Breyanzi

People who receive Breyanzi (lisocabtagene maraleucel) commonly experience an immune reaction called cytokine release syndrome (CRS). The most common symptoms include fever, low blood pressure, fast heartbeat, chills, and headache. Sometimes, CRS can cause serious problems such as heart rhythm changes, heart attack, and serious lung problems. Because CRS typically develops within a week after the Breyanzi (lisocabtagene maraleucel) infusion, your oncologist will monitor you daily for CRS symptoms the week after your infusion. After this time, you’ll need to stay close to the treatment center for at least 4 weeks. This way, if you have CRS symptoms, you can get medical help right away. If you develop CRS, typically you’ll need to stay in the hospital and be treated with corticosteroids and a medication called Actemra (tocilizumab). Because CRS can be life-threatening, get medical help right away if you experience any CRS symptoms, even if it has been many weeks after your infusion.

Breyanzi (lisocabtagene maraleucel) can also trigger another serious hypersensitivity reaction called immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS). People have reported this reaction 1-3 weeks after the Breyanzi (lisocabtagene maraleucel) infusion. IEC-SH tends to occur in people who've already been treated for CRS. Your healthcare team will also monitor you for IEC-SH in the weeks after your infusion.

Some people taking Breyanzi (lisocabtagene maraleucel) have developed nervous system problems. The more common symptoms include headache, trouble with speech, and tremor. Potentially life-threatening symptoms include seizures and swelling in the brain. Nervous system problems typically develop around 8 days after the Breyanzi (lisocabtagene maraleucel) infusion. Your oncology team will monitor you for symptoms for at least 4 weeks after your treatment. If you have symptoms of nervous system problems, seek medical help right away.

Because Breyanzi (lisocabtagene maraleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems, it’s only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your oncology team to complete special training to prescribe Breyanzi (lisocabtagene maraleucel). Additionally, the hospital or treatment center where you receive treatment must keep certain medications used to manage side effects, such as Actemra (tocilizumab), available in case you need it.

Though not common, some people who received Breyanzi (lisocabtagene maraleucel) in clinical trials have developed new cancers, including blood cancers such as myelodysplastic syndrome (MDS). Some of these cancers appeared over a year after their Breyanzi (lisocabtagene maraleucel) infusions. Your oncology team will monitor you for new cancers regularly after Breyanzi (lisocabtagene maraleucel) treatment. Ask your care team if you’re concerned about the risk of cancers from Breyanzi (lisocabtagene maraleucel).

Breyanzi (lisocabtagene maraleucel) treatment, including the lymphodepleting chemotherapy before T-cell infusion, can lower blood cell counts in your body. This might last longer than a month after the Breyanzi (lisocabtagene maraleucel) infusion. Having lower blood cell counts puts you at higher risk for infections, bleeding, and anemia.

Your oncology team will closely monitor your blood cell counts before and after Breyanzi (lisocabtagene maraleucel) treatment. Make sure you go to all lab appointments so that they can keep a close eye on your blood cell counts.

People who received Breyanzi (lisocabtagene maraleucel) have developed serious and life-threatening infections, including bacterial, viral, and fungal infections. Breyanzi (lisocabtagene maraleucel) can cause your white blood cell (WBC) levels to drop, which can raise your risk for getting sick. People who had hepatitis B in the past might have a new infection (hepatitis B reactivation) after starting Breyanzi (lisocabtagene maraleucel). Your oncology team will monitor your WBC levels with lab tests, and they might prescribe medications, such as antibiotics or antivirals, to help protect you from serious infections.

You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your healthcare team right away if you have any signs or symptoms of infection such as fever, body aches, and chills.

It’s possible for you to have an allergic reaction to Breyanzi (lisocabtagene maraleucel), including anaphylaxis. Allergic reactions may be due to dimethyl sulfoxide (DMSO), a preservative in the cell product. Let your nurse or oncologist know right away if you have symptoms of an allergic reaction during or immediately after your infusion, such as itching, trouble breathing, rash, swelling, or fast heartbeat.

Some people taking Breyanzi (lisocabtagene maraleucel) experienced low immunoglobulin levels. Immunoglobulins are proteins that are an important part of your immune system, and help fight infection. When your immunoglobulins are low, this raises your risk for getting sick.

Your oncology team will monitor your immunoglobulin levels. If they’re too low, you might need to take a medication called intravenous immunoglobulin (IVIG) to replace immunoglobulins in your body.

Breyanzi (lisocabtagene maraleucel) treatment might cause nervous system changes that can include tiredness, confusion, and seizures. Don’t drive or participate in activities that would be dangerous if you couldn’t focus for 2 months after treatment. Talk with your oncology team and caregivers so that you have a plan in place to help you with transportation to appointments, chores at home, and emotional support, before you start Breyanzi (lisocabtagene maraleucel).