Introduction
Crizocent 250 is used in the treatment of non-small cell lung cancer that is locally advanced or has spread to other areas of the body.
Crizocent 250 should be taken with food or without food, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
Nausea, vomiting, edema (swelling), and diarrhea are some common side effects of this medicine. Some serious side effects that might occur which need doctor consultation include severe stomach pain, fever, chills, shortness of breath, fast heartbeat, partial or complete loss of vision or changes in bowel habits. Your doctor may perform some blood tests during the treatment to check for liver function.
Before taking it, tell your doctor if you have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.
Uses of Crizocent 250
- Non-small cell lung cancer
Side effects of Crizocent 250
Common
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Visual impairment
- Dizziness
- Taste change
- Fatigue
- Decreased appetite
- Rash
- Decreased white blood cell count (neutrophils)
How to use Crizocent 250
Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Crizocent 250 may be taken with or without food, but it is better to take it at a fixed time.
How Crizocent 250 works
Crizocent 250 is an anti-cancer medication. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
What if you forget to take Crizocent 250?
If you miss a dose of Crizocent 250, skip it and continue with your normal schedule. Do not double the dose.
Indication
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
Administration
Take with or without food; a high-fat meal reduces AUCinf and Cmax by ~14%
Capsules should be swallowed whole
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
Contraindication
Hypersensitivity
Mode 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
Precaution
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
Side Effect
>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%)
Pregnancy Category Note
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