Zykadia 150 mg hard capsules
What is Zykadia and what it is used?
Zykadia is an anticancer medicine that contains the active substance Ceritinib. It is used to treat adult patients with an advanced stage of lung form, the non-small cell lung cancer called (NSCLC) used.Zykadia is only used in patients whose disease caused by a defect in one as ALK caused designated (anaplastic lymphoma kinase) gene.
How does Zykadia?
In patients with ALK -Defekten an abnormal protein is produced which promotes the growth of cancer cells. Zykadia inhibits the action of this abnormal protein and brakes in this way the growth and spread of NSCLC.
If you want to know more about how Zykadia works or why this medicine has been prescribed, ask your doctor or pharmacist.
What should you consider before taking Zykadia?
Zykadia must not be taken,
- if you are allergic to Ceritinib or any of the listed in section 6 excipients of the formulation.
Warnings and Precautions
Please talk to your doctor or pharmacist before taking Zykadia.
- if you have problems with your liver.
- if you have problems with your lungs or breathing.
- if you have problems with your heart, including very slow heartbeat, or if your electrocardiogram (ECG) abnormalities of cardiac activity can be seen, which are called "prolongation of the QT interval".
- if you have diabetes (high blood sugar levels).
- if you have problems with your pancreas.
- if you are currently taking steroids.
Please inform your doctor or pharmacist immediately if problems occur during treatment with Zykadia following signs or symptoms with you:
- Fatigue, itchy skin, yellowing of the skin or the whites of your eyes, nausea (feeling sick) or vomiting, loss of appetite, pain in the right upper abdomen, dark or brown-colored urine, unusual tendency to bleed or bruise. These may be signs and symptoms of liver problems.
- new onset or worsening of cough with or without sputum, fever, chest pain, difficulty breathing or shortness of breath. These may be symptoms of lung problems.
- Pain or discomfort in the chest, changes in the heartbeat (acceleration or deceleration), dizziness, fainting, dizziness, bluish discoloration of lips, shortness of breath, swelling of the legs or the skin. These signs and symptoms may indicate heart problems.
- Severe diarrhea, nausea or vomiting. These are symptoms of indigestion.
- excessive thirst or frequent urination. These may be symptoms of high blood sugar.
Your doctor may need to adjust the treatment to you or interrupt Zykadia temporarily or completely settle.
Blood tests during treatment with Zykadia
Your doctor should perform before starting treatment, every 2 weeks during the first month of treatment and subsequently at the treatment every month, blood tests. These tests are used to monitor your liver function. Your doctor should also perform blood tests to check the functionality of your pancreas and blood sugar levels before starting treatment with Zykadia and periodically during treatment.
Children and adolescents
The use of Zykadia in children and adolescents up to 18 years is not recommended.
Taking Zykadia with other medicines
Tell your doctor or pharmacist if you are taking other medicines / apply, have recently taken / used any other medicines or are considering taking other medicines / apply, even if it is not prescribed assuch. B. vitamins or herbal supplements, for it for a significant interaction with Zykadia. It is particularly important that you mention here the following medicines:
Medicinal products that may increase the risk of side effects from Zykadia:
- Medicines to treat AIDS / HIV ( z. B. ritonavir, saquinavir).
- Medicines used to treat infections. These include drugs to combat fungal infections (so-called. Antifungals such as ketoconazole, itraconazole, voriconazole, posaconazole) and medicines used to treat certain types of bacterial infections (antibiotics such as z. B. telithromycin).
The following medicines may reduce the efficacy of Zykadia:
- St. John's wort, a herbal medicine used to treat depression.
- Anticonvulsant (antiepileptic drugs as such. As phenytoin, carbamazepine and phenobarbital).
- Drugs used to treat tuberculosis ( z. B. rifampicin, rifabutin).
Zykadia may increase the side effects of the following medicines:
- Medicines used to treat an irregular heartbeat or other heart problems ( eg. As amiodarone, disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide and digoxin).
- Medicines used to treat stomach problems ( eg. As cisapride).
- Medicines to treat mental disorders ( eg. As haloperidol, droperidol, pimozide).
- Medicines to treat depression ( eg. As nefazodone).
- Midazolam, a medicine before the treatment of acute seizures or for use as a sedative and during operations or other medical interventions.
- Warfarin and dabigatran, medicines used to prevent blood clots.
- Diclofenac, a drug used to treat joint pain and inflammation.
- Alfentanil and fentanyl medicines used to treat severe pain.
- Astemizole, an antihistamine to prevent allergic reactions.
- Cyclosporine, sirolimus and tacrolimus, drugs used after organ transplants to prevent rejection reactions.
- Ergotamine, a drug for the treatment of migraine.
- Domperidone, a drug used to treat nausea and vomiting.
- Moxifloxacin and clarithromycin, medicines to treat bacterial infections.
- Methadone, a drug used to treat pain and opioid dependence.
- Chloroquine and halofantrine, medicines to treat malaria.
- Topotecan, a drug used to treat certain types of cancer.
- Colchicine, a drug used to treat gout.
- Pravastatin and rosuvastatin, medicines to lower cholesterol.
- Sulfasalazine, a drug to treat inflammatory bowel disease or rheumatoid arthritis.
