Tecartus Side Effects Center

Last updated on RxList: 10/17/2022
Tecartus Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tecartus?

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL).

What Are Side Effects of Tecartus?

Side effects of Tecartus include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Tecartus

The dosing of Tecartus is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The Tecartus dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Tecartus In Children

The safety and efficacy of Tecartus have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Tecartus?

Tecartus may interact with other medicines.

ell your doctor all medications and supplements you use.

Tecartus During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tecartus; it may harm a fetus and is generally not recommended for use during pregnancy. Sexually active females of reproductive potential should have a negative pregnancy test prior to starting treatment with Tecartus. It is unknown if Tecartus passes into breast milk or if it would affect a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Tecartus (budesonide, glycopyrrolate, and formoterol fumarate) Inhalation Aerosol, for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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.

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Tecartus Consumer Information

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 caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Call your doctor at once if you have:

  • severe drowsiness;
  • trouble speaking or writing;
  • trouble with daily activities;
  • a 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;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats.

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

Common side effects may include:

  • slurred speech;
  • fever, chills, cough, or other signs of infection;
  • feeling tired or light-headed;
  • fast or irregular heartbeats;
  • tremor, problems with speech or muscle movement;
  • headache, muscle or joint pain;
  • nausea, loss of appetite;
  • diarrhea, constipation;
  • swelling, kidney problems;
  • rash; or
  • sleep problems (insomnia).

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.

Tecartus Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cytokine Release Syndrome [see WARNINGS AND PRECAUTIONS]
  • Neurologic Toxicities [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Severe Infections [see WARNINGS AND PRECAUTIONS]
  • Prolonged Cytopenias [see WARNINGS AND PRECAUTIONS]
  • Hypogammaglobulinemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

The safety of TECARTUS was evaluated in a Phase 2 single-arm clinical study (ZUMA-2) in which a total of 82 patients with relapsed/refractory MCL received a single dose of CAR-positive viable T cells (2 × 106 or 0.5 × 106 anti-CD19 CAR T cells/kg) that was weight-based [see Clinical Studies].

The most common adverse reactions (incidence ≥ 20%) were pyrexia, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection – pathogen unspecified, chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia. Serious adverse reactions occurred in 66% of patients. The most common serious adverse reactions (> 2%) were encephalopathy, pyrexia, infection – pathogen unspecified, CRS, hypoxia, aphasia, renal insufficiency, pleural effusion, respiratory failure, bacterial infections, dyspnea, fatigue, arrhythmia, tachycardia, and viral infections.

The most common (≥ 10%) Grade 3 or higher reactions were anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia,pyrexia, hyponatremia, hypertension, infection-pathogen unspecified, pneumonia, hypocalcemia, and lymphopenia.

Table 3 summarizes the adverse reactions that occurred in at least 10% of patients treated with TECARTUS and Table 4 describes the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients.

Table 3. Summary of Adverse Reactions Observed in at Least 10% of Patients Treated with TECARTUS in ZUMA-2 (N=82)

