Tasigna (nilotinib) is an oral medication used to treat a certain type of chronic myelogenous leukemia (CML). It’s a type of targeted anticancer treatment. Tasigna (nilotinib) is one of the recommended options for CML in adults and children. But, it’s taken twice a day and can’t be taken with food, so it can be hard to schedule around your meals.
Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
Tasigna (nilotinib) is a tyrosine kinase inhibitor (TKI). It blocks a certain protein in your body called BCR-ABL tyrosine kinase. This protein is only found on cancer cells like those of CML and not on normal, healthy cells. It causes the cancer cells to grow and multiply. By blocking this protein, Tasigna (nilotinib) kills cancer cells and stops their spread.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
bone pain
chills
clay-colored stools
confusion
dark urine
decreased appetite
difficult or labored breathing
fainting
flushed, dry skin
fruit-like breath odor
headache
hoarseness
increased hunger
increased thirst
increased urination
irregular heartbeat, recurrent
itching, skin rash
loss of appetite
lower back or side pain
muscle aches, cramps, or pain
no blood pressure
no breathing
no pulse
numbness, tingling, pain, or weakness in the hands or feet
painful or difficult urination
pale skin
pinpoint red spots on the skin
seizures
stomach pain or tenderness
stuffy or runny nose
sweating
swelling of the hands, ankles, feet, or lower legs
tightness in the chest
trembling
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
weakness and heaviness of the legs
yellow eyes or skin
Less common
Decreased urine output
dizziness
fast heartbeat
loss of consciousness
muscle cramps in the hands, arms, feet, legs, or face
nervousness
numbness and tingling around the mouth, fingertips, or lips
rapid weight gain
Less common or rare
Bladder pain
bloody or cloudy urine
body aches or pain
cough producing mucus
depressed mood
dry skin and hair
ear congestion
feeling cold
frequent urge to urinate
loss of voice
muscle stiffness
pain or tenderness around the eyes and cheekbones
sensitivity to heat
slowed heartbeat
swelling or puffiness of the face
tender, swollen glands in the neck
trouble sleeping
trouble swallowing
weight changes
white patches in the mouth or throat or on the tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Recommended treatment option for CML in certain adults
Can be used in children
More precise in the way it targets cancer cells, compared to traditional chemotherapy
Can’t be taken around the time you eat food
Requires regular blood tests so your provider can monitor for side effects
Available as brand only, so can be expensive
Contains lactose, so might not be a good option for people who are lactose intolerant or have problems absorbing certain sugars
Swallow Tasigna (nilotinib) whole with water.
Don’t eat for at least 2 hours before your Tasigna (nilotinib) dose or for at least 1 hour after. Also, avoid grapefruit and grapefruit juice while taking the medication. Food and grapefruit can raise the levels of the medication in your body and cause more side effects.
Certain medications can interact with Tasigna (nilotinib), which can change the levels of Tasigna (nilotinib) in your body and affect how safe they are for you. Some medications, like proton pump inhibitors (PPIs), can affect how well Tasigna (nilotinib) works to treat CML. Others can raise your risk of side effects from Tasigna (nilotinib). Tell your provider and pharmacist about all the medications you take, including supplements and over-the-counter medications. Before starting any new medications, make sure your provider knows you're taking Tasigna (nilotinib). If needed, your provider can guide you to safer alternatives or how to best take your medications.
If you miss a dose of Tasigna (nilotinib), don’t try to make up that dose. Skip the missed dose, and take your next dose at your next regularly scheduled time. Don't take two doses at the same time.
If you’re able to become pregnant, use birth control, such as birth control pills or condoms, while taking Tasigna (nilotinib) and for at least 2 weeks after your last dose. It’s possible for this medication to cause harm to an unborn baby.
Ask your provider or pharmacist about the best way to handle and throw away Tasigna (nilotinib) safely. Anticancer medications can be very harmful to people who handle or come into contact with them.
Tasigna (nilotinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of or current heart rhythm problems (arrhythmias) | Low blood levels of potassium or magnesium | Take certain medications that interact with Tasigna (nilotinib) or cause abnormal heart rhythms | Take Tasigna (nilotinib) with food
Tasigna (nilotinib) can cause a serious heart rhythm problem called QT prolongation. This can lead to fainting, seizures, or death. Because of this risk, your provider will perform an electrocardiogram (EKG) to check your heart’s electrical activity before you start Tasigna (nilotinib) and while you take the medication. They might also check your blood for certain electrolytes that can affect your heart rhythm. Seek immediate medical attention if you develop symptoms of an abnormal heartbeat, like feeling lightheaded, faint, or have a fast heartbeat.
Certain medications and foods can increase the amount of Tasigna (nilotinib) in your body, which raises your risk of abnormal heart rhythms. Taking other medications that can also cause QT prolongation can raise your risk even more. Make sure to let your healthcare providers know about all the medications you take, including over-the-counter products, vitamins, and herbal supplements, before starting Tasigna (nilotinib). They will make sure your medications are safe for you to take.
