Tasigna

The active ingredient in Tasigna is nilotinib hydrochloride monohydrate. It is a tyrosine kinase inhibitor (TKI) that works by inhibiting a protein in your body known as BCR-ABL tyrosine kinase. This protein is only detected on cancer cells, such as those in CML, and not on healthy cells. It encourages cancer cells to expand and reproduce. Tasigna kills and prevents the spread of cancer cells by inhibiting the activity of this protein.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Tasigna. However, the following is a synopsis of the general guidelines for the use of Tasigna:

• Tasigna is typically taken every twelve hours. Follow the guidelines on the prescription label. Do not change the dose of your medication or take it for longer than indicated.
• Take Tasigna on an empty stomach. Do not take with food. Food can raise nilotinib levels in your blood, thus increasing the risk of side effects.
• Avoid eating for at least two hours before and one hour after taking Tasigna.
• Take this medication with a full glass of water. Swallow the capsule whole.
• If you are unable to take a capsule whole, you may open it and mix the drug with no more than 1 teaspoon of applesauce. Swallow immediately, without chewing. Do not store the mixture for later use.
• Tasigna should be taken long-term. You should not stop taking this medication unless your doctor instructs you to.
• Tasigna can reduce the number of blood cells that assist the body in fighting infections. Your blood will need to be tested frequently. Your cancer treatments may be postponed depending on the results of these tests.
• Nilotinib can induce severe heart problems. Before and during your therapy with this medication, your heart function may be assessed using an electrocardiograph, or ECG (also known as an EKG).
• If you are taking an antacid that contains aluminum, magnesium, or calcium, take it at least 2 hours before or 2 hours after.
• If you are taking an H2 blocker medicine like famotidine, take it at least 10 hours before or 2 hours after Tasigna.

Some mild or common side effects of nilotinib seen in clinical trials include:

• Nausea or vomiting.
• Rash.
• Headache.
• Muscle pain.
• Back pain.
• Joint pain.
• Tiredness.
• Constipation.
• Diarrhea.
• Sore throat.
• Night sweats.

Some individuals may experience serious side effects while using Tasigna. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Irregular heartbeat symptoms include rapid beating, chest discomfort, dizziness, and fainting.
• Low blood cell counts, including red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia).
• Swelling in the face, arm, or legs (edema), ascites (abnormal build-up of water in the stomach), or fluid retention in other parts of the body.
• Serious bleeds include persistent bleeding or bruising, a substantial amount of bleeding, blood in the urine, vomiting blood, and bloody or black and tarry faeces.
• Heart problems include chest pain, racing heartbeat, shortness of breath, swelling of the legs or feet, unexpected weight gain, and weariness.
• Stroke symptoms include weakness on one side of the body, severe headaches, difficulty seeing or speaking, and confusion.
• Abnormal electrolyte levels and renal difficulties include a racing heart, muscle cramps or spasms, numbness, nausea, vomiting, dark urine, less frequent urination, and pain on either side of the lower back.
• Allergic reaction to the medication, such as skin rash, hives, or swelling.
• Increased risk of pancreatitis. Symptoms include sudden severe stomach pain with or without nausea and vomiting.
• Tumor lysis syndrome. Symptoms include a change in the amount of your urine, joint stiffness or pain, swelling, rapid weight gain, abdominal or back pain, or unusual tiredness or weakness.

These are not all of the possible side effects of Tasigna. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Tasigna, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Blood or bone marrow issues.
• Low blood levels of potassium or magnesium.
• Long QT syndrome.
• Heart attack, heartbeat issues, or a family member who has these problems.
• History of a stroke.
• High blood pressure.
• Bleeding problems.
• Liver disease.
• Kidney disease.
• Pancreatitis (inflammation of the pancreas).
• Severe problems with lactose (milk sugar).
• Surgical removal of your stomach (gastrectomy).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of the medicine that is absorbed in the body.

Boxed Warning

This medication may cause QT interval prolongation, with sudden deaths reported. ECG monitoring is required at baseline, 7 days after starting, periodically thereafter, and after any dose changes. Check and correct low potassium or magnesium before and during treatment. Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Avoid combining with other QT-prolonging drugs or strong CYP3A4 inhibitors. For capsules, do not eat within 2 hours before and 1 hour after taking a dose.

• Low blood levels of potassium and magnesium
• QT prolongation (heart rhythm problem)

Many patients may notice an improvement in their blood counts within the first few weeks when the drug begins to reduce the number of leukaemia cells circulating in the blood. This is frequently the first indication that the medication is having an effect. Tasigna is a long-term medication and is typically taken for at least 3 years.

When Tasigna is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Grapefruit or grapefruit juice.
• St. John’s wort.

For newly diagnosed Ph+ CML in adults, the recommended beginning dose is 300 mg orally twice a day, approximately 12 hours apart.

If you've previously tried a similar medication that didn't work to treat your cancer, the typical dose of Tasigna (nilotinib) capsules is 400 mg by mouth twice a day.

Dosing for children is based on their body surface area (BSA), which includes height and weight. The dosage ranges from 50 mg to 400 mg taken orally twice a day (approximately 12 hours apart).

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store at room temperature and keep out of reach of children.

Novartis Inc. is the company that manufactures Tasigna.

There are generic versions available of Tasigna.

Stopping Tasigna should never be done on your own; it must be properly planned and managed by your hematologist or oncologist. This is because Tasigna is used to treat chronic myeloid leukaemia (CML), and discontinuing it abruptly without medical supervision can cause the disease to relapse or worsen.

If you are pregnant, do not use Tasigna. It could harm the unborn child. Use effective birth control to avoid pregnancy while taking this medication and for at least 14 days following the last dose.

It is not known if Tasigna passes into your breast milk. Do not breastfeed while you are taking Tasigna and for at least 14 days after your last dose.