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Drug Formulary

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ceritinib

( se ri' ti nib )

Other Name(s): Zykadia™

Appearance: capsule

ceritinib patient.pdf

ceritinib pour le patient.pdf

Medication Information Sheet

ceritinib (se ri' ti nib)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Zykadia (TM)

Appearance:

capsule

What is this medication for?

For treating certain types of lung cancer.

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), such as:
- heart problems (including irregular or low heartbeat)
- liver or kidney problems
- diabetes or high blood sugar
- problems with your pancreas
- or any allergies
Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this treatment may affect your sexual health.
How this treatment may affect your ability to have a baby, if this applies to you.

This treatment may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until 3 months after your last treatment dose. Talk to your health care team about which birth control options are best for you.
Do not breastfeed while on this treatment.

How is this medication given?

IMPORTANT: You must talk to your health care team about whether to take this medication with food or not.

This medication is usually taken once a day by mouth.
Swallow whole with a glass of water and take with food (for example a snack or full meal).
You may need to take more than 1 capsule to have the correct dose. Follow the instructions given to you by your health care team.
Do not open, crush or chew capsules.
If you miss a dose, take it if it is within 12 hours from the missed dose, otherwise skip and take your next dose as scheduled. Do not double the dose to make up for the forgotten one.
If vomiting occurs after taking the dose, do not take a replacement dose. Continue with the next scheduled dose.

To Treat Diarrhea

Diarrhea is when you have loose bowel movements (watery poo) or you need to go poo (have bowel movements) more often than usual. Diarrhea may start a few days after your treatment.

You may be given a medication called loperamide (Imodium®) to help treat your diarrhea. Take this medication only if you need it. Keep your loperamide with you all the time. When diarrhea starts, take the loperamide right away.

If you start to have diarrhea:

Take 2 tablets (4mg) of loperamide right away.
Take 1 tablet after each loose bowl movement (watery poo).
Do not take more than 8 tablets every day.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?
- This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment not work as well or cause severe side effects.
- Tell your health care team about all of your:
  - prescription and over-the-counter (non-prescription) medications and all other drugs, such as marijuana (medical or recreational)
  - natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
- Check with your health care team before starting or stopping any of them.
What should I do if I feel unwell, have pain, a headache or a fever?
- Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol) or ibuprofen (Advil)).
  - Fever can be a sign of infection that may need treatment right away.
  - If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).
- You have a fever if your temperature taken in your mouth (oral temperature) is:
  - 38.3°C (100.9°F) or higher at any time
    
    OR
  - 38.0°C (100.4°F) or higher for at least one hour.
If you do have a fever:
- Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
- Ask your health care team for the Fever pamphlet for more information.
If you do not have a fever but have mild symptoms such as headache or mild pain:
- Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
- Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
- Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

What to DO while on this medication:

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.

What NOT to DO on this medication:

DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while taking this drug. They may increase the amount of drug in your blood and increase side effects.
DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

How should I safely store this medication?

Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.

What are the side effects of this medication?

The following table lists side effects that you may have when getting ceritinib.

The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed. Read over the side effect table so that you know what to look for and when to get help.

Keep this paper during your treatment so that you can refer to it if you need to.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
Diarrhea (May be severe) What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day)
Liver problems (May be severe) Your health care team may check your liver function with a blood test. The liver changes do not usually cause any symptoms. What to look for? Rarely, you may develop yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. This may be severe. What to do? If you have any symptoms of liver problems, get emergency medical help right away.	Get emergency medical help right away
Nausea and vomiting What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. Take your anti-nausea medication(s) as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your health care team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if severe

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. Ask your health care team for the Fatigue pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Pains or cramps in the belly What to look for? Pain or cramps in your belly. Constipation and diarrhea can cause pain in your belly. What to do? If the pain is severe, gets worse or doesn’t go away, talk to your health care team about other possible causes.	Talk to your health care team if it does not improve or if it is severe
Low appetite What to look for? Loss of interest in food or not feeling hungry. Weight loss. What to do? Try to eat your favourite foods. Eat small meals throughout the day. You may need to take meal supplements to help keep your weight up. Talk to your health care team if you have no appetite. Ask your health care team for the Loss of Appetite pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Abnormal kidney lab tests (May be severe) What to look for? Swelling, passing very little or no pee, or new unusual weight gain. Your doctor may check your kidney function regularly. To prevent bladder or kidney problems: Drink at least 6 to 8 glasses of water or other liquids every day (unless your doctor told you to drink more or less). What to do? If you have these signs, call your health care team or go to your closest emergency department.	Talk to your health care team if it does not improve or if it is severe
Rash; dry, itchy skin What to look for? You may have cracked, rough, flaking or peeling areas of the skin. Your skin may look red and feel warm, like a sunburn. Your skin may itch, burn, sting or feel very tender when touched. What to do? To prevent and treat dry skin: Use fragrence-free skin moisturizer. Protect your skin from the sun and the cold. Use sunscreen with UVA and UVB protection and a SPF of at least 30. Avoid perfumed products and lotions that contain alcohol. Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less. Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.	Talk to your health care team if it does not improve or if it is severe
Constipation What to look for? Having bowel movements (going poo) less often than normal. Small hard stools (poo) that look like pellets. The need to push hard and strain to have any stool (poo) come out. Stomach ache or cramps. A bloated belly, feeling of fullness, or discomfort. Leaking of watery stools (poo). Lots of gas or burping. Nausea or vomiting. What to do? To help prevent constipation: Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains. Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less. Be Active. Exercise can help to keep you regular. If you take opioid pain medication, ask your health care team if eating more fibre is right for you. To help treat constipation: If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do. Ask your health care team for the Constipation Pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Mild joint, muscle pain or cramps What to look for? New pain in your muscles or joints, muscle cramps, or feeling achy. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" on page 3 before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Anemia (low red blood cells) What to look for? You may feel more tired or weaker than normal. Pale skin and cold hands and feet. You may feel short of breath, dizzy or lightheaded. This may occur in days to weeks after your treatment starts. What to do? If your health care team has told you that you have anemia (low red blood cells): Rest often and eat well. Light exercise, such as walking may help. You may need medication or a blood transfusion. If it is very bad, your doctor may need to make changes to your treatment regimen.	Talk to your health care team if it does not improve or if it is severe
High blood sugar (May be severe) What to look for? You may feel thirsty and pee more often. Your doctor may check your blood sugar level. You may be advised to change your diet or take medication to treat high blood sugar. What to do? Check your blood sugar regularly if you have diabetes.	Talk to your health care team as soon as possible
Heart problems What to look for? You may have an irregular heartbeat, shortness of breath, chest pain or fainting spells. Swelling in your legs, ankles and belly. Sharp pain in the centre or left side of the chest (often worsens when taking a deep breath). Extreme tiredness that prevents you from exercising or doing normal activities. What to do? Get emergency medical help right away.	Get emergency medical help right away
Abnormal levels of pancreas tests (lipase, amylase) Your health care team will check your pancreas function with a blood test regularly.	Talk to your health care team if it does not improve or if it is severe

Other rare, but serious side effects are possible. If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

Slow heartbeat
Pain, swelling and hardening of a vein in your limb(s)
New cough, breathing problems, shortness of breath, or coughing blood
Blurred vision, sensitivity to light or eye pain
Pain in the centre of your belly that may extend to your back
Muscle weakness; seizures; feeling confused

Who do I contact if I have questions or need help?

My cancer health care provider is: ________________________________________________

During the day I should contact:__________________________________________________

Evenings, weekends and holidays:________________________________________________

Other Notes:

____________________________________________________________________________

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

ceritinib

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