In addition, there have been very rare cases of sudden death (0.3%) in people with CML who’ve taken Tasigna (nilotinib). It’s possible that other abnormal heart rhythms occurred that may have caused some of these deaths.
Risk factors: History of heart problems | At risk of heart problems
In clinical studies, serious blood flow problems that can lead to blood clots, heart attack, or stroke have happened in people taking Tasigna (nilotinib). Make sure your provider knows your full medical history. They might monitor you more closely if you have a history of heart conditions. Contact your provider right away if you develop symptoms of low blood flow in the leg like leg pain, swelling, or cramping. Get medical help as soon as possible if you experience symptoms of a heart attack (e.g., chest pain, shortness of breath, feeling faint) or stroke (e.g., numbness or weakness on one side of the body, sudden problems walking or speaking).
Tasigna (nilotinib) can cause the levels of your red blood cells, white blood cells, and platelets to drop. When these cell counts are lower than normal, you can feel more tired. You can also have a higher risk of bleeding, bruising, and developing infections. Your provider will check your blood counts often while you’re taking Tasigna (nilotinib). Let your provider know right away if you experience fevers, chills, or bleeding and bruising that doesn’t stop or go away, because you might need to have your dose lowered or stop this medication.
Risk factors: History of pancreatitis
Some people taking Tasigna (nilotinib) might develop higher blood levels of lipase, a protein that’s made by the pancreas. This can raise the risk of pancreatitis. If you’ve had this pancreatic problem in the past, you might be at higher risk of developing it again during treatment. Your provider will monitor your lipase levels while you’re taking Tasigna (nilotinib). Let your provider know immediately if you have sudden pain in your stomach that happens with nausea and vomiting. This can be a symptom of pancreatitis.
Tasigna (nilotinib) can cause liver problems. More serious cases of liver problems happened more commonly in children compared to adults who were taking the medication. Your provider will monitor your liver health regularly through lab work while you’re taking Tasigna (nilotinib). Let your provider know if you experience tiredness, loss of appetite, nausea or vomiting, dark urine, right-side stomach pain, or yellowing of the eyes or skin, as these can be signs of liver problems.
Tasigna (nilotinib) can cause new or worsening swelling in the arms or legs (peripheral edema), or fluid buildup in the heart or lungs. Some symptoms of fluid buildup include shortness of breath during rest or exercise, rapid weight gain, or swelling in your arms or legs. Let your provider know if you develop any of these symptoms during treatment.
In clinical studies, a small number of people taking Tasigna (nilotinib) experienced bleeding. These bleeding events were rarely serious, but a few were life threatening. Let your provider know if you notice bleeding or bruising that doesn’t stop or go away, a large amount of bleeding, changes in vision, or sudden headache or confusion. Your provider will decide if you need treatment for your bleeding.
Risk factors: Previous treatment that didn’t work | Higher tumor burden | Advanced cancer stage | High white blood cell count | Dehydration | Kidney damage
Though rare, some people who previously failed other treatments developed a condition called tumor lysis syndrome (TLS) after starting Tasigna (nilotinib). This condition happens when many cancer cells die quickly and break down in your body. This causes a rapid release of the cells’ contents like uric acid and electrolytes. Large amounts of these contents in the blood can cause serious kidney damage and abnormal heart rhythms, which can be dangerous if not treated right away. Other risk factors include having a lot of cancerous cells (high tumor burden), dehydration, and a history of kidney damage. TLS typically occurs in the first week of starting treatment. Tell your provider right away if you experience any symptoms of TLS, such as urinating less than usual or have dark urine, muscle cramps, or a racing heartbeat.
Risk factors: Taking the medication for a long time
A small number of children who’ve taken Tasigna (nilotinib) for more than 4 years have experienced a slower growth rate. The impact on growth rate was greater in children younger than 12 years old than in those who were older. Your child’s provider will monitor your child’s growth while they’re taking Tasigna (nilotinib).
Based on animal studies, Tasigna (nilotinib) can harm an unborn baby or raise the risk for miscarriage (pregnancy loss). Because of this risk, you should take a pregnancy test before starting treatment to make sure you’re not pregnant. Also, use birth control while taking Tasigna (nilotinib) and for at least 2 weeks after the last dose. Let your provider know right away if you become pregnant during this time.
Adults:
For newly-diagnosed Ph+ CML, the typical starting dose is 300 mg by mouth twice a day (about 12 hours apart).
If you’ve taken a similar medication before that didn’t work to treat your cancer, the typical dose of Tasigna (nilotinib) is 400 mg by mouth twice a day.
Children:
Dosing will depend on the child’s body surface area (BSA), which takes into account their height and weight. Dosage starts from 50 mg to 400 mg by mouth twice a day (about 12 hours apart).
Your dose might differ if you’re taking certain medications that interact with Tasigna (nilotinib), you’ve had your stomach surgically removed, or if you have liver problems.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Low blood levels of potassium and magnesium
Long QT syndrome (heart rhythm problem)
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