Zykadia - Ceritinib Tablets

What is this medication?

CERITINIB (se RI ti nib) treats lung cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Zykadia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Heart disease
• History of irregular heartbeat or rhythm
• History of pancreatitis
• Liver disease
• Low levels of magnesium or potassium in the blood
• Lung or breathing disease, such as asthma or COPD
• An unusual or allergic reaction to ceritinib, lactose, gelatin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is less than 12 hours before the next dose. If it is less than 12 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Do not take this medication with any of the following:

• Alfuzosin
• Certain medications for cholesterol, such as lovastatin or simvastatin
• Certain medications for fungal infections, such as fluconazole, isavuconazonium, posaconazole, voriconazole
• Cisapride
• Dronedarone
• Eletriptan
• Eplerenone
• Ergot alkaloids, such as dihydroergotamine or ergotamine
• Flibanserin
• Ivabradine
• Lomitapide
• Lurasidone
• Naloxegol
• Pimozide
• Ranolazine
• Saquinavir
• Silodosin
• Thioridazine
• Tolvaptan
• Triazolam
• Ubrogepant
• Venetoclax

This medication may also interact with the following:

• Alfentanil
• Certain antibiotics, such as clarithromycin or telithromycin
• Certain antivirals for HIV or AIDS
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cyclosporine
• Dofetilide
• Fentanyl
• Grapefruit juice
• Nefazodone
• Other medications that cause heart rhythm changes
• Quinidine
• Rifampin
• Sirolimus
• St. John's wort
• Tacrolimus
• Warfarin
• Ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Talk to your care team if you or your partner wish to become pregnant or think either of you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 6 months after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after the last dose. Talk to your care team about reliable forms of contraception. Do not father a child while taking this medication or for 3 months after the last dose. Use a condom while having sex during this time period.

Do not breast-feed while taking this medication and for 2 weeks after the last dose.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Loss of appetite with weight loss
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.