Tecartus

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



 
 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tecartus 0.4 – 2 × 108 cells dispersion for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
2.1 General description 
 
Tecartus (autologous anti-CD19-transduced CD3+ cells) is a gene therapy medicinal product 
containing autologous T cells genetically modified ex vivo using a retroviral vector encoding an 
anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable 
fragment (scFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.  
 
2.2 Qualitative and quantitative composition 
 
Each patient specific single infusion bag contains a dispersion of anti-CD19 CAR T cells in 
approximately 68 mL for a target dose of 2 x 106 anti-CD19 CAR-positive viable T cells/kg body 
weight (range: 1 x 106 – 2 x 106 cells/kg), with a maximum of 2 x 108 anti-CD19 CAR-positive viable 
T cells. 
 
Excipient(s) with known effect 
 
This medicinal product contains 300 mg sodium. 
Each dose contains 0.05 mL of dimethyl sulfoxide (DMSO) per mL of Tecartus. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Dispersion for infusion. 
 
A clear to opaque, white to red dispersion. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell 
lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase 
(BTK) inhibitor.  
 
4.2 Posology and method of administration 
 
Tecartus must be administered in a qualified treatment centre by a physician with experience in the 
treatment of haematological malignancies and trained for administration and management of patients 
treated with Tecartus. At least 1 dose of tocilizumab for use in the event of cytokine release syndrome 
(CRS) and emergency equipment must be available prior to infusion. The qualified treatment centre 
must have access to an additional dose of tocilizumab within 8 hours of each previous dose. 



 
 

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Patients are expected to enrol in a registry and will be followed in the registry in order to better 
understand the long-term safety and efficacy of Tecartus. 
 
Posology 
 
Tecartus is intended for autologous use only (see section 4.4). 
 
A single dose of Tecartus contains 2 × 106 CAR-positive viable T cells per kg of body weight (range: 
1 x 106–2 x 106 cells/kg), or maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and 
above in approximately 68 mL dispersion in an infusion bag. 
 
Tecartus is recommended to be infused 3 to 14 days after completion of the lymphodepleting 
chemotherapy. The availability of the treatment must be confirmed prior to starting the 
lymphodepleting regimen. 
 
Pre-treatment (lymphodepleting chemotherapy) 
• A lymphodepleting chemotherapy regimen consisting of cyclophosphamide 500 mg/m² and 

fludarabine 30 mg/m² should be administered intravenously on the 5th, 4th, and 3rd day before 
infusion of Tecartus. 

 
Pre-medication 
• To minimise potential acute infusion reactions, it is recommended that patients be 

pre-medicated with paracetamol 500 to 1,000 mg given orally and diphenhydramine 12.5 to 
25 mg intravenous or oral (or equivalent) approximately 1 hour prior to infusion. 

• Prophylactic use of systemic corticosteroids is not recommended (see section 4.5). 
 
Monitoring after infusion 
• Patients should be monitored daily for the first 10 days following infusion for signs and 

symptoms of potential CRS, neurologic events and other toxicities. Physicians should consider 
hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or 
neurologic events. 

• After the first 10 days following the infusion, the patient should be monitored at the physician’s 
discretion. 

• Patients should be instructed to remain within proximity (within 2 hours of travel) of a qualified 
treatment centre for at least 4 weeks following infusion. 

 
Special populations 
 
Elderly 
No dose adjustment is required in patients ≥65 years of age. 
 
Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human 
immunodeficiency virus (HIV) 
There is no experience with manufacturing Tecartus for patients with a positive test for HIV, active 
HBV, or active HCV infection. Therefore, the benefit/risk has not yet been established in this 
population. 
 
Paediatric population 
The safety and efficacy of Tecartus in children and adolescents aged less than 18 years have not yet 
been established. No data are available. 
 
Method of administration 
 
Tecartus is for intravenous use only. 
 
Tecartus must not be irradiated. Do NOT use a leukodepleting filter. 



 
 

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Precautions to be taken before handling or administering the medicinal product 
This medicinal product contains genetically modified human blood cells. Healthcare professionals 
handling Tecartus should take appropriate precautions (wearing gloves and glasses) to avoid potential 
transmission of infectious diseases (see section 6.6). 
 
Preparation for infusion 
• Verify that the patient’s identity (ID) matches the patient identifiers on the Tecartus metal 

cassette. 
• The Tecartus infusion bag must not be removed from the metal cassette if the information on the 

patient-specific label does not match the intended patient. 
• Once the patient ID is confirmed, remove the infusion bag from the metal cassette. 
• Check that the patient information on the metal cassette label matches that on the bag label. 
• Inspect the infusion bag for any breaches of container integrity before thawing. If the bag is 

compromised, follow the local guidelines for handling of waste of human-derived material (or 
immediately contact Kite). 

• Place the infusion bag inside a second bag. 
• Thaw Tecartus at approximately 37 °C using either a water bath or dry thaw method until there 

is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse clumps of 
cellular material. If visible cell clumps remain, continue to gently mix the contents of the bag. 
Small clumps of cellular material should disperse with gentle manual mixing. Tecartus should 
not be washed, spun down, and/or re-suspended in new media prior to infusion. Thawing should 
take approximately 3 to 5 minutes. 

• Once thawed, Tecartus is stable at room temperature (20 °C – 25 °C) for up to 3 hours. 
However, Tecartus infusion should begin within 30 minutes of thaw completion. 

 
Administration 
• For autologous single use only. 
• Tocilizumab and emergency equipment should be available prior to infusion and during the 

monitoring period. 
• A leukodepleting filter must not be used. 
• Central venous access is recommended for the administration. 
• Verify the patient ID again to match the patient identifiers on the Tecartus bag. 
• Prime the tubing with sodium chloride 9 mg/mL (0.9%) solution for injection (0.154 mmol 

sodium per mL) prior to infusion. 
• Infuse the entire content of the Tecartus bag within 30 minutes by either gravity or a peristaltic 

pump.  
• Gently agitate the bag during infusion to prevent cell clumping. 
• After the entire content of the bag is infused, rinse the tubing at the same infusion rate with 

sodium chloride 9 mg/mL (0.9%) solution for injection (0.154 mmol sodium per mL) to ensure 
all the treatment is delivered. 

 
For instructions on the handling, accidental exposure to and disposal of the medicinal product, see 
section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Contraindications of the lymphodepleting chemotherapy must be considered. 
 



 
 

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4.4 Special warnings and precautions for use 
 
Traceability 
 
The traceability requirements of cell-based advanced therapy medicinal products must apply. To 
ensure traceability the name of the product, the batch number and the name of the treated patient 
should be kept for a period of 30 years.  
 
General 
 
Warnings and precautions of lymphodepleting chemotherapy must be considered. 
 
Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of 
potential CRS, neurologic events and other toxicities. Physicians should consider hospitalisation for 
the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurologic events. After 
the first 10 days following infusion, the patient should be monitored at the physician’s discretion. 
 
Counsel patients to remain within the proximity of a qualified treatment centre for at least 4 weeks 
following infusion and to seek immediate medical attention should signs or symptoms of CRS or 
neurological adverse reactions occur. Monitoring of vital signs and organ functions should be 
considered depending on the severity of the reaction. 
 
Reasons to delay treatment 
 
Due to the risks associated with Tecartus treatment, infusion should be delayed if a patient has any of 
the following conditions: 
• Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions, or 

hypotension) including from preceding chemotherapies. 
• Active uncontrolled infection or inflammatory disease. 
• Active graft-versus-host disease (GvHD). 
 
In some cases, the treatment may be delayed after administration of the lymphodepleting 
chemotherapy regimen. If the infusion is delayed for more than 2 weeks after the patient has received 
the lymphodepleting chemotherapy, lymphodepleting chemotherapy regimen should be administered 
again (see section 4.2)  
 
Serological testing 
 
Screening for HBV, HCV, and HIV should be performed before collection of cells for manufacturing 
of Tecartus (see section 4.2). 
 
Blood, organ, tissue and cell donation 
 
Patients treated with Tecartus should not donate blood, organs, tissues, or cells for transplantation. 
 
