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Written By Veda Maddala , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
Last Updated Oct 9, 2024 | 12:36 PM IST

Nilosure 200 Capsule is used to treat Philadelphia chromosome-positive chronic myeloid leukaemia (a type of blood cancer). It contains Nilotinib, which works by blocking the action of an abnormal protein produced by an abnormal Philadelphia chromosome that signals abnormal white blood cells (cancerous cells) to multiply. Thus, it stops the multiplication, inhibits the growth of cancerous cells, and then causes their death.

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Prescription drug

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Prescription drug
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Composition

NILOTINIB-200MG

Consume Type

ORAL

Return Policy

Not Returnable

Expires on or after

Apr-26

for this medicine

About Nilosure 200 Capsule

Nilosure 200 Capsule 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.

Nilosure 200 Capsule 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 Nilosure 200 Capsule as prescribed. You are recommended to take Nilosure 200 Capsule for as long as your doctor has advised it for you based on your medical condition. Sometimes, Nilosure 200 Capsule may cause common side effects such as vomiting, nausea, diarrhoea, headache, constipation, tiredness, and muscle and joint pain. Most of these side effects of Nilosure 200 Capsule 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 Nilosure 200 Capsule if you are pregnant or breastfeeding. You are recommended to use effective contraceptive methods while taking Nilosure 200 Capsule and for two weeks after completing the course of Nilosure 200 Capsule. Nilosure 200 Capsule is not recommended for children below one year of age. Drive only if you are alert as Nilosure 200 Capsule 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 Nilosure 200 Capsule, contact your doctor immediately, as these might be symptoms of liver problems. 

Uses of Nilosure 200 Capsule

Treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)

Medicinal Benefits

Nilosure 200 Capsule 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. Nilosure 200 Capsule 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

Take this medicine on an empty stomach or as advised by the doctor. Avoid eating food for at least 2 hours before taking Nilosure 200 Capsule and avoid eating for at least 1 hour after taking Nilosure 200 Capsule. Swallow it as a whole with a glass of water. If you are unable to swallow it, open the capsule and sprinkle the contents in 1 teaspoon of applesauce and take it right away (within 15 minutes). Do not use more than one teaspoon of apple sauce for each capsule, and do not use any food other than apple sauce.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Nilosure 200 Capsule

  • Vomiting
  • Nausea
  • Diarrhoea
  • Headache
  • Constipation
  • Tiredness
  • Muscle and joint pain

Drug Warnings

If you are allergic to Nilotinib or any other medicines, please tell your doctor. Avoid taking Nilosure 200 Capsule if you are pregnant or breastfeeding. You are recommended to use effective contraceptive methods while taking Nilosure 200 Capsule and for two weeks after completing the course of Nilosure 200 Capsule. Nilosure 200 Capsule is not recommended for children below one year of age. Nilosure 200 Capsule 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 Nilosure 200 Capsule. Therefore, your doctor will monitor the growth of your child at regular visits. Drive only if you are alert as Nilosure 200 Capsule may cause dizziness or visual disorders as side effects in some people. Nilosure 200 Capsule 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 Nilosure 200 Capsule, 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 Nilosure 200 Capsule may contain lactose. Most people who have mild or moderate lactose intolerance can take Nilosure 200 Capsule. Avoid taking Nilosure 200 Capsule 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 Nilosure 200 Capsule.

Drug Interactions

Drug-Drug Interaction: Nilosure 200 Capsule 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 Nilosure 200 Capsule.

Drug-Food Interaction: Avoid grapefruit juice, grapefruit and any supplement containing grapefruit extract while taking Nilosure 200 Capsule as it may increase the amount of Nilotinib in the body and cause serious side effects. Also, Nilosure 200 Capsule may interact with St. John’s wort (a herbal product used to treat depression). 

Drug-Disease Interaction: Avoid taking Nilosure 200 Capsule 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 Nilosure 200 Capsule.

Drug-Drug Interactions Checker List

  • DISOPYRAMIDE
  • QUINIDINE
  • AMIODARONE
  • SOTALOL
  • PROCAINAMIDE
  • CLARITHROMYCIN
  • MOXIFLOXACIN
  • CHLOROQUINE
  • HALOPERIDOL
  • PIMOZIDE
  • METHADONE
  • FENTANYL
  • ALFENTANIL
  • PHENYTOIN
  • CARBAMAZEPINE
  • PHENOBARBITAL
  • WARFARIN
  • RIFAMPICIN
  • ITRACONAZOLE
  • KETOCONAZOLE
  • VORICONAZOLE
  • CYCLOSPORINE
  • TACROLIMUS
  • SIROLIMUS

Habit Forming

No

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

  • Nilosure 200 Capsule 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 Nilosure 200 Capsule, please contact your doctor immediately, as these might be symptoms of QTc prolongation.

Regular tests are recommended during treatment with Nilosure 200 Capsule:

  • 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 Nilosure 200 Capsule 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.

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.  

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Alcohol

Consult your doctor

The interaction of Nilosure 200 Capsule with alcohol is unknown. Please discuss with your doctor if you have any concerns regarding this.

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Pregnancy

Unsafe

Nilosure 200 Capsule 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 Nilosure 200 Capsule. Also, you are advised to use effective birth control measures during treatment with Nilosure 200 Capsule and for up to 2 weeks after the last dose of Nilosure 200 Capsule.

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Breast Feeding

Unsafe

You are recommended to avoid breastfeeding during treatment with Nilosure 200 Capsule and for two weeks after the final dose. Inform your doctor if you are breastfeeding.

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Driving

Caution

If you experience side effects such as dizziness or visual disorders, avoid driving or operating machinery until you are alert.

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Liver

Caution

Inform your doctor if you have liver problems before taking Nilosure 200 Capsule. Your doctor may adjust the dose if necessary based on your condition.

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Kidney

Consult your doctor

Limited information is available on the use of Nilosure 200 Capsule in patients with impaired kidney function. Therefore, if you have kidney problems, inform your doctor before taking Nilosure 200 Capsule.

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Children

Caution

Nilosure 200 Capsule is not recommended for children below 1 year of age as the safety and effectiveness were not established.

Country of origin

India

Manufacturer/Marketer address

407-408, Sharda Chambers, New Marine Lines, Mumbai 400 020 (Maharashtra), New Marine Lines, Marine Lines, Mumbai, Maharashtra 400020
Other Info - NIL0157

Author Details

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FAQs

Nilosure 200 Capsule is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
Nilosure 200 Capsule contains Nilotinib, an anticancer drug. 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.
You are not recommended to take antacids and Nilosure 200 Capsule at the same time. You are advised to take antacids containing magnesium hydroxide, aluminium hydroxide, and simethicone about two hours before or two hours after taking Nilosure 200 Capsule. However, please consult a doctor before taking other medicines with Nilosure 200 Capsule.
You are recommended to avoid grapefruit juice, grapefruit and any supplement containing grapefruit extract while taking Nilosure 200 Capsule as it may increase the amount of Nilotinib in the body and cause serious side effects.

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