Blincyto Kit

GENERIC NAME(S): Blinatumomab

OTHER NAME(S): Blincyto Solution, Reconstituted (Recon Soln)

WARNINGS:

Blinatumomab may cause certain serious (sometimes fatal) side effects, including cytokine release syndrome-CRS and infusion reactions. Symptoms may include fever, chills, headache, nausea, vomiting, stomach/abdominal pain, trouble breathing, skin rash, weakness, or low blood pressure. Blinatumomab can also cause serious brain, spinal cord, and nerve disorders with symptoms such as headache, trouble sleeping, seizures, confusion, loss of consciousness, or speech and balance problems. Tell your doctor right away if you develop any of these symptoms.

You may be given this medication in a hospital or clinic so your doctor can watch for these serious side effects and provide treatment if needed. If you have side effects, your doctor may temporarily stop or slow down your treatment with this medication. Also, your doctor may prescribe other medications before you receive blinatumomab to decrease the risk of side effects.

Who should not take Blincyto Kit?

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Uses

Uses

This medication is used to treat a certain type of cancer (acute lymphocytic leukemia-ALL). Blinatumomab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.

How to use Blincyto Kit

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start using blinatumomab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

The dosage and treatment schedule are based on your medical condition, weight, and response to treatment. To reduce your risk of side effects, your doctor may prescribe other medications (such as dexamethasone) before each treatment to help reduce side effects. Also, your doctor may start this medication at a low dose and gradually increase your dose.

This medication is given by slow injection (infusion) into a vein as directed by your doctor. A special machine (infusion pump) is used for giving the injection, usually over 4 weeks (28 days), followed by a break (usually 2 weeks) during which you will not be given blinatumomab. After the break, your doctor will decide if you will be given another treatment cycle with this medication. In later treatment cycles, your breaks may be longer (8 weeks). Do not change the settings on the infusion pump since you might get the wrong dose. Ask your health care professional right away if you have any questions about the infusion pump.

Side Effects

Side Effects

See also Warning section.

Nausea, heartburn, constipation, shaking (tremor), swelling ankles/feet/hands, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Blinatumomab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using blinatumomab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, brain/nerve disorders, current or returning infections, seizures.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Blinatumomab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using blinatumomab. Blinatumomab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 2 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as complete blood count, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

Storage

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.