Prospecto: information for the patient

Zykadia150mg hard capsules

ceritinib

Read the entire prospect carefully before starting to take this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.See section4.

1.What isZykadiaand what is it used for

2.What you need to know before starting to takeZykadia

3.How to takeZykadia

4.Possible adverse effects

5.Storage ofZykadia

6.Contents of the package and additional information

What isZykadia

Zykadia is a cancer medication that contains the active ingredient 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 administered to patients whose disease is caused by a defect in a gene called ALK (anaplastic lymphoma kinase).

How it worksZykadia

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 the growth and spread of NSCLC.

If you have any doubts about how Zykadia works or why you have been prescribed this medication, consult your doctor or pharmacist.

Do not takeZykadia

• if you are allergic to ceritinib or any of the other ingredients in this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeZykadia:

• if you have liver problems.
• if you have lung problems or difficulty breathing.
• if you have heart problems, including a slow heart rate, or if an electrocardiogram (ECG) has shown that you have a heart rhythm abnormality known as “prolonged QT interval”.
• if you have diabetes (high blood sugar).
• if you have pancreas problems.
• if you are currently taking steroids.

Inform your doctor or pharmacist immediately if you experience any of the following signs or symptoms during treatment withZykadia:

• fatigue, itching, yellowing of the skin or the white part of the eye, nausea (feeling of dizziness) or vomiting, loss of appetite, pain in the right upper abdomen (stomach), dark or brown urine, bleeding or bruising that occurs more easily than normal. These may be signs or symptoms of liver problems.
• appearance or worsening of cough with or without mucus, fever, chest pain, difficulty breathing or rapid breathing. 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.

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

Blood tests during Zykadia treatment

Your doctor should perform blood tests before starting treatment, every 2weeks during the first three months of treatment, and then every month thereafter. The purpose of these tests is to check your liver function. Your doctor should also perform blood tests to check your pancreas function and blood sugar level before starting treatment with Zykadia and regularly during treatment.

Children and adolescents

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

Other medications and Zykadia

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication,including over-the-counter medications such as vitamins or herbal supplements, as they may interact with Zykadia. It is especially important to inform about the following medications.

Medications that may increase the risk of adverse effects ofZykadia:

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

The following medications may reduce the effectiveness ofZykadia:

• St. John's Wort, a plant-based medication used to treat depression.
• antiepileptic medications (e.g. phenytoin, carbamazepine, or phenobarbital) used to stop seizures or attacks.
• medications used to treat tuberculosis (e.g. rifampicin, rifabutin).

Zykadiamay increase the adverse effects associated with the following medications:

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

Consult your doctor or pharmacist if you are unsure if your medication is one of the medications listed above.

During treatment with Zykadia, these medications should be used with caution or may need to be avoided. If you are taking any of these medications, your doctor may need to prescribe an alternative medication.

You should also inform your doctor if you are already taking Zykadia and are prescribed a new medication 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

You should 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 should use an effective method of birth control during treatment with Zykadia and for 3months after stopping treatment. Discuss with your doctor the methods of birth control 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, consult your doctor before taking this medication. Your doctor will discuss the potential risks of taking Zykadia during pregnancy with you.

Zykadia should not be used during breastfeeding.Along with your doctor, you will decide whether to breastfeed or take Zykadia. Do not do both.

Driving and operating machinery

You should be particularly careful when driving or operating machinery while taking Zykadia as it may cause visual disturbances or fatigue.

Zykadia contains sodium

This medication contains less than 1mmol of sodium (23mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

How much to take

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

• TakeZykadiaonce a day at the same time every day, with food (for example, a snack or a full meal). If you cannot eat while taking Zykadia, consult your doctor.
• You must 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 dose according to the established schedule.

For how long to takeZykadia

• Continue takingZykadiafor the time 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 doubts about how long you should takeZykadia, consult your doctor or pharmacist.

If you take moreZykadiathan you should

If you accidentally take too many capsules, or if someone accidentally takes your medication, contact a doctor or hospital immediately. You may need medical treatment.

If you forgot to takeZykadia

What you should do if you forgot to take a dose depends on how much time is left until the next dose:

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

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withZykadia

Do not interrupt the treatment with this medication before informing your doctor. If you have any other doubts about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP treatment withZykadiaand seek medical help immediately if you experience any of the following signs, which may be signs of an allergic reaction:

• Difficulty breathing or swallowing
• Swelling in the face, lips, tongue, or throat
• Intense itching on the skin, with red rash or pimples

Some side effects could be serious

If you experience any of the following side effects, inform 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 in 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, rapid breathing, (possible signs of lung problems)
• Fatigue, itching on the skin, yellow discoloration of the skin or the white part of the eye, nausea (sensation of dizziness) or vomiting, decreased appetite, right upper abdominal pain, dark or brown urine, bleeding or bruising that appears more easily than normal (possible signs of liver problems)
• Diarrhea, severe nausea or vomiting
• Excessive thirst, increased frequency of urination (symptoms of high blood sugar levels)
• Intense pain in the upper abdomen (sign of pancreatitis, also known as inflammation of the pancreas)

Other possible side effects

The following are other possible side effects. If these side effects become severe, inform your doctor or pharmacist.

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

• Fatigue (fatigue and asthenia)
• Altered results in blood tests that control 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
• Decreased appetite
• Weight loss
• Constipation
• Rash
• Altered results in blood tests to control kidney function (high level of creatinine)
• Heartburn (possible sign of a gastrointestinal tract alteration)
• Reduction in the number of red blood cells, known as anemia

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

• Visual problems
• Low level of phosphate in the blood (this is detected in the blood test)
• High level of enzymes called lipase and/or amylase in the blood (this is detected in the blood test)
• Significant decrease in urine elimination (possible risk of a kidney problem)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the blister after CAD and EXP. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature.
• Do not use this medication if you observe any damage to the packaging or signs of manipulation.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition ofZykadia

• The active ingredient ofZykadiais ceritinib. Each hard capsule contains 150mg of ceritinib.
• The other components are:
• Capsule content: anhydrous colloidal silica; low-substituted hydroxypropylcellulose; sodium starch glycolate (type A) (see “Zykadia contains sodium” in section2); magnesium stearate; microcrystalline cellulose.
• Capsule coating: gelatin, indigotin (E132) and titanium dioxide (E171).
• Printing ink: Shellac (blanched, wax-free) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.

Appearance ofZykadiaand contents of the pack

Zykadiahard capsules have a white opaque body and a blue opaque cap, and measure approximately 23.3mm in length, with the text“LDK 150MG”printed on the cap and“NVR”on the body. They contain a white to off-white powder.

The capsules are presented in blisters and are available in packs containing 40, 90 or 150(3packs of 50) capsules.Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible 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

Roonstraβe 25

D‑90429 Nürnberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

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

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu