TM Owner Pfizer
Xalkori 250mg Capsule
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Indications & Clinical Uses
- Xalkori 250 mg capsules contain crizotinib, a kinase inhibitor cancer medicine.
- In the US it is approved for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours are ALK-positive or ROS1-positive, for children aged 1 year and older and young adults with relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma, and for adults and children aged 1 year and older with unresectable, recurrent or refractory ALK-positive inflammatory myofibroblastic tumour.
- The adult dose is 250 mg twice daily; children are dosed by body surface area (280 mg/m2 twice daily).
- EU labelling covers ALK-positive and ROS1-positive advanced NSCLC.
- Xalkori is also supplied as 200 mg capsules and as oral pellets (20, 50 and 150 mg) for younger patients, so strengths and forms must not be swapped without instruction.
- It is started and supervised by a cancer specialist and taken at home.
Side Effects
- In adults with NSCLC the very common reactions (25% or more) include vision disorders (71%), diarrhoea (61%), nausea (56%), swelling (49%), vomiting (46%), constipation (43%), upper respiratory infection (32%), decreased appetite (30%), fatigue (29%), neuropathy (21%), dizziness (18%) and raised liver enzymes.
- Vision disorders include flashes, blurred or double vision, light sensitivity and floaters.
- Serious effects: fatal liver injury (reported in 0.1% of 1,719 NSCLC patients), lung inflammation (interstitial lung disease or pneumonitis), QT prolongation, slow heart rate (bradycardia, 13%) and severe vision loss (0.2%).
- In children with lymphoma or tumours, severe nausea, vomiting and diarrhoea were seen.
- There is no boxed warning.
- Report yellow skin or eyes, dark urine, new cough or breathlessness, fainting, palpitations or any vision loss straight away.
Precautions & Warnings
- Liver blood tests are taken regularly, initially every 2 weeks, and treatment may be interrupted or stopped for liver injury.
- Xalkori is permanently stopped if interstitial lung disease or pneumonitis is diagnosed.
- ECGs and electrolytes are monitored, and Xalkori should be avoided in congenital long QT syndrome.
- Heart rate is monitored because bradycardia is common, and any change in vision should be reported.
- Xalkori can harm an unborn baby: women who could become pregnant must use effective contraception during treatment and for 45 days after the last dose, and men with partners who could become pregnant should use condoms during treatment and for 90 days after.
- Do not breastfeed during treatment and for 45 days after the last dose.
- The US label lists no contraindications.
- Store capsules at 20°C to 25°C.
- Older Pfizer regional labelling cites storage below 30°C.
Avoid Interactions
- Increase in effect or toxicity: strong CYP3A inhibitors raise crizotinib levels, so the label says to avoid them; if unavoidable, a second dose reduction is used.
- Xalkori itself can raise levels of CYP3A substrate medicines, so avoid combinations where small changes in levels could cause serious harm.
- Other medicines that slow the heart rate (bradycardia-causing drugs) should be avoided in combination, and QT-prolonging medicines need extra ECG monitoring.
- Reduced efficacy: strong CYP3A inducers lower crizotinib levels and should be avoided.
- Tell your healthcare provider about every prescription medicine, non-prescription product, herbal remedy and supplement you take before starting Xalkori and whenever anything changes.
References
Frequently Asked Questions
Xalkori (crizotinib) treats adults with advanced ALK-positive or ROS1-positive non-small cell lung cancer. In the US it is also used for ALK-positive anaplastic large cell lymphoma and inflammatory myofibroblastic tumour in children aged 1 year and older. A cancer specialist prescribes it.
Adults with lung cancer take Xalkori (crizotinib) 250 mg by mouth twice daily, as directed by their cancer specialist. Children are dosed by body surface area, at 280 mg/m2 twice daily. Xalkori capsules and oral pellets have different strengths, so use only the form and dose you were given.
Xalkori (crizotinib) very commonly causes vision problems, diarrhoea, nausea, vomiting, swelling, constipation, tiredness and raised liver enzymes. Serious effects include liver injury, lung inflammation, slow heart rate and severe vision loss. Get urgent help for yellow skin, dark urine, new breathlessness, fainting or sudden loss of vision.
Avoid strong CYP3A inhibitors and inducers with Xalkori (crizotinib), as they change its blood levels; the label says to avoid inducers and to reduce the dose if an inhibitor is unavoidable. Also avoid other medicines that slow the heart rate. Tell your healthcare provider about all your medicines.
While taking Xalkori (crizotinib) you need liver blood tests, initially every 2 weeks, because fatal liver injury has occurred. You also need ECGs and electrolyte checks for QT prolongation, and heart rate monitoring for bradycardia. Tell your healthcare provider straight away about any change in your vision.
No. Xalkori (crizotinib) can harm an unborn baby. Women who could become pregnant must use effective contraception during treatment and for 45 days after the last dose. Men with partners who could become pregnant should use condoms during treatment and for 90 days after. Do not breastfeed during treatment and for 45 days afterwards.
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