150 mg film-coated tablets
ceritinib
What Zykadia is and what it is used for
What Zykadia is
Zykadia is a cancer medicine, which contains the active substance ceritinib. It is used to treat adults with advanced stages of a form of lung cancer called non-small cell lung cancer (NSCLC). Zykadia is only given to patients whose disease is caused by a defect in a gene called ALK (anaplastic lymphoma kinase).
How Zykadia works
In patients with ALK defects, an abnormal protein is produced that stimulates the growth of cancer cells. Zykadia blocks the effect of this abnormal protein, thereby slowing the growth and spread of non-small cell lung cancer.
Ask your doctor or pharmacist if you have any questions about how Zykadia works or why it has been prescribed for you.
What you need to know before you take Zykadia
Do not take Zykadia
- if you are allergic to ceritinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zykadia:
- if you have liver problems
- if you have problems with your lungs or have difficulty breathing
- if you have problems with your heart, e.g. slow heart rate, or if the results of an electrocardiogram ( ECG ) have shown that you have an abnormality in the electrical activity of your heart called “QT prolongation”
- if you have diabetes (high blood sugar)
- if you have problems with the pancreas
- if you are currently being treated with steroids.
Talk to your doctor or pharmacist immediately if you get any of the following signs or symptoms during treatment with Zykadia:
- tiredness, itchy skin, yellowing of the skin or the whites of the eyes, nausea or vomiting, decreased appetite, pain on the right side of the abdomen (stomach), dark or brown urine, bleeding or bruising more easily than usual. These may be signs or symptoms of liver problems.
- new or worsening cough with or without phlegm, fever, chest pain, difficulty breathing, or shortness of breath. These can be symptoms of lung problems.
- chest pain or discomfort, changed heart rhythm (faster or slower), feeling unsteady, fainting, dizziness, bluish lips, shortness of breath, swollen legs, or swollen skin. These may be signs or symptoms of heart problems.
- severe diarrhea, nausea, or vomiting. These are symptoms of digestive problems.
- severe thirst and increased urine output. These can be symptoms of high blood sugar.
The doctor may need to adjust your treatment or stop the use of Zykadia temporarily or permanently.
Blood tests during treatment with Zykadia
The doctor will take some blood samples before you start treatment, every two weeks during the first three months of treatment, and then every month. The blood samples are taken to check the function of the liver. The doctor should also take blood tests to check the function of the pancreas and the level of sugar in the blood before you start treatment with Zykadia and regularly during treatment.
Children and young people
The use of Zykadia is not recommended in children and adolescents up to 18 years of age.
Other medicines and Zykadia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines, including non-prescription medicines such as vitamins and herbal remedies. They can affect or be affected by Zykadia. You must tell us if you are taking any of the following medicines:
Medicines that can increase the risk of side effects from Zykadia:
- medicines to treat AIDS/HIV (eg ritonavir and saquinavir)
- medicines for the treatment of infection er. This applies to medicines against fungal infections (eg ketoconazole, itraconazole, voriconazole, and posaconazole) and medicines against certain types of bacterial infections ( antibiotics such as telithromycin).
The following medicines may make Zykadia less effective:
- St. John’s wort is a (traditional) herbal medicine used to treat mild depression and mild anxiety.
- medicines to stop seizures ( antiepileptics such as phenytoin, carbamazepine, and phenobarbital)
- medicines to treat tuberculosis (eg rifampicin and rifabutin).
Zykadia may increase the side effects of the following medicines:
- medicines to treat irregular heart rhythms or other heart problems (eg, amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide, and digoxin )
- medicines to treat stomach problems (eg cisapride)
- medicines to treat mental health problems (eg haloperidol, droperidol, and pimozide)
- medicines to treat depression (eg nefazodone)
- midazolam is a medicine used to treat acute seizures or as a sedative before or during surgery or other procedures
- warfarin and dabigatran, medicines to prevent blood clots
- diclofenac, a medicine for the treatment of pain and inflammation in the joints
- alfentanil and fentanyl, drugs used to treat severe pain
- ciclosporin, sirolimus, and tacrolimus, medicines used in organ transplants to prevent rejection of the organ
- dihydroergotamine and ergotamine, medicines for the treatment of migraine
- domperidone, a medicine to treat nausea and vomiting
- moxifloxacin and clarithromycin, medicines to treat bacterial infections
- methadone, a drug used to treat pain and opioid addiction
- chloroquine and halofantrine, drugs to treat malaria.
- topotecan is a medicine used to treat certain types of cancer.
- colchicine, a medicine used to treat gout.
- pravastatin and rosuvastatin, are 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 unsure whether any of your medicines belong to the above groups.
These medicines should be taken with caution and may need to be avoided during treatment with Zykadia. If you are taking any of these, your doctor may have to prescribe another, alternative medicine for you.
Also, always tell the doctor if you are already taking Zykadia and you have been prescribed a new medicine that you have not already taken at the same time as Zykadia.
Birth control pills
If you take Zykadia while taking birth control pills, the birth control pills may not work.
Zykadia with food and drink
Do not eat grapefruit or drink grapefruit juice during treatment. This can cause the amount of Zykadia in the blood to rise to harmful levels.
