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Click here for Xalkori® (crizotinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Safety

XALKORI has a well-tolerated and generally manageable side effect profile.1

Adverse reactions reported in XALKORI clinical studies (N=1722).1*

Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in Table 3. Terms actually reported in the study up to the data cut-off date and contributing to the relevant adverse reaction are indicated in parentheses, as listed below.

  1. Neutropaenia (Febrile neutropenia, Neutropenia, Neutrophil count decreased).
  2. Anaemia (Anaemia, Haemoglobin decreased, Hypochromic anaemia).
  3. Leukopenia (Leukopenia, White blood cell count decreased).
  4. Neuropathy (Burning sensation, Dysaesthesia, Formication, Gait disturbance, Hyperaesthesia, Hypoaesthesia, Hypotonia, Motor dysfunction, Muscle atrophy, Muscular weakness, Neuralgia, Neuritis, Neuropathy peripheral, Neurotoxicity, Paraesthesia, Peripheral motor neuropathy, Peripheral sensorimotor neuropathy, Peripheral sensory neuropathy, Peroneal nerve palsy, Polyneuropathy, Sensory disturbance, Skin burning sensation). 
  5. Vision disorder (Diplopia, Halo vision, Photophobia, Photopsia, Vision blurred, Visual acuity reduced, Visual brightness, Visual impairment, Visual perseveration, Vitreous floaters). 
  6. Dizziness (Balance disorder, Dizziness, Dizziness postural, Presyncope).
  7. Bradycardia (Bradycardia, Heart rate decreased, Sinus bradycardia).
  8. Cardiac failure (Cardiac failure, Cardiac failure congestive, Ejection fraction decreased, Left ventricular failure, Pulmonary oedema). Across clinical studies (n=1722), 19 (1.1%) patients treated with crizotinib had any grade cardiac failure, 8 (0.5%) patients had Grade 3 or 4, and 3 (0.2%) patients had fatal outcome. 
  9. Interstitial lung disease (Acute respiratory distress syndrome, Alveolitis, Interstitial lung disease, Pneumonitis). 
  10. Abdominal pain (Abdominal discomfort, Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness). 
  11. Oesophagitis (Oesophagitis, Oesophageal ulcer).
  12. Gastrointestinal perforation (Gastrointestinal perforation, Intestinal perforation, Large intestine perforation).
  13. Elevated transaminases (Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Hepatic function abnormal, Liver function test abnormal, Transaminases increased). 
  14. Renal cyst (Renal abscess, Renal cyst, Renal cyst haemorrhage, Renal cyst infection).
  15. Blood creatinine increased (blood creatinine increased, creatinine renal clearance decreased). 
  16. Oedema (Face oedema, Generalised oedema, Local swelling, Localised oedema, Oedema, Oedema peripheral, Periorbital oedema). 
  17. Blood testosterone decreased (Blood testosterone decreased, Hypogonadism, Secondary hypogonadism).​​​​​​​

* The patients described reflect exposure to XALKORI in 1,669 patients with ALK+ advanced NSCLC in 2 randomised Phase 3 studies and in 2 single-arm studies, and in 53 patients with ROS1+ advanced NSCLC who participated in a single-arm study (for a total of 1,722 patients).1​​​​​​​​​​​​​​


PP-XLK-GBR-1167. March 2021

Indication

XALKORI as a monotherapy is indicated for:1

  • The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
  • The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
  • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)

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