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Kymriah Side Effects

Generic Name: tisagenlecleucel

Note: This document contains side effect information about tisagenlecleucel. Some of the dosage forms listed on this page may not apply to the brand name Kymriah.

For the Consumer

Applies to tisagenlecleucel: intravenous suspension

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Fast breathing.
  • Feeling very tired or weak.
  • A fast heartbeat.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Not hungry.
  • Headache.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Belly pain.
  • Feeling tired or weak.
  • Pain in arms or legs.
  • Muscle or joint pain.
  • Back pain.
  • Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to tisagenlecleucel: intravenous suspension

General

The most common adverse reactions (incidence greater than 30%) are cytokine release syndrome, hypogammaglobulinemia, infections-pathogen unspecified, prolonged neutropenia, pyrexia, decreased appetite, headache, encephalopathy, bleeding episodes, and hypotension.[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (79%), hypogammaglobulinemia (43%)
Common (1% to 10%): Graft versus host disease[Ref]

Other

Very common (10% or more): Infections-pathogen unspecified (41%), pyrexia (40%), viral infectious disorders (26%), fatigue (22%), bacterial infectious disorders (19%), fungal infectious disorders (13%), face edema (10%), peripheral edema (10%), chills (10%)
Common (1% to 10%): Multiple organ dysfunction syndrome[Ref]

Hematologic

Very common (10% or more): Prolonged neutropenia (40%), prolonged thrombocytopenia (27%), hypofibrinogenemia with cytokine release syndrome (16%), increased international normalized ratio (13%)
Common (1% to 10%): Disseminated intravascular coagulation, histiocytosis lymphocytic hemophagocytosis, coagulopathy
Frequency not reported: Neutropenia, anemia, thrombocytopenia[Ref]

Metabolic

Very common (10% or more): Decreased appetite (37%), worsening hypokalemia (27%), worsening hypophosphatemia (19%), fluid overload (10%)
Common (1% to 10%): Tumor lysis syndrome[Ref]

Nervous system

Very common (10% or more): Headache (37%), encephalopathy (34%)
Common (1% to 10%): Tremor, intracranial hemorrhage, seizure
Frequency not reported: Disturbances in consciousness, aphasia[Ref]

Cardiovascular

Very common (10% or more): Hypotension (31%), bleeding episodes (31%), tachycardia (26%), hypertension (19%)
Common (1% to 10%): Cardiac failure, cardiac arrest, capillary leak syndrome, prolonged activated partial thromboplastin time[Ref]

Gastrointestinal

Very common (10% or more): Nausea (26%), diarrhea (26%), vomiting (26%), constipation (18%), abdominal pain (16%)
Common (1% to 10%): Abdominal compartment syndrome[Ref]

Respiratory

Very common (10% or more): Hypoxia (24%), cough (19%), pulmonary edema (16%), tachypnea (12%), pleural effusion (10%), nasal congestion (10%)
Common (1% to 10%): Respiratory distress, respiratory failure, acute respiratory distress syndrome[Ref]

Psychiatric

Very common (10% or more): Delirium (21%), anxiety (13%)
Frequency not reported: Disorientation, confusion, agitation, mutism[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (16%), myalgia (15%), arthralgia (12%), back pain (10%)[Ref]

Renal

Common (1% to 10%): Increased blood creatinine[Ref]

Hepatic

Very common (10% or more): Increased AST (28%), acute kidney injury (22%), increased ALT (21%), increased bilirubin (21%)[Ref]

References

1. "Product Information. Kymriah (tisagenlecleucel)." Novartis Pharmaceuticals, East Hanover, NJ.

Some side effects of Kymriah may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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