Blincyto – Consumer Medicine Information
|Condition:||Acute Lymphoblastic Leukemia|
|Class:||Antineoplastics, Miscellaneous antineoplastics|
|Form:||Intravenous (IV), Powder|
|Ingredients:||blinatumomab, citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dehydrate, sodium hydroxide and water for injection|
Read this Medication Guide before you receive BLINCYTO and before each BLINCYTO infusion. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
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:;
Neurologic problems. Symptoms of neurologic problems may include:
- difficulty in speaking or slurred speech
- loss of consciousness
- confusion and disorientation
- loss of balance
Your healthcare provider will check you 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.
What is BLINCYTO?
BLINCYTO is a prescription medicine used to treat a certain type of acute lymphoblastic leukemia (ALL). Acute lymphoblastic leukemia is a cancer of the blood in which a particular kind of white blood cell is growing out of control. There is limited experience in using BLINCYTO in children.
Who should not receive 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 receiving BLINCYTO?
Before you receive BLINCYTO, tell your healthcare provider about all of your medical conditions, including if you:
- 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.
- 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.
- 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.
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.
How will I receive BLINCYTO?
- BLINCYTO will be given to you by intravenous (IV) infusion into your vein by an infusion pump.
- You will receive BLINCYTO by continuous IV infusion for 4 weeks (28 days), followed by a 2 week break during which you will not be given BLINCYTO. This is one treatment cycle. After the 2 week break, your healthcare provider will decide if you will be given additional treatment cycles of BLINCYTO.
- Your healthcare provider may give you BLINCYTO in a hospital or clinic for the first 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 receiving 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.
What are the possible side effects of BLINCYTO?
See “What is the most important information I should know?” BLINCYTO may cause serious side effects, including:
- Infections. BLINCYTO may cause life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop 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. Tell your healthcare provider right away if you get a fever.
- Abnormal liver blood test. Your healthcare provider will do blood tests before you start BLINCYTO and during treatment with BLINCYTO to check your liver.
The most common side effects of BLINCYTO include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side of effects of BLINCYTO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store BLINCYTO?
Intravenous 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.
General information about 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.
If you would like more information about BLINCYTO, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BLINCYTO that is written for health professionals.
For more information, go to www.blincyto.com or call Amgen at 1-800-772-6436.
What are the ingredients in BLINCYTO?
Active ingredient: blinatumomab
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dehydrate, sodium hydroxide and water for injection.
This Medication Guide has been approved by the U.S. Food and Drug Administration.