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Drug overview for KYMRIAH (tisagenlecleucel):
Generic name: TISAGENLECLEUCEL (TIS-a-JEN-lek-LOO-sel)
Drug class: Antineoplastic - CAR-T/TCR-T cell immunotherapy
Therapeutic class: Antineoplastics
Tisagenlecleucel is a CD19-directed genetically modified autologous T-cell immunotherapy.
No enhanced Uses information available for this drug.
Generic name: TISAGENLECLEUCEL (TIS-a-JEN-lek-LOO-sel)
Drug class: Antineoplastic - CAR-T/TCR-T cell immunotherapy
Therapeutic class: Antineoplastics
Tisagenlecleucel is a CD19-directed genetically modified autologous T-cell immunotherapy.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for KYMRIAH (tisagenlecleucel) have been approved by the FDA:
Indications:
B-cell acute lymphoblastic leukemia
Diffuse large B-cell lymphoma
Follicular lymphoma
Professional Synonyms:
Follicular B-cell lymphoma
Follicular B-cell non-Hodgkin's lymphoma
Indications:
B-cell acute lymphoblastic leukemia
Diffuse large B-cell lymphoma
Follicular lymphoma
Professional Synonyms:
Follicular B-cell lymphoma
Follicular B-cell non-Hodgkin's lymphoma
The following dosing information is available for KYMRIAH (tisagenlecleucel):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Administer a lymphodepleting regimen if needed before infusion of tisagenlecleucel. Confirm the availability of tisagenlecleucel before starting lymphodepleting regimen. Lymphodepleting regimen differs based on indication.
See Full Prescribing Information for additional information.
Do NOT use a leukodepleting filter.
Verify the patient's identity prior to infusion. Check that the patient's identity matches the patient identifiers on each infusion bag.
Premedicate with acetaminophen and an H1-antihistamine. Avoid prophylactic use of systemic corticosteroids as they may interfere with the activity of tisagenlecleucel.
Confirm availability of tocilizumab prior to infusion.
For autologous use only. For IV use only.
*Dosing of tisagenlecleucel is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
*Dosage for Pediatric B-cell ALL: For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.
For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.
For autologous use only. For IV use only.
*Dosing of tisagenlecleucel is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
*Young Adult B-cell ALL (up to 25 years of age): For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.
For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.
*Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma: Administer 0.6 to 6.0 x 108 CAR-positive viable T cells intravenously.
Administer a lymphodepleting regimen if needed before infusion of tisagenlecleucel. Confirm the availability of tisagenlecleucel before starting lymphodepleting regimen. Lymphodepleting regimen differs based on indication.
See Full Prescribing Information for additional information.
Do NOT use a leukodepleting filter.
Verify the patient's identity prior to infusion. Check that the patient's identity matches the patient identifiers on each infusion bag.
Premedicate with acetaminophen and an H1-antihistamine. Avoid prophylactic use of systemic corticosteroids as they may interfere with the activity of tisagenlecleucel.
Confirm availability of tocilizumab prior to infusion.
For autologous use only. For IV use only.
*Dosing of tisagenlecleucel is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
*Dosage for Pediatric B-cell ALL: For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.
For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.
For autologous use only. For IV use only.
*Dosing of tisagenlecleucel is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
*Young Adult B-cell ALL (up to 25 years of age): For patients 50 kg or less, administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight intravenously.
For patients above 50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) intravenously.
*Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma: Administer 0.6 to 6.0 x 108 CAR-positive viable T cells intravenously.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for KYMRIAH (tisagenlecleucel):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KYMRIAH (tisagenlecleucel):
Drug contraindication overview.
None.
None.
There are 0 contraindications.
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Infection |
| Pregnancy |
| Viral hepatitis B |
There are 0 moderate contraindications.
The following adverse reaction information is available for KYMRIAH (tisagenlecleucel):
Adverse reaction overview.
Pediatric and Young Adult B-cell ALL (up to 25 years of age): The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, infections-pathogen unspecified, hypogammaglobulinemia, fever, decreased appetite, viral infectious disorders, headache, febrile neutropenia, hemorrhage, musculoskeletal pain, vomiting, encephalopathy, diarrhea, hypotension, cough, nausea, bacterial infectious disorders, pain, hypoxia, tachycardia, edema, fatigue, and acute kidney injury. Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma: The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogen unspecified, fever, diarrhea, nausea, fatigue, hypotension, edema, hemorrhage, dyspnea, and headache. Adult Relapsed or Refractory Follicular Lymphoma: The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, infections-pathogens unspecified, fatigue, musculoskeletal pain, headache, and diarrhea.
