Danziten
Danziten (nilotinib) is an oral medication used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), a type of blood cancer. It's FDA approved for people who are newly diagnosed or who have previously received treatment with imatinib. The medication comes as a tablet that's taken by mouth twice a day, about 12 hours apart, with or without food. Common side effects include rash, nausea, and headache.
What is Danziten (nilotinib)?
What is Danziten (nilotinib) used for?
- Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults
- Ph+ CML in adults when imatinib no longer works or causes side effects that are too difficult to tolerate
How Danziten (nilotinib) works
Danziten (nilotinib) is a tyrosine kinase inhibitor, specifically a BCR-ABL inhibitor. It works by blocking a protein called BCR-ABL, which tells cancer cells to grow and spread.
By blocking BCR-ABL, Danziten (nilotinib) can slow or stop the growth of these cancer cells.
Drug facts
| Common Brands | Danziten |
|---|---|
| Drug Class | Tyrosine kinase inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Danziten (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
Newly diagnosed Ph+ CML
- Rash (38%)
- Headache (32%)
- Common cold symptoms (27%)
- Tiredness (23%)
- Nausea (22%)
- Joint pain (22%)
- Itching (21%)
- Constipation (20%)
Ph+ CML after previous treatment
- Nausea (22-37%)
- Rash (29-36%)
- Headache (20-35%)
- Tiredness (23-32%)
- Itching (20-32%)
- Vomiting (13-29%)
- Diarrhea (24-28%)
- Fever (22-28%)
- Cough (18-27%)
- Night sweats (12-27%)
- Constipation (19-26%)
- Joint pain (16-26%)
- Common cold symptoms (15-24%)
- Pain in the arms and legs (18-20%)
Less Common Side Effects
Newly diagnosed Ph+ CML
- Hair loss
- Dry skin
- Diarrhea
- Vomiting
- Stomach pain
- Indigestion
- Dizziness
- Fever
- Back pain
- Pain in the arms and legs
- Cough
Ph+ CML after previous treatment
- Hair loss
- Stomach pain
- Indigestion
- Weakness
- Swelling
- Muscle pain
- Shortness of breath
- Sore throat
- Reduced appetite
- Trouble sleeping
- High blood pressure
Danziten (nilotinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Abnormal heart rhythm problem: lightheadedness, pounding heartbeat, dizziness, fainting, seizures, chest discomfort
- Low blood cell counts: fever, chills, sore throat, unusual tiredness, easy bleeding or bruising, weakness, shortness of breath
- Heart and blood vessel blockage problems: chest pain or discomfort, numbness or weakness, problems walking or speaking, leg pain, leg feels cold, change in skin color of your leg
- Inflammation of the pancreas: severe upper stomach pain, nausea, vomiting
- Liver problems: yellow skin and eyes, dark urine, stomach pain
- Tumor lysis syndrome: dark urine, urinating less, muscle cramps, weakness, racing heartbeat
- Bleeding: black stools, blood in vomit, blood in urine, severe headache, heavy bruising
- Fluid buildup: rapid weight gain, swelling, shortness of breath
The following Danziten (nilotinib) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Burning, pain, tingling, or color changes in the hands, arms, legs, or feet
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- High potassium level—muscle weakness, fast or irregular heartbeat
- Infection—fever, chills, cough, or sore throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
- Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain
- Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Danziten (nilotinib)
Pros
- Can be taken with or without food
- Tablet taken by mouth
- Option if imatinib doesn't work or causes bothersome side effects
Cons
- Risk of dangerous heart rhythm changes
- Requires frequent labs and monitoring
- Interactions with many medications
Pharmacist tips for Danziten (nilotinib)
- Take Danziten (nilotinib) twice a day, about 12 hours apart each day. You can take it with or without food.
- Swallow Danziten (nilotinib) tablets whole with water. Don't cut, crush, or chew the tablets because this can change how your body absorbs the medication.
- If you miss a dose of Danziten (nilotinib), skip it and take your next dose at the usual time. Don't take two doses at once to make up for a missed dose.
- Danziten (nilotinib) can cause changes in your electrolyte levels, including potassium, calcium, sodium, and phosphate. Your care team will check your blood tests before and during treatment and treat any abnormal levels if needed.
- Tell your prescriber and pharmacist about all medications and supplements you take before starting Danziten (nilotinib). Some medications, such as clarithromycin, ketoconazole, and rifampin can change the amount of this medication in your body and affect how well it works or your risk of side effects.
- Ask your oncologist before taking heartburn medications with Danziten (nilotinib). Proton pump inhibitors (PPIs) aren't recommended because they can lower the amount of medication your body absorbs. If needed, take an H2 blocker about 10 hours before or 2 hours after your dose, or an antacid about 2 hours before or after your dose.
- Avoid grapefruit and grapefruit juice while taking Danziten (nilotinib). Grapefruit can raise the amount of medication in your body and increase your risk of side effects.
- Danziten (nilotinib) can lower your red blood cells, white blood cells, and platelets. Tell your care team if you feel very weak, develop a fever or other signs of infection, or have unusual bruising or bleeding.
- Danziten (nilotinib) can affect your heart or cause fluid buildup. Tell your care team right away if you have swelling, shortness of breath, chest pain, fainting, or a fast or racing heartbeat.
