Nilotinib

Uses	Chronic myelogenous leukaemia (CML)
Therapy	Anti-Neoplastic
Side Effects	Rash, Headache, Nausea, Low Blood Counts

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Molecule Description

Nilotinib is an anti-cancer medicine. Nilotinib belongs to a class of medicines called kinase inhibitors. It is used in the management of certain types of Philadelphia chromosome-positive chronic myelogenous leukaemia (CML). BCR-ABL, an abnormal protein, is responsible for the uncontrolled growth of CML cells. Nilotinib works by blocking this BCR-ABL protein, thus stopping or slowing the growth of CML cells. Nilotinib can affect the heart's electrical rhythm (causing a prolonged QT interval on an ECG) and may increase the risk of serious or life-threatening abnormal heart rhythms. Attend all scheduled ECGs before and during treatment so that your doctor can monitor your heart health. Seek urgent medical care if you experience a fast and irregular heartbeat, or feel light-headed or faint. Your doctor will also check your blood levels of potassium and magnesium during treatment. Take this medicine on a completely empty stomach with no food for at least 2 hours before each dose and at least 1 hour after. Nilotinib can cause side effects like lowered blood cell counts, raising the risk of infection, bleeding, or anemia. It can also affect the liver and pancreas. Watch out for and report signs such as fever, infection, unusual bruising or bleeding, and sudden stomach pain with nausea or vomiting. Before starting treatment, tell your doctor about medical conditions like heart problems, previous history of stroke, liver disease, pancreatitis, low potassium or magnesium levels. Avoid grapefruit and grapefruit products throughout treatment, as they can raise Nilotinib levels. Use effective contraception after discussing with your doctor and avoid breastfeeding during Nilotinib treatment.

Uses

Nilotinib is used in the management of chronic myelogenous leukaemia (CML)

Contraindications

When should one not use Nilotinib

Nilotinib is contraindicated in patients with:
Known low blood potassium (hypokalaemia)
Known low blood magnesium (hypomagnesaemia)
Long QT syndrome (condition that affects your heart’s electrical system )
Known hypersensitivity to nilotinib or any of the ingredients in the medicine

Side effects

Common side effects of this drug are:

Skin rash and itching
Headache
Nausea, vomiting, diarrhoea, constipation
Tiredness (fatigue) and weakness
Joint pain and muscle pain
Runny/blocked nose or throat symptoms (nasopharyngitis)
Fever
Night sweats
Hair thinning, dry skin
Stomach discomfort or indigestion
Dizziness
Swelling of the arms or legs
Cough, shortness of breath
Low blood cell counts noted on blood tests (low platelets, white cells and red cells)
Raised blood sugar, raised cholesterol or triglycerides
Difficulty sleeping
Feeling light-headed, fainting, or an irregular heartbeat
Fever, chills, or other signs of infection; unexplained bruising or bleeding; or unusual tiredness or breathlessness
Sudden stomach pain with nausea and vomiting
Yellowing of the skin or eyes, dark urine, or stomach pain
Chest pain, leg pain, sudden numbness or weakness, or sudden trouble walking or speaking
Uncontrolled bleeding, sudden severe headache, vision changes, or confusion
Rapid weight gain, swelling, or new shortness of breath

Precautions and Warnings

Pregnancy

Nilotinib should generally be avoided during pregnancy unless your doctor considers it necessary.It may harm an unborn baby. Women who can become pregnant should use effective contraception during treatment and as advised by their doctor.

Breast Feeding

Breastfeeding is not recommended during treatment with Nilotinib. Discuss with your doctor when you can safely resume breastfeeding.

Driving

The medicine can commonly cause dizziness, fatigue, fainting and blurred vision. If you experience these effects, inform your healthcare professional and avoid activities that may be unsafe while experiencing them.

Alcohol

Nilotinib can affect the liver. It is best to limit or avoid alcohol during treatment and discuss your individual situation with your doctor, particularly if you have any history of liver problems.

Other General Warnings

Talk to your doctor if

You have a heart condition, irregular heartbeat, or a personal or family history of heart disease.
You have a history of stroke.
You have liver disease
You have a history of pancreatitis (inflammation of the pancreas)
You have low blood potassium or magnesium levels
You have a severe intolerance to lactose or galactose
You have a history of bleeding problems
You have a previous surgery that removed your entire stomach (total gastrectomy)
Report any irregular heartbeat, dizziness, or fainting to your doctor immediately.
Attend all scheduled ECG and blood-test appointments, as your doctor closely monitors your heart rhythm and blood counts during treatment.
Seek urgent care for sudden stomach pain with vomiting, or yellowing of the skin/eyes.
Tell your doctor about all other medicines and supplements you take. Never start a new medicine without consulting your doctor.
Keep out of the sight and reach of children and pets at all times.

Mode of Action

How Does It Work?

Nilotinib belongs to a class of medicines called kinase inhibitors. It targets an abnormal protein called BCR-ABL. Nilotinib binds to BCR-ABL, stopping growth signals that stimulate cancer cells. Nilotinib thus reduces the number of leukaemia cells over time and helps slow the progression of CML.

Interactions

Interactions with other medicines

Nilotinib can affect the heart's electrical rhythm by prolonging the QT interval. Taking it with other medicines that have the same effect may increase the risk of abnormal heart rhythms.
Ketoconazole and ritonavir may increase the amount of Nilotinib in your body and raise the risk of side effects. These medicines should generally be avoided.
Rifampin and phenytoin may reduce the amount of Nilotinib in your body and make it less effective. These medicines should generally be avoided.
Omeprazole and other proton pump inhibitors (PPIs) may reduce the absorption of Nilotinib and are generally not recommended. If you need treatment for acidity, your doctor can suggest a suitable alternative.
Always tell your doctor about all prescription medicines, over-the-counter medicines, vitamins, supplements, and herbal products you take.
Herbal product you take, which can significantly reduce how well Nilotinib works.

Interactions with food items

Nilotinib must be taken on an empty stomach. Food, especially a high-fat meal, substantially increases the amount of medicine absorbed, which raises the risk of serious heart-rhythm side effects. Avoid eating for at least 2 hours before and at least 1 hour after each dose. Avoid grapefruit, grapefruit juice, and grapefruit-containing supplements completely during treatment, as they raise Nilotinib.

Dosage

Overdose

No specific antidote for Nilotinib overdose is available. If an overdose is taken or suspected, seek urgent medical attention immediately.

Missed a Dose

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed one. If you are ever unsure whether you took a dose, contact your doctor for guidance.

Frequently Asked Questions (FAQs)

Taking this medicine with food can increase its absorption. This increases the risk of serious heart-rhythm side effects. Taking the medicine on an empty stomach helps keep its blood levels more predictable.

It is usually recommended to avoid antacids and heartburn medicines (proton pump inhibitors), as they can affect Nilotinib absorption. Consult your doctor about alternatives in such a case. Your doctor will recommend the most suitable medicine after evaluating your condition.

Grapefruit and its products can increase Nilotinib levels in the blood. This can increase the risk of developing an irregular heart rhythm. It is best to avoid them entirely during the course of the Nilotinib treatment.