Ask your doctor or pharmacist if you are unsure whether a medicine that you apply, listed in the above list.
This drug should be used during treatment with Zykadia with caution or avoided altogether. When you apply one of the mentioned medicines, your doctor may need to prescribe a different medicine you may.
You should also tell when you get your doctor already taking Zykadia and prescribed a new medicine that you have not been administered with Zykadia.
Contraceptive oral medicines
When you apply Zykadia simultaneously with contraceptive medicines that you take, the contraceptive effect can be canceled.
Taking Zykadia together with food and drink
During treatment with Zykadia You should not eat grapefruit or drink grapefruit juice, because otherwise the concentration of Zykadia can rise so high in your blood, it hurts you.
pregnancy and breast feeding period
During and up to 3 months after the end of treatment with Zykadia You must use effective contraception method. Talk to your doctor about which methods are right for you.
The use of Zykadia during pregnancy is not recommended unless the potential benefit outweighs the potential risk to the child. If you are pregnant, if you suspect you may be pregnant or intend to become pregnant, ask before taking this medicine your doctor for advice. He will discuss with you the potential risks associated with taking Zykadia during pregnancy.
During lactation Zykadia should not be used. You and your doctor will work together to decide if you should take Zykadia breastfeeding or. Both the same time you should not do.
Driving and using machines
If you perform during treatment with Zykadia a vehicle or operating machinery, special caution is necessary as blurred vision or somnolence can occur
How to take Zykadia?
Take this medicine exactly as your doctor has told a. Check with your doctor if you are unsure.
How much Zykadia you should take?
The recommended dose is 750 mg (five capsules) once daily. Your doctor will tell you exactly how many capsules you need to take. Do not change the dose without consulting your doctor.
- Take once daily Zykadia always around the same time a.
- Take the capsules on an empty stomach. At least two hours before and two hours after ingestion Do not eat.
- Swallow the capsules whole with water without chewing them or crushed.
- If you need to vomit after swallowing the Zykadia capsules take until the next scheduled ingestion, no further capsules.
How long should Zykadia be taken?
- Take Zykadia for as long as your doctor tells you.
- Treatment with Zykadia is a long-term therapy can be continued for months. Your doctor will monitor your condition to check whether the treatment has the desired effect.
If you have questions about the duration of your Zykadia treatment, consult your doctor or pharmacist.
If you take more of Zykadia than you should
If you have accidentally taken too many capsules or if someone else accidentally takes your medicine, immediately contact a doctor or hospital. Perhaps a medical treatment is necessary.
If you forget to take Zykadia
What should you do if you miss a dose, depends on how long it takes until the next administration.
- If you should take the next sequential dose in 12 hours or later, take the forgotten capsules as soon as you remember. Then take the next capsules at the usual time.
- If you should take the next sequential dose in less than 12 hours, skip the forgotten capsules.Then take the next capsules at the usual time.
Do not take a double dose if you have forgotten dose.
If you stop taking Zykadia
Stop taking this medicine have not spoken without first checking with your doctor. If you have questions, please contact your doctor
Possible side effects are possible?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Zykadia and take immediate medical help if you experience the following, which may be indicative of an allergic reaction:
- Difficulty breathing or swallowing
- Swelling of the face, lips, tongue, or throat
- Severe itching of the skin with red rash or raised wheals
Some side effects can be serious
If you experience any of the following side effects occur, please tell your doctor or pharmacist:
- Pain or discomfort in the chest, changes in the heartbeat (acceleration or deceleration), dizziness, fainting, dizziness, bluish discoloration of lips, shortness of breath, swelling of the legs or the skin (possibly signs or symptoms of heart problems)
- First appearance or worsening of cough with or without sputum, fever, chest pain, difficulty breathing or shortness of breath (possibly signs of lung problems)
- Fatigue, itchy skin, yellowing of the skin or the whites of your eyes, nausea (feeling sick) or vomiting, loss of appetite, pain in the right upper abdomen (abdominal pain), dark or brown-colored urine, unusual tendency to bleed or bruise (possibly signs or symptoms of liver problems)
- Diarrhea, nausea or vomiting Strong
- Excessive thirst, increased urination (symptoms of high blood sugar levels)
- Severe pain in the upper abdomen (signs of inflammation of the pancreas, also known as pancreatitis)
Other possible side effects
Below more side effects are listed. Let us know if these side effects are severe your doctor or pharmacist.
Very common (may be more than 1 of 10 patients treated):
- Abnormal results of blood tests for control of liver function (high levels of the enzymes alanine aminotransferase and / or aspartate aminotransferase and / or gamma-glutamyl transferase, high bilirubin levels)
- stomach pain
- decreased appetite
- skin rash
- Abnormal results of blood tests for monitoring of renal function (increase in creatinine)
- Heartburn (possible signs of indigestion)
- Decrease in red blood cells (anemia)
Common (may affect up to 1 in 10 patients treated):
- blurred vision
- Low phosphate levels in the blood (this disorder is through blood tests discovered)
- High levels of the enzymes lipase and / or amylase in the blood (this disorder is through blood tests discovered)
- Significantly decreased urine output (possible sign of kidney problem)