Blincyto

Generic name: Blinatumomab
Drug class: CD19 monoclonal antibodies

Usage of Blincyto

Blincyto is used to treat a certain type of acute lymphoblastic leukemia, a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Blincyto is used to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in remission when only a small number of cancer cells remain in the body (minimal residual disease).

Blincyto is also used to treat adults and children with B-cell precursor ALL that has come back or did not respond to previous treatments.

Blincyto is given after other cancer treatments have been tried without success.

Blincyto side effects

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 to Blincyto: 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 (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.

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 Blincyto side effects may include:

reactions during the injection;

low blood cell counts;

fever, infections; 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.

Before taking Blincyto

You should not use Blincyto if you are allergic to blinatumomab.

To make sure Blincyto is safe for you, tell your doctor if you have:

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 Blincyto, 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 Blincyto 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 Blincyto and for at least 48 hours after your last dose.

You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

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How to use Blincyto

Blincyto is given around the clock (continuous) using an infusion pump. A healthcare provider will give you this injection. The medicine enters the body through a catheter placed into a vein.

You may receive your first dose of Blincyto 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 Blincyto if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Blincyto 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 Blincyto.

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.

Blincyto 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.

Warnings

Some side effects may occur during the Blincyto 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 Blincyto is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

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 other drugs will affect Blincyto

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.

Popular FAQ

You can find the Blincyto FDA package insert by calling Amgen, the manufacturer, at 1 800-772-6436 (800-77-AMGEN) or by searching on the Amgen website under prescribing information. You can also locate the Blincyto label on the Drugs@FDA website or under the FDA Professional Drug Information section on Drugs.com.

Blincyto is a type of immunotherapy called a bispecific monoclonal antibody. This means that it binds to two different molecules at the same time – a protein called CD19 which exists on the surface of B-cell leukemia or lymphoma cells and a protein called CD3 which is expressed on T cells (a specific type of immune system cell). Blincyto may also be called a targeted treatment.

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

The cost of a Blincyto (blinatumomab) vial is about $5,169 per 35 microgram (mcg) single-dose vial. This price will vary based upon your length of treatment, insurance, and other fees. When Blincyto was first approved by the FDA, Amgen announced that the price for the drug was $178,000 per year. Continue reading

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