Active central nervous system (CNS) lymphoma 
 
There is no experience of use of this medicinal product in patients with active CNS lymphoma defined 
as detectable cerebrospinal fluid malignant cells or brain metastases confirmed by imaging. Therefore, 
the benefit/risk of Tecartus has not been established in this population. 
 
Concomitant disease 
 
Patients with a history of or active CNS disorder or inadequate renal, hepatic, pulmonary, or cardiac 
function were excluded from the study. These patients are likely to be more vulnerable to the 
consequences of the adverse reactions described below and require special attention. 
 



 
 

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Cytokine release syndrome 
 
Nearly all patients experienced some degree of CRS. Severe CRS, which can be life-threatening, was 
very commonly observed with Tecartus with a median time to onset of 3 days (range: 1 to 13 days). 
Patients should be closely monitored for signs or symptoms of these events, such as high fever, 
hypotension, hypoxia, chills, tachycardia and headache (see section 4.8). CRS should be managed at 
the physician’s discretion, based on the patient’s clinical presentation and according to the CRS 
management algorithm provided in Table 1. 
 
Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including 
infection.  
 
Management of cytokine release syndrome associated with Tecartus 
At least 1 dose per patient of tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, must be on site 
and available for administration prior to Tecartus infusion. The qualified treatment centre should have 
access to an additional dose of tocilizumab within 8 hours of each previous dose. 
 
Treatment algorithms have been developed to ameliorate some of the CRS symptoms experienced by 
patients on Tecartus. These include the use of tocilizumab or tocilizumab and corticosteroids, as 
summarised in Table 1. Patients who experience Grade 2 or higher CRS (e.g. hypotension, not 
responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with 
continuous cardiac telemetry and pulse oximetry. For patients experiencing severe CRS, consider 
performing an echocardiogram to assess cardiac function. For severe or life-threatening CRS, consider 
intensive-care supportive therapy. 
 
CRS has been known to be associated with end organ dysfunction (e.g., hepatic, renal, cardiac, and 
pulmonary). In addition, worsening of underlying organ pathologies can occur in the setting of CRS. 
Patients with medically significant cardiac dysfunction should be managed by standards of critical care 
and measures such as echocardiography should be considered. In some cases, macrophage activation 
syndrome (MAS) and haemophagocytic lymphohistiocytosis (HLH) may occur in the setting of CRS. 
 
Evaluation for haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) 
should be considered in patients with severe or unresponsive CRS. 
 
Tecartus continues to expand and persist following administration of tocilizumab and corticosteroids. 
Tumour necrosis factor (TNF) antagonists are not recommended for management of 
Tecartus-associated CRS. 
 
Table 1 CRS grading and management guidance 
 
CRS Grade (a) Tocilizumab Corticosteroids 
Grade 1 
Symptoms require symptomatic 
treatment only (e.g., fever, nausea, 
fatigue, headache, myalgia, 
malaise). 

If not improving after 24 hours, 
administer tocilizumab 
8 mg/kg intravenously over 1 hour 
(not to exceed 800 mg). 

N/A 



 
 

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CRS Grade (a) Tocilizumab Corticosteroids 
Grade 2 
Symptoms require and respond to 
moderate intervention. 
Oxygen requirement less than 40% 
FiO2 or hypotension responsive to 
fluids or low-dose of one 
vasopressor or Grade 2 organ 
toxicity (b). 

Administer tocilizumab (c) 8 mg/kg 
intravenously over 1 hour (not to 
exceed 800 mg). 
Repeat tocilizumab every 8 hours 
as needed if not responsive to 
intravenous fluids or increasing 
supplemental oxygen. Limit to a 
maximum of 3 doses in a 24 hour 
period; maximum total of 4 doses if 
no clinical improvement in the 
signs and symptoms of CRS, or if 
no response to second or 
subsequent doses of tocilizumab, 
consider alternative measures for 
treatment of CRS. 
If improving, discontinue 
tocilizumab. 

If no improvement within 24 hours 
after starting tocilizumab, manage 
as per Grade 3. 
If improving, taper corticosteroids, 
and manage as Grade 1. 

Grade 3 
Symptoms require and respond to 
aggressive intervention. 
Oxygen requirement greater than or 
equal to 40% FiO2 or hypotension 
requiring high-dose or multiple 
vasopressors or Grade 3 organ 
toxicity or Grade 4 transaminitis. 

Per Grade 2 
 

Administer methylprednisolone 
1 mg/kg intravenously twice daily 
or equivalent dexamethasone (e.g., 
10 mg intravenously every 6 hours) 
until Grade 1, then taper 
corticosteroids. 
If improving, manage as Grade 2. 
If not improving, manage as 
Grade 4. 

Grade 4 
Life-threatening symptoms. 
Requirements for ventilator support 
or continuous veno-venous 
haemodialysis or Grade 4 organ 
toxicity (excluding transaminitis). 

Per Grade 2 
 

Administer methylprednisolone 
1000 mg intravenously per day for 
3 days. 
If improving, taper corticosteroids, 
and manage as Grade 3. 
If not improving, consider alternate 
immunosuppressants. 

N/A = not available/not applicable 
(a) Lee et al 2014. 
(b) Refer to Table 2 for management of neurologic adverse reactions. 
(c) Refer to tocilizumab summary of product characteristics for details. 
 
Neurologic adverse reactions 
 
Severe neurologic adverse reactions (encephalopathy, confusional state or delirium, decreased level of 
consciousness, seizures, aphasia), which could be life-threatening, were very commonly observed in 
patients treated with Tecartus with a median time to onset of 8 days (range: 1 to 262 days) (see 
section 4.8). 
 
Patients who experience Grade 2 or higher neurologic toxicities should be monitored with continuous 
cardiac telemetry and pulse oximetry. Provide intensive-care supportive therapy for severe or 
life-threatening neurologic toxicities. Non-sedating, anti-seizure medicines should be considered as 
clinically indicated for Grade 2 or higher adverse reactions. Treatment algorithms have been 
developed to ameliorate the neurologic adverse reactions experienced by patients on Tecartus. These 
include the use of tocilizumab (if concurrent CRS) and/or corticosteroids for moderate, severe, or 
life-threatening neurologic adverse reactions as summarised in Table 2. 
 



 
 

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Table 2 Neurologic adverse reaction grading and management guidance 
 
Grading 
assessment 

Concurrent CRS No concurrent CRS 

Grade 2 Administer tocilizumab as per Table 1 for 
management Grade 2 CRS. 
If not improving within 24 hours after starting 
tocilizumab, administer dexamethasone 
10 mg intravenously every 6 hours until the 
event is Grade 1 or less, then taper 
corticosteroids. 
If improving, discontinue tocilizumab. 
If still not improving, manage as Grade 3. 

Administer dexamethasone 10 mg 
intravenously every 6 hours until the event is 
Grade 1 or less. 
If improving, taper corticosteroids 

Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. 
Grade 3 Administer tocilizumab as per Table 1 for 

management of Grade 2 CRS. 
In addition, administer dexamethasone 10 mg 
intravenously with the first dose of 
tocilizumab and repeat dose every 6 hours. 
Continue dexamethasone use until the event is 
Grade 1 or less, then taper corticosteroids. 
If improving, discontinue tocilizumab and 
manage as Grade 2. 
If still not improving, manage as Grade 4. 

Administer dexamethasone 10 mg 
intravenously every 6 hours. 
Continue dexamethasone use until the event is 
Grade 1 or less, then taper corticosteroids. 
If not improving, manage as Grade 4. 

Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. 
Grade 4 Administer tocilizumab as per Table 1 for 

management of Grade 2 CRS. 
Administer methylprednisolone 1000 mg 
intravenously per day with first dose of 
tocilizumab and continue methylprednisolone 
1000 mg intravenously per day for 2 more 
days. 
If improving, then manage as Grade 3. 
If not improving, consider alternate 
immunosuppressants. 

Administer methylprednisolone 1000 mg 
intravenously per day for 3 days. 
If improving, then manage as Grade 3. 
If not improving, consider alternate 
immunosuppressants. 

Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. 
 
Infections and febrile neutropenia 
 
Severe infections, which could be life-threatening, were very commonly observed with Tecartus (see 
section 4.8). 
 