Pediatric and Young Adult B-cell ALL (up to 25 years of age): The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, infections-pathogen unspecified, hypogammaglobulinemia, fever, decreased appetite, viral infectious disorders, headache, febrile neutropenia, hemorrhage, musculoskeletal pain, vomiting, encephalopathy, diarrhea, hypotension, cough, nausea, bacterial infectious disorders, pain, hypoxia, tachycardia, edema, fatigue, and acute kidney injury. Adult Relapsed or Refractory Diffuse Large B-cell Lymphoma: The most common adverse reactions (incidence greater than 20%) are CRS, infections-pathogen unspecified, fever, diarrhea, nausea, fatigue, hypotension, edema, hemorrhage, dyspnea, and headache. Adult Relapsed or Refractory Follicular Lymphoma: The most common adverse reactions (incidence greater than 20%) are cytokine release syndrome, infections-pathogens unspecified, fatigue, musculoskeletal pain, headache, and diarrhea.
There are 32 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cytokine release syndrome Encephalopathy Hypogammaglobulinemia Hypoxia Infection Neutropenic disorder Tachycardia Thrombocytopenic disorder Viral infection |
Acute respiratory distress syndrome Bacterial infection Cardiac arrhythmia Fungal infection Hemophagocytic lymphohistiocytosis Hemorrhage Hypertension Hypotension Kidney disease with reduction in glomerular filtration rate (GFr) Pancytopenia Pleural effusions Pulmonary edema Seizure disorder Tachypnea Tumor lysis syndrome |
| Rare/Very Rare |
|---|
|
Anaphylaxis Capillary leak syndrome Cardiac arrest Disseminated intravascular coagulation Intracranial bleeding Multiple organ failure Reactivation of hepatitis B Secondary malignant neoplasm of bone marrow |
There are 45 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anorexia Delirium Diarrhea Fatigue Fever Headache disorder Nausea Vomiting |
Acute abdominal pain Acute cognitive impairment Agitation Altered consciousness Aphasia Arthralgia Ascites Ataxia Back pain Body fluid retention Chills Constipation Cough Dizziness Erythema Facial edema Flushing General weakness Hyperbilirubinemia Hyperglycemia Hypokalemia Hypophosphatemia Myalgia Nasal congestion Pain Pain in oropharynx Peripheral edema Peripheral neuropathy Prolonged activated partial thromboplastin time Pruritus of skin Sleep disorder Stomatitis Symptoms of anxiety Tremor Visual changes Xerostomia |
| Rare/Very Rare |
|---|
|
Acquired horner syndrome |
The following precautions are available for KYMRIAH (tisagenlecleucel):
The safety and efficacy of tisagenlecleucel have been established in pediatric patients with r/r B-cell ALL. Use of tisagenlecleucel is supported by a single-arm trial that included 61 pediatric patients with r/r B-cell precursor ALL in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). No differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. The safety and efficacy of tisagenlecleucel in pediatric patients with r/r DLBCL and r/r FL have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data with tisagenlecleucel use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with tisagenlecleucel to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if tisagenlecleucel has the potential to be transferred to the fetus.
Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, tisagenlecleucel is not recommended for women who are pregnant, and pregnancy after tisagenlecleucel administration should be discussed with the treating physician. Report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, tisagenlecleucel is not recommended for women who are pregnant, and pregnancy after tisagenlecleucel administration should be discussed with the treating physician. Report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There is no information regarding the presence of tisagenlecleucel in human milk, the effect on the breastfed infant, and the effects on milk production. A risk to the breastfed infant cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tisagenlecleucel and any potential adverse effects on the breastfed infant from tisagenlecleucel or from the underlying maternal condition.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Tisagenlecleucel | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insuff data available; assess risk vs. benefit |
The safety and effectiveness of tisagenlecleucel have not been established in geriatric patients with r/r B-cell ALL. Clinical studies of tisagenlecleucel did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger subjects.
The following prioritized warning is available for KYMRIAH (tisagenlecleucel):
WARNING: This medication may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection.
Tell your doctor right away if you have any symptoms of CRS such as high fever, difficulty breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness. Serious nerve problems can occur after treatment with tisagenlecleucel. Tell your doctor right away if you have trouble speaking and understanding, loss of balance, or mental/mood changes such as anxiety, confusion, agitation.
WARNING: This medication may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection.
Tell your doctor right away if you have any symptoms of CRS such as high fever, difficulty breathing, chills/shaking chills, severe nausea/vomiting/diarrhea, severe muscle/joint pain, very low blood pressure, dizziness/lightheadedness. Serious nerve problems can occur after treatment with tisagenlecleucel. Tell your doctor right away if you have trouble speaking and understanding, loss of balance, or mental/mood changes such as anxiety, confusion, agitation.
