Danziten (Oral)
Nilotinib is used in adults and children at least 1 year old to treat a type of blood cancer called Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
Nilotinib is given after other treatments did not work or stopped working.
Nilotinib tablet is only used in adults.
Nilotinib may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Danziten (Oral)?
You should not use nilotinib if you are allergic to it, or if you have:
- low blood levels of potassium or magnesium; or
- a heart rhythm disorder called long QT syndrome.
Tell your doctor if you have or have ever had:
- heart problems such as irregular heartbeats, or long QT syndrome (in you or a family member);
- a stroke;
- blood circulation problems in your legs;
- bleeding problems;
- an electrolyte imbalance (such as low blood levels of potassium or magnesium);
- severe problems with lactose (milk sugar);
- pancreatitis;
- surgical removal of your stomach (total gastrectomy); or
- liver disease.
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while taking nilotinib and for at least 14 days after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while taking this medicine, and for at least 14 days after your last dose.
Side Effects
What are the side effects of Danziten (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
You may feel faint while taking nilotinib. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.
Call your doctor at once if you have:
- fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
- bleeding symptoms--nosebleeds or any bleeding that will not stop, weakness, dizziness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, jaundice (yellowing of the skin or eyes);
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, pale skin, cold hands and feet, feeling light-headed;
- signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle weakness, leg cramps, feeling jittery, fluttering in your chest;
- signs of decreased blood flow--leg pain or cold feeling, chest pain, numbness, trouble walking, skin discoloration in your legs; or
- signs of tumor cell breakdown--muscle cramps, diarrhea, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Nilotinib can affect growth in children. Tell your doctor if your child is not growing at a normal rate while taking this medicine.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- fever, nausea, vomiting, diarrhea, constipation;
- rash, itching;
- night sweats;
- low blood cell counts;
- pain in your bones, spine, joints, or muscles;
- headache, feeling tired; or
- runny or stuffy nose, sneezing, cough, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Danziten (Oral) if I’m pregnant or breastfeeding?
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while taking nilotinib and for at least 14 days after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while taking this medicine, and for at least 14 days after your last dose.
Interactions
What drugs and food should I avoid while taking Danziten (Oral)?
Grapefruit may interact with nilotinib and cause side effects. Avoid consuming grapefruit products.
Avoid taking a stomach acid reducer (such as Pepcid, Tagamet, or Zantac) within 10 hours before or 2 hours after you take nilotinib.
Avoid taking an antacid that contains aluminum, magnesium, or simethicone (such as Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, or Rolaids) within 2 hours before or 2 hours after you take nilotinib.
Dosage Guidelines & Tips
How to take Danziten (Oral)?
Use Danziten (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.
Doses are based on body surface area (height and weight) in children. Your child's dose may change if the child gains or loses weight or is still growing.
Nilotinib is usually taken twice per day (about 12 hours apart). Follow your doctor's instructions.
Nilotinib tablets are taken with or without food. Nilotinib capsules should be taken on an empty stomach, at least 2 hours before or 1 hour after a meal.
Swallow the capsule or tablet whole with a full glass of water and do not crush, chew, break, or open it.
Read and carefully follow the instructions provided with this medicine on how to prepare and take nilotinib if you cannot swallow a capsule or tablet whole. Ask your doctor or pharmacist if you don't understand these instructions.
Do not change your dose or stop using a medicine without your doctor's advice.
Nilotinib can cause a serious heart problem. Your heart function may be checked with an electrocardiogram or ECG (sometimes called an EKG) before and during your treatment with nilotinib.
You may need frequent medical tests before and during your treatment with this medicine. Your cancer treatments may change, be delayed, or discontinued based on the results.
Your doctor will need to check your progress on a regular basis.
Store at room temperature away from moisture and heat.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.