Patients should be monitored for signs and symptoms of infection before, during and after infusion and 
treated appropriately. Prophylactic antibiotics should be administered according to standard 
institutional guidelines. 
 
Febrile neutropenia has been observed in patients after Tecartus infusion (see section 4.8) and may be 
concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad 
spectrum antibiotics, fluids, and other supportive care as medically indicated. 
 
In immunosuppressed patients, life-threatening and fatal opportunistic infections including 
disseminated fungal infections and viral reactivation (e.g., HHV-6 and progressive multifocal 
leukoencephalopathy) have been reported. The possibility of these infections should be considered in 
patients with neurologic events and appropriate diagnostic evaluations should be performed.  
 



 
 

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Viral reactivation 
 
Viral reactivation, e.g. Hepatitis B virus (HBV) reactivation, can occur in patients treated with 
medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure, and 
death. 
 
Prolonged cytopenias 
 
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and 
Tecartus infusion and should be managed according to standard guidelines. Grade 3 or higher 
prolonged cytopenias following Tecartus infusion occurred very commonly and included 
thrombocytopenia, neutropenia, and anaemia (see section 4.8). Patient blood counts should be 
monitored after Tecartus infusion. 
 
Hypogammaglobulinaemia 
 
B-cell aplasia leading to hypogammaglobulinaemia can occur in patients receiving treatment with 
Tecartus. Hypogammaglobulinaemia was very commonly observed in patients treated with Tecartus 
(see section 4.8). Hypogammaglobulinaemia predisposes patients to have infections. Immunoglobulin 
levels should be monitored after treatment with Tecartus and managed using infection precautions, 
antibiotic prophylaxis, and immunoglobulin replacement in case of recurrent infections and should be 
taken according standard guidelines. 
 
Hypersensitivity reactions 
 
Serious hypersensitivity reactions including anaphylaxis, may occur due to DMSO or residual 
gentamicin in Tecartus. 
 
Secondary malignancies 
 
Patients treated with Tecartus may develop secondary malignancies. Patients should be monitored 
life-long for secondary malignancies. In the event that a secondary malignancy occurs, the company 
should be contacted to obtain instructions on patient samples to collect for testing. 
 
Tumour lysis syndrome (TLS) 
 
TLS, which may be severe, has occasionally been observed. To minimise risk of TLS, patients with 
elevated uric acid or high tumour burden should receive allopurinol, or an alternative prophylaxis, 
prior to Tecartus infusion. Signs and symptoms of TLS should be monitored, and events managed 
according to standard guidelines. 
 
Prior stem cell transplantation (GvHD) 
 
It is not recommended that patients who underwent an allogeneic stem cell transplant and suffer from 
active acute or chronic GvHD receive treatment because of the potential risk of Tecartus worsening 
GvHD.  
 
Prior treatment with anti-CD19 therapy 
 
Tecartus is not recommended if the patient has relapsed with CD19-negative disease after prior 
anti-CD19 therapy. 
 
Sodium content  
 
This medicinal product contains 300 mg sodium per infusion, equivalent to 15% of the WHO 
recommended maximum daily intake of 2 g sodium for an adult. 
 



 
 

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4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
Prophylactic use of systemic corticosteroids may interfere with the activity of Tecartus. Prophylactic 
use of systemic corticosteroids is therefore not recommended before infusion (see section 4.2).  
 
Administration of corticosteroids as per the toxicity management guidelines does not impact the 
expansion and persistence of CAR T cells. 
 
Live vaccines 
 
The safety of immunisation with live viral vaccines during or following Tecartus treatment has not 
been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the 
start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery 
following treatment. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception 
 
The pregnancy status of women of childbearing potential must be verified before starting Tecartus 
treatment. 
 
See the prescribing information for lymphodepleting chemotherapy for information on the need for 
effective contraception in patients who receive the lymphodepleting chemotherapy. 
 
There are insufficient exposure data to provide a recommendation concerning duration of 
contraception following treatment with Tecartus. 
 
Pregnancy 
 
There are no available data with Tecartus use in pregnant women. No reproductive and developmental 
toxicity animal studies have been conducted with Tecartus to assess whether it can cause foetal harm 
when administered to a pregnant woman (see section 5.3). 
 
It is not known if Tecartus has the potential to be transferred to the foetus. Based on the mechanism of 
action, if the transduced cells cross the placenta, they may cause foetal toxicity, including B-cell 
lymphocytopenia. Therefore, Tecartus is not recommended for women who are pregnant, or for 
women of childbearing potential not using contraception. Pregnant women should be advised on the 
potential risks to the foetus. Pregnancy after Tecartus therapy should be discussed with the treating 
physician. 
 
Assessment of immunoglobulin levels and B-cells in newborn infants of mothers treated with Tecartus 
should be considered. 
 
Breast-feeding 
 
It is unknown whether Tecartus is excreted in human milk or transferred to the breast-feeding child. 
Breast-feeding women should be advised of the potential risk to the breast-fed child. 
 
Fertility 
 
No clinical data on the effect of Tecartus on fertility are available. Effects on male and female fertility 
have not been evaluated in animal studies. 
 



 
 

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4.7 Effects on ability to drive and use machines 
 
Tecartus has major influence on the ability to drive and use machines. 
 
Due to the potential for neurologic events, including altered mental status or seizures, patients should 
not drive or operate heavy or potentially dangerous machines until at least 8 weeks after infusion or 
until resolution of neurologic adverse reactions. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The safety data described in this section reflect exposure to Tecartus in ZUMA-2, a Phase 2 study 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) based on a recommended dose which 
was weight-based. 
 
The most significant and frequently occurring adverse reactions were cytokine release syndrome 
(91%), infections (56%) and encephalopathy (51%). 
 
Serious adverse reactions occurred in 57% of patients. The most common serious adverse reactions 
included encephalopathy (26%), infections (28%) and cytokine release syndrome (15%). 
 
Grade 3 or higher adverse reactions were reported in 65% of patients. The most common Grade 3 or 
higher non-haematological adverse reactions included infections (32%) and encephalopathy (24%). 
The most common Grade 3 or higher haematological adverse reactions included neutropenia (99%), 
leukopenia (98%), lymphopenia (96%), thrombocytopenia (65%) and anaemia (56%). 
 
Tabulated list of adverse reactions 
 
Adverse reactions described in this section were identified in patients exposed to Tecartus in 
ZUMA-2. These reactions are presented by system organ class and by frequency. Frequencies are 
defined as: very common (≥1/10); common (≥1/100 to <1/10). Within each frequency grouping, 
adverse reactions are presented in the order of decreasing seriousness. 
 
Table 3 Adverse drug reactions identified with Tecartus 
 

System Organ Class (SOC) Frequency Adverse reactions 
Infections and infestations  
 Very common Unspecified pathogen infections 

Viral infections 
Bacterial infections  
Fungal infections 

Blood and lymphatic system disorders 
 Very common Neutropeniaa 

Lymphopeniaa 
Leukopeniaa 
Anaemiaa 
Thrombocytopeniaa 
Coagulopathy  

Immune system disorders 
 Very common Cytokine Release Syndromeb 

Hypogammaglobulinaemia  
Metabolism and nutrition disorders 
 Very common Hypophosphataemiaa 

Decreased appetite 
Common Dehydration 

Hypoalbuminemiaa 



 
 

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System Organ Class (SOC) Frequency Adverse reactions 
Psychiatric disorders 
 Very common Insomnia  

Delirium  
Anxiety 

Nervous system disorders 
 Very common Encephalopathy  

Tremor 
Headache  
Aphasia  
Dizziness  
Neuropathy  

Common Ataxia  
Seizure 
Increased intracranial pressure  

Cardiac disorders 
 Very common Tachycardias  

Bradycardias  
 Common Non-ventricular arrhythmias  
Vascular disorders 
 Very common Hypotension  

Hypertension  
Thrombosis  

Common Haemorrhage  
Respiratory, thoracic and mediastinal disorders 
 Very common Cough  

Pleural effusion  
Dyspnoea  
Hypoxia 

Common Respiratory failure 
Pulmonary oedema 

Gastrointestinal disorders 
 Very common Constipation 

Nausea 
Diarrhoea 
Oral pain  
Abdominal pain  
Vomiting  
Dysphagia 

Common Dry mouth 
Skin and subcutaneous tissue disorders 
 Very common Rash  
Musculoskeletal and connective tissue disorders 
 Very common Motor dysfunction  

Musculoskeletal pain  
Renal and urinary disorders 
 Very common Renal insufficiency  

Urine output decreased  
General disorders and administration site conditions 
 Very common Fatigue  

Oedema  
Pyrexia 
Pain  
Chills 

Investigations 
 Very common Alanine aminotransferase increaseda 

Aspartate aminotransferase increaseda 
Hypokalaemiaa 
Hyponatraemiaa 
Hypocalcaemiaa 
Blood uric acid increaseda 



 
 

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System Organ Class (SOC) Frequency Adverse reactions 
Only cytopenias that resulted in (i) new or worsening clinical sequelae or (ii) that required therapy or (iii) adjustment in 
current therapy are included in Table 3. 
a Frequency based on Grade 3 or higher laboratory parameter. 
b See section Description of selected adverse reactions. 

