About NILOTINIB
NILOTINIB belongs to the class of anticancer drugs called tyrosine kinase inhibitors used in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Ph+ CML is a type of blood cancer that causes white blood cells to behave differently.
NILOTINIB contains Nilotinib which works by blocking the action of an abnormal protein (Bcr-Abl tyrosine kinase) produced by an abnormal Philadelphia chromosome that signals abnormal white blood cells (cancerous cells) to multiply. Thereby, it stops the multiplication and inhibits the growth of cancerous cells and then causes the death of these cells.
Take NILOTINIB as prescribed. You are recommended to take NILOTINIB for as long as your doctor has advised it for you based on your medical condition. Sometimes, NILOTINIB may cause common side effects such as vomiting, nausea, diarrhoea, headache, constipation, tiredness, and muscle and joint pain. Most of these side effects of NILOTINIB do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.
If you are allergic to Nilotinib or any other medicines, please tell your doctor. Avoid taking NILOTINIB if you are pregnant or breastfeeding. You are recommended to use effective contraceptive methods while taking NILOTINIB and for two weeks after completing the course of NILOTINIB. NILOTINIB is not recommended for children below one year of age. Drive only if you are alert as NILOTINIB may cause dizziness or visual disorders as side effects in some people. If you have yellow skin and eyes, dark-coloured urine, or stomach pain while taking NILOTINIB, contact your doctor immediately, as these might be symptoms of liver problems.
Uses of NILOTINIB
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
Medicinal Benefits
NILOTINIB contains Nilotinib, an anticancer drug used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). In chronic myeloid leukemia (CML) patients, a change in genetic material (DNA) triggers a signal that tells the body to produce more abnormal white blood cells (cancerous cells). Nilotinib works by blocking this signal and thus stops the production of cancerous cells. NILOTINIB is used in adults and children with newly diagnosed Ph+ CML in the chronic phase and in adults with Ph+ CML in the accelerated and chronic phase who did not tolerate or no longer benefit from other treatments, including Imatinib.
Directions for Use
Storage
Side Effects of NILOTINIB
- Vomiting
- Nausea
- Diarrhoea
- Headache
- Constipation
- Tiredness
- Muscle and joint pain
In-Depth Precautions and Warning
Drug Warnings
If you are allergic to Nilotinib or any other medicines, please tell your doctor. Avoid taking NILOTINIB if you are pregnant or breastfeeding. You are recommended to use effective contraceptive methods while taking NILOTINIB and for two weeks after completing the course of NILOTINIB. NILOTINIB is not recommended for children below one year of age. NILOTINIB may affect the growth and development of children with chronic phase Ph+ CML. Some children and adolescents may have slower than normal growth while taking NILOTINIB. Therefore, your doctor will monitor the growth of your child at regular visits. Drive only if you are alert as NILOTINIB may cause dizziness or visual disorders as side effects in some people. NILOTINIB may increase the risk of liver problems, especially in people with a history of liver problems. Therefore, if you have yellow skin and eyes, dark-coloured urine, or stomach pain while taking NILOTINIB, contact your doctor immediately, as these might be symptoms of liver problems. Inform your doctor if you have a severe problem with lactose (milk sugar) or other sugars as NILOTINIB may contain lactose. Most people who have mild or moderate lactose intolerance can take NILOTINIB. Avoid taking NILOTINIB if you have low levels of magnesium or potassium in the blood or long QTc syndrome. If you have had a surgical procedure involving the removal of the entire stomach (total gastrectomy), inform your doctor before taking NILOTINIB.
Drug Interactions
Drug-Drug Interaction: NILOTINIB may interact with anti-arrhythmic drugs (disopyramide, quinidine, amiodarone, sotalol, procainamide), antibiotics (clarithromycin, moxifloxacin), antimalarial drugs (chloroquine), antipsychotics (haloperidol, pimozide), opioid analgesics (methadone, fentanyl, alfentanil), anticonvulsants (phenytoin, carbamazepine, phenobarbital), blood thinner (warfarin), anti-HIV drug (rifampicin), antifungals (itraconazole, ketoconazole, voriconazole) and immunosuppressants (cyclosporine, tacrolimus, sirolimus). Inform your doctor if you are using any medicines before taking NILOTINIB.
