Aucatzyl (obecabtagene autoleucel): Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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Overview: Aucatzyl is a type of immunotherapy that is used to treat a type of blood cancer called acute lymphocytic leukemia (ALL). It is made from your own white blood cells to kill your cancer cells. It is given as an intravenous (IV) infusion in the hospital. Common side effects include fever, headache, nausea, diarrhea, and feeling tired. You will be monitored closely for at least four weeks after receiving it. Notify your healthcare provider right away if you notice a rash or any breathing changes.

Uses

What is Aucatzyl used for?

Aucatzyl (obecabtagene autoleucel) is commonly used to treat a type of blood cancer called acute lymphoblastic leukemia (ALL).

Aucatzyl may also be used for other conditions as determined by your healthcare provider.

How does Aucatzyl work (mechanism of action)?

Aucatzyl is a type of medicine known as immunotherapy, which means the medicine makes your immune system fight cancer cells. Aucatzyl is made by using your own T cells, which are a type of white blood cell. Your healthcare provider will collect your blood and send it to a company that will make the Aucatzyl specifically for you. The T cells in Aucatzyl find and attack cancer cells with specific CD19 markers on them. The T cells kill the cancer cells, helping to stop the cancer from growing or spreading.

How is Aucatzyl supplied (dosage forms)?

Brands and other names

Aucatzyl

Dosage forms and strengths

Aucatzyl is available in an injectable form that is given by a healthcare provider.

How should I store Aucatzyl?

Aucatzyl is usually given by a healthcare provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Aucatzyl?

The most common side effects of Aucatzyl are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

Cytokine release syndrome (see below)
Infections (see below)
Muscle or joint pain
Fever
Nausea or diarrhea
Blood disorders (see below)
Low blood pressure, which can lead to a fast and irregular heartbeat, trouble breathing, or dizziness/lightheadedness
Tiredness
Headache
Confusion, trouble speaking, slurring your words, from a brain problem, called encephalopathy
Bleeding

There may be other side effects of Aucatzyl that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Aucatzyl?

While less common, the most serious side effects of Aucatzyl are described below, along with what to do if they happen.

Severe Allergic Reactions. Aucatzyl may cause allergic reactions, which can be serious. Tell your healthcare provider and get help right away if you have any of the following symptoms of a serious allergic reaction.

Breathing problems or wheezing
Racing heart
Fever or general ill feeling
Swollen lymph nodes
Swelling of the face, lips, mouth, tongue, or throat
Trouble swallowing or throat tightness
Itching, skin rash, or pale red bumps on the skin called hives
Nausea or vomiting
Dizziness, feeling lightheaded, or fainting
Stomach cramps
Joint pain

Cytokine Release Syndrome (CRS). Aucatzyl can cause a dangerous and sometimes life-threatening problem called cytokine release syndrome. CRS occurs when your immune system responds too much to medicines or infection. CRS may happen right away or several days after you get Aucatzyl. Get emergency help and show the healthcare provider your Aucatzyl wallet card if you have any of the following symptoms of CRS.

Fever
Fast or racing heart
Low blood pressure
Dizziness or feeling lightheaded
Trouble breathing
Severe nausea, vomiting, or diarrhea
Severe headache

Neurologic Problems. Aucatzyl can cause a condition called immune effector cell-associated neurotoxicity (ICANS). Get emergency help and show the healthcare provider your Aucatzyl wallet card if you get any of the following symptoms.

Confusion
Tremor
Seizures
Balance problems
Trouble talking

Cancer. Aucatzyl can cause a new cancer, including some blood cancers, to develop or cause a previously treated cancer to recur. Tell your healthcare provider about any new symptoms that you may get and that you use Aucatzyl. Show any healthcare providers that you see for a new cancer your Aucatzyl wallet card. Contact Autolus (the company that makes Aucatzyl) at 855-288-5227 if you get another cancer.

Blood Disorders. Before you get Aucatzyl, you will likely use other medicines that can cause blood disorders, such low red blood cell levels (anemia), low platelet levels (thrombocytopenia), and low white blood cell levels (neutropenia). These low levels can last for several weeks. Keep all of your appointments for lab work while using Aucatzyl. Get help right away and show the healthcare provider your Aucatzyl wallet card if you have any of the following symptoms of blood disorders.

Fever
Shortness of breath
Pale or yellowish skin
Easy bruising or bleeding
Frequent infection
Unusual weakness or tiredness
Dizziness, lightheadedness, or feeling like you are about to pass out
Headache
Fast or abnormal heartbeat

Infections. Aucatzyl can reduce your antibody levels. Antibodies help you fight infections. Low antibody levels can increase your risk of infections, including serious infections. Call your healthcare provider right away and show the healthcare provider your Aucatzyl wallet card if you have an infection or any of the following symptoms.

Burning or stinging when you pee
Cough or coughing up blood
Fever, sweats, chills/shivering, or muscle aches
Shortness of breath
Diarrhea or stomach pain
Weight loss

Decreased Alertness or Coordination. Aucatzyl can affect your alertness, memory, or coordination. Do not drive, operate heavy machinery, or do other activities that require alertness or coordination for at least eight weeks after getting Aucatzyl.

Warnings & Precautions

Who should not use Aucatzyl?

Allergies to Ingredients. People who are allergic to any of the following should not use Aucatzyl.

Aucatzyl
Obecabtagene autoleucel
Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Aucatzyl.

What should I know about Aucatzyl before using it?

Aucatzyl is made from your own cells. It may take more than one try to make the right dose of Aucatzyl for you.

Before your dose of Aucatzyl can be made, you will get other medicines to prepare your body. You may need to use birth control for some time after receiving these medicines. Talk to your healthcare provider about these details and if you have any concerns.

Aucatzyl will be given to you by a healthcare provider through an intravenous (IV) line that goes into your vein. You will likely stay in the hospital for several days or weeks after receiving your dose for close monitoring. After you are able to leave the hospital, you should stay near the hospital or healthcare facility where you got Aucatzyl for at least four weeks after your dose.

Keep all appointments to check your blood work so that your healthcare provider can check for side effects.

After using Aucatzyl, you should not donate blood, organs, tissues, or cells to be transplanted.

What should I tell my healthcare provider before using Aucatzyl?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Aucatzyl is right for you.

In particular, make sure that you discuss any of the following.

Vaccines. Talk with your healthcare provider about any vaccines that you may need. You should not receive certain vaccines right before or while using Aucatzyl. Tell your healthcare provider about any vaccines you have recently received or have scheduled.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

Seizures
Stroke
Memory problems (new or worsening)
Breathing problems
Heart problems
Past infections, including HIV and hepatitis B or C
An infection, including any recent infections

Pregnancy. It is not known if or how Aucatzyl could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. A negative pregnancy test may be needed before you can start treatment with Aucatzyl.

Breastfeeding. It is not known if Aucatzyl passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Aucatzyl while breastfeeding.

How can I get more information about Aucatzyl?

For more information about Aucatzyl, you can visit the manufacturer’s website at www.aucatzyl.com or call them at 855-288-5227.

Interactions

Does Aucatzyl interact with foods or drinks?

There are no known interactions between Aucatzyl and foods or drinks.

It is unknown if drinking alcohol will affect Aucatzyl, but both Aucatzyl and alcohol can increase your risk of bleeding. The risk of dizziness, tiredness, and lightheadedness may be increased if you drink alcohol while using Aucatzyl. It is best to limit the amount of alcohol you drink.

Does Aucatzyl interact with other medicines (drug interactions)?

There are no known interactions between Aucatzyl and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker