Blinatumomab in Acute Lymphoblastic Leukemia
What Is Blinatumomab?
Blinatumomab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Blinatumomab is used to treat a certain type of acute lymphoblastic leukemia in adults and children. This medicine is given after other cancer treatments have been tried without success.
Blinatumomab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.
Blinatumomab may also be used for purposes not listed in this medication guide.
Some side effects may occur during the injection.Tell your caregiver right awayif you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.
Tell your caregivers right away if you have signs of a condition called cytokine release syndrome: fever, chills, headache, muscle pain, feeling weak or tired, sudden swelling, skin rash, wheezing, or trouble breathing.
Alsotell your caregivers or seek emergency medical attention ifyou have slurred speech, confusion, loss of balance, or seizure (convulsions). These could be signs of life-threatening nerve problems.
You should not use blinatumomab if you are allergic to it.
Tell your doctor if you have ever had:
- 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 blinatumomab, 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 blinatumomab 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 this medicine and for at least 48 hours after your last dose.
You should not breast-feed while using this medicine and for at least 48 hours after your last dose.
Blinatumomab Side Effects
Some side effects may occur during the injection.Tell your caregiver right awayif 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 yousigns of an allergic reaction:hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Also tell your caregivers or seek emergency medical attention if you havesigns 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. Tell your caregivers right away if you have signs of this condition, which may include:
- high fever, chills, extreme tiredness;
- nausea, vomiting;
- sudden rash;
- a light-headed feeling, like you might pass out; or
While you are using blinatumomab at home, 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 side effects may include:
- swelling in your hands or feet;
- changes in blood pressure;
- low blood cell counts;
- fever, infections; or
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.
Do not receive a "live" vaccine while using blinatumomab,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 blinatumomab.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Other drugs may affect 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.
A healthcare provider will give you this injection. Blinatumomab is givenaround the clock(continuous) using an infusion pump. The medicine enters the body through a catheter placed under into a vein.
You may receive your first dose 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 blinatumomab if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Blinatumomab 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 blinatumomab.
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.
Blinatumomab 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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Since blinatumomab is given around the clock, it does not have a daily dosing schedule.
Call your pharmacist for new medicine if you do not receive your IV bags on time.
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