Anthropometric Measurements as Predictors of Low Birth Weight Among Tanzanian Neonates: A Hospital-Based Study
November 7, 2025
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Brand Name :
Tecartus
Synonyms :
brexucabtagene autoleucel
Class :
Antineoplastic, Anti-CD19 CAR-T cell
Brand Name :
Tecartus
Synonyms :
brexucabtagene autoleucel
Class :
Antineoplastic, Anti-CD19 CAR-T cell
Dosage Forms & StrengthsÂ
IV solutionÂ
CAR-positive viable T cells  2 x 10(6)/kg, with a maximum of 2 x 10(8)Â
It is indicated for relapsed or refractory mantle cell lymphoma
Prior to Therapy:
Before injecting this medication, give cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV as a lymphodepleting chemotherapy regimen on the 4th, 5th, and 3rd days
The dosage of CAR-positive viable T cells 2 x 10(6)/kg, with a maximum of 2 x 10(8)
Each single infusion bag has a suspension of chimeric antigen receptor (CAR)-positive T cells in about 68 mL
Dose Adjustments
Management of Cytokine release syndrome:
Grade 1
Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
If symptoms persist after 24 hours, administer tocilizumab at a dose of 8 mg/kg intravenously over 1 hour, with a maximum dose not exceeding 800 mg
Grade 2
Moderate intervention is required for symptoms, such as oxygen requirement <40% FiO2 hypotension responsive to fluids, a low dose of one vasopressor, or Grade 2 organ toxicity
Administer tocilizumab at a dose of 8 mg/kg intravenously over 1 hour, with a maximum dose not exceeding 800 mg
Repeat tocilizumab every 8 hours as necessary if there is no response to intravenous fluids or if supplemental oxygen needs to increase; do not exceed three doses within a 24-hour period or a total of 4 doses
If there is improvement, discontinue tocilizumab
If there is no improvement after 24 hours of starting tocilizumab, administer methylprednisolone (1 mg/kg intravenously twice daily) or dexamethasone (10 mg intravenously every 6 hours) until Grade 1, then taper corticosteroids
Grade 3
Symptoms necessitate aggressive intervention, such as oxygen requirement ≥40% FiO2, hypotension requiring high-dose or multiple vasopressors, Grade 3 organ toxicity, or Grade 4 transaminitis
Administer tocilizumab as outlined in Grade 2; discontinue if there is improvement
Prescribe corticosteroid doses as specified for Grade 2; taper if there is improvement or manage as Grade 4 if there is no improvement
Grade 4
Symptoms are posing a risk to life, necessitating ventilator assistance, ongoing venovenous hemodialysis, or organ toxicity of Grade 4 (excluding transaminitis)
Administer Tocilizumab according to Grade 2; if there's an improvement, discontinue
Inject Methylprednisolone 1000 mg intravenously daily for three days; reduce if there's an improvement or contemplate alternative immunosuppressants if no improvement is observed
Grading and management of Neurologic toxicity:
For Grades 2, 3, or 4: Contemplate the use of non-sedating antiseizure medications (such as levetiracetam) as a preventive measure against seizures
Grade 1
In the presence of concurrent Cytokine Release Syndrome (CRS), administer tocilizumab following the guidelines for Grade 1 CRS. If no concurrent CRS is observed, provide supportive care
Grade 2 with concurrent CRS
Administer tocilizumab following the specified doses for CRS Grade 2. If there's no improvement within 24 hours of initiating tocilizumab, administer 10 mg of dexamethasone intravenously every 6 hours if the individual is not already using other corticosteroids. Continue the use of dexamethasone until the event reaches Grade 1 or lower, then gradually taper over a 3-day period
Grade 2 or 3 without concurrent Cytokine Release Syndrome (CRS)
Initiate dexamethasone at 10 mg intravenously every 6 hours if the individual is not already using other corticosteroids. Continue this regimen until the event reaches Grade 1 or lower, then taper over a 3-day period. If the situation is Grade 3 and there is no improvement, handle it as Grade 4, employing intravenous methylprednisolone
Grade 3 with concurrent CRS
Administer tocilizumab following the doses specified for CRS Grade 2. Additionally, initiate dexamethasone at 10 mg intravenously every 6 hours if the person is not already using other corticosteroids. Continue the dexamethasone regimen until the event reaches Grade 1 or lower, then taper over a 3-day period
