Xalkori
Xalkori Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Xalkori (crizotinib) is an oral receptor tyrosine kinase inhibitor indicated for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Xalkori is not available in a generic form. Common side effects with Xalkori use include gastrointestinal disorders, upper respiratory infection, decreased appetite, and insomnia.
Xalkori (crizotinib) is available in a 200 and 250 mg strength capsules. The recommended dose and schedule of Xalkori is 250 mg taken orally twice daily. Capsules should be swallowed whole. Xalkori may be taken with or without food. If a dose of Xalkori is missed, then it should be taken as soon as the patient remembers unless it is less than six hours until the next dose, in which case the patient should not take the missed dose. Patients should not take two doses at the same time to make up for a missed dose. Serious side effects include pneumonitis, QT prolongation and hepatic alterations. Patients should inform their doctors if they of their partner are pregnant or planning to become pregnant. Xalkori may harm unborn babies. Patients should also inform their doctors if they are breastfeeding or if they plan to breastfeed. It is not known if Xalkori passes into breast milk. Women who are able to become pregnant and men who take Xalkori should use birth control during treatment and for three months after stopping Xalkori. The safety and efficacy of Xalkori in pediatric patients has not been established.
Our Xalkori Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Xalkori in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using crizotinib and call your doctor at once if you have a serious side effect such as:
- severe dizziness, fainting, fast or pounding heartbeats;
- vision problems such as blurred vision, increased sensitivity of your eyes to light, or seeing flashes of light or "floaters";
- chest pain, dry cough or cough with mucus, wheezing, feeling short of breath;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- mild dizziness;
- tired feeling;
- nausea, vomiting, stomach pain, loss of appetite;
- diarrhea, constipation;
- mild rash or itching;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- numbness or tingling; or
- swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Xalkori (crizotinib) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xalkori FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Studies A and B, patients with locally advanced or metastatic ALK-positive NSCLC received crizotinib 250 mg orally twice daily continuously. Among the 255 patients for whom data on Grade 1-4 adverse reactions are available, median exposure to study drug was 5.1 months in Study A and 7.8 months in Study B. Dosing interruptions occurred in 36% and 45% of patients in Studies A and B, and lasted greater than 2 weeks in 13% and 19% of patients in Studies A and B, respectively. Dose reductions occurred in 44% and 29% of patients in Studies A and B, respectively. The rates of treatment-related adverse events resulting in permanent discontinuation were 6% in Study A and 3% in Study B. The most common adverse reactions ( ≥ 25%) across both studies were vision disorder, nausea, diarrhea, vomiting, edema, and constipation. Grade 3-4 adverse reactions in at least 4% of patients in both studies included ALT increased and neutropenia.
Among the 397 patients for whom information on deaths and serious adverse reactions is available, deaths within 28 days of the last dose of study drug occurred in 45 patients. Ten (2.5%) patients died within 28 days of their first dose of study drug. Causes of death included disease progression (32 patients), respiratory events (9), and other (4). Respiratory causes of death included pneumonia (2), hypoxia (2), ARDS (1), dyspnea (1), pneumonitis (1), empyema (1), and pulmonary hemorrhage (1). Other causes of deaths included septic shock, DIG, cardiovascular event, and death due to unknown cause (1 each). Serious adverse events in greater than or equal to 2% of patients included pneumonia, dyspnea, and pulmonary embolism.
Table 3 lists the common adverse reactions on Studies A and B in patients receiving XALKORI.