 
Description of selected adverse reactions 
 
Cytokine release syndrome 
CRS occurred in 91% of patients. Fifteen percent (15%) of patients experienced Grade 3 or higher 
(severe or life-threatening) CRS. The median time to onset was 3 days (range: 1 to 13 days) and the 
median duration was 10 days (range: 1 to 50 days). All patients (100%) recovered from CRS. 
 
The most common signs or symptoms associated with CRS among the patients who experienced CRS 
included pyrexia (99%), hypotension (60%), hypoxia (37%), chills (33%), tachycardia (27%), 
headache (24%), fatigue (16%), nausea (13%), alanine aminotransferase increased (13%), aspartate 
aminotransferase increased (12%), diarrhoea (11%), and sinus tachycardia (11%). Serious adverse 
reactions that may be associated with CRS included hypotension, pyrexia, hypoxia, acute kidney 
injury, and tachycardia. See section 4.4 for monitoring and management guidance. 
 
Neurologic events and adverse reactions 
Neurologic adverse reactions occurred in 68% of patients. Thirty-three percent (33%) of patients 
experienced Grade 3 or higher (severe or life-threatening) adverse reactions. The median time to onset 
was 8 days (range: 1 to 262 days). Neurologic events resolved for 47 out of 56 patients with a median 
duration of 13 days (range: 1 to 567 days). Three patients had ongoing neurologic events at the time of 
death, including one patient with the reported event of serious encephalopathy and another patient with 
the reported event of serious confusional state. The remaining unresolved neurologic events were 
Grade 2. Eighty-five percent of all treated patients experienced the first CRS or neurological event 
within the first 7 days after Tecartus infusion. 
 
The most common neurologic adverse reactions included encephalopathy (51%), tremor (38%), 
aphasia (20%), and delirium (18%). Serious adverse reactions including encephalopathy (26%), 
aphasia (6%) and seizure (2%) have been reported in patients administered with Tecartus. Serious 
cases of cerebral oedema which may become fatal have occurred in patients treated with Tecartus. See 
section 4.4 for monitoring and management guidance. 
 
Febrile neutropenia and infections 
Febrile neutropenia was observed in 6% of patients after Tecartus infusion. Infections occurred in 56% 
of patients in ZUMA-2. Grade 3 or higher (severe, life-threatening or fatal) infections occurred in 32% 
of patients including unspecified pathogen, bacterial, and viral infections in 26%, 6%, and 4% of 
patients respectively. See section 4.4 for monitoring and management guidance. 
 
Prolonged cytopenias 
Cytopenias are very common following prior lymphodepleting chemotherapy and Tecartus therapy.  
 
Prolonged (present on or beyond Day 30 or with an onset at Day 30 or beyond) Grade 3 or higher 
cytopenias occurred in 55% of patients and included thrombocytopenia (38%), neutropenia (37%), and 
anaemia (17%). See section 4.4 for management guidance. 
 
Hypogammaglobulinaemia 
In ZUMA-2, hypogammaglobulinaemia occurred in 16% of patients. Grade 3 or higher 
hypogammaglobulinemia occurred in 1% of patients. See section 4.4 for management guidance. 
 
Immunogenicity 
 
The immunogenicity of Tecartus has been evaluated using an enzyme-linked immunosorbent assay 
(ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the 



 
 

14 

anti-CD19 CAR. To date, no anti-CD19 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, CAR T-cell function and persistence 
of Tecartus, or the safety or effectiveness of Tecartus, was altered in these patients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There are no data regarding the signs of overdose with Tecartus. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned 
 
Mechanism of action 
 
Tecartus, a CD19-directed genetically modified autologous T-cell immunotherapy, binds to CD19 
expressing cancer cells and normal B cells. Following anti-CD19 CAR T-cell engagement with CD19 
expressing target cells, the CD28 co-stimulatory domain and CD3-zeta signalling domain activate 
downstream signalling cascades that lead to T-cell activation, proliferation, acquisition of effector 
functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to 
killing of CD19-expressing cells. 
 
Pharmacodynamic effects 
 
In ZUMA-2, after Tecartus infusion, pharmacodynamic responses were evaluated over a 4-week 
interval by measuring transient elevation of cytokines, chemokines, and other molecules in blood. 
Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, interferon-gamma 
(IFN-γ) and IL-2 receptor alpha were analysed. Peak elevation was generally observed between 4 and 
8 days after infusion and levels generally returned to baseline within 28 days. 
 
Due to the on target, off-tumour effect of Tecartus a period of B-cell aplasia is expected following 
treatment. 
 
Translational analyses performed to identify associations between cytokine levels and incidence of 
CRS or neurologic events showed that higher levels (peak and AUC at 1 month) of multiple serum 
analytes were associated with Grade 3 or higher neurologic adverse reactions and Grade 3 or higher 
CRS. 
 
Clinical efficacy and safety 
 
Relapsed or refractory MCL: ZUMA-2 
The efficacy and safety of Tecartus in adult patients with relapsed or refractory MCL who had 
previously received anthracycline or bendamustine-containing chemotherapy, an anti CD20 antibody, 
and a Bruton’s tyrosine kinase inhibitor (BTKi) (ibrutinib or acalabrutinib), was evaluated in a phase 2 
single-arm, open-label, multicenter trial. Eligible patients also had disease progression after last 
regimen or refractory disease to the most recent therapy. Patients with active or serious infections, 
prior allogeneic haematopoietic stem cell transplantation (HSCT), detectable cerebrospinal fluid 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 
 

15 

malignant cells or brain metastases, and any history of central nervous system lymphoma or CNS 
disorders were ineligible. In total, 74 patients were enrolled (i.e. leukapheresed) and 68 patients were 
treated with Tecartus. Three patients did not receive Tecartus due to manufacturing failure. Two other 
patients were not treated due to progressive disease (death) following leukapheresis. One patient was 
not treated with Tecartus after receiving lymphodepleting chemotherapy due to ongoing active atrial 
fibrillation. ITT was defined as all patients who underwent leukapheresis. A summary of the patient 
baseline characteristics is provided in Table 4. 
 
Table 4 Summary of baseline characteristics for ZUMA-2 
 
Category All leukapheresed (ITT) 

(N=74) 
Age (years) 

Median (min, max) 65 (38, 79) 
≥ 65 58% 

Male gender 84% 
Median number of prior therapies (min, max) 3 (1; 5) 
Relapsed/refractory subgroup 

Relapsed after auto-SCT 42% 
Refractory to last MCL therapy 39% 
Relapsed after last MCL therapy 19% 

Patients with disease stage IV 86% 
Patients with bone marrow involvement 51% 
Morphological characteristic 

Classical MCL 54% 
Blastoid MCL 26% 
Other 1% 
Unknown 19% 

Received bridging therapy 
Yes 38% 
No 62% 

Ki-67 IHC by central laboratory 
N 49 
Median 65% 

Auto-SCT, autologous stem cell transplant; IHC, immunohistochemistry; Max, maximum; MCL, mantle cell lymphoma; 
Min, minimum; 

 
Tecartus was administered to patients as a single intravenous infusion at a target dose of 
2 × 106 anti-CD19 CAR T cells/kg (maximum permitted dose: 2 × 108 cells) after lymphodepleting 
chemotherapy regimen of cyclophosphamide 500 mg/m² intravenously and fludarabine 30 mg/m² 
intravenously, both given on the 5th, 4th, and 3rd day before treatment. Bridging chemotherapy between 
leukapheresis and lymphodepleting chemotherapy was permitted to control disease burden. 
 
