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Bengali DIL edition of crizotinib instructions

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Bengali DIL edition of crizotinib instructions

产品详情

Note: before purchasing and taking medicines, a hospital genetic test report and a doctor's diagnosis report or certificate must be produced


indication
Crizotinib capsules can be used for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are anaplastic lymphoma kinase (ALK) - positive as determined by an SFDA approved assay.
Usage
This article is used in a medical institution experienced in its use and under the guidance of a specific professional technician. A positive ALK assessment confirmed by a well validated assay is obtained before administration of this product.
The recommended dose of crizotinib capsules is 250 mg orally twice daily. Medication should be continued if the patient benefits from clinical treatment. The capsule should be swallowed as a whole. Crizotinib capsules are available either as same or in different servings with food. If one dose of crizotinib capsule was missed, the missed dose was supplemented, unless it was less than 6 hours from the next dose.
warning
(1) Hepatotoxicity: symptoms of hepatotoxicity occur in 0.1% of patients after taking crizotinib. Patients are required to have regular liver function tests and make medication changes as appropriate: suspend dosing, dose modifications, or are discontinuing.
(2) Interstitial lung disease (ILD) / pneumonia: interstitial lung disease (ILD) / pneumonia symptoms were reported in 2.9% of patients after crizotinib administration. Dosing was discontinued for patients who developed interstitial lung disease (ILD) / pneumonia.
(3) Prolonged QT interval: symptoms of QT prolongation have been reported in 2.1% of patients after crizotinib administration. Electrocardiographic, electrolyte monitoring is required in patients with a previous history of or a trend toward QT prolongation, and in patients on medication. Medication adjustments were made according to the patient's actual condition: suspended, dose adjusted or yes terminated.
(4) Bradycardia: crizotinib can be bradycardic. Regular heart rate and blood pressure checks are required for the patient. Medication adjustments were made according to the patient's actual condition: suspended, dose adjusted or yes terminated.
(5) Severe visual impairment: severe visual impairment has been reported in 0.2% of patients after crizotinib administration. Crizotinib was discontinued in patients with severe visual impairment, and an ophthalmologic evaluation was performed.
(6) Embryo fetal toxicity: there is a possibility of fetal toxicity after the administration of crizotinib. Counsel women of reproductive potential to take effective birth control measures.
Adverse effects
The adverse effects of the drug are: hepatotoxicity, interstitial lung disease, QT prolongation, bradycardia, severe visual disturbances, etc.
Common AES (≥ 25%) were: visual impairment, nausea, diarrhea, vomiting, edema, constipation, transaminase elevation, fatigue, decreased appetite, upper respiratory tract infection, vertigo, and psychiatric disorders.
Note: adverse reactions with respect to the drug are detailed in the [warnings and precautions] section of the specification.
Drug drug interactions
Drugs that may increase crizotinib plasma concentrations: coadministration of crizotinib with a strong cytochrome P450 (CYP) 3A inhibitor increases crizotinib plasma concentrations. Avoid concomitant use of strong CYP3A inhibitors, including but not limited to atazanavir [atazanavir], clarithromycin [clarithromycin], indinavir [indinavir], itraconazole [itraconazole], ketoconazole, nefazodone [nefazodone], nelfinavir [nelfinavir], ritonavir [ritonavir], saquinavir [saquinavir], telithromycin Acenocoumarycin [troleandomycin] and voriconazole [voriconazole], citrons, and pummelo juice may increase crizotinib plasma concentrations. Caution use concomitantly with moderate CYP3A inhibitors.
Agents that may attenuate crizotinib plasma concentrations: coadministration of crizotinib with a strong CYP3A inducer decreases crizotinib plasma concentrations. Avoid concomitant use of strong CYP3A inducers including, but not limited to, carbamazepine [carbamazepine], phenobarbital [phenobarbital], phenytoin [phenotin], rifabutin [rifabutin], rifampin [rifampin], and St. John's wort.
Drugs that may cause altered crizotinib plasma concentrations: crizotinib inhibits CYP3A both in vitro and in vivo. Concomitant use of a narrow therapeutic range of CYP3A substrates should be avoided in patients taking crizotinib, including, but not limited to, alfentanil [alfentanil], cyclosporine [cyclosporine], dihydroergotamine [dihydroergotamine], ergotamine [fentanyl], pimozide [pimozide], quinidine [quinidine], sirolimus [sirolimus], and tacrolimus [tacrolimus]. Dose reductions of CYP3A substrates may be necessary if patients taking crizotinib require concomitant use of these CYP3A substrates with a narrow therapeutic range.

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