Grade 4 with concurrent Cytokine Release Syndrome (CRS)
Initiate tocilizumab following the specified doses for CRS Grade 2. Simultaneously, administer methylprednisolone at 1000 mg intravenously per day for three days, starting with the first dose of tocilizumab. If improvement is observed, proceed with the management as outlined above
Grade 4 without concurrent CRS
Administer methylprednisolone at 1000 mg intravenously per day for three days. If improvement occurs, manage the situation as described above. If there is no improvement, consider exploring alternative immunosuppressants
Acute Lymphoblastic Leukemia(All)Â
Approved for adult patients experiencing refractory or relapsed B-cell precursor acute lymphoblastic leukemia (ALL), the treatment regimen involves lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the intravenous infusion of brexucabtagene autoleucel
Before commencing lymphodepleting chemotherapy, ensure the availability of brexucabtagene autoleucel
Lymphodepleting chemotherapy involves the intravenous administration of fludarabine at 25 mg/m2 over 30 minutes on the fourth, third, and second day preceding the infusion of brexucabtagene autoleucel
Additionally, cyclophosphamide is given at 900 mg/m2 intravenously over 60 minutes on the second day before the infusion of brexucabtagene autoleucel
Intravenous infusion of brexucabtagene autoleucel is exclusively for autologous use and should be administered post-completion of lymphodepleting chemotherapy
The dosage is determined based on the quantity of chimeric antigen receptor (CAR)-positive viable T cells. The target dose is 1x 106 CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1x 108 CAR-positive viable T cells
Dose Adjustments
Management of Cytokine release syndrome:
Grade 1
Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
If symptoms persist after 24 hours, administer tocilizumab at a dose of 8 mg/kg intravenously over 1 hour, with a maximum dose not exceeding 800 mg
Grade 2
Moderate intervention is required for symptoms, such as oxygen requirement <40% FiO2 hypotension responsive to fluids, a low dose of one vasopressor, or Grade 2 organ toxicity
Administer tocilizumab at a dose of 8 mg/kg intravenously over 1 hour, with a maximum dose not exceeding 800 mg
Repeat tocilizumab every 8 hours as necessary if there is no response to intravenous fluids or if supplemental oxygen needs to increase; do not exceed three doses within a 24-hour period or a total of 4 doses
If there is improvement, discontinue tocilizumab
If there is no improvement after 24 hours of starting tocilizumab, administer methylprednisolone (1 mg/kg intravenously twice daily) or dexamethasone (10 mg intravenously every 6 hours) until Grade 1, then taper corticosteroids
Grade 3
Symptoms necessitate aggressive intervention, such as oxygen requirement ≥40% FiO2, hypotension requiring high-dose or multiple vasopressors, Grade 3 organ toxicity, or Grade 4 transaminitis
Administer tocilizumab as outlined in Grade 2; discontinue if there is improvement
Prescribe corticosteroid doses as specified for Grade 2; taper if there is improvement or manage as Grade 4 if there is no improvement
Grade 4
Symptoms are posing a risk to life, necessitating ventilator assistance, ongoing venovenous hemodialysis, or organ toxicity of Grade 4 (excluding transaminitis)
Administer Tocilizumab according to Grade 2; if there's an improvement, discontinue
Inject Methylprednisolone 1000 mg intravenously daily for three days; reduce if there's an improvement or contemplate alternative immunosuppressants if no improvement is observed
Grading and management of Neurologic toxicity:
For Grades 2, 3, or 4: Contemplate the use of non-sedating antiseizure medications (such as levetiracetam) as a preventive measure against seizures
Grade 1
In the presence of concurrent Cytokine Release Syndrome (CRS), administer tocilizumab following the guidelines for Grade 1 CRS. If no concurrent CRS is observed, provide supportive care
Grade 2 with concurrent CRS
Administer tocilizumab following the specified doses for CRS Grade 2. If there's no improvement within 24 hours of initiating tocilizumab, administer 10 mg of dexamethasone intravenously every 6 hours if the individual is not already using other corticosteroids. Continue the use of dexamethasone until the event reaches Grade 1 or lower, then gradually taper over a 3-day period
