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Zykadia

(ceritinib)

How does this medication work? What will it do for me?

Ceritinib belongs to the group of cancer-fighting medications known as antineoplastics and more specifically to a class of medications called protein kinase inhibitors. These medications slow the growth of blood vessels that feed nutrients to cancer cells. By slowing the growth of these blood vessels, ceritinib can help reduce the size of tumours.

Ceritinib is used to treat anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer that cannot be cured by surgical removal or that has spread to other parts of the body. Ceritinib is used when treatment with crizotinib has failed or it is not well tolerated.

Ceritinib has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual recommended dose of ceritinib is 750 mg (5 × 150 mg capsules) taken by mouth once a day. Take this medication at the same time each day. Your doctor may adjust your dose depending on how you tolerate ceritinib. Swallow the capsules whole – do not crush, dissolve, or open them.

Ceritinib must be taken on an empty stomach. Do not eat for at least 2 hours before or 2 hours after taking this medication. Do not take ceritinib with grapefruit, starfruit, pomegranate, Seville oranges, or other similar fruits, since they may interact with ceritinib.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each hard, size #00 gelatin capsule, with the opaque blue cap marked in black ink “LDK 150MG” and opaque white body marked in black ink “NVR”, contains 150 mg of ceritinib. Nonmedicinal ingredients: colloidal anhydrous silica, L-hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Capsule shell: gelatin, indigotine (E132), and titanium dioxide (E171); printing ink: black iron oxide.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to ceritinib or any ingredients of the medication
  • have congenital (present at birth) long QT syndrome

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • decreased appetite
  • diarrhea
  • headache
  • heartburn
  • low heart rate
  • nausea
  • rash
  • symptoms of neuropathy (e.g., numbness, prickling or tingling, burning, freezing, throbbing and/or shooting pain in the hands and or feet)
  • tiredness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • chest pain
  • fever
  • heart rhythm abnormality (e.g., dizziness, fainting, or chest discomfort)
  • low blood pressure
  • pounding heartbeat
  • severe nausea, vomiting or diarrhea
  • signs of anemia (low red blood cells; e.g., dizziness,  pale skin, unusual tiredness or weakness, shortness of breath)
  • slow heart rate
  • symptoms of high blood sugar (e.g., frequent urination, hunger, thirst)
  • symptoms of kidney problems (e.g., pain in the back or side, blood in the urine)
  • symptoms of liver problems (e.g., feeling more tired than usual, decreased appetite, yellowing of the skin or whites of the eyes, stomach pain, dark urine, nausea, vomiting, itching, or bleeding or bruising more easily than normal)
  • symptoms of low levels of phosphate in the blood (e.g., muscle pain and weakness, change in mental state)
  • symptoms of lung infection or inflammation (e.g., difficulty breathing, cough, or fever)
  • vision changes (e.g., blurred vision, flashes of light, double vision)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of bleeding in the stomach or digestive system (e.g., bloody, black or tarry stools, spitting up blood, vomiting blood or material that looks like coffee grounds)
  • signs of fluid buildup around the heart (e.g., chest pain or pressure, shortness of breath, nausea, difficulty swallowing)
  • signs of inflammation of the heart muscle (e.g., sharp stabbing chest pain that becomes worse with cough, swallowing, breathing, laying flat)
  • signs of pancreatitis (e.g.,  abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide,  moxifloxacin, mefloquine, pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with ceritinib. You are more at risk for this type of abnormal heart rhythm and its complications if you:

  • are female
  • are older than 65 years of age
  • have a family history of sudden cardiac death
  • have a history of heart disease or abnormal heart rhythms
  • have a slow heart rate
  • have congenital prolongation of the QT interval
  • have diabetes
  • have had a stroke
  • have low potassium, magnesium, or calcium levels
  • have nutritional deficiencies

If you have heart disease and abnormal heart rhythms or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Birth control: Use effective birth control while using this medication, as this medication may harm the baby if used during pregnancy. Both men and women should use effective birth control (e.g., condoms, birth control pill) during treatment and for at least 90 days after treatment is finished. If you or your partner become pregnant while taking this medication, contact your doctor immediately.

Diabetes: This medication can cause increases in blood sugars. If you have diabetes or a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart problems: This medication can decrease heart rate, which may contribute to heart failure or worsen symptoms of heart disease. If you have heart disease such as angina, congestive heart failure, or arrhythmia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a heart rate of less than 60 beats per minute, or frequently feel faint or dizzy, contact your doctor.

