Blinatumomab (blin-a-TOOM-oh-mab)

Treats acute lymphoblastic leukemia (ALL).

Brand Name(s):

Blincyto

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV 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.
• Your doctor may also give you other medicines (including steroid medicine) before starting treatment with this medicine.
• Your doctor may also give you cancer treatment through an IV that is placed into your spinal cord before and during treatment to prevent ALL from coming back.
• 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 if are using cyclosporine or warfarin. Tell your doctor if you are also using other cancer medicines or had a radiation treatment to the brain.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive a live vaccine for at least 2 weeks before the start of treatment, during treatment, and until recovery following the last cycle of this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment with this medicine and for at least 48 hours after your last dose.
• Do not breastfeed during treatment and for at least 48 hours after the last dose.
• Tell your doctor 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, which may be life-threatening
  • Nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS)
  • Serious infections, including sepsis and pneumonia
  • Tumor lysis syndrome
  • Pancreatitis (swelling of the pancreas)
• This medicine may make you dizzy, confused, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
• Chest pain, trouble breathing
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Fever, chills, headache, cough, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Problems with balance, walking, or speaking, confusion
• Rapid weight gain, swelling of the feet or lower legs
• Seizures or tremors
• Sudden and severe stomach pain, nausea, vomiting
• Yellow skin or eyes

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

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

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