ZYKADIA 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Zykadia150mg hard capsules

ceritinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zykadia and what is it used for
2. What you need to know before you take Zykadia
3. How to take Zykadia
4. Possible side effects
5. Storage of Zykadia
6. Contents of the pack and other information

1. What is Zykadia and what is it used for

What isZykadia

Zykadia is a cancer medicine that contains the active substance ceritinib. It is used to treat adult patients with advanced stages of a type of lung cancer called non-small cell lung cancer (NSCLC). Zykadia is only given to patients whose disease is due to a defect in a gene called ALK (anaplastic lymphoma kinase).

HowZykadiaworks

In patients with ALK defects, an abnormal protein is produced that stimulates the growth of cancer cells. Zykadia blocks the action of this abnormal protein and thus slows down the growth and spread of NSCLC.

If you have any questions about how Zykadia works or why you have been prescribed this medicine, ask your doctor or pharmacist.

2. What you need to know before you take Zykadia

Do not takeZykadia

• if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Zykadia:

• if you have liver problems.
• if you have lung problems or breathing difficulties.
• if you have heart problems, including a slow heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an abnormality in the electrical activity of the heart known as "prolonged QT interval".
• if you have diabetes (high blood sugar levels).
• if you have pancreas problems.
• if you are currently taking steroids.

Tell your doctor or pharmacist immediately if you experience any of the following signs or symptoms during treatment with Zykadia:

• fatigue, itching, yellowing of the skin or the white part of the eye, nausea (feeling sick) or vomiting, loss of appetite, pain in the right upper abdomen (stomach), dark or brown urine, bleeding or bruising that appears more easily than normal. These may be signs of liver problems.
• appearance or worsening of cough with or without mucus, fever, chest pain, breathing difficulties or shortness of breath. These may be symptoms of lung problems.
• chest pain or discomfort, changes in heart rhythm (fast or slow), fainting, dizziness, blue discoloration of the lips, difficulty breathing, swelling of the lower limbs or skin. These may be signs or symptoms of heart problems.
• severe diarrhea, nausea or vomiting. These are symptoms of digestive problems.
• excessive thirst or increased frequency of urination. These may be symptoms of high blood sugar levels.

Your doctor may need to adjust your treatment or interrupt Zykadia temporarily or permanently.

Blood tests during treatment with Zykadia

Your doctor should perform blood tests before starting treatment, every 2 weeks during the first 3 months of treatment, and after this period, your doctor should perform a blood test every month. The purpose of these tests is to check your liver function. Your doctor should also perform blood tests to check the functioning of your pancreas and blood sugar levels before starting treatment with Zykadia and regularly during treatment.

Children and adolescents

Zykadia is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zykadia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, such as vitamins or herbal supplements, as they may interact with Zykadia. It is especially important to tell your doctor about the following medicines.

Medicines that may increase the risk of side effects of Zykadia:

• medicines used to treat HIV/AIDS (e.g. ritonavir, saquinavir).
• medicines used to treat infections. These include medicines to treat fungal infections (antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines to treat certain types of bacterial infections (antibiotics such as telithromycin).

The following medicines may reduce the effectiveness of Zykadia:

• St. John's Wort, a herbal medicine used to treat depression.
• medicines used to stop seizures or fits (antiepileptics such as phenytoin, carbamazepine or phenobarbital).
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin).

Zykadia may increase the side effects associated with the following medicines:

• medicines used to treat irregular heart rhythm or other heart problems (e.g. amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide and digoxin).
• medicines used to treat stomach problems (e.g. cisapride).
• medicines used to treat mental health problems (e.g. haloperidol, droperidol, pimozide).
• medicines used to treat depression (e.g. nefazodone).
• midazolam, a medicine used to treat acute seizures or as a sedative before or during surgery or medical procedures.
• warfarin and dabigatran, a medicine used to prevent blood clots.
• diclofenac, a medicine used to treat joint pain and inflammation.
• alfentanil and fentanyl, medicines used to treat severe pain.
• cyclosporin, sirolimus and tacrolimus, medicines used in organ transplantation to prevent rejection of the transplanted organ.
• dihydroergotamine and ergotamine, medicines used to treat migraine.
• domperidone, a medicine used to treat nausea and vomiting.
• moxifloxacin and clarithromycin, medicines used to treat bacterial infections.
• methadone, a medicine used to treat pain and for the treatment of opioid dependence.
• chloroquine and halofantrine, medicines used to treat malaria.
• topotecan, a medicine used to treat certain types of cancer.
• colchicine, a medicine used to treat gout.
• pravastatin and rosuvastatin, medicines used to lower cholesterol levels.
• sulfasalazine, a medicine used to treat inflammatory bowel disease or rheumatoid arthritis.

Ask your doctor or pharmacist if you are not sure if your medicine is one of the medicines listed above.

During treatment with Zykadia, these medicines should be used with caution or you may need to avoid using them. If you are taking any of these, your doctor may need to prescribe an alternative medicine.

You should also tell your doctor if you are already taking Zykadia and are prescribed a new medicine that you have not taken before with Zykadia.

Oral contraceptives

If you take Zykadia while taking oral contraceptives, they may not be effective.