For patients treated with Tecartus, the median time from leukapheresis to product release was 13 days 
(range: 9 to 20 days) and the median time from leukapheresis to Tecartus infusion was 27 days (range: 
19 to 74 days, with the exception of one outlier of 134 days). The median dose was 
2.0 × 106 anti-CD19 CAR T cells/kg. All patients received Tecartus infusion on day 0 and were 
hospitalized until day 7 at the minimum. 
 
The primary endpoint was objective response rate (ORR) as determined by Lugano 2014 criteria by an 
independent review committee. Secondary endpoints included duration of response (DOR), overall 
survival (OS), progression free survival (PFS) and severity of adverse events. 
 



 
 

16 

An analysis set was defined a priori which consisted of the first 60 patients treated with Tecartus who 
were evaluated for response 6 months after the Week 4 disease assessment after Tecartus infusion. In 
this analysis set of 60 patients the ORR was 93% with a CR rate of 67%. The ORR was significantly 
higher than the prespecified historical control rate of 25% at a 1-sided significance level of 0.025 
(p < 0.0001). Results in the ITT set are shown in Table 5. 
 
Table 5 Summary of efficacy results for ZUMA-2 
 

Category All leukapheresed a(ITT) 
(N = 74) 

Objective response rate (ORR), n (%) [95% CI] 62 (84%) [73.4, 91.3] 

CR n (%) [95% CI] 44 (59%) [47.4, 70.7] 
PR n (%) [95% CI] 18 (24%) [15.1, 35.7] 

Duration of response (DOR)b 
Median in months [95% CI] NR [10.4, NE] 
Range c in months 0.0+, 35.0+ 
Ongoing responses, CR+PR, CR, n (%) d 32 (43%), 30 (41%) 

Progression free survival  
Median, months [95% CI] 16.2 [9.9, NE] 

Overall survival 
Median, months [95% CI] NR [24.6, NE] 
6 month OS (%) [95% CI] 83.6 [72.9, 90.3] 
12 month OS (%) [95% CI] 76.6 [65.1, 84.8] 
24 month OS (%) [95% CI] 66.5 [52.8, 77.1] 

Median Follow-up in months (min, max) 16.8 [7.2, 37.6] 
CI, confidence interval; CR, complete remission; ITT, intent to treat; NE, not estimable; NR, not reached; OS, overall 
survival; PR, partial remission. 
a Of the 74 patients that were enrolled (i.e. leukapheresed), 69 patients received lymphodepleting 

chemotherapy, and 68 patients received Tecartus. 
b Among all responders. DOR is measured from the date of first objective response to the date of progression or 

death.   
c A + sign indicates a censored value. 
d At the data cutoff date. Percentages are calculated using the total number of patients in the analysis set as the 

denominator. 
 



 
 

17 

Figure 1 Kaplan Meier DOR in the intent to treat set 
 

D
ur

at
io

n 
of

 R
es

po
ns

e 
(P

ro
ba

bi
lit

y)
 

 
1.0 

 
 
 
 

0.8 
 
 
 
 

0.6 
 
 
 
 

0.4 
 
 
 
 

0.2 
 
 
 
 

0.0 

 
  Time (Months) 

 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Tecartus in all subsets of the paediatric population in treatment of mantle cell lymphoma (see 
section 4.2 for information on paediatric use). 
 
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme.  
This means that further evidence on this medicinal product is awaited. 
The European Medicines Agency will review new information on this medicinal product at least every 
year and this SmPC will be updated as necessary. 
 
5.2 Pharmacokinetic properties 
 
Following infusion of Tecartus, anti-CD19 CAR T cells exhibited an initial rapid expansion followed 
by a decline to near baseline levels by 3 months. Peak levels of anti-CD19 CAR T cells occurred 
within the first 7 to 15 days after the infusion. 
 
The number of anti-CD19 CAR T cells in blood was associated with objective response (CR or PR) 
(Table 6). 
 
Table 6 Kinetic parameters of autologous anti-CD19-transduced CD3+ cells in ZUMA-2 
 
Number of anti-CD19 CAR T cell Responding patients 

(CR or PR) 
Non-responding patients P-Value 

(N=63) (N=5)  
Peak (cells/μL) 
Median [min; max], n 

97.52 [0.24, 2589.47], 62 0.39 [0.16, 22.02], 5 0.0020 

AUC0–28 (cells/μL·days) 
Median [min; max], n 

1386.28 [3.83 to 
2.77 × 104], 62 

5.51 [1.81, 293.86], 5 0.0013 

P-value is calculated by Wilcoxon test 
 

Censored Median (95% CI) 
Not reached (10.4, NE) 



 
 

18 

Median peak anti-CD19 CAR T-cell values were 74.08 cells/μL in patients ≥65 years of age (n=39) 
and 112.45 cells/μL in patients <65 years of age (n=28). Median anti-CD19 CAR T-cell AUC values 
were 876.48 cells/μL∙day in patients ≥65 years of age and 1640.21 cells/μL∙day in patients <65 years 
of age. 
 
Gender had no significant impact on AUCDay 0–28 and Cmax of Tecartus. 
 
Studies of Tecartus in patients with hepatic and renal impairment were not conducted. 
 
5.3 Preclinical safety data 
 
Tecartus comprises engineered human T cells; therefore, there are no representative in vitro assays, 
ex vivo models, or in vivo models that can accurately address the toxicological characteristics of the 
human product. Hence, traditional toxicology studies used for medicinal product development were 
not performed. 
 
No carcinogenicity or genotoxicity studies have been conducted. 
 
No studies have been conducted to evaluate the effects of this treatment on fertility, reproduction, and 
development. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Cryostor CS10 
Sodium chloride 
Human albumin 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
Tecartus is stable for 1 year when stored frozen in the vapour phase of liquid nitrogen (≤ − 150°C). 
 
Tecartus is stable at room temperature (20 °C to 25 °C) for up to 3 hours after thawing. However, 
Tecartus infusion should begin within 30 minutes of thaw completion and the total infusion time 
should not exceed 30 min. Thawed product should not be refrozen. 
 
6.4 Special precautions for storage 
 
Tecartus must be stored in the vapour phase of liquid nitrogen (≤ − 150 °C) and must remain frozen 
until the patient is ready for treatment to ensure viable live autologous cells are available for patient 
administration. 
 
For storage conditions after thawing of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container and special equipment for use, administration or 

implantation 
 
Ethylene-vinyl acetate cryostorage bag with sealed addition tube and two available spike ports, 
containing approximately 68 mL of cell dispersion. 



 
 

19 

 
One cryostorage bag is individually packed in a shipping metal cassette. 
 
6.6 Special precautions for disposal and other handling 
 
Irradiation could lead to inactivation of the product. 
 
Precautions to be taken for the transport and disposal of the medicinal product 
 
Tecartus should be transported within the facility in closed, break-proof, leak-proof containers.  
 
Tecartus contains genetically modified human blood cells. Local guidelines on handling of waste of 
human-derived material should be followed for unused medicinal products or waste material. All 
material that has been in contact with Tecartus (solid and liquid waste) should be handled and 
disposed of in accordance with local guidelines on handling of waste of human-derived material.  
 
Accidental exposure to Tecartus must be avoided. Local guidelines on handling of human-derived 
material should be followed in case of accidental exposure, which may include washing of the 
contaminated skin and removal of contaminated clothes. Work surfaces and materials which have 
potentially been in contact with Tecartus must be decontaminated with appropriate disinfectant. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Kite Pharma EU B.V. 
Tufsteen 1 
2132 NT Hoofddorp 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1492/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/


 
 

20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE CONDITIONAL 
MARKETING AUTHORISATION 

 
 



 
 

21 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance 
 
Kite Pharma, Inc. 
2355 Utah Avenue 
El Segundo 
California 
CA 90245 
United States 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Kite Pharma EU B.V. 
Tufsteen 1 
2132 NT Hoofddorp 
The Netherlands 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



 
 

22 

• Additional risk minimisation measures 
 
Key elements: 
 
Availability of tocilizumab and site qualification 
 
To minimise the risks associated with the treatment of Tecartus, the MAH must ensure that hospitals 
and their associated centres that dispense Tecartus are specially qualified in accordance with the 
agreed controlled distribution program. 
 
