ceritinib

Posted on March 16th, 2015 by

Class: Biological Therapy

Generic Name: ceritinib

Trade Name: Zykadia™

For which conditions is this drug approved? Zykadia is approved for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase) whose disease has worsened after taking Xalkori® (crizotinib) or cannot tolerate Xalkori.

What is the mechanism of action? Zykadia is a kinase inhibitor. These drugs work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Specifically, Zykadia targets ALK.

How is Zykadia typically given (administered)? Zykadia is given orally (capsule) once daily at a dose of 750 mg.

How are patients typically monitored? Zykadia can cause complications involving the liver, so patients will have liver function monitored at least monthly. Patients should also be monitored for high blood sugar (hyperglycemia) and have heart rate and blood pressure checked regularly.

 

What are the common (occur in 30% or more of patients) side effects of treatment with Zykadia?

  • Diarrhea
  • Nausea
  • Elevated transaminases (enzymes used to monitor liver health)
  • Vomiting
  • Abdominal pain
  • Fatigue
  • Decreased appetite

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Zykadia?

  • Constipation
  • Esophageal disorder
  • Rash
  • Neuropathy

 This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your medical conditions, including if you have:
    • Liver problems
    • Diabetes or high blood sugar
    • Heart problems, particularly a condition called long QT syndrome
  • Take Zykadia exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.
  • Take Zykadia one time each day.
  • Take Zykadia on an empty stomach—do not eat for two hours before and for two hours after.
  • If you miss a dose of Zykadia, take it as soon as you remember. BUT, if your next dose is due within 12 hours, skip the missed dose and take the next dose at your regular time.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your doctor if you’re pregnant or plan to become pregnant. Zykadia may harm your unborn baby. Women who are able to become pregnant should use an effective method of birth control during treatment with Zykadia and for at least two weeks after stopping Zykadia. Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell you doctor is you are breastfeeding or plan to breastfeed. It is not known if Zykadia passes into your breast milk. You should not breastfeed if you take Zykadia.
  • Do not consume grapefruit and grapefruit juice during treatment with Zykadia.
  • Tell your healthcare provider if you start to take or have any changes in heart or blood pressure medicines.

When should patients notify their physician?

  • Tell you doctor if your have stomach and intestinal problems. Zykadia causes stomach and intestinal problems in most people. This includes diarrhea, nausea, vomiting, and pain in the stomach area. These problems can sometimes be severe.
  • Tell your doctor is you have signs of liver problems. These include:
    • Feeling tired
    • Your skin or the whites of your eyes turning yellow
    • Decreased appetite
    • Your urine turning dark or brown
    • Itching skin
    • Nausea or vomiting
    • Pain on the right side of your stomach area
    • Bleeding or bruising more easily than normal

 

  • Tell your doctor if you have signs of lung problems. These include:
    • Trouble breathing or shortness of breath
    • Cough with or without mucous
    • Fever
    • Chest pain

 

  • Tell your doctor if you have signs of heart problems. These include:
    • Very slow, very fast, or abnormal
    • New chest pain or discomfort
    • Dizziness or lightheadedness
    • Fainting
    • Abnormal heartbeats

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Tags: Biological Therapy, C, Drug Dictionary, non-small cell lung cancer

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