Pregnancy and breastfeeding
You must use a highly effective method of contraception during treatment with Zykadia and for 3 months after the end of treatment. Talk to your doctor about suitable birth control methods for you.
Zykadia is not recommended during pregnancy unless the possible benefit of the treatment outweighs the possible risk to the child. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. The doctor will talk to you about the possible risks of taking Zykadia during pregnancy.
Zykadia should not be used during breastfeeding. You and your doctor decide together whether you should breastfeed or take Zykadia. You should not do both.
Driving ability and use of machinery
Be especially careful when driving or operating machinery while taking Zykadia, as the medicine may make you tired or cause visual disturbances.
Zykadia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to take Zykadia
Always take this medicine as directed by your doctor. Consult a doctor if you are unsure.
How much Zykadia should you take?
The recommended dose is 450 mg (three tablets) with food once a day, although your doctor may change this recommendation if necessary. The doctor tells you exactly how many tablets you need to take. Do not change the dose without talking to your doctor.
- Take Zykadia once a day, at about the same time each day, with food (for example, a snack or a full meal). If you cannot eat food while taking Zykadia, talk to your doctor.
- Swallow the tablets whole with water. The tablets should not be chewed or crushed.
- If you vomit after swallowing the Zykadia tablets, do not take any more tablets until your next scheduled dose.
How long should you take Zykadia?
- Keep taking Zykadia as long as your doctor tells you to.
- This is a long-term treatment that can last for several months. The doctor will regularly check your condition to see that the treatment is having the desired effect.
Ask your doctor or pharmacist if you have questions about how long to take Zykadia.
If you have taken too much Zykadia
If you have accidentally taken too many tablets or if someone else has accidentally taken your medicine, contact your doctor or hospital immediately for advice. You may need care.
If you forget to take Zykadia
What to do if you forget to take a dose depends on how long it is until the next dose.
- If your next dose is in 12 hours or more, take the missed tablets as soon as you remember. Then take the next dose of tablets at the usual time.
- If your next dose is less than 12 hours away, skip the missed tablets. Then take the next dose of tablets at the usual time.
Do not take a double dose to make up for a missed dose.
If you stop taking Zykadia
Do not stop taking this medicine before talking to your doctor.
If you have any further questions about this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Zykadia and seek medical attention immediately if you notice any of the following, 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 red rashes or bumps.
Some side effects can be serious
Tell your doctor or pharmacist immediately if you get any of the following side effects:
- chest pain or discomfort, change in heart rhythm (faster or slower), feeling unsteady, fainting, dizziness, bluish lips, shortness of breath, swollen legs or swollen skin (may be signs or symptoms of heart problems)
- new or worsening cough with or without phlegm, fever, chest pain, difficulty breathing, or shortness of breath (may be signs of lung problems)
- tiredness, itching, yellowing of the skin or the whites of the eyes, nausea or vomiting, decreased appetite, pain on the right side of the abdomen, dark or brown urine, bleeding or bruising more easily or normally (may be signs or symptoms of liver problems)
- severe diarrhea, nausea, or vomiting
- severe thirst, increased frequency of urination (symptoms of high blood sugar)
- severe pain in the upper part of the stomach (a sign of inflammation of the pancreas, also called pancreatitis ).
Other possible side effects are
Other side effects are reported below. If these side effects become severe, contact a doctor or pharmacist.
Very common (may affect more than 1 in 10 people):
- fatigue (exhaustion and weakness)
- abnormal liver function values in blood tests (high levels of the enzyme alanine aminotransferase and /or aspartate aminotransferase and/or gamma-glutamyltransferase and/or alkaline phosphatases in the blood, high bilirubin levels)
- abdominal pain
- reduced appetite
- weight loss
- constipation
- rash
- abnormal results on blood tests that test kidney function (high creatinine level)
- heartburn (may be a sign of problems in the gastrointestinal tract)
- reduced number of red blood cells, i.e. anemia.
Common (may affect up to 1 in 10 people):
- vision problems
- low phosphate levels in the blood (detected in blood tests)
- high levels of enzymes in the blood called lipase and/or amylase (detected in blood tests)
- greatly reduced urine output (which may be a sign of kidney problems).
How to store Zykadia
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton and blister card after “EXP”. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if you notice that the packaging is damaged or appears to have been tampered with in any way.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in Zykadia is ceritinib. Each film-coated tablet contains 150 mg of ceritinib.
- Other ingredients are:
- Tablet core: cellulose, microcrystalline; hydroxypropyl cellulose, low substituted; povidone; croscarmellose sodium (see “Zykadia contains sodium” in section 2); magnesium stearate; silica, colloidal, anhydrous.
- Film coating: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine, aluminum lacquer (E132).
Appearance and package sizes of the medicine
Zykadia film-coated tablets (tablets) are light blue, round, (approximate diameter: 9.1 mm), biconvex with beveled edges, unscored, debossed with “NVR” on one side and “ZY1” on the other side.
The tablets are in a blister pack containing 84 (4 blisters with 21 tablets each) tablets.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Lek farmacevtska družba dd, Poslovna enota PROIZVODNJA LENDAVA
Trimline 2D
9220 Lendava
Slovenia
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
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| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
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| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
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