Danziten®: Nilotinib Re-engineered To Free You From Mealtime Restrictionsa


aPatients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during Danziten® treatment.

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What is Danziten®?


Danziten® is a prescription medicine used to treat the following:



Adults with a certain type of leukemia called Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are newly diagnosed



Adults with CP-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


Danziten® is a re-engineered form of nilotinib. Danziten® has the same effectiveness as Tasigna® (nilotinib) capsules, but without the mealtime restrictions required when taking Tasigna®.


Danziten® is a type of medicine called a tyrosine kinase inhibitor (TKI). TKIs are “targeted therapies” which mean they identify and attack specific types of cancer cells while causing less damage to normal cells compared with traditional chemotherapy treatments. In CML, TKIs work by targeting the abnormal BCR::ABL1 protein that causes uncontrolled CML cell growth, causing CML cells to die.

Danziten® may help you achieve your treatment goals


Nilotinib's effectiveness was studied in several clinical trials. In one trial, nilotinib was compared with another TKI, imatinib, in patients with CML.

Reach important treatment
milestones with nilotinib

3-month Milestone:

Early Molecular Response (EMR)

Nilotinib

Imatinib

91%

234 out of 258 patients

vs

67%

176 out of 264 patients

91% of patients on nilotinib 300 mg twice dailya achieved EMR at 3 months vs 67% of patients taking imatinib 400 mg once daily

12-month Milestone:

Complete Cytogenic Response (CCyR)

Nilotinib

Imatinib

80%

226 out of 282 patients

vs

65%

184 out of 283 patients

80% of patients on nilotinib 300 mg twice dailya achieved CCyR at 12 months vs 65% of patients taking imatinib 400 mg once daily

24-month Treatment Response Achievement:

Major Molecular Response (MMR)

Nilotinib

Imatinib

62%

175 out of 282 patients

vs

38%

108 out of 283 patients

62% of patients on nilotinib 300 mg twice dailya achieved MMR at 12 months vs 38% of patients taking imatinib 400 mg once daily

aThe effectiveness of 142 mg twice daily of Danziten® tablets for the treatment of adult patients with newly diagnosed Ph+ CML-CP has been established from an adequate and well-controlled study of Tasigna® capsules, which has a different recommended dosage than Danziten®.

Achieving milestones and MMR may help patients on the path to treatment-free remission (TFR)


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.