What is Blincyto?
Blincyto is a prescription medicine used to treat adults and children with:
- B-cell precursor acute lymphoblastic leukemia (ALL) in remission with molecular evidence of leukemia
- B-cell precursor ALL that has come back or did not respond to previous treatments
ALL is a cancer of the blood in which a particular kind of white blood cell is growing out of control.
What is the most important information I should know about Blincyto?
Call your healthcare provider or get emergency medical help right away if you get any of the symptoms listed below.
Blincyto may cause serious side effects that can be severe, life-threatening, or lead to death, including:
- Cytokine Release Syndrome (CRS) and Infusion Reactions. Symptoms of CRS and infusion reactions may include:
- tiredness or weakness
- face swelling
- wheezing or trouble breathing
- low blood pressure
- skin rash
- Neurologic problems. Symptoms of neurologic problems may include:
- loss of balance
- difficulty in speaking or slurred speech
- loss of consciousness
- difficulty with facial movements, hearing, vision, or swallowing
- trouble sleeping
- confusion and disorientation
Your healthcare provider will check for these problems during treatment with Blincyto. Your healthcare provider may temporarily stop or completely stop your treatment with Blincyto, if you have severe side effects.
See “What are the possible side effects of Blincyto?” below for other side effects of Blincyto.
Who should not use Blincyto?
Do not receive Blincyto if you are allergic to blinatumomab or to any of the ingredients of Blincyto. See the end of this Medication Guide for a complete list of ingredients in Blincyto.
What should I tell my healthcare provider before using Blincyto?
Before receiving Blincyto, tell your healthcare provider about all of your medical conditions, including if you or your child:
- have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
- have an infection
- have ever had an infusion reaction after receiving Blincyto or other medications
- have a history of radiation treatment to the brain, or chemotherapy treatment
- are scheduled to receive a vaccine. You should not receive a “live vaccine” within 2 weeks before you start treatment with Blincyto, during treatment, and until your immune system recovers after you receive your last cycle of Blincyto. If you are not sure about the type of vaccine, ask your healthcare provider.
- are pregnant or plan to become pregnant. Blincyto may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Blincyto.
- If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Blincyto.
- Females who are able to become pregnant should use an effective form of birth control during treatment with Blincyto, and for at least 48 hours after the last dose of Blincyto.
- are breastfeeding or plan to breastfeed. It is not known if Blincyto passes into your breast milk. You should not breastfeed during treatment with Blincyto and for at least 48 hours after your last treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Blincyto?
- Blincyto will be given to you by intravenous (IV) infusion into your vein by an infusion pump.
- Your healthcare provider will decide the number of treatment cycles of Blincyto.
- You will receive Blincyto by continuous IV infusion for 4 weeks (28 days), followed by a 2 week (14 days) break during which you will not receive Blincyto. This is 1 treatment cycle (42 days).
- Your healthcare provider may prescribe continued therapy.
- You will receive Blincyto by continuous IV infusion for 4 weeks (28 days), followed by an 8 week (56 days) break during which you will not receive Blincyto. This is 1 treatment cycle (84 days).
- Your healthcare provider may give you Blincyto in a hospital or clinic for the first 3 to 9 days of the first treatment cycle and for the first 2 days of the second cycle to check you for side effects. If you receive additional treatment cycles of Blincyto or if your treatment is stopped for a period of time and restarted, you may also be treated in a hospital or clinic.
- Your healthcare provider may change your dose of Blincyto, delay, or completely stop treatment with Blincyto if you have certain side effects.
- Your healthcare provider will do blood tests during treatment with Blincyto to check you for side effects.
- Before you receive Blincyto, you will be given a corticosteroid medicine to help reduce infusion reactions.
- It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.
- 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 infusion pump settings may cause a dose that is too high or too low to be given.
Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
What should I avoid while taking Blincyto?
Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving Blincyto because Blincyto can cause neurological symptoms, such as dizziness, seizures, and confusion.
Blincyto may cause serious side effects, including:
See “What is the most important information I should know about Blincyto?”
- Infections. Blincyto may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.
- Low white blood cell counts (neutropenia). Neutropenia is common with Blincyto treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell count during treatment with Blincyto. Tell your healthcare provider right away if you get a fever.
- Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start Blincyto and during treatment with Blincyto.
- Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with Blincyto and corticosteroids. It may be severe and lead to death. Tell your healthcare provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.
The most common side effects of Blincyto include:
- low platelet count (thrombocytopenia)
- reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
- low red blood cell count (anemia)
These are not all the possible side effects of Blincyto.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Blincyto
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Blincyto for a condition for which it was not prescribed. Do not give Blincyto to other people even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Blincyto that is written for health professionals.
How should I store Blincyto?
Intravenous (IV) bags containing Blincyto for infusion will arrive in a special package.
- Do not open the package.
- Do not freeze the package.
- The package containing Blincyto will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C) for up to 8 days.
- Do not throw away (dispose of) any Blincyto in your household trash. Talk with your healthcare provider about disposal of Blincyto and used supplies.
Keep Blincyto and all medicines out of reach of children.
What are the ingredients in Blincyto?
Active ingredient: blinatumomab
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide and preservative-free sterile water for injection.
For more information, go to www.blincyto.com or call Amgen at 1-800-772-6436.