The following icd codes are available for KYMRIAH (tisagenlecleucel)'s list of indications:
| B-cell acute lymphoblastic leukemia | |
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
| C91.02 | Acute lymphoblastic leukemia, in relapse |
| Diffuse large b-cell lymphoma | |
| C83.3 | Diffuse large b-cell lymphoma |
| C83.30 | Diffuse large b-cell lymphoma, unspecified site |
| C83.31 | Diffuse large b-cell lymphoma, lymph nodes of head, face, and neck |
| C83.32 | Diffuse large b-cell lymphoma, intrathoracic lymph nodes |
| C83.33 | Diffuse large b-cell lymphoma, intra-abdominal lymph nodes |
| C83.34 | Diffuse large b-cell lymphoma, lymph nodes of axilla and upper limb |
| C83.35 | Diffuse large b-cell lymphoma, lymph nodes of inguinal region and lower limb |
| C83.36 | Diffuse large b-cell lymphoma, intrapelvic lymph nodes |
| C83.37 | Diffuse large b-cell lymphoma, spleen |
| C83.38 | Diffuse large b-cell lymphoma, lymph nodes of multiple sites |
| C83.39 | Diffuse large b-cell lymphoma, extranodal and solid organ sites |
| C83.398 | Diffuse large b-cell lymphoma of other extranodal and solid organ sites |
| Follicular lymphoma | |
| C82 | Follicular lymphoma |
| C82.0 | Follicular lymphoma grade I |
| C82.00 | Follicular lymphoma grade i, unspecified site |
| C82.01 | Follicular lymphoma grade i, lymph nodes of head, face, and neck |
| C82.02 | Follicular lymphoma grade i, intrathoracic lymph nodes |
| C82.03 | Follicular lymphoma grade i, intra-abdominal lymph nodes |
| C82.04 | Follicular lymphoma grade i, lymph nodes of axilla and upper limb |
| C82.05 | Follicular lymphoma grade i, lymph nodes of inguinal region and lower limb |
| C82.06 | Follicular lymphoma grade i, intrapelvic lymph nodes |
| C82.07 | Follicular lymphoma grade i, spleen |
| C82.08 | Follicular lymphoma grade i, lymph nodes of multiple sites |
| C82.09 | Follicular lymphoma grade i, extranodal and solid organ sites |
| C82.1 | Follicular lymphoma grade II |
| C82.10 | Follicular lymphoma grade Ii, unspecified site |
| C82.11 | Follicular lymphoma grade Ii, lymph nodes of head, face, and neck |
| C82.12 | Follicular lymphoma grade Ii, intrathoracic lymph nodes |
| C82.13 | Follicular lymphoma grade Ii, intra-abdominal lymph nodes |
| C82.14 | Follicular lymphoma grade Ii, lymph nodes of axilla and upper limb |
| C82.15 | Follicular lymphoma grade Ii, lymph nodes of inguinal region and lower limb |
| C82.16 | Follicular lymphoma grade Ii, intrapelvic lymph nodes |
| C82.17 | Follicular lymphoma grade Ii, spleen |
| C82.18 | Follicular lymphoma grade Ii, lymph nodes of multiple sites |
| C82.19 | Follicular lymphoma grade Ii, extranodal and solid organ sites |
| C82.2 | Follicular lymphoma grade IIi, unspecified |
| C82.20 | Follicular lymphoma grade IIi, unspecified, unspecified site |
| C82.21 | Follicular lymphoma grade IIi, unspecified, lymph nodes of head, face, and neck |
| C82.22 | Follicular lymphoma grade IIi, unspecified, intrathoracic lymph nodes |
| C82.23 | Follicular lymphoma grade IIi, unspecified, intra-abdominal lymph nodes |
| C82.24 | Follicular lymphoma grade IIi, unspecified, lymph nodes of axilla and upper limb |
| C82.25 | Follicular lymphoma grade IIi, unspecified, lymph nodes of inguinal region and lower limb |
| C82.26 | Follicular lymphoma grade IIi, unspecified, intrapelvic lymph nodes |
| C82.27 | Follicular lymphoma grade IIi, unspecified, spleen |
| C82.28 | Follicular lymphoma grade IIi, unspecified, lymph nodes of multiple sites |
| C82.29 | Follicular lymphoma grade IIi, unspecified, extranodal and solid organ sites |
| C82.3 | Follicular lymphoma grade IIia |
| C82.30 | Follicular lymphoma grade IIia, unspecified site |
| C82.31 | Follicular lymphoma grade IIia, lymph nodes of head, face, and neck |
| C82.32 | Follicular lymphoma grade IIia, intrathoracic lymph nodes |
| C82.33 | Follicular lymphoma grade IIia, intra-abdominal lymph nodes |
| C82.34 | Follicular lymphoma grade IIia, lymph nodes of axilla and upper limb |
| C82.35 | Follicular lymphoma grade IIia, lymph nodes of inguinal region and lower limb |
| C82.36 | Follicular lymphoma grade IIia, intrapelvic lymph nodes |