Grade 2 or 3 without concurrent Cytokine Release Syndrome (CRS)
Initiate dexamethasone at 10 mg intravenously every 6 hours if the individual is not already using other corticosteroids. Continue this regimen until the event reaches Grade 1 or lower, then taper over a 3-day period. If the situation is Grade 3 and there is no improvement, handle it as Grade 4, employing intravenous methylprednisolone
Grade 3 with concurrent CRS
Administer tocilizumab following the doses specified for CRS Grade 2. Additionally, initiate dexamethasone at 10 mg intravenously every 6 hours if the person is not already using other corticosteroids. Continue the dexamethasone regimen until the event reaches Grade 1 or lower, then taper over a 3-day period
Grade 4 with concurrent Cytokine Release Syndrome (CRS)
Initiate tocilizumab following the specified doses for CRS Grade 2. Simultaneously, administer methylprednisolone at 1000 mg intravenously per day for three days, starting with the first dose of tocilizumab. If improvement is observed, proceed with the management as outlined above
Grade 4 without concurrent CRS
Administer methylprednisolone at 1000 mg intravenously per day for three days. If improvement occurs, manage the situation as described above. If there is no improvement, consider exploring alternative immunosuppressants
Safety and efficacy are not seen in pediatricsÂ
Refer to the adult dosingÂ
It may enhance the immunosuppressive effects when combined with risankizumab
clofarabine and brexucabtagene autoleucel increase the effect of each other by immunosuppression
By immunosuppressive effects, the effects of the other drug increase and results in risk of infection.
By immunosuppressive effects, the both the drugs action either decreases or results in risk of infection.
when melphalan is combined with brexucabtagene autoleucel, the risk or severity of adverse effects can be increased
when both the drugs combine the effect of both drugs increases by immunosuppressive effects
 when both the drugs are combined, the immunosuppressive effects of both the drugs increases and lead to an increased risk of infection     
increases the risk of serious infection due to immunosuppression rit
either of the drugs increases the effect of one another causing immunosuppression risk of infection increases on administering both the drugs simultaneously
interaction raises immunosuppressive effects and risk of infection
when taken in combination, gemcitabine and brexucabtagene increase the effect of one another due to immunosuppression/risk of infection
increase immunosuppressive effects and risk of infection
increase immunosuppressive effects and risk of infection
either of the drug in combination increases the effect of the other due to immunosuppression/risk of infection
when both drugs are combined, there may be an increased risk of adverse effects  
when both drugs are combined, there may be an increased risk of infection Â
when both drugs are combined, there may be an increased risk of adverse effects 
may increase the immunosuppressive effects of each other
may enhance the immunosuppressive effects of each other
may increase the effects of each other
the effect of either of the drugs is increased due to immunosuppression
the potential for methemoglobinemia can be heightened when brexucabtagene autoleucel is used in conjunction with ambroxol
the risk or severity of methemoglobinemia may increase when brexucabtagene autoleucel is combined with articaine
combining brexucabtagene autoleucel with benzocaine may elevate the risk or severity of methemoglobinemia
the risk of methemoglobinemia can be increased with the combination of brexucabtagene autoleucel and benzyl alcohol
using brexucabtagene autoleucel alongside bupivacaine may heighten the risk or severity of methemoglobinemia
the risk severity of methemoglobinemia can be increased when brexucabtagene autoleucel is used in conjunction with capsaicin
the potential for methemoglobinemia can be increased when brexucabtagene autoleucel is combined with proparacaine
combining brexucabtagene autoleucel with ropivacaine may elevate the risk or severity of methemoglobinemia
