When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to blinatumomab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how blinatumomab works. Tell your doctor the name of every medicine you take, especially if you take the following:
  
  • Cyclosporine
  • Warfarin

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, any type of infection, or a history of seizures.
• This medicine may cause the following problems, some of which could be serious or life-threatening:
  
  • Cytokine release syndrome or infusion reaction
  • Neurological problems
  • Infections including sepsis and pneumonia
  • Tumor lysis syndrome
• This medicine may make you dizzy, confused, or less alert than you are normally. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Fever, chills, headache, nausea, cough, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Problems with balance, walking, or speaking, confusion
• Rapid weight gain, swelling of the feet or lower legs
• Seizures or tremors
• Trouble breathing or chest pain
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, abdominal pain
• Headache, trouble sleeping
• Joint pain or swelling, pain in your back, legs, or bones
• Rash

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088