Axicabtagene Ciloleucel Suspension

GENERIC NAME(S): Axicabtagene Ciloleucel

WARNINGS:

This medication may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms of CRS such as high fever, difficulty breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness.

Serious nerve problems can occur after treatment with axicabtagene ciloleucel. Tell your doctor right away if you have trouble speaking and understanding, loss of balance, or mental/mood changes such as anxiety, confusion, memory loss.

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Yescarta REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Who should not take Axicabtagene Ciloleucel Suspension?

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Uses

Uses

Axicabtagene ciloleucel is used to treat a certain type of cancer (non-Hodgkin lymphoma) that has not gotten better or that has come back after at least 2 other kinds of treatment. This type of treatment is known as gene therapy. Axicabtagene ciloleucel is made from your own white blood cells and is given only to you. The white blood cells have been changed to have a specific protein (chimeric antigen receptor-CAR) that helps your body slow or stop the growth of certain cancer cells.

How to use Axicabtagene Ciloleucel Suspension

Read the Medication Guide provided by your healthcare professional before you start using this product. If you have any questions, ask your healthcare professionals.

Your doctor may give you 3 days of chemotherapy before treatment with this product to prepare your body.

This product is given by slow injection into a vein as directed by your doctor, usually over less than 30 minutes. To decrease the risk of side effects, your doctor may also give you other medications (such as acetaminophen, diphenhydramine) before injecting axicabtagene ciloleucel. The dosage is based on your medical condition and weight. You should plan to stay for at least 4 weeks near the place of your treatment (for example, within 2 hours' drive). Your doctor will check to see if your treatment is working and help you manage any side effects.

Side Effects

Side Effects

See also Warning section.

Headache, tiredness, or loss of appetite may occur. If any of these effects last or get worse, 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.

Although axicabtagene ciloleucel is used to treat cancer, it may rarely increase your risk of developing other cancers. Also, this product may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection and any infection you have may get worse. Tell your doctor right away if you develop unusual growths or lumps, swollen glands, signs of infection (such as a sore throat that doesn't go away, fever, chills), easy or unusual bruising/bleeding, or unusual tiredness.

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 receiving axicabtagene ciloleucel, 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: past/current/recent infection (including hepatitis, HIV).

This product can make you more likely to get infections or may worsen any current infections. 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.

This drug may make you dizzy, affect your coordination, or make it harder for you to think clearly. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely (at least 8 weeks after receiving treatment is recommended by the manufacturer). Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this product. Axicabtagene ciloleucel may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product 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

Lab and/or medical tests (such as complete blood counts) should be done before and after you receive this product. Women of childbearing age should have a pregnancy test before receiving this product. Keep all medical and lab appointments.

After receiving this treatment, do not donate blood, organs, tissues, or cells.

Missed Dose

If your dose is interrupted or stopped, contact your doctor right away to establish a new dosing schedule.

Storage

Not applicable. This product is given in a hospital or clinic and will not be stored at home.Information last revised October 2018. Copyright(c) 2018 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.