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blinatumomab

Generic Name: blinatumomab (BLIN a TOOM oh mab)
Brand Name: Blincyto

What is blinatumomab?

Blinatumomab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Blinatumomab is used to treat a type of blood cancer called Philadelphia chromosome-negative B-precursor acute lymphoblastic leukemia (ALL). 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 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: high fever, nausea, sudden swelling or redness, or extreme tiredness.

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 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:

  • a history of nerve problems (neurologic disorder), such as unexplained confusion, trouble speaking, or problems with balance;

  • any type of infection; or

  • if you have ever had a reaction while receiving a blinatumomab injection.

It is not known whether blinatumomab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

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.

How is blinatumomab given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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.

Blinatumomab is given around the clock (continuous) using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. A healthcare provider will show you how to use an infusion pump and inject your medicine. Do not give yourself an injection if you do not understand these instructions. Call your doctor, nurse, or pharmacist for help.

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.

You may be given medication to prevent certain side effects while you are receiving blinatumomab.

Your injections will be prepared at the pharmacy and you will receive the medicine in IV bags. Store these bags in the refrigerator, protected from light. Do not freeze. If you need to transport the medicine, place it in a cooler with ice packs.

The blinatumomab mixture does not contain a preservative. You must use a prepared IV bag within 8 days of when it was mixed at the pharmacy.

If an IV bag reaches room temperature, you must use it within 48 hours after it was mixed.

Each IV bag is injected slowly (over 24 hours or 48 hours). How long it takes to empty the bag will depend on the "infusion rate" determined by your doctor. Carefully follow the dosing instructions on your IV bag label. 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.

Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

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.

You will also need frequent blood tests to check your liver function.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

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?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Blinatumomab side effects

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or you have a headache, skin rash, trouble breathing, or swelling in your face.

Get emergency medical help if you have any of these 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;

  • loss of balance; or

  • seizure (convulsions).

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, nausea;

  • extreme tiredness; or

  • sudden swelling or redness.

While you are using blinatumomab at home, call your doctor at once if you have:

  • stabbing chest pain, wheezing, feeling short of breath;

  • cough with yellow or green mucus;

  • jaundice (yellowing of the skin or eyes);

  • low white blood cell counts--fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; 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, constipation;

  • swelling in your hands or feet;

  • fever;

  • tremors or shaking;

  • rash; 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.

See also: Side effects (in more detail)

Blinatumomab dosing information

Usual Adult Dose for Acute Lymphoblastic Leukemia:

A SINGLE CYCLE OF TREATMENT CONSISTS OF 4 WEEKS OF CONTINUOUS IV INFUSION FOLLOWED BY A 2 WEEK TREATMENT FREE INTERVAL:
For patients at least 45 kg in weight:
-Cycle 1:
9 mcg/day IV via continuous infusion on Days 1 through 7 and 28 mcg/day IV via continuous infusion on Days 8 through 28
-Subsequent cycles:
28 mcg/day IV via continuous infusion on Days 1 through 28

PREMEDICATION:
-The patient should be premedicated with dexamethasone 20 mg IV 1 hour prior to the first dose of each cycle, prior to a step dose (such as Cycle 1 day 8), or when restarting an infusion after an interruption of 4 or more hours.

Comments:
-Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended.
-The infusion line should not be flushed especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
-This drug should be administered as a continuous IV infusion at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm.
-The infusion line should not be flushed especially when changing infusion bags. Flushing when changing bags or at completion of infusion can result in excess dosage and complications thereof.
-The infusion bags should be infused over 24 or 48 hours.

Uses: For the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

What other drugs will affect blinatumomab?

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02. Revision Date: 2015-01-07, 9:59:19 PM.

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