Tasigna (Nilotinib Hydrochloride Monohydrate)
Tasigna (nilotinib hydrochloride monohydrate) Dosage and Side Effects
TASIGNA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Warnings and Precautions
TASIGNA should be given under the supervision of a doctor experienced in the use of anti-cancer drugs. Serious side effects with TASIGNA include:
- Sudden cardiac deaths,
- Prolongation of the QT interval (abnormal electrical signal of the heart),
- Ischemic heart disease (heart disorder), ischemic, cerebrovascular events (stroke or other problems due to decreased blood flow to the brain) and peripheral arterial occlusive disease (PAOD) (problems with decreased blood flow to your leg), rare fatal cases have been reported,
- Liver toxicity (increase of liver enzymes), fatal cases have been reported,
- Pancreatitis (inflammation of the pancreas),
- Myelosuppression (decrease of the production of blood cells).
TASIGNA should not be used in patients who have uncorrectable low levels of potassium or magnesium.
BEFORE you use TASIGNA talk to your doctor or pharmacist if you:
- have a heart disorder, or a heart rhythm disorder (or a family history of heart rhythm disorder) such as an irregular heartbeat or an abnormal electrical signal of the heart called “prolongation of the QT interval”,
- have a personal history of fainting spells,
- have a family history of sudden cardiac death at age of less than 50 years,
- are being treated with medicines that affect the heart beat (antiarrhythmics) or medicines that may have an unwanted effect on the function of the heart (QT prolongation)
- have electrolyte problems (e.g., low blood potassium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration),
- have an eating disorder or are following a strict diet,
- have diabetes, especially with associated nerve disorders,
- had a stroke or other problems due to decreased blood flow to the brain,
- have problems with decreased blood flow to your legs,
- have liver/kidney disease,
- have had pancreatitis (inflammation of the pancreas),
- have intolerance to lactose (milk sugar). TASIGNA contains lactose,
- are pregnant or plan to get pregnant. TASIGNA is not recommended during pregnancy as it may harm the fetus. Women who can get pregnant must use highly effective birth control during treatment with TASIGNA and at least 4 weeks after ending treatment,
- are a male patient and are concerned about your fertility (ability to father a child),
- are a sexually active male. Men who take TASIGNA must use highly effective birth control during treatment with TASIGNA, and at least 4 weeks after ending treatment. Tell your doctor right away if your female partner becomes pregnant,
- breast-feeding or plan to breast-feed. Women should not breast-feed while taking TASIGNA,
- have had a surgical procedure involving the removal of the entire stomach (total gastrectomy).
- have ever had or might now have a hepatitis B virus infection (a viral infection of the liver). This is because during treatment with TASIGNA, hepatitis B may become active again, which can be fatal in some cases. Your doctor will check for signs of this infection before and during treatment with TASIGNA.
TASIGNA can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heart beat, which may uncommonly (0.17%) lead to sudden cardiac death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.
Blood tests will also monitor the level of fatty substances (cholesterol and lipids) and sugar (glucose) in your blood.
There is no experience with the use of TASIGNA in children and adolescents.
During the treatment with TASIGNA, you will need to have certain tests, including blood tests, to monitor how TASIGNA works.
TASIGNA may cause dizziness. DO NOT drive or use machines if you feel dizziness or are unable to see well while taking TASIGNA.
As with all medicines, TASIGNA can cause side effects. The side effects of TASIGNA are as follows:
- nausea, constipation, vomiting;
- muscle pain, pain in joints;
- itching, rash, hives;
- hair loss;
- tiredness (fatigue).
If any of these affects you severely, tell your doctor.
- upper respiratory tract infections;
- abdominal pain, dyspepsia (digestion problems); diarrhea; eating disorder (anorexia), disturbed sense of taste;
- pain (bone and extremity);
- muscle spasms;
- skin reddening, dry skin;
- insomnia, depression, anxiety;
- dizziness, spinning sensation (vertigo).
If any of these affects you severely, tell your doctor.
TASIGNA may also cause:
- a decrease of the production of blood cells (low levels of white cells, red cells, platelets);
- an increased blood level of lipase or amylase (inflammation of the pancreas);
- an increase in liver enzymes (liver dysfunction or toxicity);
- an increased blood level of creatinine (reduced kidney function), and high or low levels of potassium or low level of magnesium;
- an increase of cholesterol and other fats (lipids) in your blood;
- low blood level of insulin (an enzyme regulating blood sugar level);
- an increase of prothrombin time.
- a previous hepatitis B virus infection (a viral infection of the liver) to become active again when you have had a hepatitis B infection in the past (hepatitis B virus reactivation), which can be fatal in some cases
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Call your doctor as soon as possible if you faint (loss of consciousness) or have an irregular heartbeat while taking TASIGNA as these may be due to a serious heart condition.