Drug-Food Interaction: Avoid grapefruit juice, grapefruit and any supplement containing grapefruit extract while taking NILOTINIB as it may increase the amount of Nilotinib in the body and cause serious side effects. Also, NILOTINIB may interact with St. John’s wort (a herbal product used to treat depression).
Drug-Disease Interaction: Avoid taking NILOTINIB if you have low levels of magnesium or potassium in the blood or long QTc syndrome. If you have had pancreatitis, stroke or other problems due to decreased blood flow to the brain, have QTc prolongation or a family history of it, bleeding problems, irregular heartbeat, have low problems with decreased blood flow to your legs, have low levels of magnesium or potassium in blood, heart or liver problems, inform your doctor before taking NILOTINIB.
Drug-Drug Interactions Checker List:
Safety Advice
Alcohol
consult your doctorThe interaction of NILOTINIB with alcohol is unknown. Please discuss with your doctor if you have any concerns regarding this.
Pregnancy
unsafeNILOTINIB is not recommended for use during pregnancy as it may harm the unborn baby. Therefore, inform your doctor if you are pregnant or planning for pregnancy before taking NILOTINIB. Also, you are advised to use effective birth control measures during treatment with NILOTINIB and for up to 2 weeks after the last dose of NILOTINIB.
Breast Feeding
unsafeYou are recommended to avoid breastfeeding during treatment with NILOTINIB and for two weeks after the final dose. Inform your doctor if you are breastfeeding.
Driving
cautionIf you experience side effects such as dizziness or visual disorders, avoid driving or operating machinery until you are alert.
Liver
cautionInform your doctor if you have liver problems before taking NILOTINIB. Your doctor may adjust the dose if necessary based on your condition.
Kidney
consult your doctorLimited information is available on the use of NILOTINIB in patients with impaired kidney function. Therefore, if you have kidney problems, inform your doctor before taking NILOTINIB.
Children
cautionNILOTINIB is not recommended for children below 1 year of age as the safety and effectiveness were not established.
Habit Forming
Diet & Lifestyle Advise
- Drink nutrient-rich liquids such as juices, shakes and soups if you have trouble swallowing solid food.
- Eat frequently by opting for 4 to 6 smaller meals a day instead of 2 to 3 big meals.
- Consume a variety of vegetables, including legumes.
- Eat whole grains, whole fruits, and fat-free or low-fat dairy products.
- Include a variety of proteins in the diet, such as lean meats, poultry, seafood, soy, beans, and eggs.
- Use healthy oils such as olive oil.
- Drink plenty of water to keep yourself hydrated.
Special Advise
- NILOTINIB can cause a possibly life-threatening heart problem called QTc prolongation (causes irregular heartbeat, which may lead to sudden death). Therefore, if you faint, feel lightheaded or have an irregular heartbeat while taking NILOTINIB, please contact your doctor immediately, as these might be symptoms of QTc prolongation.
Regular tests are recommended during treatment with NILOTINIB:
- To monitor the number of blood cells (red blood cells, white blood cells and platelets), liver and pancreas function in the body to see how NILOTINIB is tolerated.
- To monitor electrolytes (magnesium, potassium) in the body that are essential in the functioning of the heart.
- To check the level of fats and sugar in the blood.
- Also, ECG is recommended to check the heart rate.
Patients Concern
Disease/Condition Glossary
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML): It is a common form of chronic myeloid leukemia (CML) that occurs when specific chromosomes swap positions, causing an abnormality in the chromosomes, creating the Philadelphia chromosome. The abnormal chromosomes produce an abnormal protein called Bcr-Abl tyrosine kinase, which then triggers a signal to produce abnormal white blood cells in the bone marrow. CML is a type of blood cancer which makes the body produce too many abnormal white blood cells. Many people with Ph+ CML will not experience symptoms before their diagnosis. However, if symptoms do occur, they include weight loss, weakness, night sweats, extreme tiredness, feeling full after only small meals, bone pain, and easy bleeding.
