Blinatumomab, Injection

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KEY POINTS

• This medicine is given by IV to treat acute lymphoblastic leukemia.
• This medicine may cause serious side effects that can be severe or life-threatening. These include cytokine release syndrome, infusion reactions, and nervous system problems. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• You may get serious infections more easily when receiving this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: CD3 T-cell engager

Generic and brand names: blinatumomab, injection; Blincyto

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat acute lymphoblastic leukemia (ALL).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Nervous system problems such as seizures, trouble speaking, loss of balance, or confusion

Tell your healthcare provider if you have an infection or have infections that keep coming back. Also, tell your healthcare provider if you have recently had a vaccination or are scheduled to receive any kind of vaccination. It is best to have vaccines up to date before you start treatment with this medicine.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start receiving this medicine and each time you have an infusion.

This medicine is given by your healthcare provider. It is given as an IV infusion using an infusion pump. Usually, you will receive this medicine by continuous infusion for 4 weeks, followed by a 2 week break. Your healthcare provider will determine how many treatment cycles you will receive. You may receive this medicine in a hospital or clinic, where you will be monitored closely for side effects.

You must keep the area around the IV catheter clean to reduce your risk of getting an infection. Your provider will show you how to care for your catheter site. Do not change the settings on your infusion pump. Call your healthcare provider right away if you have any problems with your pump or your pump alarm sounds.

What should I watch out for?

This medicine may cause serious side effects that can be severe or life-threatening. These include cytokine release syndrome, infusion reactions, and nervous system problems. Contact your healthcare provider if you have:

• Fever and chills
• Nausea and vomiting
• Tiredness or weakness
• Dizziness
• Face swelling
• Headache
• Wheezing or trouble breathing
• Rash
• Seizures
• Trouble talking or slurred speech
• Fainting
• Severe confusion
• Loss of balance

You may get serious infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause dizziness, confusion, or seizures. Do not drive or operate machinery while you are receiving this medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Yellowing of your skin or eyes; dark urine; severe stomach pain, diarrhea, or vomiting; loss of appetite; fever, cough, or sore throat; breathing problems; severe dizziness or fainting; unusual tiredness or weakness; headache; increased thirst; muscle pain or cramps; unusual bruising or bleeding; irregular heartbeat; chest pain; confusion; new or sudden changes in thinking, walking, talking, or seeing; any skin rash, itching, or skin sores; unexplained swelling of your hands, ankles, or feet; tremors; seizures.

Other: Joint pain, nausea, constipation, diarrhea, mild tiredness, back pain, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Cancer medicines
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), anakinra (Kineret), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade)
• Natalizumab (Tysabri)
• Vaccines
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.