- Pregnancy: Use birth control while taking Danziten (nilotinib) if pregnancy is possible. Danziten (nilotinib) can harm an unborn baby, so it's important to avoid pregnancy during treatment and for 14 days after your last dose.
- Breastfeeding: Don't breastfeed while taking Danziten (nilotinib) and for 14 days after your last dose. The medication could cause serious side effects in a breastfed baby.
Risks and warnings for Danziten (nilotinib)
Danziten (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.
Heart rhythm changes and sudden deaths
- Risk factors: Low potassium | Low magnesium | History of heart rhythm problems | Taking medications that interact with Danziten (nilotinib) | Taking medications that can cause heart rhythm problems
Danziten (nilotinib) can cause QT prolongation, a change in your heart's electrical activity that can lead to a dangerous heart rhythm. In severe cases, it can cause fainting, seizures, or sudden death. Your risk might be higher when you first start treatment, after your dose changes, or if something raises the amount of medication in your body.
Your risk is also higher if you have heart rhythm problems, low potassium or magnesium levels, or take other medications that affect your heart rhythm. Your care team will check your heart with electrocardiograms (ECGs) and monitor your electrolyte levels before and during treatment. Tell your care team right away if you feel lightheaded, faint, or have a fast, pounding, or irregular heartbeat.
Low blood cell counts
Danziten (nilotinib) can cause your red blood cells, white blood cells, and platelets to drop too low. This can make you feel weak or tired, raise your risk of infection, and cause you to bruise or bleed more easily.
Your care team will check your blood counts every 2 weeks for the first 2 months and then monthly. Tell your oncology care team right away if you have a fever, chills, unusual tiredness, shortness of breath, nosebleeds, or easy bruising.
Heart and blood vessel blockages
Danziten (nilotinib) can raise the risk of serious problems caused by reduced blood flow to your heart, brain, or legs. These can include heart attack, stroke, or blocked arteries and can become life-threatening.
Your oncology care team will check your heart health and manage risk factors, such as high blood pressure or high cholesterol, during treatment. Get medical help right away if you have chest pain, trouble breathing, sudden weakness or numbness, trouble speaking, or severe pain in your arms or legs.
Inflammation of the pancreas
- Risk factors: History of pancreatitis
Danziten (nilotinib) can raise levels of certain pancreas enzymes, such as lipase. In some cases, this can lead to pancreatitis, or inflammation of the pancreas.
Your care team will check your lipase levels during treatment, especially if you've had pancreas problems before. Tell them right away if you have severe or ongoing stomach pain, nausea, or vomiting.
Liver problems
Danziten (nilotinib) can cause liver problems, which might show up as changes in your liver blood tests. Because liver problems don't always cause symptoms at first, your care team will usually check your liver tests every month and as needed.
Tell your care team right away if you have yellowing of your skin or eyes, dark urine, pain on the right side of your stomach, loss of appetite, or unusual tiredness.
Tumor lysis syndrome
- Risk factors: Worsening cancer | High white blood cell count | Dehydration
Danziten (nilotinib) can cause tumor lysis syndrome (TLS), a serious condition that happens when many cancer cells break down quickly. This can cause dangerous changes in your electrolyte levels and lead to kidney or heart problems. Drink plenty of fluids as directed by your care team, and tell them right away if you have dark urine, urinate less than usual, have muscle cramps, or notice a pounding heartbeat.
Bleeding
Danziten (nilotinib) can cause serious bleeding, which can sometimes be life-threatening. Bleeding can happen in different parts of your body, including your stomach or intestines. Tell your care team right away if you have unusual bruising, bleeding that won't stop, blood in your urine, red or black stools, or vomit that contains blood or looks like coffee grounds.
Fluid buildup
Danziten (nilotinib) can cause your body to hold onto too much fluid. This can lead to swelling, rapid weight gain, or fluid buildup around your lungs or heart, which can make it hard to breathe. Tell your care team right away if you have sudden weight gain, new or worsening swelling, or shortness of breath.
Slowed growth in children
- Risk factors: Children younger than 12 years old
Danziten (nilotinib) isn't FDA approved for children. But other nilotinib products used in children have been linked to slower growth, especially in those younger than 12 years old. The oncology care team will monitor the child's growth and development during treatment.
Harm to unborn baby
Danziten (nilotinib) can harm an unborn baby based on animal studies and how the medication works. If you can become pregnant, use effective birth control during treatment and for 14 days after your last dose. Tell your care team right away if you become pregnant during treatment.
Danziten (nilotinib) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 71mg | 112 tablets | $17,310.25 | $154.56 |
| 95mg | 112 tablets | $17,310.25 | $154.56 |
Typical dosage for Danziten (nilotinib)
- Newly diagnosed Ph+ CML: The typical dose is 142 mg by mouth twice a day, about 12 hours apart.
- Ph+ CML after previous treatment: The typical dose is 190 mg by mouth twice a day, about 12 hours apart.
How much does Danziten (nilotinib) cost?
$17,310.25
Danziten (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 Danziten (nilotinib) will not be safe for you to take.
- Low potassium levels
- Low magnesium levels
- Long QT syndrome (heart rhythm problem)
What are alternatives to Danziten (nilotinib)?
Certain blood cancers
Certain skin cancer
Certain tumors in the digestive tract
Danziten (nilotinib) images
