Blincyto

(blin-a-TOOM-oh-mab)

Trade Name: Blincyto ^®

Blincyto ^® is the trade name for the generic drug Blinatumomab In some cases, health care professionals may use the generic name blinatumomab when referring to the trade drug name Blincyto^®.

Drug Type:

Blincyto ^® is a monoclonal antibody. A bispecific T-cell engager” (BiTE) antibody (for more detail, see "How this drug works" section below).

What Blincyto^® Is Used For:

Blincyto ^® is used in the treatment of acute lymphoblastic leukemia (ALL)

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful. This is called “off-label use”.

How Blincyto^® Is Given:

• Blincyto ^® is given as an intravenous injection through a vein (IV) as a continuous infusion over 28 days.

• Hospitalization is recommended for the first 9 days of cycle 1, and the first 2 days of the second cycle. For all future cycle starts and re-starting (if treatment is interrupted for more than 4 hours) supervision by a healthcare professional or hospitalization is recommended.

The amount of Blincyto^® that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects:

Important things to remember about the side effects of Blincyto^®:

• Most people will not experience all of the Blincyto^® side effects listed.
• Blincyto ^® side effects are often predictable in terms of their onset, duration, and severity.
• Blincyto ^® side effects are almost always reversible and will go away after therapy is complete.
• There is no relationship between the presence or severity of Blincyto^® side effects and the effectiveness of the medication.
• Blincyto ^® side effects may be manageable. There may be options to minimize or prevent them.

The following Blincyto ^® side effects are common (occurring in greater than 30%) for patients taking Blincyto ^®:

• Fever
• Neurotoxicity : In studies, some patients experienced serious neurologic complications, which can occur at any time, even a week or more into the infusion. These included seizures, confusion, disorientation, difficulty speaking or slurred speech, loss of balance of loss of consciousness. Notify your care team right away if you develop any neurologic changes.

• Headache
• Infection

These are less common side effects (occurring in about 10-29%) of patients receiving Blincyto ^® :

• Low white blood cells
• Nausea

• Swelling
• Low potassium
• Rash
• Diarrhea
• Constipation
• Tremor
• Cough
• Anemia
• Fatigue
• Chills
• Shortness of breath
• Insomnia (sleep problems)
• Abdominal pain
• Dizziness
• Back pain
• Vomiting
• Increased liver enzymes
• Low magnesium
• Bone pain
• High blood sugar
• Low platelet count (thrombocytopenia)
• Weight gain
• Chest pain
• Low blood pressure (hypotension)
• Decreased appetite

An uncommon but serious side effect of Blincyto^® is the occurrence of cytokine release syndrome. This can happen when the T-cells (part of the body’s immune system) are activated by the medication when it is first given - causing them to release substances called cytokines. Cytokines are the same substances released by immune cells that make people feel ill when they have an infection or the flu. This reaction, if left untreated can be very dangerous. You will be monitored closely for this syndrome. If you experience difficulty breathing or swallowing, wheezing, flushing, hives or rash, fever, headache, nausea, lightheadedness, shaking or chills, inform your nurse immediately. The infusion may be slowed, or stopped temporarily,

This list includes common and less common side effects for those taking Blincyto ^® . Blincyto ^® side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When To Contact Your Doctor or Health Care Provider:

Contact your health care provider immediately and go to the emergency room, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38°C or higher, chills)
• Seizures, confusion, disorientation, difficulty speaking or slurred speech, loss of balance or loss of consciousness.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Signs of infection (sweats, cough, flu-like symptoms, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body)
• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness (particularly with standing).
• Dark, tea-colored urine.
• Upper abdominal pain.
• Yellowing of your skins or the whites of your eyes.
• Black or tarry stools, or blood in your stools.
• Blood in the urine.
• Pain or burning with urination.
• Extreme fatigue (unable to carry on self-care activities).
• Diarrhea (4-6 episodes in a 24-hour period).
• Unusual bleeding or bruising.

Always inform your health care provider if you experience any unusual symptoms.

Blincyto^® Precautions:

• Before starting Blincyto^® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Blincyto^®.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting Blincyto^®. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while takingBlincyto^®. Use effective contraception while taking Blincyto^® and for at least 1 month after the last dose of Blincyto^®. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Blincyto^®.
• Avoid driving, or operating heavy or dangerous machinery during treatment.

Blincyto^® Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Avoid sun exposure. Wear SPF 30 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
• For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
• Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.

Monitoring and Testing While Taking Blincyto ^®:

You will be checked regularly by your doctor while you are taking Blincyto^®, to monitor side effects and check your response to therapy. 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) will also be ordered by your doctor.

How Blincyto^® Works:

Blincyto ^® is classified as a monoclonal antibody. Monoclonal antibodies are a type of "targeted" cancer therapy.

Antibodies are an integral part of the body's immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually given only for cancers in which antigens (and the respective antibodies) have been identified already.

Blincyto ^® is a type of monoclonal antibody called a “bispecific T-cell engager” (BiTE) antibody. It works by directing the body’s T-cells (part of the immune system) to target and bind with the CD19 protein on the surface of B-cell leukemia or lymphoma cells.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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