Crizocent 250 Capsule
Crizotinib
250mg
Incepta Pharmaceuticals Ltd.
| Pack size | 12's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1500.00 AED |
Indications
Crizocent 250 Capsule 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 twice daily
Continue treatment as long as patient is deriving clinical benefit from therapy
Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily.
Systemic ALCL: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area.
Unresectable IMT:
Adult: The recommended dosage is 250 mg orally twice daily.
Child Dose
Anaplastic Large Cell Lymphoma
Indicated for relapsed or refractory, systemic ALK-positive anaplastic large cell lymphoma (ALCL) in children and young adults aged >1 year
Assess the ability to swallow intact capsules before prescribing
280 mg/m2 PO BID
Inflammatory Myofibroblastic Tumors (IMT):
Indicated for unresectable, recurrent, or refractory inflammatory myofibroblastic tumors (IMT) in adults and pediatric patients aged >1 year who are ALK-positive
<1 year: Safety and efficacy not established
>1 year
The recommended dosage is 280 mg/m2 orally twice daily based on body surface area.
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
Hepatotoxicity: Fatal hepatotoxicity has occurred. Monitor with periodic liver testing. Temporarily suspend, dose reduce, or permanently discontinue Crizotinib.
Interstitial Lung Disease (ILD)/Pneumonitis: Permanently discontinue in patients with ILD/pneumonitis.
QT Interval Prolongation: Monitor electrocardiograms and electrolytes in patients who have a history of or predisposition for QTc prolongation, or who are taking medications that prolong QT. Temporarily suspend, dose reduce, or permanently discontinue Crizotinib.
Bradycardia: Crizotinib can cause bradycardia. Monitor heart rate and blood pressure regularly. Temporarily suspend, dose reduce, or permanently discontinue Crizotinib.
Severe Visual Loss: Crizotinib can cause visual changes including severe visual loss. Monitor and evaluate for ocular toxicity throughout treatment. Discontinue Crizotinib in patients with severe visual loss.
Gastrointestinal Toxicity in Pediatric and Young Adult Patients with ALCL or Pediatric Patients with IMT: Crizotinib can cause severe nausea, vomiting, diarrhea, and stomatitis. Provide standard antiemetic and antidiarrheal agents. Temporarily suspend, dose reduce, or permanently discontinue Crizotinib.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception
MONITORING PARAMETERS
Monitor liver function once a week during the first 2 months of treatment, then at least monthly thereafter and as clinically indicated.
Monitor ECG and electrolytes (correct if abnormal) in all patients before starting treatment, then periodically and as clinically indicated thereafter.
Monitor for signs and symptoms of treatment-emergent bradycardia (including syncope, dizziness and hypotension)—monitor blood pressure and heart rate regularly.
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
Strong CYP3A Inhibitors: Avoid concomitant use.
Strong CYP3A Inducers: Avoid concomitant use.
CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions.
Contraindicated (8)
dronedarone
flibanserin
lefamulin
lomitapide
lonafarnib
pimozide
posaconazole
thioridazine
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
Crizocent 250 250mg Capsule manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Crizotinib. Crizocent 250 is availble in Bangladesh.
Farmaco BD drug index information on Crizocent 250 Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.