Table 3: Adverse Reactions in ≥ 10% of Patients with Locally
Advanced or Metastatic ALK-Positive NSCLC on Studies A and B1
| Adverse Event | Treatment Emergent N=255 |
Treatment Related N=255 |
||
| All Grades n (%) |
Grade 3/4 n (%) |
All Grades n (%) |
Grade 3/4 n (%) |
|
| Eye Disorders | ||||
| Vision Disorder2 | 163 (64%) | 0 | 159 (62%) | 0 |
| Gastrointestinal Disorders | ||||
| Nausea | 145 (57%) | 2 ( < 1%) | 136 (53%) | 0 |
| Diarrhea | 124 (49%) | 1 ( < 1%) | 109 (43%) | 0 |
| Vomiting | 116(45%) | 3(1%) | 101 (40%) | 0 |
| Constipation | 98 (38%) | 2 ( < 1%) | 69 (27%) | 1 ( < 1%) |
| Esophageal Disorder3 | 51 (20%) | 3 (1%) | 29(11%) | 0 |
| Abdominal Pain4 | 40 (16%) | 1 ( < 1%) | 20 (8%) | 0 |
| Stomatitis5 | 27(11%) | 1 ( < 1%) | 15 (6%) | 1 ( < 1%) |
| General Disorders | ||||
| Edema6 | 97 (38%) | 2 ( < 1%) | 72 (28%) | 0 |
| Fatigue | 80(31%) | 6 (2%) | 51 (20%) | 4 (2%) |
| Chest Pain/Discomfort7 | 30 (12%) | 1 ( < 1%) | 3(1%) | 0 |
| Fever | 30 (12%) | 1 ( < 1%) | 2 ( < 1%) | 0 |
| Infections and Infestations | ||||
| Upper Respiratory Infection8 | 50 (20%) | 1 ( < 1%) | 4 (2%) | 0 |
| Investigations | ||||
| Alanine Aminotransferase Increased | 38 (15%) | 17 (7%) | 34 (13%) | 14 (5%) |
| Aspartate Aminotransferase Increased | 29(11%) | 7 (3%) | 24 (9%) | 5 (2%) |
| Metabolism and Nutrition | ||||
| Decreased Appetite | 69 (27%) | 3 (1%) | 49 (19%) | 0 |
| Musculoskeletal | ||||
| Arthralgia | 29(11%) | 3 (1%) | 4 (2%) | 0 |
| Back Pain | 28(11%) | 0 | 2 ( < 1%) | 0 |
| Nervous System Disorders | ||||
| Dizziness9 | 60 (24%) | 0 | 42 (16%) | 0 |
| Neuropathy10 | 58 (23%) | 1 ( < 1%) | 34 (13%) | 1 ( < 1%) |
| Headache | 34 (13%) | 1 ( < 1%) | 10 (4%) | 0 |
| Dysgeusia | 33 (13%) | 0 | 30 (12%) | 0 |
| Psychiatric Disorders | ||||
| Insomnia | 30 (12%) | 0 | 8 (3%) | 0 |
| Respiratory Disorders | ||||
| Dyspnea | 57 (22%) | 16 (6%) | 5 (2%) | 3(1%) |
| Cough | 54(21%) | 3 (1%) | 9 (4%) | 0 |
| Skin Disorders | ||||
| Rash | 41 (16%) | 0 | 25 (10%) | 0 |
| 1 Study A used CTCAE v4.0, and Study B used CTCAE
v3.0. 2 Includes diplopia, photopsia, photophobia, vision blurred, visual field defect, visual impairment, vitreous floaters, visual brightness, and visual acuity reduced. 3 Includes dyspepsia, dysphagia, epigastric discomfort/pain/burning, esophagitis, esophageal obstruction/pain/spasm/ulcer, gastroesophageal reflux, odynophagia, and reflux esophagitis. 4 Includes abdominal discomfort, abdominal pain, abdominal pain upper, and abdominal tenderness. 5 Includes mouth ulceration, glossodynia, glossitis, cheilitis, mucosal inflammation, oropharyngeal pain/discomfort, oral pain, and stomatitis. 6 Includes edema, edema localized, and peripheral edema. 7 Includes chest pain, chest discomfort, and musculoskeletal chest pain. 8 Includes nasopharyngitis, rhinitis, pharyngitis, and upper respiratory tract infection. 9 Includes balance disorder, dizziness, and presyncope. 10 Includes burning sensation, dysesthesia, hyperesthesia, hypoesthesia, neuralgia, paresthesia, peripheral neuropathy, peripheral motor neuropathy, and peripheral sensory neuropathy. |
||||
Vision disorders including visual impairment, photopsia, vision blurred, vitreous floaters, photophobia, and diplopia were reported in 159 (62%) patients in clinical trials. These events generally started within two weeks of drug administration. Consider ophthalmological evaluation, particularly if patients experience photopsia or experience new or increased vitreous floaters. Severe or worsening vitreous floaters and/or photopsia could also be signs of a retinal hole or pending retinal detachment. Advise patients to exercise caution when driving or operating machinery due to the risk of developing a vision disorder [see PATIENT INFORMATION].
Neuropathy as defined in Table 3 and attributed to study drug by the investigator was reported in 34 (13%) patients. While most events were Grade 1, Grade 2 motor neuropathy and Grade 3 peripheral neuropathy were reported in 1 patient each. Dizziness and dysgeusia were also very commonly reported in these studies, but were all Grade 1 or 2 in severity.
Bradycardia occurred in 12 (5%) patients treated with XALKORI. All of these cases were Grade 1 or 2 in severity.
Complex renal cysts occurred in 2 (1%) patients treated with XALKORI. There were no reports of abnormal urinalyses or renal impairment in these cases.
Laboratory Abnormalities
Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 5.2%, 0.4%, and 11.4% of patients, respectively.
Read the entire FDA prescribing information for Xalkori (crizotinib) »
Additional Xalkori Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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