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KYMRIAH (TISAGENLECLEUCEL)
- B-cell acute lymphoblastic leukemia
- Diffuse large b-cell lymphoma
0.2 x 10exp6 to 2.5 x 10exp8 cell intravenous suspension
- Dosage information is not available
0.6 x 10exp8 to 6 x10exp8 cell intravenous suspension
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Hepatitis B immune due to latent hepatitis B infection
- Pregnancy
- Reactivation of hepatitis B
- Severe infection
Severe
Moderate
- None
KYMRIAH (TISAGENLECLEUCEL)
- B-cell acute lymphoblastic leukemia
- Diffuse large b-cell lymphoma
- Cytokine release syndrome
- Encephalopathy
- Hypogammaglobulinemia
- Hypoxia
- Infection
- Neutropenic disorder
- Tachycardia
- Thrombocytopenic disorder
- Viral infection
- Anorexia
- Delirium
- Diarrhea
- Fatigue
- Fever
- Headache disorder
- Nausea
- Vomiting
More Frequent
Severe
Less Severe
- Acute respiratory distress syndrome
- Bacterial infection
- Cardiac arrhythmia
- Chemotherapy-induced hyperuricemia
- Fungal infection
- Hemophagocytic lymphohistiocytosis
- Hemorrhage
- Hypertension
- Hypotension
- Kidney disease with reduction in GFR
- Pancytopenia
- Pleural effusions
- Pulmonary edema
- Seizure disorder
- Tachypnea
- Acute abdominal pain
- Acute confusion
- Agitation
- Altered consciousness
- Aphasia
- Arthralgias
- Ataxia
- Back pain
- Body fluid retention
- Chills
- Constipation
- Cough
- Dizziness
- Facial edema
- Myalgias
- Nasal congestion
- Pain
- Pain in oropharynx
- Peripheral edema
- Peripheral neuropathy
- Sleep disorder
- Symptoms of anxiety
- Tremor
- Visual changes
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Capillary leak syndrome
- Cardiac arrest
- Disseminated intravascular coagulation
- Intracranial bleeding
- Multiple organ failure
- Reactivation of hepatitis B
- Secondary malignant neoplasm of bone marrow
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
None
Tisagenlecleucel
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Tisagenlecleucel
Insuff data available; assess risk vs. benefit
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insuff data available; assess risk vs. benefit |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- 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.<br /><br />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.<br /><br /> For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Kymriah REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
| B-cell acute lymphoblastic leukemia | |
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
| 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 |
| 0-9 | A-Z |
|---|---|
| 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 |
| C91.0 | Acute lymphoblastic leukemia [ALl] |
| C91.00 | Acute lymphoblastic leukemia not having achieved remission |
Formulary Reference Tool