nilotinib
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.
What is Tasigna (nilotinib)?
What is Tasigna (nilotinib) used for?
- Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
How Tasigna (nilotinib) works
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.
Drug facts
Side effects of Tasigna (nilotinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Rash (up to 38%)
- Nausea (up to 37%)
- Headache (up to 35%)
- Tiredness (up to 32%)
- Itchy skin (up to 32%)
- Vomiting (up to 29%)
- Diarrhea (up to 28%)
- Fever (up to 28%)
- Cold-like symptoms (up to 27%)
- Cough (up to 27%)
- Sweating at night (up to 27%)
- Constipation (up to 26%)
- Joint pain (up to 26%)
- Pain in arms or legs (up to 20%)
*Side effects listed were reported in adults. Side effects in children might differ. Please see source for more details.
Less Common Side Effects
- Muscle, back, or bone pain
- Muscle spasms
- Mouth or throat pain
- Stomach pain
- Decreased appetite
- Indigestion or heartburn
- Stomach flu
- Flu-like symptoms
- Dizziness
- Lower energy and body strength
- Swelling of the face, arms, or legs
- High blood pressure
- Trouble breathing
Tasigna (nilotinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Irregular heartbeat: fast heartbeat, chest discomfort, dizziness, fainting
- Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, blood in the urine, throwing up blood, bloody or black and tarry stool
- Heart problems: chest pain, racing heart, shortness of breath, swelling of legs or feet, sudden weight gain, fatigue
- Stroke: weakness on one side of body, severe headache, problems with vision or speech, confusion
- Abnormal electrolyte levels and kidney problems: racing heart, muscle cramps or spasms, numbness, nausea, vomiting, dark urine, not urinating as much as usual, pain on either side of the lower back
The following Tasigna (nilotinib) side effects have also been reported
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.
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Pros and cons of Tasigna (nilotinib)
Pros
- 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
Cons
- 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
Pharmacist tips for Tasigna (nilotinib)
- 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.
Common questions about Tasigna
No. It’s important that you don’t eat any food at least 2 hours before or 1 hour after taking your Tasigna dose. Taking it too close to the time of a high-fat meal can raise the amount of Tasigna that your body absorbs. Having too much medication in your body can raise your risk of side effects.
If you’re not able to swallow the Tasigna capsules, you can open them up and mix the capsule contents with 1 teaspoon of applesauce. Only open enough capsules for 1 dose at a time. Once it’s mixed, eat the entire amount of applesauce within 15 minutes. Don’t store the applesauce with Tasigna mixed in for your next dose.
You should take Tasigna as instructed by your provider. How long you need Tasigna therapy depends on several factors, including how well the medication is working to treat your cancer and how well you tolerate it. Depending on your response to Tasigna after at least 3 years of treatment, there’s a possibility you can stop taking the medication under certain circumstances. Your provider will decide if this is an option for you. Don’t stop taking Tasigna without first discussing with your provider.
There isn’t one TKI that’s considered better than another. Other TKIs used to treat Ph+ CML in adults include imatinib (Gleevec), Sprycel (dasatinib), Bosulif (bosutinib), and Iclusig (ponatinib). They have different dosing and slightly different side effects. Some of these TKIs can also be used in children. In addition, some people have specific mutations in their cancer that certain TKIs can’t treat. Your provider will help you choose a TKI depending on many factors, including how well your body handles the side effects, other medical conditions you might have, if you have a mutation in your cancer, and available clinical evidence for use in children. Discuss with your provider about the benefits and risks for these treatment options.
Tasigna isn’t recommended for use in pregnancy because it might cause harm to your unborn baby. If you’re a woman of childbearing age, you should use birth control while taking Tasigna and for 2 weeks after the last dose. Let your provider know right away if you become pregnant while taking this medication.
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Risks and warnings for Tasigna (nilotinib)
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.
Changes in heart rhythm
- 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.
Blood flow problems, heart attack, or stroke
- 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).
Low blood counts
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.
Pancreatitis (inflammation of the pancreas)
- 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.
Liver problems
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.
Fluid buildup or swelling in the body
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.
Bleeding
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.
Tumor lysis syndrome
- 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.
Growth problems in children
- 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).
Harm to unborn baby
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.
Tasigna (nilotinib) dosage
Bottle| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 120 capsules of 50mg | 1 bottle | $3,975.63 | $3,975.63 |
Interactions between Tasigna (nilotinib) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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.
- Bepridil
- Colchicine
- Dronedarone
- Eliglustat
- Fluconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Nelfinavir
- Piperaquine
- Posaconazole
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Varicella Virus Vaccine, Live
- Ziprasidone
- Zoster Vaccine, Live
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.
