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Precautions of Crizotinib

1. Hepatotoxicity

Monitor liver function tests, including ALT, AST, and total bilirubin, every 2 weeks during the first 2 months of  treatment, then once a month, and as clinically indicated, with more frequent repeat testing for increased liver  transaminases, alkaline phosphatase, or total bilirubin in patients who develop increased transaminases.  Withhold, reduce dose, or permanently discontinue Crizotinib for hepatotoxicity as recommended.

2. Interstitial Lung Disease/Pneumonitis

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes of ILD/pneumonitis, and permanently discontinue Crizotinib in patients diagnosed with drug-related  ILD/pneumonitis.

3. QT Interval Prolongation

Avoid use of Crizotinib in patients with congenital long QT syndrome. Monitor ECGs and electrolytes in  patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking  medications that are known to prolong the QT interval. Withhold, reduce dose, or permanently discontinue Crizotinib for QT/QTc interval prolongation as recommended.

4. Bradycardia

Avoid using Crizotinib in combination with other medications known to cause bradycardia (e.g., beta-blockers, nondihydropyridine-calcium channel blockers, clonidine, and digoxin) to the extent possible. Monitor heart rate and blood pressure regularly. If bradycardia occurs, re-evaluate for the use of concomitant medications known  to cause bradycardia. Withhold, reduce dose, or permanently discontinue Crizotinib for bradycardia as  recommended.

5. Severe Visual Loss

Assessment of visual symptoms for all patients is recommended monthly during treatment. Report new visual  symptoms to an eye specialist.

For pediatric and young adult patients with ALCL or pediatric patients with IMT, obtain baseline and follow-up ophthalmologic examinations including retinal examination within 1 month of starting Crizotinib and every 3 months thereafter. The ophthalmological evaluation should consist of best corrected visual acuity, retinal  photographs, visual fields, optical coherence tomography (OCT), and other evaluations as appropriate. 

Permanently discontinue Crizotinib for Grade 3 or 4 ocular disorders or severe visual loss (best corrected  vision less than 20/200 in one or both eyes) unless another cause is identified. There is insufficient information to characterize the risks of resumption of Crizotinib in patients who  develop visual symptoms or visual loss. A decision to resume Crizotinib should consider the potential benefits  versus risks to the patient.

from FDA，2023.09