Class: Biological Therapy

Generic Name: blinatumomab

Trade Name: Blincyto®

For which conditions is this drug approved? Blincyto® is approved for treatment of a certain type of acute lymphoblastic leukemia (ALL): Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute ALL.

What is the mechanism of action? Blincyto is a type of drug known as a monoclonal antibody. Monoclonal antibodies target and attach to cancer cells, which tells the immune system to destroy the cancer. Specifically, Blincyto targets a protein called CD19 that’s found on the surface of B-cell leukemia cells. Another protein, CD3, that’s found on the surface of T-cell lymphocytes (part of the immune system), then connects with CD19 to destroy the cancer cells.

How is Blincyto typically given (administered)? Blincyto is given by intravenous (IV) infusion into your vein using an infusion pump. One treatment cycle includes a continuous IV infusion for four weeks, followed by a two-week break during which you will not be given Blincyto. After the two-week break, your healthcare provider will decide if you will be given Blincyto for additional treatment cycles.

How are patients typically monitored? While you’re receiving Blincyto, your doctor will monitor you for signs or symptoms of infection. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver).

What are the common (occur in 20% or more of patients) side effects of treatment with Blincyto?

• Fever
• Headache
• Nausea
• Edema
• Hypokalemia )low levels of potassium)
• Anemia
• Febrile neutropenia (fever plus low white blood cell)
• Abdominal pain
• Thrombocytopenia (low platlets)
• Neutropenia

What are the less common  side effects of treatment with Blincyto?

• Constipation
• Diarrhea
• Vomiting
• Fatigue
• Chills
• Chest pain
• Infusion reaction (cytokine release syndrome)
• Bacterial, fungal, and viral infections
• Low blood levels of magnesium (hypomagnesemia)
• High blood sugar (hyperglycemia)
• Decreased appetite
• Back pain
• Pain in arms and legs
• Bone pain
• Joint pain
• Tremor
• Dizziness
• Insomnia
• Cough
• Difficult or labored respiration (dyspnea)
• Rash
• Low blood pressure

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Before starting treatment with Blincyto, tell your doctor about all of your medical condition. Especially, be sure to tell your doctor if you have:
  • A history of neurological problems, such as seizures, confusion, trouble speaking, or loss of balance
  • An infection
  • A history of an infusion reaction after receiving Blincyto or other medications
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.
• When you’re receiving Blincyto infusions, keep the area around the IV catheter clean to reduce the risk of getting an infection.
• Call your healthcare provider or nurse right away if you have any problems with your infusion pump or your pump alarm sounds.
• Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your pump settings may cause a dose that is too high or too low to be given.

Are there any special precautions patients should be aware of before starting treatment?

• Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving Blincyto. Blincyto can cause neurological symptoms such as dizziness, seizures, and confusion.
• Blincyto may harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Blincyto passes into your breast milk. You and your healthcare provider should decide if you will take Blincyto or breastfeed. You should not do both.

When should patients notify their physician?

• Tell your doctor right away if you have signs of infusion reactions, including:
  • Fever
  • Tiredness or weakness
  • Dizziness
  • Headache
  • Low blood pressure
  • Nausea
  • Vomiting
  • Chills
  • Face swelling
  • Wheezing or trouble breathing
  • Skin rash
• Tell your doctor right away if you have signs of neurologic problems, including:
  • Seizures
  • Difficulty in speaking or slurred speech
  • Loss of consciousness
  • Confusion and disorientation
  • Loss of balance

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 09/16.

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