- Abametapir
- Acalabrutinib
- Adenovirus Vaccine
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Avapritinib
- Azithromycin
- Bacillus of Calmette and Guerin Vaccine, Live
- Bedaquiline
- Benzhydrocodone
- Boceprevir
- Bosutinib
- Brigatinib
- Buprenorphine
- Buserelin
- Captopril
- Carbamazepine
- Carvedilol
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine, Live
- Cilostazol
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
- Codeine
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Cyclophosphamide
- Dasabuvir
- Dasatinib
- Deflazacort
- Degarelix
- Delamanid
- Dengue Tetravalent Vaccine, Live
- Desipramine
- Deslorelin
- Deutetrabenazine
- Dexamethasone
- Dexlansoprazole
- Dihydrocodeine
- Diltiazem
- Disopyramide
- Dofetilide
- Dolasetron
- Domperidone
- Donepezil
- Doxepin
- Doxorubicin
- Droperidol
- Ebastine
- Efavirenz
- Elexacaftor
- Encorafenib
- Entrectinib
- Enzalutamide
- Eribulin
- Erythromycin
- Escitalopram
- Eslicarbazepine Acetate
- Esomeprazole
- Felbamate
- Felodipine
- Fentanyl
- Fingolimod
- Flecainide
- Fluoxetine
- Formoterol
- Foscarnet
- Fosnetupitant
- Fosphenytoin
- Fostemsavir
- Galantamine
- Gatifloxacin
- Gemifloxacin
- Glasdegib
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Histrelin
- Hydrocodone
- Hydroquinidine
- Hydroxychloroquine
- Hydroxyzine
- Ibrutinib
- Ibutilide
- Idelalisib
- Iloperidone
- Imipramine
- Indinavir
- Influenza Virus Vaccine, Live
- Inotuzumab Ozogamicin
- Itraconazole
- Ivabradine
- Ivacaftor
- Ivosidenib
- Ketoconazole
- Lansoprazole
- Lapatinib
- Lefamulin
- Lemborexant
- Lenvatinib
- Levofloxacin
- Lofexidine
- Lopinavir
- Lumacaftor
- Lumateperone
- Lumefantrine
- Lurbinectedin
- Macimorelin
- Mefloquine
- Meperidine
- Methadone
- Metronidazole
- Midazolam
- Mifepristone
- Mirtazapine
- Mitotane
- Mizolastine
- Moricizine
- Morphine
- Morphine Sulfate Liposome
- Moxifloxacin
- Nafarelin
- Naloxegol
- Nefazodone
- Netupitant
- Norfloxacin
- Nortriptyline
- Octreotide
- Ofloxacin
- Olanzapine
- Olaparib
- Omeprazole
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Oxycodone
- Ozanimod
- Paclitaxel
- Paliperidone
- Panobinostat
- Pantoprazole
- Papaverine
- Paroxetine
- Pasireotide
- Pazopanib
- Pemigatinib
- Pentamidine
- Pentazocine
- Perphenazine
- Pexidartinib
- Phenytoin
- Pimavanserin
- Pimozide
- Pipamperone
- Pitolisant
- Pixantrone
- Poliovirus Vaccine, Live
- Ponesimod
- Primidone
- Probucol
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quercetin
- Quetiapine
- Quinidine
- Quinine
- Rabeprazole
- Ranolazine
- Ribociclib
- Rifabutin
- Rifampin
- Rifapentine
- Rimegepant
- Risperidone
- Ritonavir
- Salmeterol
- Selpercatinib
- Selumetinib
- Sertindole
- Sertraline
- Sevoflurane
- Simeprevir
- Siponimod
- Smallpox Vaccine
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sonidegib
- Sorafenib
- Sotalol
- St John's Wort
- Sufentanil
- Sulpiride
- Sultopride
- Sunitinib
- Tacrolimus
- Tamoxifen
- Tazemetostat
- Telaprevir
- Telavancin
- Telithromycin
- Tetrabenazine
- Tezacaftor
- Ticagrelor
- Tolterodine
- Tolvaptan
- Toremifene
- Tramadol
- Trazodone
- Triclabendazole
- Trifluoperazine
- Trimipramine
- Triptorelin
- Typhoid Vaccine, Live
- Ubrogepant
- Ulipristal
- Vandetanib
- Vardenafil
- Vemurafenib
- Venetoclax
- Venlafaxine
- Verapamil
- Vilanterol
- Vincristine
- Vincristine Sulfate Liposome
- Vinflunine
- Voclosporin
- Voriconazole
- Vorinostat
- Warfarin
- Yellow Fever Vaccine
- Zanubrutinib
- Zotepine
- Zuclopenthixol
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.
- Pioglitazone
- Suvorexant
How much does Tasigna (nilotinib) cost?
Tasigna (nilotinib) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Tasigna (nilotinib) will not be safe for you to take.
- Low blood levels of potassium and magnesium
- Long QT syndrome (heart rhythm problem)
What are alternatives to Tasigna (nilotinib)?
Tasigna (nilotinib) images