Taking Zykadia with food and drinks

Do not eat grapefruit or drink grapefruit juice during treatment. It may increase the amount of Zykadia in your blood to a harmful level.

Pregnancy and breastfeeding

You must use an effective method of birth control during treatment with Zykadia and for 3 months after stopping treatment. Discuss with your doctor the birth control methods that may be suitable for you.

Zykadia is not recommended during pregnancy unless the potential benefit outweighs the potential risk to the baby. If you are pregnant, think you may be pregnant or plan to become pregnant, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.

Zykadia should not be used during breastfeeding. You and your doctor will decide whether to breastfeed or take Zykadia. You should not do both.

Driving and using machines

You should be careful when driving or using machines while taking Zykadia as it may cause visual disturbances or fatigue.

Zykadia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Zykadia

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor again.

How much to take

The recommended dose is 450 mg (three capsules) taken once a day, with food, although your doctor may change this recommendation if necessary. Your doctor will tell you exactly how many capsules you need to take. Do not change the dose without talking to your doctor.

• Take Zykadia once a day at the same time each day, with food (e.g. a snack or a full meal). If you cannot eat while taking Zykadia, consult your doctor.
• Swallow the capsules whole with water. Do not chew or crush them.
• If you vomit after swallowing the Zykadia capsules, do not take any more capsules until the next scheduled dose.

How long to take Zykadia

• Continue taking Zykadia for as long as your doctor tells you.
• This is a long-term treatment, possibly lasting months. Your doctor will monitor your condition to check that the treatment is having the desired effect.

If you have any doubts about how long you should take Zykadia, ask your doctor or pharmacist.

If you take more Zykadia than you should

If you accidentally take too many capsules, or if someone takes your medicine accidentally, contact a doctor or hospital immediately. Medical treatment may be necessary.

If you forget to take Zykadia

What you should do if you miss a dose depends on how much time is left before your next dose:

• if your next dose is 12 or more hours away, take the missed capsules as soon as you remember. Then continue with the next capsules at the usual time.
• if your next dose is less than 12 hours away, do not take the missed capsules. Wait and take the next capsules at the usual time.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zykadia

Do not stop taking Zykadia without talking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Zykadia and seek medical help immediately if you experience any of the following symptoms,which may be signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with redness or hives

Some side effects could be serious

If you experience any of the following side effects, tell your doctor or pharmacist immediately:

• chest pain or discomfort, changes in heart rhythm (fast or slow), fainting, dizziness, blue discoloration of the lips, difficulty breathing, swelling of the lower limbs or skin (possible signs or symptoms of heart problems)
• appearance or worsening of cough with or without mucus, fever, chest pain, breathing difficulties or shortness of breath (possible signs of lung problems)
• fatigue, itching, yellowing of the skin or the white part of the eye, nausea (feeling sick) or vomiting, loss of appetite, pain in the right upper abdomen (stomach), dark or brown urine, bleeding or bruising that appears more easily than normal (possible signs of liver problems)
• severe diarrhea, nausea or vomiting
• excessive thirst or increased frequency of urination (symptoms of high blood sugar levels)
• severe pain in the upper abdomen (sign of pancreatitis, also known as inflammation of the pancreas)

Other possible side effects

The following are other side effects. If these side effects become serious, tell your doctor or pharmacist.

Very common(may affect more than 1 in 10 people):

• fatigue (fatigue and asthenia)
• abnormal blood test results that check liver function (high levels of enzymes called alanine aminotransferase and/or aspartate aminotransferase and/or gamma glutamyltransferase and/or alkaline phosphatase in the blood, high levels of bilirubin)
• abdominal pain
• loss of appetite
• weight loss
• constipation
• rash
• abnormal blood test results that check kidney function (high levels of creatinine)
• heartburn (possible sign of a digestive disorder)
• reduction in the number of red blood cells, known as anemia

Common(may affect up to 1 in 10 people):

• vision problems
• low phosphate levels in the blood (this is detected in a blood test)
• high levels of enzymes called lipase and/or amylase in the blood (this is detected in a blood test)
• significant decrease in urine output (possible risk of kidney problems)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zykadia

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any damage to the packaging or if you notice signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition ofZykadia

• The active substance of Zykadia is ceritinib. Each hard capsule contains 150 mg of ceritinib.
• The other components are:
• Capsule content: anhydrous colloidal silica; low-substituted hydroxypropylcellulose; sodium glycolate starch (type A) (see "Zykadia contains sodium" in section 2); magnesium stearate; microcrystalline cellulose.
• Capsule cap: gelatin, indigotine (E132) and titanium dioxide (E171).
• Printing ink: Shellac (bleached, wax-free) glaze 45%, black iron oxide (E172), propylene glycol and ammonium hydroxide 28%.

Appearance ofZykadiaand container contents

Zykadia hard capsules have a white opaque body and a blue opaque cap, and are approximately 23.3 mm long, with the text "LDK 150MG" printed on the cap and "NVR" on the body. They contain white to off-white powder.

The capsules are presented in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules. Not all pack sizes may be marketed in your country.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Sandoz S.R.L.

Str. Livezeni nr. 7A

540472, Targu Mures

Romania

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of last revisionof this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu