Xalkori Capsules (Hard Gelatin)
Crizotinib
250mg
PFIZER PHARMACEUTICALS L.L.C.
| Pack size | 60's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | GULF DRUG EST. |
| Retail Price | 34807.50 AED |
Available as:
Indications
Xalkori Capsules (Hard Gelatin) is used for:
Non-Small Cell Lung Cancer, Indicated for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase-positive
Indicated for metastatic NSCLC tumors that are ROS1-positive
Adult Dose
Oral
Adult
Non-Small Cell Lung Cancer
Indicated for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Also indicated for metastatic NSCLC tumors that are ROS1-positive. Select patients for treatment of metastatic NSCLC based on presence of ALK or ROS1 positivity in tumor specimens.
Capsule 250 mg PO q12hr
Continue treatment as long as patient is deriving clinical benefit from therapy
Dose Modifications
Dosing interruption and/or dose reduction to 200 mg PO q12hr may be required based on safety and tolerability; decrease to 250 mg PO qDay if further reduction is needed
Hepatic impairment: Caution advised
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30-90 mL/min): No starting dose adjustment is needed; steady-state trough concentrations in these 2 groups were similar to those with normal renal function (ie, CrCl >90 mL/min)
Severe (CrCl <30 mL/min) or end-stage renal disease: Caution advised
Administration
Take with or without food; a high-fat meal reduces AUCinf and Cmax by ~14%
Capsules should be swallowed whole
Contra Indications
Hypersensitivity
Precautions
Severe, including fatal, treatment-related pneumonitis reported; monitor for pulmonary symptoms indicative of pneumonitis and permanently discontinue if diagnosed
Hepatoxicity reported; elevations in ALT and total bilirubin reported; monitor q2wk for 2 months, then monthly and as clinically indicated with more frequent testing with Grade 2-4 elevations; temporarily suspend, reduce dose, or permanently discontinue dose as indicated (see Dose Modifications)
Symptomatic bradycardia reported, including syncope; avoid coadministration with other drugs known to cause bradycardia; monitor heart rate and blood pressure regularly; temporarily suspend, reduce dose, or permanently discontinue (see Dosage Modifications)
Caution when driving or operating machinery because of vision disorder, dizziness, or fatigue associated with treatment
Can cause fetal harm when administered to pregnant women (see Pregnancy)
Interstitial Lung Disease (ILD)/Pneumonitis reported; permanently discontinue in patients with ILD/pneumonitis
Visual field defect with vision loss reported; optic atrophy and optic nerve disorder have been reported as potential causes of vision loss; discontinue with new onset of severe visual loss
Lactation
There is no information regarding the presence of crizotinib in human milk, the effects on the breastfed infant, or the effects on milk production
Because of the potential for adverse reactions in breastfed infants, do not breastfeed during treatment and for 45 days after the final dose
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action, can cause fetal harm when administered to a pregnant woman
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for at least 45 days following the final dose
Advise males taking crizotinib with female partners of reproductive potential to use condoms during treatment and for at least 90 days after the final dose
Interactions
Adverse Effects
Side effects of Crizotinib :
>10%
ALT elevation (76%), AST elevation (61%), Vision disorder (60%), Diarrhea (60%), Nausea (55%), Lymphopenia (51%), Neutropenia (49%), Vomiting (47%), Constipation (42%), Edema (31%), Hypophosphatemia (28%), Decreased appetite (27%), Fatigue (27%), Dysgeusia (26%), Upper respiratory infection (26%), Dizziness (22%), Neuropathy (19%), Dysesthesia (19%), Gait disturbance (19%), Hypoesthesia (19%), Muscular weakness (19%), Neuralgia (19%), Peripheral neuropathy (19%), Paresthesia (19%), Peripheral sensory neuropathy (19%), Polyneuropathy (19%), Burning sensation in skin (19%), Hypokalemia (18%)
1-10%
Weight decreased (10%), Rash (9%), Dyspepsia (8%), Pulmonary embolism (6%), QT prolongation (5%), Bradycardia (5%), Pneumonia (4.1%), Pneumonitits (4%), Renal cyst (4%), ARDS (4%), Pulmonary embolism (3.5%), Syncope (3%), Dyspnea (2.3%), Hepatic failure (1%), Esophagitis (2%)
<1%
Vision loss, grade 4 (0.2%), Hypogonadism; decreased blood testosterone (1%)
Mechanism of Action
Inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and Recepteur d’Origine Nantais (RON)
The gene’s expression and signaling that contribute to increased cell proliferation and survival of the tumors become activated following the expression of ALK oncogenic fusion proteins
Inhibits the signaling that promotes the expression of these oncogenic fusion proteins, thereby inhibiting tumor cell proliferation
Note
Xalkori 250mg Capsules (Hard Gelatin) manufactured by PFIZER PHARMACEUTICALS L.L.C.. Its generic name is Crizotinib. Xalkori is availble in United Arab Emirates.
Farmaco UAE drug index information on Xalkori Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.