Axicabtagene Ciloleucel

>10%:

Cardiovascular: Hypotension (57%), tachycardia (57%), cardiac arrhythmia (23%), edema (19%), hypertension (15%), thrombosis (10%), cardiac failure (6%), capillary leak syndrome (3%)

Central nervous system: Brain disease (57%; lasted up to 173 days), fatigue (46%), headache (44% to 45%), chills (40%), dizziness (21%), motor dysfunction (19%), aphasia (18%), delirium (17%)

Endocrine & metabolic: Hypophosphatemia (grade 3 or 4: 50%), hyponatremia (grade 3 or 4: 19%), weight loss (16%), increased uric acid (grade 3 or 4: 13%), dehydration (11%)

Gastrointestinal: Decreased appetite (44%), diarrhea (38%), nausea (34%), vomiting (26%), constipation (23%), abdominal pain (14%), xerostomia (11%)

Hematologic & oncologic: Lymphocytopenia (grade 3 or 4: 100%), leukopenia (grade 3 or 4: 96%), neutropenia (grade 3 or 4: 93%), anemia (grade 3 or 4: 66%), thrombocytopenia (grade 3 or 4: 58%), febrile neutropenia (36%), hypogammaglobulinemia (15%)

Hepatic: Increased direct serum bilirubin (grade 3 or 4: 13%)

Hypersensitivity: Cytokine release syndrome (94%)

Infection: Infection (26%), viral infection (16%), bacterial infection (13%)

Neuromuscular & skeletal: Tremor (31%), limb pain (17%), back pain (15%), myalgia (14%)

Renal: Renal insufficiency (12%)

Respiratory: Hypoxia (32%), cough (30%), dyspnea (19%), pleural effusion (13%)

Miscellaneous: Fever (86%)

1% to 10%:

Central nervous system: Anxiety (9%), insomnia (9%), ataxia (6%), seizure (4%), cognitive dysfunction (comprehending mathematics: 2%), myoclonus (2%)

Dermatologic: Skin rash (9%)

Endocrine & metabolic: Hypokalemia (grade 3 or 4: 10%)

Genitourinary: Urinary tract infection (>2%)

Hematologic & oncologic: Blood coagulation disorder (2%), natural killer cell count increased (hemophagocytic lymphohistiocytosis/macrophage activation syndrome: 1%)

Hepatic: Increased serum ALT (grade 3 or 4: 10%)

Hypersensitivity: Hypersensitivity reaction (1%)

Infection: Fungal infection (5%), clostridium infection (>2%)

Neuromuscular & skeletal: Arthralgia (10%)

Respiratory: Pulmonary edema (9%), pulmonary infection (>2%)

Frequency not defined: Central nervous system: Cerebral edema, leukoencephalopathy, seizure

Screen for HBV, HCV, and HIV (prior to collection of cells for manufacturing). Monitor immunoglobulin levels and blood counts (after treatment). Pregnancy testing is recommended prior to therapy (in sexually active women of reproductive potential).

Monitor for signs/symptoms of CRS and neurological toxicities for at least 4 weeks after treatment (monitor daily for the first 7 days after infusion at the health care facility), monitor for hypersensitivity reactions and for signs/symptoms of infection. Monitor (life-long) for secondary malignancies.

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.
• Dry mouth.
• Weight loss.
• Feeling tired or weak.
• Pain in arms or legs.
• Muscle or joint pain.
• Muscle spasm.
• Muscle weakness.
• Back pain.
• Shakiness.
• Dizziness.

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.