the risk or severity of methemoglobinemia can be increased with the combination of brexucabtagene autoleucel and tetracaine
Actions and Spectrum:Â
Actions:Â
The action of brexucabtagene autoleucel involves activating the body’s immune system by utilizing autologous cellular immunotherapy. This process entails preparing the medication with cells derived from the patient’s own blood. The activated immune system then works to combat cancer cells, providing a targeted and personalized approach to treating mantle cell lymphoma and certain cases of acute lymphoblastic leukemia in adults that have returned or are unresponsive to other treatments.Â
Spectrum:Â
The spectrum of action for brexucabtagene autoleucel involves its efficacy in treating mantle cell lymphoma and specific cases of acute lymphoblastic leukemia in adults that have returned or are unresponsive to other treatments. This cellular immunotherapy, prepared using the patient’s own blood cells, activates the immune system to target and combat cancer cells. The personalized nature of this treatment allows for a focused and tailored approach within the realm of these particular hematologic malignancies.Â
Frequency not definedÂ
Severe InfectionsÂ
Neurologic ToxicitiesÂ
HypogammaglobulinemiaÂ
Cytokine Release SyndromeÂ
Prolonged CytopeniasÂ
Hemophagocytic-lymphohistiocytosis/Macrophage Activation SyndromeÂ
Hypersensitivity ReactionsÂ
Black Box Warning:Â
Cytokine Release Syndrome:Â
Reports indicate the occurrence of Cytokine Release Syndrome (CRS), including instances with fatal or life-threatening reactions in a majority of patients. This treatment is contraindicated for patients with active infections or inflammatory disorders. Severe or life-threatening CRS should be addressed using tocilizumab, with or without corticosteroids.Â
Neurological Toxicities:Â
Life-threatening neurological toxicities have been reported, potentially concurrent with CRS or after CRS resolution. Monitoring and providing supportive care and/or corticosteroids as necessary is recommended. Common neurological toxicities include encephalopathy, headache, tremor, aphasia, and delirium. A vigilant monitoring period of at least seven days at a certified healthcare facility following infusion is advised for signs and symptoms of neurologic toxicities.Â
Restricted Access Program:Â
This treatment is exclusively available under REMS, i.e., the Risk Evaluation and Mitigation Strategy known as the Yescarta and Tecartus REMS program. Additional details can be found at www.yescartatecartusrems.com or by contacting 1-844-454-KITE (5483).Â
REMS Requirements:Â
Healthcare facilities involved in dispensing and administering brexucabtagene autoleucel must enroll and adhere to the REMS requirements. Certified healthcare facilities must have immediate onsite access to tocilizumab and ensure for every patient, at least two doses of tocilizumab are available within 2 hours after brexucabtagene autoleucel IV infusion if needed for CRS treatment. Additionally, healthcare providers involved in prescribing, dispensing, or administering brexucabtagene autoleucel must undergo training on managing CRS and neurological toxicities.Â
Contraindication/Caution:Â
ContraindicationsÂ
CautionsÂ
Abstain from driving or engaging in activities involving heavy or potentially hazardous machinery for a minimum of eight weeks following TECARTUS infusionÂ
Undergo regular monitoring of blood countsÂ
Reach out to Kite at 1-844-454-KITE (5483) in case of a diagnosis of a secondary malignancy Â
Pregnancy consideration:Â Â
No data is available regarding the administration of the drug during pregnancy.Â
Breastfeeding warnings:Â Â
No data is available regarding the excretion of drug in breast milk.Â
Pregnancy category:Â
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: No data is available for the drug under this category.Â
Pharmacology:Â
In genetically modified autologous T-cell immunotherapy, a patient’s own T cells are reprogrammed to express a chimeric antigen receptor (CAR) targeting CD19. This CAR is designed to identify and bind to CD19-expressing malignant and normal B cells.Â
After the engagement of anti-CD19 CAR T-cells with CD19-expressing target cells, downstream signaling cascades are activated through the CD28 and CD3-zeta costimulatory domains.
