What is the most important information I should know about blinatumomab?
Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.
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: fever, chills, headache, muscle pain, feeling weak or tired, sudden swelling, skin rash, wheezing, or trouble breathing.
Also tell your caregivers or seek emergency medical attention if you have slurred speech, confusion, loss of balance, or seizure (convulsions). These could be signs of life-threatening nerve problems.
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. 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, blinatumomab produced complete remission in many people. However, further studies are needed to determine if this medicine can lengthen survival time.
Blinatumomab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using blinatumomab?
You should not use blinatumomab if you are allergic to it.
To make sure blinatumomab is safe for you, 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.
It is not known whether blinatumomab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 48 hours after your last dose.
How is blinatumomab given?
A healthcare provider will give you this injection. Blinatumomab is given around the clock (continuous) using an infusion pump. The medicine enters the body through a catheter placed under into a vein.
Your doctor may want you to be in a hospital or clinic setting for several days when you first start using blinatumomab, to quickly treat any serious side effects that occur. 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.
Do not change the settings on your infusion pump without the assistance of a healthcare professional.
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.
You may be given medication to prevent certain side effects while you are receiving blinatumomab.
Blinatumomab is usually given around the clock for 4 weeks, followed by 2 weeks off the medicine. Your doctor will determine how long to treat you with blinatumomab, or if you should receive it for more than one 4-week period.
Be sure to keep the skin clean around your catheter (IV) to reduce the risk of infection.
Blinatumomab can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using blinatumomab?
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), zoster (shingles), and nasal flu (influenza) vaccine. Ask your doctor how soon it is safe for you to receive a vaccine after you stop using blinatumomab.
This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
What are the possible side effects of blinatumomab?
Some side effects may occur during the injection. Tell your caregiver right away if 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 you signs 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 have signs 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
- wheezing.
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 --pale skin, easy bruising, unusual bleeding, purple or red pinpoint spots under your skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
-
signs of tumor cell breakdown --lower back pain, blood in your urine, little or no urination; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.
Common side effects may include:
- nausea, stomach pain;
- swelling in your hands or feet;
- low blood cell counts, low potassium;
- fever; or
- headache.
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.
What other drugs will affect blinatumomab?
Other drugs may interact with 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.
Where can I get more information?
Your doctor or pharmacist can provide more information about blinatumomab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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