Taking Danziten®

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How should I take Danziten®?


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Take as prescribed by your healthcare provider

Twice daily, ~12 hours apart

With or without food

What you need to know when taking Danziten®

DO

  • Take Danziten® exactly as prescribed

  • Take Danziten® doses twice daily ~12 hours apart

  • Swallow tablets whole with water

  • Take with or without food

  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements

DON'T

  • Do not change your dose or stop taking Danziten® unless your doctor tells you

  • Do not switch from Danziten® to other medicines that contain nilotinib without talking to your doctor. The amount of nilotinib in a dose of Danziten® may not be the same as the amount in other medicines that contain nilotinib

  • Do not cut, crush, or chew the tablets. If you cannot swallow Danziten® whole, tell your doctor

  • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment

  • Do not take medications that are strong CYP3A inhibitors or strong CYP3A inducers when taking Danziten®

  • Avoid taking medicines or supplements with nilotinib that can cause QTc prolongation

  • Nilotinib can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. Do not take any other medicine during treatment with Danziten® unless your healthcare provider tells you it is okay to do so

  • Do not take 2 doses at the same time to make up for a missed dose. If you miss a dose, just take your next dose at your regular time

If you take too much Danziten®, call your doctor or go to the nearest hospital emergency room right away. Symptoms may include vomiting and drowsiness.

Danziten® is a long-term treatment. You should continue taking Danziten® every day for as long as your doctor tells you. Do not change dose or stop taking Danziten® without first consulting your doctor.

What can I expect when taking Danziten®?

During treatment with Danziten® your doctor will do tests to check for side effects and to see how well Danziten® is working for you

  • Some of these tests are used to check your blood cell counts, electrical activity of your heart, electrolytes, liver and pancreas functions, and occasionally, to check the cells in the bone marrow

  • Based on these test results, your doctor may change your dose or may have you stop Danziten® for some time or lower your dose if you have side effects

Your doctor will also monitor your CML during treatment with Danziten® to see if you are in remission

  • After at least 3 years of treatment with Danziten®, your doctor may do certain tests to determine if you continue to be in remission. Based on your test results, your doctor may decide if you may be eligible to try stopping treatment with Danziten®. This is called treatment-free remission (TFR)

  • Your doctor will carefully monitor your CML during and after you stop taking Danziten®. Based on your test results, your doctor may need to restart your Danziten® treatment if your CML is no longer in remission

What important information should I know about taking Danziten®?

Danziten® can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.

Your doctor should check the electrical activity of your heart with a test called an electrocardiogram (ECG):

  • Before starting Danziten®

  • 7 days after starting Danziten®

  • With any dose changes

  • Regularly during Danziten® treatment

Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with Danziten®. These can be symptoms of QTc prolongation.

IMPORTANT SAFETY INFORMATION

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Danziten® (nilotinib) tablets, for oral use

DANZITEN is a prescription medicine used to treat:

  • adults who have been newly diagnosed with a certain type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
  • adults with chronic phase Ph+ CML or accelerated phase Ph+ CML who:
    • are no longer benefiting from other treatments, including imatinib (Gleevec), or
    • have taken other treatments, including imatinib (Gleevec), and cannot tolerate them.

WARNING: QT PROLONGATION and SUDDEN DEATHS

See Full Prescribing Information for complete Boxed Warning.

  • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. (5.3) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. (5.3, 5.4, 5.8, 5.12)
  • Sudden deaths have been reported in patients receiving nilotinib. (5.4) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome. (4, 5.3)
  • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. (7.1, 7.2)

ADDITIONAL IMPORTANT SAFETY INFORMATION

Do not take DANZITEN if you have:
  • low levels of potassium or magnesium in your blood
  • long QTc syndrome
What are the possible side effects of DANZITEN?

DANZITEN can cause serious side effects, including:

Low blood cell counts: Low blood cell counts (red blood cells, white blood cells, and platelets) are common with DANZITEN, but can also be severe. Your healthcare provider will check your blood counts regularly during treatment with DANZITEN. Call your healthcare provider or get medical help right away if you develop any signs or symptoms of low blood counts, including fever, unexplained bleeding or bruising, shortness of breath, chills or other signs of infection, and unexplained weakness.

Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take DANZITEN may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms, including chest pain or discomfort, problems walking or speaking, your leg feels cold, numbness or weakness, leg pain, and change in the skin color of your leg.

Pancreas inflammation (pancreatitis): Tell your healthcare provider right away if you develop any symptoms of pancreatitis, including sudden stomach area pain with nausea and vomiting.

Liver problems: DANZITEN can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with DANZITEN. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including stomach area (abdominal pain), yellow skin and eyes, and dark-colored urine.

Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. Your healthcare provider may do blood tests to check you for TLS. TLS can cause you to have kidney failure and the need for dialysis treatment or an abnormal heartbeat.

Bleeding problems: Serious bleeding problems and death have happened during treatment with DANZITEN. Tell your healthcare provider right away if you develop any signs and symptoms of bleeding during treatment with DANZITEN.

Fluid retention: Your body may hold too much fluid (fluid retention): Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.

Abnormal growth or development in children: Effects on growth and development have happened in children with chronic phase Ph+ CML during treatment with nilotinib. Some children and adolescents may have slower than normal growth during treatment with nilotinib.

The most common side effects of DANZITEN include:
  • nausea
  • rash
  • headache
  • tiredness
  • vomiting
  • diarrhea
  • cough
  • constipation
  • muscle and joint pain
  • runny or stuffy nose, sneezing, sore throat
  • night sweats
Side effects in adults attempting treatment free remission:
If you and your healthcare provider decide that you can stop taking DANZITEN and try treatment free remission (TFR), you may have more muscle and bone (musculoskeletal) symptoms than before you stopped treatment. Symptoms may include:
  • muscle pain
  • arm and leg pain
  • joint pain
  • bone pain
  • spine pain

These are not all the possible side effects of DANZITEN. Please see Full Prescribing Information for a full list.

Before taking DANZITEN, tell your doctor about all your medical conditions, including:
  • have heart problems
  • have had a stroke or other problems due to decreased blood flow to the brain
  • have irregular heartbeat
  • have QTc prolongation or a family history of it
  • have liver problems
  • have had pancreatitis
  • have low blood levels of potassium or magnesium in your blood
  • have bleeding problems
  • had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
  • are pregnant or plan to become pregnant. Nilotinib can harm your unborn baby. Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with DANZITEN.
In females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with DANZITEN.
  • Use effective birth control (contraception) during treatment with DANZITEN and for 14 days after the last dose
  • are breastfeeding or plan to breastfeed. It is not known if Nilotinib passes into your breast milk. Do not breastfeed during treatment and for 14 days after your last dose of DANZITEN.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take DANZITEN. If you take:
  • a medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take DANZITEN, or about 2 hours after you take DANZITEN.
  • an antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take DANZITEN.
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine.

The Important Safety Information does not include all the information needed to use DANZITEN safely and effectively. Please see Full Prescribing Information for DANZITEN.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.