Blincyto is used to treat a certain type of acute lymphoblastic leukemia, a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Blincyto is used to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer cells remain in the body (minimal residual disease).

Blincyto is also used to treat adults and children with B-cell precursor ALL that has come back or did not respond to previous treatments.

Blincyto is given after other cancer treatments have been tried without success.

Some side effects may occur during the Blincyto injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.

A serious side effect of Blincyto is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Also tell your caregivers or seek emergency medical attention if you have slurred speech, confusion, loss of balance, or seizure (convulsions). These could be signs of life-threatening nerve problems.

Before taking this medicine

You should not use Blincyto if you are allergic to blinatumomab.

To make sure Blincyto is safe for you, tell your doctor if you have:

• nerve problems (neurologic disorder), such as seizures, confusion, trouble speaking, or problems with balance;

• chemotherapy, or radiation treatment to your brain;

• any type of infection; or

• a reaction to a blinatumomab injection.

Before using Blincyto, tell your doctor if you have recently received a vaccine or if you are scheduled for a booster dose.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Blincyto if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using Blincyto and for at least 48 hours after your last dose.

You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

Blincyto is given around the clock (continuous) using an infusion pump. A healthcare provider will give you this injection. The medicine enters the body through a catheter placed into a vein.

You may receive your first dose of Blincyto in a hospital or clinic setting to quickly treat any serious side effects. You may also need to be in a hospital if you start using the medicine again after not using it for a short time.

Your injections will be prepared at the pharmacy and you will receive the medicine in IV bags. Keep the IV bags in their original package and do not open the package. Store it in the refrigerator, protected from light. Do not freeze. Each IV bag will be unpackaged and prepared by a healthcare provider.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Blincyto if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Blincyto is usually given around the clock. Your doctor will determine how often you need to use this medicine, and for how long.

Do not change the settings on your infusion pump without the assistance of a healthcare professional.

You may be given medication to prevent certain side effects while you are receiving Blincyto.

When it is time to change IV bags, call your doctor or pharmacist if you do not have a new IV bag ready to attach to the infusion pump.

Be sure to keep the skin clean around your catheter (IV) to reduce the risk of infection.

Blincyto can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

You should not use Blincyto if you are allergic to blinatumomab.

To make sure Blincyto is safe for you, tell your doctor if you have:

• nerve problems (neurologic disorder), such as seizures, confusion, trouble speaking, or problems with balance;

• chemotherapy, or radiation treatment to your brain;

• any type of infection; or

• a reaction to a blinatumomab injection.

Before using Blincyto, tell your doctor if you have recently received a vaccine or if you are scheduled for a booster dose.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Blincyto if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using Blincyto and for at least 48 hours after your last dose.

You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

Since dosing and infusion pump programming is administered by a healthcare professional, you are not likely to miss a dose.

Call your pharmacist for new medicine if you do not receive your IV bags on time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fever, tremors, and headache.

Do not receive a "live" vaccine while using Blincyto, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Ask your doctor how soon it is safe for you to receive a vaccine after you stop using this medicine.

Avoid driving or hazardous activity until you know how Blincyto will affect you. Your reactions could be impaired.

Some side effects may occur during the injection. Tell your caregiver right away if you feel weak, nauseated, light-headed, tired, chilled or feverish, or you have a headache, muscle pain, skin rash, wheezing, trouble breathing, or swelling in your face.

Get emergency medical help if you signs of an allergic reaction to Blincyto: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems, such as:

• slurred speech, confusion;

• problems with balance;

• a seizure (convulsions); or

• loss of consciousness.

A serious side effect of blinatumomab is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.

Call your doctor at once if you have:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common Blincyto side effects may include:

• reactions during the injection;

• low blood cell counts;

• fever, infections; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.