Ceritinib - Oral

Ceritinib is used to treat a certain type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to other parts of the body which is caused by a defect in a gene called anaplastic lymphoma kinase (ALK).

Take Ceritinib exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

Take this medicine together with food or immediately after a meal. Try to take it at the same time each day.

Swallow the tablet or capsule whole with a glass of water. Do not chew or crush the tablet or capsule.

If you vomit after taking Ceritinib, do not repeat the dose. Take the next dose at your normal scheduled time.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the treatment timeframe depending on the severity of your condition and your response to the medication.

Ceritinib must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

If the next dose is in 12 hours or more, take the missed dose and return to your normal dosing schedule.

If the next dose is in less than 12 hours, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Inform your doctor if you have the following conditions:

• slow heartbeat
• heart rhythm disorder
• imbalance of essential minerals in the body
• severe kidney disease
• severe liver disease

Let your doctor know if you are pregnant or planning to become pregnant.

Both men and women must use proven birth control methods during Ceritinib therapy and for 6 months (in women) or 3 months (in men) after stopping the treatment. You may wish to discuss birth control methods with your doctor or pharmacist.

Inform your doctor if you are breastfeeding.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy test must be done before treatment to know if this medicine is suited for you to take.
• Screening and assessment of tumour status are needed before treatment to check the appropriateness of Ceritinib therapy.
• Routine tests (e.g. liver and kidney function, blood sugar levels, ECG [test used to record the electrical activity of the heart]) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs and symptoms of stomach and lung problems may also be needed.

Ceritinib may cause tiredness or some problems with your eyesight. If affected, do not drive or take part in any activity in which you need to be alert or need to see clearly.

This medicine may also make your skin more sensitive to sunlight. Apply sunscreen when going outdoors and avoid prolonged exposure to sunlight and UV lamps.

Other side effects include any of the following: nausea, abdominal pain, constipation, difficulty swallowing, weight loss, and rash.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• severe diarrhoea, pass out bloody or black as tar stools and vomiting blood or ground coffee-like material
• yellowing of the skin or eyes, dark coloured urine, swelling in the legs and ankles
• slow or irregular heartbeat
• shortness of breath, chest pain, cough which may contain blood

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking or using any of these medicines:

• medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenobarbital, phenytoin
• medicines for irregular heartbeat e.g. amiodarone, disopyramide, quinidine
• medicines to treat fungal infection e.g. ketoconazole, itraconazole, voriconazole
• medicines used in organ transplants or certain immune disorders e.g. ciclosporin, sirolimus, tacrolimus
• medicines for mood disorders e.g. quetiapine, haloperidol
• cholesterol-lowering medicines e.g. rosuvastatin, pravastatin
• strong painkillers e.g. fentanyl, methadone, alfentanil
• certain antibiotics e.g. clarithromycin, moxifloxacin
• medicines that reduce stomach acid production
• rifampicin (medicine to treat TB [lung infection known as tuberculosis])
• ritonavir (medicine for HIV infection)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Ceritinib.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Avoid excessive consumption of grapefruit or grapefruit juice (more than 1 litre a day).

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.

As Ceritinib is a cancer medicine, always return any unused or expired tablets or capsules to the clinic, hospital, or pharmacy for disposal. Do not throw it away in the household waste.