Interactions with this medication
Tell your doctor or pharmacist before taking TASIGNA if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes in particular:
- antiarrhythmics such as amiodarone, disopyramide, procainamide, quinidine, sotalol, digoxin, ibutilide, flecainide, propafenone—used to treat irregular heart beat;
- verapamil—used to treat high blood pressure and some types of irregular heart beat;
- chloroquine, halofantrine, clarithromycin, haloperidol, moxifloxacin, methadone, bepridil, pimozide—medicines that may have an unwanted effect on the function of the heart (QT prolongation);
- laxatives, enemas, water pills, amphotericin B, high dose corticosteroids—medicines that can disturb electrolyte levels;
- chlorpromazine, droperidol, ziprasidone—used to stabilize thinking and behaviour;
- fluoxetine, citalopram, venlafaxine, tricyclic/tetracyclic antidepressants e.g. amitriptyline, imipramine, maprotiline—used to treat mood disorder;
- pentamidine—used to prevent and treat Pneumocystis carinii pneumonia;
- chloroquine—used to treat malaria;
- vorinostat, sunitinib, lapatinib—used to treat cancers;
- salmeterol, formoterol—used to treat asthma;
- ketoconazole, itraconazole, voriconazole, levofloxacin, ciprofloxacin, fluconazole, erythromycin, clarithromycin, telithromycin, tacrolimus, cefazolin—used to treat infections;
- domperidone—used to treat gastrointestinal motility disorder;
- metoclopramide, prochlorperazine, ondansetron and dolasetron—used to treat nausea;
- ritonavir—an anti-HIV medicine from the class “antiproteases”;
- carbamazepine, phenobarbital, phenytoin—used to treat epilepsy;
- rifampicin—used to treat tuberculosis;
- St. John's Wort—a herbal product (also known as Hypericum perforatum);
- midazolam—used to relieve anxiety before surgery;
- warfarin—used to treat blood coagulation disorders (such as blood clots or thromboses);
- morphine, methadone—used to treat moderate to severe pain;
- buprenorphine—substitute treatment for opioids dependence;
- cyclosporine A—used to prevent organ transplantations rejections, and to treat autoimmune conditions;
- alfentanil and fentanyl—used to treat pain and used as a sedative before or during surgery or medical procedure;
- cyclosporine, sirolimus and tacrolimus—medicines that suppress the “self-defense” ability of the body and fight infections—commonly used to prevent the rejection of transplanted organs such as liver, heart and kidney;
- dihydroergotamine and ergotamine—used to treat dementia;
- levothyroxine—used to treat thyroid deficiency;
- statins (such as simvastatin and lovastatin)—class of drugs used to treat high level of fats in blood.
In addition, if you are taking TASIGNA, discuss with your doctor before taking antacids (medicines against heartburn). These medications need to be taken separately from TASIGNA:
- antacids called H2 blockers which suppress the production of acid in the stomach—should be taken approximately 10 hours before and approximately 2 hours after you take TASIGNA;
- antacids such as those containing aluminum hydroxide, magnesium hydroxide and simethicone which neutralize the high acidity of the stomach—should be taken approximately 2 hours before or approximately 2 hours after you take TASIGNA.
If you need to see other doctors, you should also tell him or her that you are taking TASIGNA.
Do not take TASIGNA with food. Take the capsules at least 2 hours after any food and then wait at least 1 hour before eating again. Taking TASIGNA with food may increase the amount of TASIGNA in the blood, possibly to a harmful level.
Do not take any products or juices containing grapefruit, star fruit, pomegranate, Seville oranges or similar fruits while taking TASIGNA. This may increase the amount of TASIGNA in blood, possibly to a harmful level.
If you are unable to swallow capsules, you may mix the content of each capsule in one teaspoon of applesauce (pureed apple) and swallow the mixture immediately. No other food should be used.
Proper Use of this medication
Capsules to be taken orally on an empty stomach, at least two hours after any food and wait at least 1 hour before eating again.
Swallow the capsules whole with water. Do not open the capsules.
If you are unable to swallow capsules:
- Open the capsules
- Mix the content of each capsule in one teaspoon of applesauce (pureed apple)
- Use only one single teaspoon of applesauce (not more).
- Use only applesauce (no other food).
Swallow the mixture immediately
If you have taken more TASIGNA than you should have, or if someone else accidentally takes your capsules, contact your doctor or the nearest hospital emergency room or a local poison control centre immediately. You may be asked to show them the pack of capsules.
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for the forgotten capsules.
Other related products
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.