These cascades result in T-cell activation, proliferation, the acquisition of effector functions, and the secretion of inflammatory cytokines and chemokines. The culmination of these events leads to the elimination of CD19-expressing cells through the killing mechanism.Â
Pharmacodynamics:Â
Following the infusion of TECARTUS, pharmacodynamic responses were assessed over a four-week period by measuring the transient increase in cytokines, chemokines, and other molecules in the blood. The analysis included levels of cytokines and chemokines such as IL-10, IL-6, IL-8, IL-15, TNF-α, sIL2Rα and IFN-Îł. After infusion, levels usually peaked eight days later and recovered to baseline in twenty-eight days on average.Â
Due to TECARTUS’s on-target effect, a phase of B cell aplasia is anticipated.Â
Pharmacokinetics:Â
AbsorptionÂ
Time to peak plasma concentration: 7-15 daysÂ
DistributionÂ
Median peak plasma concentration: 102.4 cells/mcL (responsive patients); 12 cells/mcL (nonresponsive [NR] patients)Â
MetabolismÂ
It is not applicable, as brexucabtagene autoleucel is a cellular therapy derived from the patient’s own white blood cells. Â
Elimination and ExcretionÂ
Area under the curve (AUC) for days 0-28: 1487 cells/mcLâ‹…days (responsive patients); 169.5 cells/mcLâ‹…days (NR patients)Â Â
Please note that the pharmacokinetic profile of brexucabtagene autoleucel is unique due to its nature as a personalized cellular immunotherapy.Â
Pharmacology:Â
In genetically modified autologous T-cell immunotherapy, a patient’s own T cells are reprogrammed to express a chimeric antigen receptor (CAR) targeting CD19. This CAR is designed to identify and bind to CD19-expressing malignant and normal B cells.Â
After the engagement of anti-CD19 CAR T-cells with CD19-expressing target cells, downstream signaling cascades are activated through the CD28 and CD3-zeta costimulatory domains. These cascades result in T-cell activation, proliferation, the acquisition of effector functions, and the secretion of inflammatory cytokines and chemokines.Â
The culmination of these events leads to the elimination of CD19-expressing cells through the killing mechanism.Â
Pharmacodynamics:Â
Following the infusion of TECARTUS, pharmacodynamic responses were assessed over a four-week period by measuring the transient increase in cytokines, chemokines, and other molecules in the blood. The analysis included levels of cytokines and chemokines such as IL-10, IL-6, IL-8, IL-15, TNF-α, sIL2Rα and IFN-γ.
After infusion, levels usually peaked eight days later and recovered to baseline in twenty-eight days on average. Due to TECARTUS’s on-target effect, a phase of B cell aplasia is anticipated.Â
Pharmacokinetics:Â
AbsorptionÂ
Time to peak plasma concentration: 7-15 daysÂ
DistributionÂ
Median peak plasma concentration: 102.4 cells/mcL (responsive patients); 12 cells/mcL (nonresponsive [NR] patients)Â
MetabolismÂ
It is not applicable, as brexucabtagene autoleucel is a cellular therapy derived from the patient’s own white blood cells. Â
Elimination and ExcretionÂ
Area under the curve (AUC) for days 0-28: 1487 cells/mcLâ‹…days (responsive patients); 169.5 cells/mcLâ‹…days (NR patients)Â Â
Please note that the pharmacokinetic profile of brexucabtagene autoleucel is unique due to its nature as a personalized cellular immunotherapy.Â
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