The MAH must ensure on-site, immediate access to at least 1 dose of tocilizumab for each patient as 
cytokine release syndrome (CRS) management medication prior to treating patients. Hospitals and 
their associated centres should have access to an additional dose of tocilizumab within 8 hours of each 
previous dose. 
 
Tecartus will only be supplied to hospitals and associated centres that are qualified and only if the 
healthcare professionals (HCP) involved in the treatment of a patient have completed the educational 
program. 
 
Educational program – Prior to the launch of Tecartus in each Member State the MAH must agree 
the content and format of the educational materials with the National Competent Authority. 
 
HCP Educational program 
 
The MAH shall ensure that in each Member State where Tecartus is marketed, all HCPs who are 
expected to prescribe, dispense, and administer Tecartus shall be provided with a guidance document 
to: 

– provide information about the safety and efficacy long-term follow up study and the 
importance of contributing to such a study 

– facilitate identification of CRS and serious neurologic adverse reactions 
– facilitate management of the CRS and serious neurologic adverse reactions 
– ensure adequate monitoring of CRS and serious neurologic adverse reactions 
– facilitate provision of all relevant information to patients 
– ensure that adverse reactions are adequately and appropriately reported 
– ensure that detailed instructions about the thawing procedure are provided 
– before treating a patient, ensure that at least 1 dose of tocilizumab for each patient is 

available on site. The qualified treatment centre must have access to additional doses of 
tocilizumab within 8 hours 
 

Patient Educational program 
 
To inform and explain to patients: 

– the risks of CRS and serious neurologic adverse reactions, associated with Tecartus 
– the need to report the symptoms to their treating doctor immediately 
– the need to remain in the proximity of the location where Tecartus was received for at 

least 4 weeks following Tecartus infusion 
– the need to carry the patient alert card at all times 

 



 
 

23 

• Obligation to conduct post-authorisation measures 
 
The MAH shall complete, within the stated timeframe, the below measures: 
 
Description Due date 
In order to further characterise the long-term efficacy and 
safety of Tecartus in adult patients with relapsed or refractory 
Mantle cell Lymphoma (MCL) the MAH shall conduct and 
submit the results of a prospective study based on data from a 
registry, according to an agreed protocol. 

Interim reports to be submitted in 
accordance with the RMP. 
 
30 June 2042 

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 
 
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) 
No 726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 

Description Due date 

In order to confirm the long-term efficacy and safety of Tecartus in adult 
patients with relapsed or refractory MCL and the Benefit/Risk balance in the 
female, elderly and severely diseased patients, the MAH shall submit the 
results of a prospective study investigating efficacy and safety based on data 
from the same registry used to characterise the long-term efficacy and safety 
of Tecartus, according to an agreed protocol. 

30 September 
2025 

In order to confirm the long-term efficacy and safety of Tecartus in adult 
patients with relapsed or refractory MCL the MAH shall submit the 
24 months follow-up data from all treated patients in cohort 1 of the pivotal 
study ZUMA-2. 

31 March 2022 

 
  



 
 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 
  



 
 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



 
 

26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
METAL CASSETTE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tecartus 0.4 – 2 × 108 cells dispersion for infusion 
autologous anti-CD19-transduced CD3+ cells (CAR+ viable T cells) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Autologous human T cells transduced with retroviral vector encoding an anti-CD19 chimeric antigen 
receptor (CAR) with a target dose of 2 × 106 anti-CD19 CAR positive viable T cells/kg. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Cryostor CS10, human albumin, sodium chloride.  
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Dispersion for infusion 
One sterile infusion bag. 
Contents: approximately 68 mL of cell dispersion. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Do not irradiate. 
For intravenous use only. 
Gently mix the contents of the bag while thawing. 
Do NOT use a leukodepleting filter. 
STOP confirm patient ID prior to infusion. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
For autologous use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 
 

27 

9. SPECIAL STORAGE CONDITIONS 
 
Store frozen in vapour phase of liquid nitrogen ≤ − 150 °C. 
Do not refreeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Contains genetically-modified cells. 
Unused medicine or waste material must be disposed of in compliance with the local guidelines on 
handling of waste of human-derived material. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Kite Pharma EU B.V. 
Tufsteen 1 
2132 NT Hoofddorp  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1492/001 
 
 
13. BATCH NUMBER, DONATION AND PRODUCT CODES 
 
Lot: 
Kite Patient ID: 
Additional Patient ID: 
Patient Name: 
Patient DOB: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
Not applicable. 
 
 



 
 

28 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
Not applicable. 



 
 

29 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INFUSION BAG 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Tecartus 0.4 – 2 × 108 cells dispersion for infusion 
autologous anti-CD19-transduced CD3+ cells (CAR+ viable T cells) 
For intravenous use only. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER, DONATION AND PRODUCT CODES 
 
Lot: 
Kite Patient ID: 
Additional Patient ID: 
Patient Name: 
Patient DOB: 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Contents: approximately 68 mL of cell dispersion. 
 
 
6. OTHER 
 
For autologous use only. 
Verify patient ID. 
  



 
 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



 
 

31 

Package leaflet: Information for the patient 
 

Tecartus 0.4 – 2 × 108 cells dispersion for infusion 
autologous anti-CD19-transduced CD3+ cells (CAR+ viable T cells) 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you are given this medicine because it contains important 
information for you. 
– Keep this leaflet. You may need to read it again. 
– Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on 

it. 
– Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to 

hospital. 
– If you have any further questions, ask your doctor or nurse. 
– If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Tecartus is and what it is used for 
2. What you need to know before you are given Tecartus 
3. How Tecartus is given 
4. Possible side effects 
5. How to store Tecartus 
6. Contents of the pack and other information 
 
 
1. What Tecartus is and what it is used for 
 
Tecartus is a gene therapy medicine used for treating mantle cell lymphoma in adults. It is used when 
other medicines have stopped working for you (relapsed or refractory mantle cell lymphoma). The 
medicine is made specially for you from your own white blood cells that have been modified and are 
known as autologous anti-CD19-transduced CD3+ cells. 
 
Mantle cell lymphoma is a cancer of a part of the immune system (the body’s defences). It affects a 
type of white blood cell called B-lymphocytes. In mantle cell lymphoma, B-lymphocytes grow in an 
uncontrolled way and build up in the lymph tissue, bone marrow or blood. 
 
How Tecartus works 
The white blood cells are taken from your blood and are genetically modified so that they can target 
the cancer cells in your body. When Tecartus is infused into your blood, the modified white blood 
cells will kill the cancer cells. 
 
 
2. What you need to know before you are given Tecartus 
 
You are not to be given Tecartus 
– if you are allergic to any of the ingredients of this medicine (listed in section 6). If you think you 

may be allergic, ask your doctor for advice. 
– if you can’t receive the medicine to reduce the number of white blood cells in your blood 

(lymphodepleting chemotherapy) (see also section 3, How Tecartus is given). 
 



 
 

32 

Warnings and precautions 
Tecartus is made from your own white blood cells and should only be given to you (autologous use).  
 
Tests and checks 
Before you are given Tecartus your doctor will: 
• Check your lungs, heart, kidney and blood pressure. 
• Look for signs of infection or inflammation; and decide whether you need to be treated before 

you are given Tecartus. 
• Check if your cancer is getting worse. 
• Look for signs of graft-versus-host disease that can happen after a transplant. This happens 

when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, 
diarrhoea and bloody stools. 

• Check your blood for uric acid and for how many cancer cells there are in your blood. This will 
show if you are likely to develop a condition called tumour lysis syndrome. You may be given 
medicines to help prevent the condition. 

• Check for hepatitis B, hepatitis C or HIV infection. 
• Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next 

few months. 
• Check if you have previously received a treatment that attaches to the protein called CD19. 
 
