information for: BESPONSA

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BESPONSA. Talk about any health conditions or problems you may have, including if you:

• have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease (VOD), a condition in which the blood vessels in the liver become damaged and obstructed by blood clots. VOD may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes. This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant. A stem cell transplant is a procedure to transplant another person’s stem cells (cells which develop into new blood cells) into your bloodstream. This procedure may take place if your disease responds completely to treatment.
• have signs or symptoms of a low number of blood cells known as neutrophils (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or a low number of blood cells known as platelets; these signs and symptoms include developing an infection or fever or bruising easily or getting frequent nose bleeds.
• have signs and symptoms of an infusion-related reaction, such as fever and chills during or shortly after the BESPONSA infusion.
• have signs and symptoms of a syndrome known as tumor lysis syndrome, which may be associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps), during or shortly after the BESPONSA infusion.
• have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels.
• have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.

Other warnings you should know about:

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
• You must avoid becoming pregnant or fathering a child. Women must use effective contraception during treatment and at least 8 months after the last dose of treatment. Men must use effective contraception during treatment and at least 5 months after the last dose of treatment. Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.
• Seek advice regarding fertility preservation before treatment.
• If you need treatment with BESPONSA, you must stop breastfeeding during treatment and for at least 2 months after treatment. Talk to your doctor.

Driving and using machines

• If you feel unusually tired (this is a very common side effect of BESPONSA), take special care when driving or using machines.

Vaccinations

• You should not receive a live vaccine within 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of cells called B-lymphocytes following your last dose of BESPONSA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.