Adverse ReactionAny Grade (%)Grade 3 or Higher (%)
Blood and Lymphatic System Disorders
  Coagulopathy a102
Cardiac Disorders
  Tachycardias b450
  Bradycardias c100
  Non-ventricular Arrhythmias d104
Gastrointestinal Disorders
  Nausea351
  Constipation290
  Diarrhea285
  Abdominal pain e170
  Oral pain f160
  Vomiting g130
  Dysphagia102
General Disorders and Administration Site Conditions
  Pyrexia9415
  Fatigue h481
  Chills410
  Edema i352
  Pain j172
Immune System Disorders
  Cytokine release syndrome9118
  Hypogammaglobulinemia k161
Infections and Infestations
  Infection – pathogen unspecified4324
  Viral infections184
  Bacterial infections136
Metabolism and nutrition disorders
  Decreased appetite260
Musculoskeletal and Connective Tissue Disorders
  Musculoskeletal pain l372
  Motor dysfunction m174
Nervous System Disorders
  Encephalopathy n5124
  Tremor382
  Headache o 351
  Aphasia p207
  Dizzines q 186
  Neuropathy r132
Psychiatric Disorders
  Insomnia210
  Delirium s185
  Anxiety160
Renal and Urinary Disorders
  Renal insufficiency t189
  Urine output decreased u111
Respiratory, Thoracic and Mediastinal Disorders
  Hypoxia4020
  Cough v380
  Dyspnea w246
  Pleural effusion215
Skin and Subcutaneous Tissue Disorders
  Rash x224
Vascular Disorders
  Hypotension y5727
  Hypertension1811
  Thrombosis z174
a. Coagulopathy includes coagulopathy, disseminated intravascular coagulation, international normalized ratio increased.
b. Tachycardias includes tachycardia, sinus tachycardia.
c. Bradycardias includes bradycardia, sinus bradycardia.
d. Non-ventricular arrhythmias includes atrial fibrillation, atrial flutter, cardiac flutter, palpitations, supraventricular tachycardia.
e. Abdominal pain includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
f. Oral pain includes oral pain, gingival pain, lip pain, oral mucosal erythema, oropharyngeal pain.
g. Vomiting includes vomiting, retching.
h. Fatigue includes fatigue, lethargy, malaise.
i. Edema includes eyelid edema, face edema, generalized edema, localised edema, edema, edema peripheral, periorbital edema, peripheral swelling, scrotal edema, swelling face.
j. Pain includes pain, allodynia, dysaesthesia, ear pain, facial pain, non-cardiac chest pain.
k. Hypogammaglobulinemia includes hypogammaglobulinemia, blood immunoglobulin G decreased.
l. Musculoskeletal pain includes musculoskeletal pain, arthralgia, back pain, bone pain, dysarthria, flank pain, groin pain, mya lgia, neck pain, pain in extremity.
m. Motor dysfunction includes asthenia, intensive care acquired weakness, mobility decreased, muscle twitching, muscular weakness, myopathy.
n. Encephalopathy includes encephalopathy, altered state of consciousness, amnesia, balance disorder, cognitive disorder , confusional state, disturbance in attention, dysgraphia, dyskinesia, memory impairment, mental status changes, neurotoxicity, somnolence .
o. Headache includes headache, migraine.
p. Aphasia includes aphasia, communication disorder.
q. Dizziness includes dizziness, presyncope, syncope.
r. Neuropathy includes hyperaesthesia, neuropathy peripheral, paraesthesia, paraesthesia oral.
s. Delirium includes delirium, agitation, disorientation, hallucination, hypomania, irritability, nervousness, personality change.
t. Renal insufficiency includes acute kidney injury, blood creatinine increased.
u. Urine output decreased includes urine output decreased, urinary retention.
v. Cough includes cough, upper-airway cough syndrome.
w. Dyspnea includes dyspnea, dyspnea exertional.
x. Rash includes rash, erythema, rash erythematous, rash maculo-papular, rash pustular.
y. Hypotension includes hypotension, orthostatic hypotension.
z. Thrombosis includes thrombosis, deep vein thrombosis, embolism, pulmonary embolism.

Other clinically important adverse reactions that occurred in less than 10% of patients treated with TECARTUS include the following:

  • Gastrointestinal disorders: dry mouth (7%)
  • Infections and infestations disorders: fungal infections (9%)
  • Metabolism and nutrition disorders: dehydration (6%)
  • Nervous system disorders: ataxia (7%), seizure (5%), increased intracranial pressure (2%)
  • Respiratory, thoracic and mediastinal disorders: respiratory failure (6%), pulmonary edema (4%)
  • Skin and subcutaneous tissue disorders: rash (9%)
  • Vascular disorders: hemorrhage (7%)

Table 4. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in ZUMA-2 Following TECARTUS Infusion (N = 82)

Grades 3 or 4 (%)
Leukopenia95
Neutropenia95
Lymphopenia86
Thrombocytopenia63
Anemia55
Hypophosphatemia30
Hypocalcemia21
Blood uric acid increased17
Hyponatremia16
Aspartate Aminotransferase increased15
Alanine Aminotransferase increased15
Hypokalemia10

Immunogenicity

TECARTUS has the potential to induce anti-product antibodies, which has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR. To date, no anti-CAR T-cell antibody immunogenicity has been observed. Based on an initial screening assay, 17 patients tested positive for antibodies; however, a confirmatory orthogonal cell-based assay demonstrated that all 17 patients were antibody negative at all time points tested. There is no evidence that the kinetics of initial expansion and persistence of TECARTUS, or the safety or effectiveness of TECARTUS, was altered in these patients.

Read the entire FDA prescribing information for Tecartus (Brexucabtagene Autoleucel Suspension)

© Tecartus Patient Information is supplied by Cerner Multum, Inc. and Tecartus Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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