In some cases, it might not be possible to go ahead with the planned treatment with Tecartus. If 
Tecartus infusion is delayed for more than 2 weeks after you have received lymphodepleting 
chemotherapy you may have to receive more chemotherapy (see also section 3, How Tecartus is 
given). 
 
After you have been given Tecartus 
Tell your doctor or nurse immediately or get emergency help right away if you have any of the 
following: 
• Chills, extreme tiredness, weakness, dizziness, headache, cough, shortness of breath, rapid or 

irregular heartbeat, severe nausea, vomiting, or diarrhoea which may be symptoms of a 
condition known as cytokine release syndrome. Take your temperature twice a day for 3 to 
4 weeks after treatment with Tecartus. If your temperature is high, see your doctor immediately. 

• Fits, shaking, or difficulty speaking or slurred speech, loss of consciousness or decreased level 
of consciousness, confusion and disorientation, loss of balance or coordination. 

• Fever (e.g. temperature above 38°C), which may be a symptom of an infection. 
• Extreme tiredness, weakness and shortness of breath, which may be symptoms of a lack of red 

blood cells. 
• Bleeding or bruising more easily, which may be symptoms of low levels of cells in the blood 

known as platelets. 
 
If any of the above apply to you (or you are not sure), talk to your doctor or nurse.  
 
Your doctor will regularly check your blood counts as the number of blood cells and other blood 
components may decrease. 
 
You will be asked to enrol in a registry for at least 15 years in order to better understand the long-term 
effects of Tecartus.  
 
Do not donate blood, organs, tissues, or cells for transplants. 
 
Children and adolescents 
Tecartus should not be used in children and adolescents below 18 years of age. 
 
Other medicines and Tecartus 
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. 
 



 
 

33 

Before you are given Tecartus tell your doctor or nurse if you are taking any medicines that weaken 
your immune system such as corticosteroids, since these medicines may interfere with the effect of 
Tecartus. 
 
In particular, you must not be given certain vaccines called live vaccines: 
• In the 6 weeks before you are given the short course of lymphodepleting chemotherapy to 

prepare your body for the Tecartus cells. 
• During Tecartus treatment. 
• After treatment while the immune system is recovering. 
 
Talk to your doctor if you need to have any vaccinations. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before being given this medicine. This is because the effects of Tecartus in 
pregnant or breast-feeding women are not known, and it may harm your unborn baby or your 
breast-fed child. 
• If you are pregnant or think you may be pregnant after treatment with Tecartus, talk to your 

doctor immediately. 
• You will be given a pregnancy test before treatment starts. Tecartus should only be given if the 

results show you are not pregnant. 
 
Discuss pregnancy with your doctor if you have received Tecartus. 
 
Driving and using machines 
Tecartus can cause problems such as altered or decreased consciousness, confusion and seizures (fits) 
in the 8 weeks after it is given. 
 
Do not drive, use machines, or take part in activities that need you to be alert for at least 8 weeks after 
your Tecartus treatment or until your doctor tells you that you have completely recovered. 
 
Tecartus contains sodium, dimethylsulfoxide (DMSO) and gentamicin 
This medicine contains 300 mg sodium (main component of cooking/table salt) in each infusion. This 
is equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult. It also 
contains DMSO and gentamicin which may cause severe hypersensitivity reactions. 
 
 
3. How Tecartus is given 
 
Tecartus will always be given to you by a healthcare professional. 
 
• Since Tecartus is made from your own white blood cells, your cells will be collected from you 

to prepare your medicine. Your doctor will take some of your blood using a catheter placed in 
your vein (a procedure call leukapheresis). Some of your white blood cells are separated from 
your blood and the rest of your blood is returned to your vein. This can take 3 to 6 hours and 
may need to be repeated. 

• Your white blood cells are sent away to a manufacturing center to make your Tecartus. It 
usually takes about 2 to 3 weeks to make Tecartus but the time may vary. 

 
Medicines given before Tecartus treatment 
A few days before you receive Tecartus, you will be given lymphodepleting chemotherapy, which will 
allow the modified white blood cells in Tecartus to multiply in your body when the medicine is given 
to you. 
 



 
 

34 

During the 30 to 60 minutes before you are given Tecartus you may be given other medicines. This is 
to help prevent infusion reactions and fever. These other medicines may include: 
• Paracetamol. 
• An antihistamine such as diphenhydramine. 
 
How you are given Tecartus 
Tecartus will always be given to you by a doctor in a qualified treatment centre. 
 
• Tecartus is given in a single dose. 
• Your doctor or nurse will give you a single infusion of Tecartus through a catheter placed into 

your vein (intravenous infusion) over about 30 minutes. 
• Tecartus is the genetically modified version of your white blood cells. Your healthcare 

professional handling the treatment will therefore take appropriate precautions (wearing gloves 
and glasses) to avoid potential transmission of infectious diseases and will follow local 
guidelines on handling of waste of human-derived material to clean up or dispose of any 
material that has been in contact with it. 

 
After you are given Tecartus 
• You should stay close to the hospital where you were treated for at least 4 weeks after Tecartus 

treatment. Your doctor will recommend that you return to the hospital daily for at least 10 days 
or that you stay at the hospital as an in-patient for the first 10 days after Tecartus treatment. This 
is so your doctor can check if your treatment is working and help you if you have any side 
effects. 

 
If you miss any appointments, call your doctor or your treatment centre as soon as possible to 
reschedule your appointment. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not try 
to treat your side effects on your own. 
 
Tecartus can cause side effects that may be serious or life-threatening. Get urgent medical attention 
if you get any of the following side effects after the Tecartus infusion. 
 
Very common: may affect more than 1 in 10 people 
– Fever, chills, reduced blood pressure which may cause symptoms such as dizziness, 

lightheadedness, fluid in the lungs, which may be severe and can be fatal (all symptoms of a 
condition called cytokine release syndrome). 

– Loss of consciousness or decreased level of consciousness, confusion or memory loss due to 
disturbances of brain function, difficulty speaking or slurred speech, involuntary shaking 
(tremor), fits (seizures), sudden confusion with agitation, disorientation, hallucination or 
irritability (delirium). 

– Fever, chills, which may be signs of an infection. 
 
Other possible side effects 
Other side effects are listed below. If these side effects become severe or serious, tell your doctor 
immediately. 
 
Very common: may affect more than 1 in 10 people 
– Abnormally low number of white blood cells, which may increase your risk of infection.  
– Low number of cells that help clot the blood (thrombocytopenia), alteration of the blood’s 

ability to form clots: symptoms can include excessive or prolonged bleeding or bruising. 
– High blood pressure. 
– Decrease in the number of red blood cells (cells that carry oxygen): symptoms can include 

extreme tiredness with a loss of energy. 



 
 

35 

– Extreme tiredness. 
– Fast or slow heartbeat. 
– Decrease of oxygen reaching body tissues: symptoms can include changes to the colour of your 

skin, confusion, rapid breathing. 
– Shortness of breath, cough. 
– Nausea, constipation, diarrhoea, abdominal pain, vomiting, difficulty swallowing. 
– Muscle pain, joint pain, bone pain, pain in the extremities of the body. 
– Lack of energy or strength, muscular weakness, difficulty moving, muscle spasm. 
– Headache. 
– Kidney problems causing your body to hold onto fluid, build-up of fluids in tissue (oedema) 

which can lead to weight gain and difficulty in breathing, decrease output of urine. 
– High levels of uric acid seen in blood tests. 
– Low levels of sodium, phosphate, potassium or calcium seen in blood tests. 
– Decreased appetite, sore mouth. 
– Difficulty sleeping, anxiety. 
– Swelling in the limbs, fluid around the lungs (pleural effusion). 
– Skin rash. 
– Low levels of immunoglobulins seen in blood test, which may lead to infections. 
– Increase in liver enzymes seen in blood tests. 
– Blood clots: symptoms can include pain in the chest or upper back, difficulty breathing, 

coughing up blood or cramping pain, swelling in a single leg, warm and darkened skin around 
the painful area. 

– Nerve pain. 
 
