Applies to tisagenlecleucel: intravenous suspension.

Serious side effects of Tisagenlecleucel

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
• bleeding gums
• bloody urine
• blue lips, fingernails, or skin
• blurred vision
• chest pain, discomfort, or tightness
• chills
• confusion as to time, place, or person
• cough
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• 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
• dry mouth
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• hallucinations
• headache
• hoarseness
• holding false beliefs that cannot be changed by fact
• hostility
• increase in heart rate
• increased blood pressure
• increased menstrual flow or vaginal bleeding
• increased sweating
• irritability
• loss of appetite
• loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle, joint, or bone pain
• nausea
• nervousness
• nosebleeds
• painful or difficult urination
• pale skin
• pounding in the ears
• problems with speech or speaking
• prolonged bleeding from cuts
• rapid shallow breathing
• rapid weight gain
• red or black, tarry stools
• red or dark brown urine
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness and unsteady walk
• slow or fast heartbeat
• stiff neck
• sunken eyes
• swelling of the face, arms, fingers, feet, or lower legs
• trembling and shaking of hands
• trouble breathing
• 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
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Other side effects of Tisagenlecleucel

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

• Anxiety
• decreased appetite
• diarrhea
• difficulty in moving
• joint pain
• muscle pain or stiffness
• pain in the arms or legs
• stuffy nose

For Healthcare Professionals

Applies to tisagenlecleucel: intravenous suspension.

General

The most common adverse reactions (greater than 20%) were cytokine release syndrome (79%), hypogammaglobulinemia (43%), infections-pathogen unspecified (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), bleeding episodes (31%), tachycardia (26%), nausea (26%), diarrhea (26%), vomiting (26%), viral infectious disorders (26%), hypoxia (24%), fatigue (25%), acute kidney injury (24%), edema (21%), cough (21%), and delirium (21%).^[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (79%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, immunoglobulins decreased, blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased) (43%), infections pathogen unspecified (41%), viral infections (26%), bacterial infections (19%), fungal infections (13%)

Common (1% to 10%): Graft versus host disease

Frequency not reported: Immunogenicity^[Ref]

Other

Very common (10% or more): Pyrexia (40%), increased aspartate aminotransferase (28%), hypokalemia (27%), fatigue/malaise (25%), hypophosphatemia pain (18%)

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%), hypophosphatemia (24%), edema (e.g., face edema, generalized edema, localized edema, edema peripheral) (21%), hypokalemia (12%), hyponatremia (11%), weight loss (11%), fluid overload (10%)

Common (1% to 10%): Tumor lysis syndrome^[Ref]

Nervous system

Very common (10% or more): Headache/migraine (37%), encephalopathy (e.g., encephalopathy, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, lethargy, mental status changes, somnolence, automatism) (34%), delirium (e.g., delirium, agitation, hallucination, hallucination visual, irritability, restlessness) (21%), chills (10%)

Common (1% to 10%): Tremor, dizziness, seizure, speech disorder/aphasia/dysarthria, motor dysfunction^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (31%), tachycardia/sinus tachycardia (26%)

Common (1% to 10%): Disseminated intravascular coagulation, cardiac arrest, cardiac failure, capillary leak syndrome, thrombosis^[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, oropharyngeal pain^[Ref]

Psychiatric

Very common (10% or more): Delirium (21%), anxiety (13%), sleep disorders/insomnia/nightmare (10%)

Frequency not reported: Disorientation, confusion, agitation, mutism^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (15%), arthralgia (12%), back pain/pain in extremity (10%)

Common (1% to 10%): Muscle spasms^[Ref]

Renal

Common (1% to 10%): Acute kidney injury (24%), increased blood creatinine^[Ref]

Hepatic

Very common (10% or more): Acute kidney injury (e.g., acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, blood creatinine increased) (24%), increased alanine aminotransferase (21%), increased bilirubin (21%)^[Ref]

Oncologic

Frequency not reported: Secondary malignancies/cancer recurrence^[Ref]

Ocular

Common (1% to 10%): Visual impairment/blurred vision

Dermatologic

Very common (10% or more): Rash/rash maculopapular/rash papular/rash pruritic (16%)