Crizotinib

Generic name: Crizotinib
Brand names: Xalkori
Dosage form: oral capsule
Drug class: Multikinase inhibitors

Usage of Crizotinib

Crizotinib (Xalkori) is a type of cancer drug called a kinase inhibitor that is used to treat three rare forms of tumors.

Crizotinib is used to treat a type of non-small cell lung cancer (NSCLC) in people with an error in genes called ROS1 or ALK (anaplastic lymphoma kinase). An ROS1 error occurs in about 1 percent of people with NSCLC, while and ALK error occurs in about 5 percent of cases.

Defects in ROS1 and ALK cause cells to grow out of control causing cancer. Crizotinib works to help to stop or slow the growth of cancer. It does this by blocking the action of ROS1 and ALK and is known as a ROS1 tyrosine kinase inhibitor and an ALK tyrosine kinase inhibitor.

When Crizotinib was approved by the US Food and Drug Administration (FDA) in 2011, it was the first therapy to be approved for patients with ROS1-positive NSCLC.

Crizotinib is also used to treat a rare form of non-Hodgkin lymphoma (NHL) in children and young adults called anaplastic large cell lymphoma (ALCL) that has a defect in the ALK gene. About 90 percent of cases of ALCL in young people are ALK-positive.

Crizotinib is also used to treat children and adults with unresectable (unable to be removed by surgery), recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. IMT is a type of tumor that forms in mucosal surfaces, which are found in your mouth, eyes, nose, digestive system, lungs and urinary and genital tracts. IMT also forms in mesentery, a type of tissue that connects the organs in your abdomen. IMT is usually benign (non-cancerous).

Crizotinib side effects

Crizotinib may cause serious side effects, including:

  • See "Important information" above.

    • The most common side effects of crizotinib in people with NSCLC include:

  • vision problems
  • nausea, diarrhea, or vomiting
  • swelling of your hands, feet, face, and eyes
  • constipation
  • increased liver function blood tests
  • tiredness
  • decreased appetite
  • upper respiratory infection
  • dizziness
  • feeling of numbness or tingling in your arms or legs

    • The most common side effects of crizotinib in people with ALCL include:

  • diarrhea, vomiting, or nausea
  • vision problems
  • headache
  • muscle and joint pain
  • mouth sores
  • tiredness
  • decreased appetite
  • fever
  • stomach-area (abdominal) pain
  • cough
  • itchy skin
  • low blood counts

    • The most common side effects of crizotinib in adults with IMT include:

  • vision problems
  • nausea
  • swelling of your hands, feet, face, or eyes

    • The most common side effects of crizotinib in children with IMT include:

  • diarrhea, vomiting, or nausea
  • stomach-area (abdominal) pain
  • rash
  • vision problems
  • upper respiratory infection
  • cough
  • fever
  • muscle and joint pain
  • tiredness
  • swelling of your hands, feet, face, or eyes
  • constipation
  • headache

    • Crizotinib may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

    These are not all of the possible side effects of this medication. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Crizotinib

    Tell your doctor if you are pregnant, or plan to become pregnant. Crizotinib can harm the unborn baby.

    Females who are able to become pregnant:

  • Your healthcare provider will check to see if you are pregnant before starting treatment.
  • Effective birth control (contraception) should be used during treatment and for at least 45 days after the final dose.
  • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with crizotinib.

    • Males who have female partners who can become pregnant:

  • You should use condoms during treatment with crizotinib and for at least 90 days after the final dose.

    • Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if crizotinib passes into the breast milk. Do not breastfeed during treatment with this medication and for 45 days after the final dose. Talk to your healthcare provider about the best way to feed the baby during this time.

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    How to use Crizotinib

  • In patients with metastatic (cancer that has spread) NSCLC the recommended dosage of crizotinib is 250 mg orally twice daily.
  • In patients with systemic ALCL the recommended dosage of crizotinib is 280 mg/m2 orally twice daily based on body surface area.
  • In patients with unresectable IMT the recommended adult dosage of crizotinib is 250 mg orally twice daily and the recommended pediatric dosage is 280 mg/m2 orally twice daily based on body surface area.
  • See full prescribing information for dosage adjustments by indication for patients with moderate or severe hepatic impairment or severe renal impairment.

    • Warnings

    Crizotinib may cause serious side effects, including:

  • Liver problems. Crizotinib may cause life-threatening liver injury that may lead to death. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with this medication, then once a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms:
  • yellowing of your skin or the white part of your eyes
  • severe tiredness
  • dark or brown (tea color) urine
  • nausea or vomiting
  • decreased appetite
  • pain on the right side of your stomach
  • bleed or bruise more easily than normal
  • itching
  • Lung problems (pneumonitis). Crizotinib may cause life-threatening lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
  • trouble breathing or shortness of breath
  • cough with or without mucous
  • fever
  • Heart problems. Crizotinib may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly during treatment with this medication. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your healthcare provider if you take any heart or blood pressure medicines.
  • Severe vision problems. Vision problems are common with crizotinib. These problems usually happen within 1 week of starting treatment. Vision problems with this medication can be severe and may cause partial or complete loss of vision in one or both eyes. Your healthcare provider may hold or permanently stop your treatment and refer you to an eye specialist if any vision problems develop during treatment. Tell your healthcare provider right away if you have any new vision problems, loss of vision or any change in vision, including:
  • double vision
  • seeing flashes of light
  • blurry vision
  • light hurting your eyes
  • new or increased floaters In addition, for children or young adults taking crizotinib to treat ALCL or children taking it to treat IMT: Your healthcare provider may refer you to an eye specialist before starting this medication, and within 1 month of starting it to check for vision problems. You should have an eye examination every 3 months during treatment with this medication and more often if there are any new vision problems.
  • Severe stomach, intestine, and mouth (gastrointestinal) problems in children or young adults with ALCL or children with IMT. Crizotinib may cause severe diarrhea, nausea, vomiting, or mouth sores. Tell your healthcare provider right away if problems with swallowing, vomiting, or diarrhea develop during treatment.
  • Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.
  • Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

    • See "What are the side effects of crizotinib?" below for more information about side effects.

    What other drugs will affect Crizotinib

    Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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