Common: may affect up to 1 in 10 people 
– Low levels of albumin seen in blood tests. 
– Excessive bleeding. 
– Irregular heartbeat (arrhythmia). 
– Loss of control of body movements. 
– Dry mouth, dehydration. 
– Breathlessness (respiratory failure). 
– Difficulty breathing which makes you unable to speak in full sentence, cough due to fluid in the 

lungs. 
– Increase of the pressure inside your skull. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Tecartus 
 
The following information is intended for doctors only. 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the container label and infusion bag 
after EXP. 
 
Store frozen in vapour phase of liquid nitrogen ≤ − 150 °C until thawed for use. 
Do not refreeze. 
 
This medicine contains genetically modified human blood cells. Local guidelines on handling of waste 
of human-derived material should be followed for unused medicinal product or waste material. As this 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 
 

36 

medicine will be given by qualified healthcare professionals, they are responsible for the correct 
disposal of the product. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Tecartus contains 
The active substance is autologous anti-CD19-transduced CD3+ cells. Each patient-specific single 
infusion bag contains a dispersion of anti-CD19 CAR T cells in approximately 68 mL for a target dose 
of 2 × 106 anti-CD19 CAR-positive viable T cells/kg. 
The other ingredients (excipients) are: Cryostor CS10, sodium chloride, human albumin. See section 2 
“Tecartus contains sodium”. 
 
What Tecartus looks like and contents of the pack 
Tecartus is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag 
individually packed in a metal cassette. A single infusion bag contains approximately 68 mL of cell 
dispersion. 
 
Marketing Authorisation Holder 
Kite Pharma EU B.V. 
Tufsteen 1 
2132 NT Hoofddorp 
The Netherlands 
 
Manufacturer 
Kite Pharma EU B.V. 
Tufsteen 1 
2132 NT Hoofddorp 
The Netherlands 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 
België/Belgique/Belgien 
Gilead Sciences Belgium SRL-BV 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Lietuva 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

България 
Gilead Sciences Ireland UC 
Тел.: + 353 (0) 1 686 1888 
 

Luxembourg/Luxemburg 
Gilead Sciences Belgium SRL-BV 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Česká republika 
Gilead Sciences s.r.o. 
Tel: + 420 910 871 986 
 

Magyarország 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Danmark 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Malta 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Deutschland 
Gilead Sciences GmbH 
Tel: + 49 (0) 89 899890-0 
 

Nederland 
Gilead Sciences Netherlands B.V. 
Tel: + 31 (0) 20 718 36 98 
 



 
 

37 

Eesti 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

Norge 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Ελλάδα 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Österreich 
Gilead Sciences GesmbH 
Tel: + 43 1 260 830 
 

España 
Gilead Sciences, S.L. 
Tel: + 34 91 378 98 30 
 

Polska 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

France 
Gilead Sciences 
Tél : + 33 (0) 1 46 09 41 00 
 

Portugal 
Gilead Sciences, Lda. 
Tel: + 351 21 7928790 
 

Hrvatska 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

România 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ireland 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 214 825 999 
 

Slovenija 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ísland 
Gilead Sciences Sweden AB 
Sími: + 46 (0) 8 5057 1849 
 

Slovenská republika 
Gilead Sciences Slovakia s.r.o. 
Tel: + 421 232 121 210 
 

Italia 
Gilead Sciences S.r.l. 
Tel: + 39 02 439201 
 

Suomi/Finland 
Gilead Sciences Sweden AB 
Puh/Tel: + 46 (0) 8 5057 1849 
 

Κύπρος 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Sverige 
Gilead Sciences Sweden AB 
Tel: + 46 (0) 8 5057 1849 
 

Latvija 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

United Kingdom 
Gilead Sciences Ltd 
Tel: + 44 (0) 8000 113700 
 

 
This leaflet was last revised in 
 
This medicine has been given ‘conditional approval’.  
This means that there is more evidence to come about this medicine. 
The European Medicines Agency will review new information on this medicine at least every year and 
this leaflet will be updated as necessary. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
<------------------------------------------------------------------------------------------------------------------------> 
 

http://www.ema.europa.eu/


 
 

38 

The following information is intended for healthcare professionals only: 
 
It is important that you read the entire content of this procedure prior to administering Tecartus.  
 
Precautions to be taken before handling or administering the medicinal product 
• Tecartus contains genetically-modified cells. Local guidelines on handling of human-derived 

material applicable for such products should be followed. 
• Tecartus should be transported within the facility in closed, break-proof, leak-proof containers. 
• Tecartus is prepared from autologous blood of the patient collected by leukapheresis. Patient 

leukapheresis material and Tecartus may carry a risk of transmitting infectious viruses to 
healthcare professionals (HCP) handling the product. Accordingly, HCP should employ 
appropriate precautions (wearing gloves and glasses) when handling leukapheresis material or 
Tecartus to avoid potential transmission of infectious diseases. 

 
Preparation for infusion 
• Verify that the patient’s identity (ID) matches the patient identifiers on the Tecartus metal 

cassette. 
• The Tecartus infusion bag must not be removed from the metal cassette if the information on the 

patient-specific label does not match the intended patient. 
• Once the patient’s ID is confirmed, remove the infusion bag from the metal cassette. 
• Check that the patient information on the metal cassette label matches that on the bag label. 
• Inspect the infusion bag for any breaches of container integrity before thawing. If the bag is 

compromised, follow the local guidelines for handling of waste of human-derived material (or 
immediately contact Kite). 

• Place the infusion bag inside a second bag. 
• Thaw Tecartus at approximately 37 °C using either a water bath or dry thaw method until there 

is no visible ice in the infusion bag. Gently mix the contents of the bag to disperse clumps of 
cellular material. If visible cell clumps remain, continue to gently mix the contents of the bag. 
Small clumps of cellular material should disperse with gentle manual mixing. Tecartus should 
not be washed, spun down, and/or re-suspended in new media prior to infusion. Thawing should 
take approximately 3 to 5 minutes. 

• Once thawed, Tecartus is stable at room temperature (20 °C – 25 °C) for up to 3 hours. 
However, the infusion should begin within 30 minutes of thaw completion. 

 
Do NOT use a leukodepleting filter. 
 
Administration 
• The medicine must be administered in a qualified treatment centre by a physician(s) with 

experience in the treatment of haematological malignancies and trained for administration and 
management of patients treated with Tecartus. 

• Ensure that at least 1 dose of tocilizumab per patient and emergency equipment are available 
prior to infusion and during the recovery period. Hospitals and associated centres should have 
access to an additional dose of tocilizumab within 8 hours of each previous dose.  

• The patient’s identity should be matched with the patient identifiers on the infusion bag.  
• Tecartus is for autologous use only.  
• Tecartus should be administered as an intravenous infusion using latex-free intravenous tubing 

without a leukocyte depleting filter within 30 minutes by either gravity or a peristaltic pump.  
• Gently agitate the bag during infusion to prevent cell clumping. All contents of the infusion bag 

should be infused.  
• Sterile sodium chloride 9 mg/mL (0.9%) (0.154 mmol sodium per mL) solution for injection 

should be used to prime the tubing prior to infusion as well as rinse it afterwards. When the full 
volume of Tecartus has been infused, the infusion bag should be rinsed with 10 to 30 mL 
sodium chloride 9 mg/mL (0.9%) solution for injection by back priming to ensure as many cells 
as possible are infused into the patient.  

 



 
 

39 

Disposal of Tecartus 
• Any unused medicinal product or waste material that has been in contact with Tecartus (solid 

and liquid waste) should be handled and disposed of in accordance with local guidelines on 
handling of waste of human-derived material. Work surfaces and material which have 
potentially been in contact with Tecartus must be decontaminated with appropriate disinfectant. 
 

Accidental exposure  
• Accidental exposure to Tecartus must be avoided. Local guidelines on handling of 

human-derived material should be followed in case of accidental exposure, which may include 
washing of the contaminated skin, removal of contaminated clothes. 

  



 
 

40 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX IV 

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING 
AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY 

 

 



 
 

41 

Conclusions presented by the European Medicines Agency on: 

• Conditional marketing authorisation 

The CHMP having considered the application is of the opinion that the risk-benefit balance is 
favourable to recommend the granting of the conditional marketing authorisation as further 
explained in the European Public Assessment Report. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURESFOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
	CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETINGAUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY