Zykadia

The usual recommended dose of Zykadia (Ceritinib) is 450 mg (3 × 150 mg capsules) taken by mouth once a day. Take Zykadia (Ceritinib) at the same time each day. Your doctor may adjust your dose depending on how you tolerate Zykadia (Ceritinib). Swallow the capsules whole – do not crush, dissolve, or open them.

Zykadia (Ceritinib) must be taken with food. This can be either a full meal or a snack. Do not take Zykadia (Ceritinib) with grapefruit, starfruit, pomegranate, Seville oranges, or other similar fruits, since they may interact with Zykadia (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 Zykadia (Ceritinib) 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 Zykadia (Ceritinib) 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.

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 Zykadia (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.

Do not take Zykadia (Ceritinib) if you:

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

There may be an interaction between Zykadia (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 Zykadia (Ceritinib). 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.

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 Zykadia (Ceritinib).

Abnormal heart rhythms: Zykadia (Ceritinib) 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 Zykadia (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 Zykadia (Ceritinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zykadia (Ceritinib), and whether any special monitoring is needed.

Birth control: Use effective birth control while using Zykadia (Ceritinib), as Zykadia (Ceritinib) 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 Zykadia (Ceritinib), contact your doctor immediately.

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

Heart problems: Zykadia (Ceritinib) 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 Zykadia (Ceritinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zykadia (Ceritinib), 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 Zykadia (Ceritinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zykadia (Ceritinib), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Zykadia (Ceritinib) to build up in the body, causing side effects. Zykadia (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 Zykadia (Ceritinib). If you have liver problems, discuss with your doctor how Zykadia (Ceritinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zykadia (Ceritinib), 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 Zykadia (Ceritinib). 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 Zykadia (Ceritinib), contact your doctor immediately.

Nerve problems: People taking Zykadia (Ceritinib) 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: Zykadia (Ceritinib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Zykadia (Ceritinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zykadia (Ceritinib), 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 Zykadia (Ceritinib): Nausea, vomiting and diarrhea are commonly experienced by people using Zykadia (Ceritinib). If they are severe, talk to your doctor or pharmacist about medications that can be used to control these symptoms.

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

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

Children: The safety and effectiveness of using Zykadia (Ceritinib) have not been established for children.