Kidney problems: If you have severe kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. Ceritinib may also reduce liver function and can cause severe liver problems. Your doctor will monitor your liver function with blood tests while you are taking this medication. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease) causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking ceritinib, contact your doctor immediately.

Nerve problems: People taking this medication may experience symptoms of neuropathy (nerve damage) such as numbness, prickling or tingling, burning, freezing, and throbbing or shooting pain. Tell your doctor if you experience any of these symptoms.

Pancreatitis: Ceritinib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.

Unwanted effects of this medication: Nausea, vomiting and diarrhea are commonly experienced by people using this medication. If they are severe, talk to your doctor or pharmacist about medications that can be used to control these symptoms.

Pregnancy: The safety of this medication if used during pregnancy has not been determined. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if ceritinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between ceritinib and any of the following:

  • abiraterone acetate
  • alitretinoin
  • alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
  • amantadine
  • amiodarone
  • anti-cancer medications (e.g., cabazitaxel, docetaxel; doxorubicin; etoposide, ifosfamide, irinotecan, vincristine)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apomorphine
  • aprepitant
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bicalutamide
  • benzodiazepines (e.g., chlordiazepoxide, clonazepam, diazepam, lorazepam)
  • beta2-agonists (e.g., indacaterol, salmeterol, vilanterol)
  • beta-adrenergic blockers (e.g., atenolol, carvedilol, propranolol, metoprolol, sotalol)
  • bosentan
  • brinzolamide
  • bromocriptine
  • buprenorphine
  • buspirone
  • busulfan
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carbamazepine
  • celecoxib
  • chloral hydrate
  • chloroquine
  • clonidine
  • cobicistat
  • colchicine
  • conivaptan
  • corticosteroids (e.g., budesonide, dexamethasone, fluticasone, hydrocortisone, prednisone)
  • cyclosporine
  • dantrolene
  • dapsone
  • darifenacin
  • dexamethasone
  • diabetes medications (e.g., chlorpropamide, gliclazide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • digoxin
  • dipyridamole
  • disopyramide
  • domperidone
  • donepezil
  • dronabinol
  • dronedarone
  • dutasteride
  • enzalutamide
  • eplerenone
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • eszopiclone
  • ethosuximide
  • everolimus
  • famotidine
  • fingolimod
  • flecainide
  • flutamide
  • formoterol
  • fosphenytoin
  • galantamine
  • grapefruit juice
  • guanfacine
  • hepatitis C antiviral medications (e.g., boceprevir, ledipasvir, sofosbuvir,)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • indapamide
  • lanreotide
  • lidocaine
  • lithium
  • lomitapide
  • losartan
  • macitentan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maprotiline
  • maraviroc
  • mefloquine
  • methadone
  • methyldopa
  • metoclopramide
  • metronidazole
  • mifepristone
  • mirtazapine
  • mirabegron
  • mitotane
  • modafinil
  • montelukast
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • oxybutynin
  • nefazodone
  • nitrates (e.g., isosorbide dinitrate,  isosorbide mononitrate)
  • octreotide
  • oxycodone
  • pasireotide
  • perampanel
  • phenobarbital
  • phenytoin
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • pimecrolimus
  • pimozide
  • prasugrel
  • praziquantel
  • primaquine
  • primidone
  • procainamide
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • propafenone
  • propranolol
  • protein kinase inhibitors (e.g., crizotinib, dabrafenib, dasatinib, erlotinib, imatinib, lapatinib)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quetiapine
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • repaglinide
  • rifabutin
  • rifampin
  • rilpivirine
  • rivaroxaban
  • romidepsin
  • St. John’s wort
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sirolimus
  • sitaxentan
  • solifenacin
  • “statin” anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • sulfamethoxazole
  • tacrolimus
  • tamoxifen
  • tetracycline
  • temsirolimus
  • teniposide
  • tenofovir
  • tetracycline
  • theophylline
  • ticagrelor
  • ticlopidine
  • tizanidine
  • tocilizumab
  • tolterodine
  • tolvaptan
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • trimethoprim
  • “triptan” migraine medications (e.g., almotriptan, eletriptan, sumatriptan)
  • ulipristal
  • venlafaxine
  • warfarin
  • zolpidem
  • zonisamide
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zykadia

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