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Tisagenlecleucel Side Effects

For the Consumer

Applies to tisagenlecleucel: intravenous suspension

Along with its needed effects, tisagenlecleucel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tisagenlecleucel:

More common
  • Agitation
  • back pain
  • blue lips, fingernails, or skin
  • blurred vision
  • chest pain or discomfort
  • chills
  • confusion as to time, place, or person
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • decreased urine output
  • depression
  • difficult, fast, noisy breathing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • hallucinations
  • headache
  • hoarseness
  • holding false beliefs that cannot be changed by fact
  • hostility
  • increased sweating
  • irritability
  • loss of consciousness
  • lower back or side pain
  • mood or mental changes
  • muscle twitching
  • nausea
  • nervousness
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • rapid shallow breathing
  • rapid weight gain
  • seizures
  • slow or fast heartbeat
  • stiff neck
  • swelling of the face, arms, fingers, feet, or lower legs
  • trembling and shaking of hands
  • troubled breathing at rest
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusual excitement, nervousness, or restlessness
  • vomiting
  • weight gain
Less common
  • Change in the amount of urine
  • cloudy urine
  • headache, sudden or severe
  • stomach pain

Some side effects of tisagenlecleucel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

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

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