BLINCYTO contains the active ingredient blinatumomab, which is a bispecific CD19-directed CD3 T-cell engager. It is supplied as a sterile, preservative-free, white to off-white lyophilized powder for injection, with each vial containing 35 mcg of blinatumomab. The drug is intended for intravenous use after reconstitution. Key inactive ingredients include citric acid monohydrate, lysine hydrochloride, and trehalose dihydrate.

How should I use this medication?

This medication is injected into a vein. It is usually given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

Keep out of the reach of children and pets.

This medication is usually given in a hospital or clinic. In rare cases, this medication may be given at home. If you are using this medication at home, you will be instructed on how to store this medication.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Headache
• Swelling of the ankles, hands, or feet
• Tremors or shaking

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• History of radiation therapy to the brain
• Infection
• Liver disease
• Nervous system problems, such as seizures, confusion, trouble speaking, loss of balance
• Scheduled to receive a vaccine
• An unusual or allergic reaction to blinatumomab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines

This medication may also interact with the following:

• Cyclosporine
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

You may need blood work while taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 48 hours after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 48 hours after the last dose. Talk to your care team about effective forms of contraception.

Do not breast-feed while taking this medication and for 48 hours after the last dose

What are the most serious risks of this medication?

This medication can cause a serious side effect called cytokine release syndrome. Your care team will monitor you closely. Tell your care team right away if you feel faint or lightheaded or have fever, fatigue, loss of appetite, nausea, headache, shortness of breath, or a fast or irregular heartbeat.

This medication may affect the brain and nervous system. Talk to your care team right away if you have confusion, dizziness, tremors, trouble speaking, weakness, or pain, tingling, or numbness in the hands or feet. Some side effects can be severe. Call emergency services if you have seizures or trouble staying awake.