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Safety InformationSpecial warnings and precautions for use1Interstitial lung disease (pneumonitis)1
  • XALKORI® (crizotinib) has been associated with severe, life-threatening or fatal interstitial lung disease (ILD)/pneumonitis in clinical trials at a frequency of 26 (2 %) of 1669 patients treated with XALKORI® (crizotinib). These cases generally occurred within 3 months after the initiation of treatment. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis. Other potential causes of ILD/pneumonitis should be excluded. XALKORI® (crizotinib) should be permanently discontinued in patients diagnosed with treatment-related ILD/pneumonitis.
QT interval prolongation1
  • XALKORI® (crizotinib) can cause QTc prolongation which predispose to severe dysrhythmias. XALKORI® (crizotinib) should be administered with caution to patients who have a history of or predisposition for QTc prolongation, or who are taking medications that are known to prolong the QT interval. When using XALKORI® (crizotinib) in these patients, periodic monitoring with electrocardiograms and electrolytes should be considered.
  • Dose adjustments can be made for patients who develop QTc prolongation.
  • Bradycardia has been reported in clinical studies, and it was usually asymptomatic. The full effect of XALKORI® (crizotinib) on pulse rate may not develop until several weeks after start of treatment. Avoid using XALKORI® (crizotinib) in combination with other bradycardic medicines (e.g. beta-blockers, non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, clonidine, digoxin) to the extent possible, due to the increased risk of symptomatic bradycardia (syncope, dizziness, hypotension). Monthly monitoring of pulse rate and blood pressure is recommended. Dose modification is not required in cases of asymptomatic bradycardia. In cases of symptomatic bradycardia, XALKORI® (crizotinib) should be held and the use of concomitant medications should be re-evaluated.
  • Treatment of overdose with XALKORI® (crizotinib) should consist of general supportive measures. There is no antidote for XALKORI® (crizotinib).
Effects on ability to drive and use machines1
  • No studies on the effect of XALKORI® (crizotinib) on the ability to drive and use machines have been performed.
  • However, caution should be exercised when driving or operating machinery because XALKORI® (crizotinib) causes vision disturbances, dizziness and fatigue.
Adverse Events1

The adverse drug reactions listed in the table below are presented by System Organ Class (SOC) and frequency categories, defined using the following convention:1

  • Very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) or rare (≥ 1/10 000 to < 1/1 000).
  • Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Terms actually reported in the studies up to the data cutoff date and contributing to the relevant adverse reaction are indicated in parentheses, as listed below:1

  1. Neutropenia (febrile neutropenia, neutropenia, decreased neutrophil count)
  2. Leucopenia (leucopenia, decreased white blood cell count).
  3. Neuropathy (burning sensation, dysaesthesia, formication, gait disturbance, hyperaesthesia, hypoaesthesia, hypotonia, motor dysfunction, muscle atrophy, muscular weakness, neuralgia, neuritis, peripheral neuropathy, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, polyneuropathy, sensory disturbance, skin burning sensation).
  4. Dizziness (balance disorder, dizziness, postural dizziness, presyncope).
  5. Vision disorder (diplopia, halo vision, photophobia, photopsia, blurred vision, reduced visual acuity, visual brightness, visual field defect, visual impairment, vitreous floaters).
  6. Bradycardia (bradycardia, decreased heart rate, sinus bradycardia).
  7. Interstitial lung disease (acute respiratory distress syndrome, alveolitis, interstitial lung disease, pneumonitis).
  8. Elevated transaminases (increased alanine aminotransferase, increased aspartate aminotransferase, increased gammaglutamyltransferase, increased hepatic enzyme, abnormal hepatic function, abnormal liver function test, increased transaminases).
  9. Renal cyst (renal abscess, renal cyst, renal cyst haemorrhage, renal cyst infection).
  10. Increased blood creatinine (increased blood creatinine, decreased creatinine renal clearance).
  11. Oedema (face oedema, generalised oedema, local swelling, localised oedema, oedema, peripheral oedema, periorbital oedema).
Contraindications1Use of XALKORI® (crizotinib) is contraindicated in patients with hypersensitivity to crizotinib or to any of the excipients:1
  • Colloidal silicon dioxide
  • Microcrystalline cellulose
  • Anhydrous dibasic calcium phosphate
  • Sodium starch glycolate
  • Magnesium stearate
  • Hard gelatin capsule shells
  • Titanium dioxide
  • Red iron oxide
  • Shellac
  • Propylene glycol
  • Black iron oxide
Abbreviations:ALK: anaplastic lymphoma kinase; NSCLC: non-small cell lung cancer; QTc: QT interval prolongation.References:Pfizer Laboratories (Pty) Ltd. XALKORI® 200 mg and 250 mg capsules Package Insert, approved 20 March 2018.

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