Aucatzyl Side Effects

Generic name: obecabtagene autoleucel

Note: This document provides detailed information about Aucatzyl Side Effects associated with obecabtagene autoleucel. Some dosage forms listed on this page may not apply specifically to the brand name Aucatzyl.

Applies to obecabtagene autoleucel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Obecabtagene autoleucel can cause a serious side effect called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, confusion, tremors, heart problems.

Obecabtagene autoleucel may increase your risk of developing other cancers.

Obecabtagene autoleucel may cause severe or life-threatening nervous system reactions such as headache, restlessness, confusion, anxiety, sleep problems, shaking, loss of consciousness, agitation, seizures, pain or numbness, loss of balance, trouble speaking or understanding what is said to you.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Call your doctor at once if you have:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding;

• chest discomfort, wheezing, dry cough or hack, rapid weight loss;

• hemolytic anemia;

• severe drowsiness;

• pain or numbness;

• trouble speaking or writing;

• trouble with daily activities;

• tremors or shaking, seizure;

• severe ongoing nausea, vomiting, or diarrhea;

• 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;

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• kidney problems--swelling, urinating less, feeling tired or short of breath.

You may need to be treated in a hospital if you have certain side effects.

Common side effects may include:

• trouble speaking, slurred speech;

• nausea, fatigue, feeling short of breath, feeling tired;

• fast or irregular heartbeats;

• diarrhea, fever, infections;

• muscle or joint pain;

• confusion, dizziness, headache;

• low white blood cell (WBC) counts;

• bleeding problems; or

• low blood pressure (feeling like you might pass out).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to obecabtagene autoleucel: intravenous suspension.

Cardiovascular adverse events

• Very common (10% or more): Tachycardia (12%), hypotension (23%), hemorrhage (20%)
• Common (1% to 10%): Arrhythmia, palpitations, cardiac failure, thrombosis^[Ref]

Dermatologic

• Very common (10% or more): Rash (17%)
• Common (1% to 10%): Skin ulcer^[Ref]

Endocrine

• Common (1% to 10%): Adrenal insufficiency^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (29%), diarrhea (26%), vomiting (18%), abdominal pain (16%), constipation (11%)
• Common (1% to 10%): Stomatitis, ascites^[Ref]

Hematologic

• Very common (10% or more): Febrile neutropenia (26%), coagulopathy (10%)^[Ref]

Immunologic

• Very common (10% or more): Cytokine release syndrome (75%), hypogammaglobulinemia (10%)
• Common (1% to 10%): Graft versus host disease, HLH/MAS
• Postmarketing reports: T cell malignancies^[Ref]

Metabolic

• Very common (10% or more): Weight decreased (11%), decreased appetite (13%)^[Ref]

Musculoskeletal

• Very common (10% or more): Pain (36%)^[Ref]

Nervous system

• Very common (10% or more): Immune effector cell-associated neurotoxicity syndrome (24%), headache (22%), encephalopathy (21%), dizziness (14%)
• Common (1% to 10%): tremor, motor dysfunction, delirium, seizure^[Ref]

Ocular

• Common (1% to 10%): Visual impairment^[Ref]

Other

• Very common (10% or more): Fever (29%), pain (23%), fatigue (22%), edema (12%), chills (11%), unspecified infection (44%), non-COVID-19 viral infection (16%), COVID-19 (18%), bacterial infection (26%), fungal infection (15%)
• Common (1% to 10%): Infusion related reaction^[Ref]

Renal

• Common (1% to 10%): Renal impairment^[Ref]

Respiratory

• Very common (10% or more): Cough (14%)
• Common (1% to 10%): Respiratory failure, pleural effusion^[Ref]

Further information

Aucatzyl side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer