Tasigna nilotinib 200 mg Capsule, 28-count

1 INDICATIONS AND USAGE Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.

( 1.3 )

1.1Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

1.2Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib.

1.3Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

2 DOSAGE AND ADMINISTRATION Recommended Adult Dose: Newly diagnosed Ph+ CML-CP: 300 mg orally twice daily. Resistant or intolerant Ph+ CML-CP and CML-AP: 400 mg orally twice daily. ( 2.1 ) Recommended Pediatric Dose: Newly Diagnosed Ph+ CML-CP or Ph+ CML-CP and CML-AP resistant or intolerant to prior TKI therapy: 230 mg/m 2 orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).

( 2.1 ) See Dosage and Administration for full dosing instructions and dose-reduction instructions for toxicity. ( 2.1 ) Reduce starting dose in patients with baseline hepatic impairment. ( 2.7 ) Eligible newly diagnosed adult patients with Ph+ CML-CP who have received Tasigna for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received Tasigna for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.

( 2.2 , 2.3 , 5.16 )

2.1Recommended Dosage Dose Tasigna twice daily at approximately 12-hour intervals on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Advise patients to swallow the capsules whole with water [see Boxed Warning, Clinical Pharmacology (12.3)].

For patients who are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (puréed apple). The mixture should be taken immediately (within 15 minutes) and should not be stored for future use [see Clinical Pharmacology (12.3)] . Tasigna may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated.

Tasigna may be given with hydroxyurea or anagrelide if clinically indicated. Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP The recommended dosage of Tasigna is 300 mg orally twice daily. Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP The recommended dosage of Tasigna is 400 mg orally twice daily.

Dosage in Pediatric Patients with Newly Diagnosed Ph+ CML-CP or Resistant or Intolerant Ph+ CML-CP and CML-AP The recommended dosage of Tasigna for pediatric patients is 230 mg/m 2 orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1). If needed, attain the desired dose by combining different strengths of Tasigna capsules. Continue treatment as long as clinical benefit is observed or until unacceptable toxicity occurs.

Table 1: Pediatric Dosing of Tasigna (230 mg/m 2 Twice Daily, Maximum Single Dose of 400 mg) Body surface area Single dose Total daily dose Up to 0.32 m 2 50 mg 100 mg 0.33 – 0.54 m 2 100 mg 200 mg 0.55 – 0.76 m 2 150 mg 300 mg 0.77 – 0.97 m 2 200 mg 400 mg 0.98 – 1.19 m 2 250 mg 500 mg 1.20 – 1.41 m 2 300 mg 600 mg 1.42 – 1.63 m 2 350 mg 700 mg ≥ 1.64 m 2 400 mg 800 mg

2.2Discontinuation of Treatment After a Sustained Molecular Response (MR4.5) on Tasigna Patient Selection Eligibility for Discontinuation of Treatment Ph+ CML-CP patients with typical BCR-ABL transcripts, who have been taking Tasigna for a minimum of 3 years and have achieved a sustained molecular response (MR4.5, corresponding to = BCR-ABL/ABL ≤ 0.0032% IS), may be eligible for treatment discontinuation [see Clinical Studies (14.3, 14.4)] . Information on FDA authorized tests for the detection and quantitation of BCR-ABL transcripts to determine eligibility for treatment discontinuation is available at http://www.fda.gov/CompanionDiagnostics .

Patients with typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2), who achieve the sustained MR4.5 criteria, are eligible for discontinuation of Tasigna. Patients must continue to be monitored for possible loss of molecular remission after treatment discontinuation. Use the same FDA-authorized test to consistently monitor molecular response levels while on and off treatment.

Consider discontinuation…

3 DOSAGE FORMS AND STRENGTHS Capsules: 50 mg red opaque cap and light-yellow opaque body hard gelatin capsules with black radial imprint “NVR/ABL.” 150 mg red opaque hard gelatin capsules with black axial imprint “NVR/BCR.” 200 mg light-yellow opaque hard gelatin capsules with a red axial imprint “NVR/TKI.” Capsules: 50 mg, 150 mg, and 200 mg ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). A Medication Guide is required for distribution with Tasigna. The complete text of the Medication Guide is reprinted at the end of this document.

Myelosuppression Advise patients that treatment with Tasigna can cause serious thrombocytopenia, neutropenia, and anemia. Advise patients to seek immediate medical attention if symptoms suggestive of low blood counts occur, such as fever, chills or other signs of infection, unexplained bleeding or bruising, or unexplained weakness or shortness of breath [see Warnings and Precautions (5. 1 )] .