| C82.37 | Follicular lymphoma grade IIia, spleen |
| C82.38 | Follicular lymphoma grade IIia, lymph nodes of multiple sites |
| C82.39 | Follicular lymphoma grade IIia, extranodal and solid organ sites |
| C82.4 | Follicular lymphoma grade IIib |
| C82.40 | Follicular lymphoma grade IIib, unspecified site |
| C82.41 | Follicular lymphoma grade IIib, lymph nodes of head, face, and neck |
| C82.42 | Follicular lymphoma grade IIib, intrathoracic lymph nodes |
| C82.43 | Follicular lymphoma grade IIib, intra-abdominal lymph nodes |
| C82.44 | Follicular lymphoma grade IIib, lymph nodes of axilla and upper limb |
| C82.45 | Follicular lymphoma grade IIib, lymph nodes of inguinal region and lower limb |
| C82.46 | Follicular lymphoma grade IIib, intrapelvic lymph nodes |
| C82.47 | Follicular lymphoma grade IIib, spleen |
| C82.48 | Follicular lymphoma grade IIib, lymph nodes of multiple sites |
| C82.49 | Follicular lymphoma grade IIib, extranodal and solid organ sites |
| C82.5 | Diffuse follicle center lymphoma |
| C82.50 | Diffuse follicle center lymphoma, unspecified site |
| C82.51 | Diffuse follicle center lymphoma, lymph nodes of head, face, and neck |
| C82.52 | Diffuse follicle center lymphoma, intrathoracic lymph nodes |
| C82.53 | Diffuse follicle center lymphoma, intra-abdominal lymph nodes |
| C82.54 | Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb |
| C82.55 | Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb |
| C82.56 | Diffuse follicle center lymphoma, intrapelvic lymph nodes |
| C82.57 | Diffuse follicle center lymphoma, spleen |
| C82.58 | Diffuse follicle center lymphoma, lymph nodes of multiple sites |
| C82.59 | Diffuse follicle center lymphoma, extranodal and solid organ sites |
| C82.6 | Cutaneous follicle center lymphoma |
| C82.60 | Cutaneous follicle center lymphoma, unspecified site |
| C82.61 | Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck |
| C82.62 | Cutaneous follicle center lymphoma, intrathoracic lymph nodes |
| C82.63 | Cutaneous follicle center lymphoma, intra-abdominal lymph nodes |
| C82.64 | Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb |
| C82.65 | Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb |
| C82.66 | Cutaneous follicle center lymphoma, intrapelvic lymph nodes |
| C82.67 | Cutaneous follicle center lymphoma, spleen |
| C82.68 | Cutaneous follicle center lymphoma, lymph nodes of multiple sites |
| C82.69 | Cutaneous follicle center lymphoma, extranodal and solid organ sites |
| C82.8 | Other types of follicular lymphoma |
| C82.80 | Other types of follicular lymphoma, unspecified site |
| C82.81 | Other types of follicular lymphoma, lymph nodes of head, face, and neck |
| C82.82 | Other types of follicular lymphoma, intrathoracic lymph nodes |
| C82.83 | Other types of follicular lymphoma, intra-abdominal lymph nodes |
| C82.84 | Other types of follicular lymphoma, lymph nodes of axilla and upper limb |
| C82.85 | Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb |
| C82.86 | Other types of follicular lymphoma, intrapelvic lymph nodes |
| C82.87 | Other types of follicular lymphoma, spleen |
| C82.88 | Other types of follicular lymphoma, lymph nodes of multiple sites |
| C82.89 | Other types of follicular lymphoma, extranodal and solid organ sites |
| C82.9 | Follicular lymphoma, unspecified |
| C82.90 | Follicular lymphoma, unspecified, unspecified site |
| C82.91 | Follicular lymphoma, unspecified, lymph nodes of head, face, and neck |
| C82.92 | Follicular lymphoma, unspecified, intrathoracic lymph nodes |
| C82.93 | Follicular lymphoma, unspecified, intra-abdominal lymph nodes |
| C82.94 | Follicular lymphoma, unspecified, lymph nodes of axilla and upper limb |
| C82.95 | Follicular lymphoma, unspecified, lymph nodes of inguinal region and lower limb |
| C82.96 | Follicular lymphoma, unspecified, intrapelvic lymph nodes |
| C82.97 | Follicular lymphoma, unspecified, spleen |
| C82.98 | Follicular lymphoma, unspecified, lymph nodes of multiple sites |
| C82.99 | Follicular lymphoma, unspecified, extranodal and solid organ sites |
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