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Rizolung® (Crizotinib)

Rizolung® (Crizotinib)

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Capsule 200,250 mg

 

Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, HGFR, c-Met, ROS1, and RON. 




INDICATIONS

Rizolung® is a kinase inhibitor indicated for the treatment of:

 

• patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

• pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

o Limitations of Use: The safety and efficacy of Rizolung® have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

  • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.

 It is not known if Crizal is safe and effective in older adults with ALCL or in children younger than 1 year of age with ALCL or IMT.

DOSAGE AND ADMINISTRATION

•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.

○ Pediatric: The recommended dosage is 280 mg/m2 orally twice daily based on body surface area.

 

WARNINGS AND PRECAUTIONS

• Liver problems. Rizolung® may cause life-threatening liver injury. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with Rizolung®, 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:

o yellowing of your skin or the white part of your eyes

o severe tiredness

o dark or brown (tea color) urine

o nausea or vomiting

o decreased appetite

o pain on the right side of your stomach

o bleed or bruise more easily than normal

o itching

Lung problems (pneumonitis). Rizolung® may cause life-threatening lung problems. 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:

o trouble breathing or shortness of breath

o cough with or without mucous

o fever

Heart problems. Rizolung® may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly during treatment with Rizolung®. 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 Rizolung®. These problems usually happen within 1 week of starting treatment with Rizolung®. Vision problems with Rizolung® 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 with Rizolung® and refer you to an eye specialist if any vision problems develop during treatment with Rizolung®. Tell your healthcare provider right away if you have any new vision problems, loss of vision or any change in vision, including:

o double vision

o light hurting your eyes

o seeing flashes of light

o new or increased floaters

o blurry vision

In addition, for children or young adults taking Rizolung® to treat anaplastic large cell lymphoma (ALCL) or children taking Rizolung® to treat inflammatory myofibroblastic tumor (IMT): Your healthcare provider may refer you to an eye specialist before starting Rizolung®, and within 1 month of starting Rizolung® to check for vision problems. You should have an eye examination every 3 months during treatment with Rizolung® 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. Rizolung® 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 with Rizolung®.

o Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.

o Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

 

Call your healthcare provider right away if you have any of aforementioned symptoms.

 

The most common side effects of Rizolung® 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 Rizolung® in people with ALCL include:

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

The most common side effects of Rizolung® in adults with IMT include:

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

The most common side effects of Rizolung® 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

Call your doctor for medical advice about side effects.

DRUG INTERACTIONS
  • Strong or Moderate CYP3A Inhibitors

    Concomitant use of Rizolung® with strong CYP3A inhibitors may increase the risk of adverse reactions of Rizolung®. Avoid concomitant use of strong CYP3A inhibitors. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the Rizolung® dosage. Avoid grapefruit or grapefruit juice which may also increase plasma concentrations of Rizolung®. Use caution with concomitant use of moderate CYP3A inhibitors.

  • Strong CYP3A Inducers

    Concomitant use of Rizolung® with strong CYP3A inducers may decrease the efficacy of Rizolung®. Avoid concomitant use of strong CYP3A inducers.

  • CYP3A Substrates

     Concomitant use of Rizolung® increases the risk of adverse reactions of CYP3A substrates. Avoid concomitant use where minimal concentration changes may lead to serious adverse reactions. If concomitant use of Rizolung® is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling.

  • Drugs That Prolong the QT Interval

    Rizolung® can prolong the QT/QTc interval. Avoid concomitant use of Rizolung® with drugs that prolong the QT interval.

  • Drugs That Cause Bradycardia

Rizolung® can cause bradycardia. Avoid concomitant use of Rizolung® with drugs that cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, and digoxin).

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