QT Prolongation Advise patients that Tasigna can cause possibly life-threatening, abnormal heart beat. Advise patients to seek immediate medical attention if symptoms of abnormal heart beat occur, such as feeling light-headed, faint or experiencing an irregular heartbeat [see Warnings and Precautions (5. 2 )] .

Cardiac and Arterial Vascular Occlusive Events Advise patients that cardiovascular events (including ischemic heart disease, peripheral arterial occlusive disease, and ischemic cerebrovascular events) have been reported. Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular event occur, such as chest or leg pain, numbness or weakness, or problems walking or speaking occur suddenly [see Warnings and Precautions (5.4)] . Pancreatitis and Elevated Serum Lipase Advise patients that Tasigna can increase the risk of pancreatitis and that patients with a previous history of pancreatitis may be at greater risk.

Advise patients to seek immediate medical attention if symptoms suggestive of pancreatitis occur, such as sudden stomach area pain with accompanying nausea and vomiting [see Warnings and Precautions (5. 5 ) ] . Hepatotoxicity Advise patients that Tasigna can increase the risk of hepatotoxicity and that patients with previous history of liver diseases may be at risk.

Advise patients to seek immediate medical attention if any symptoms suggestive of hepatotoxicity occur, such as stomach pain, yellow skin and eyes, and dark-colored urine [see Warnings and Precautions (5.6)] . Tumor Lysis Syndrome Advise patients that Tasigna can cause TLS and to seek immediate medical attention if any symptoms suggestive of TLS occur, such as an abnormal heartbeat or less urine production [see Warnings and Precautions (5.8)] . Hemorrhage Advise patients that serious hemorrhagic events, including fatal events, have occurred in patients with CML treated with Tasigna.

Advise patients to seek immediate medical attention if symptoms suggestive of hemorrhage occur, such as uncontrolled bleeding, changes in eyesight, unconsciousness, or sudden headache or sudden confusion in surroundings [see Warnings and Precautions (5. 9 ) ] . Fluid Retention Advise patients that Tasigna can cause fluid retention and to seek immediate medical attention if any symptoms suggestive of fluid retention, such as shortness of breath, rapid weight gain, or swelling occur [see Warnings and Precautions (5.

13 ) ] . Effects on Growth and Development in Pediatric Patients Inform pediatric patients and their caregivers of the possibility of developing growth abnormalities. Growth retardation has been reported in pediatric patients treated with Tasigna.

Therefore, monitor growth and development in pediatric patients [see Warnings and Precautions (5.14)] . Treatment-Free Remission (TFR) Advise patients that frequent monitoring is required to detect possible loss of remission if TFR is attempted. Advise patients that musculoskeletal symptoms, such as muscle pain, pain in extremity, joint pain, bone pain, or spinal pain, may occur more frequently than before treatment discontinuation [see Warnings and Precautions (5.16)] .

Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or s…

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2025 Medication Guide TASIGNA ® (ta-sig-na) (nilotinib) capsules What is the most important information I should know about Tasigna?

Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG): • before starting Tasigna • 7 days after starting Tasigna • with any dose changes • regularly during Tasigna treatment You may lower your chances for having QTc prolongation with Tasigna if you: Take Tasigna on an empty stomach: Avoid eating food for at least 2 hours before the dose is taken, and Avoid eating food for at least 1 hour after the dose is taken.

Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract during treatment with Tasigna. Food and grapefruit products increase the amount of Tasigna in your body. Avoid taking other medicines or supplements with Tasigna that can also cause QTc prolongation.

Tasigna 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 Tasigna unless your healthcare provider tells you it is okay to do so. If you cannot swallow Tasigna capsules whole, you may open the Tasigna capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple).

Swallow the mixture right away (within 15 minutes). For more information, see “How should I take Tasigna?” Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with Tasigna. These can be symptoms of QTc prolongation.

What is Tasigna? Tasigna is a prescription medicine used to treat: adults and children 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. children with chronic phase Ph+ CML or accelerated phase Ph+ CML who: are no longer benefiting from treatment with a tyrosine-kinase inhibitor medicine, or have taken a tyrosine-kinase inhibitor medicine and cannot tolerate it.

It is not known if Tasigna is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase. The long-term effects of treating children with Tasigna for a long period of time are not known. Who should not take Tasigna?

Do not take if you have: low levels of potassium or magnesium in your blood long QTc syndrome Before taking Tasigna, tell your healthcare provider about all of your medical conditions, including if you: have heart problems have had a stroke or other problems due to decreased blood flow to the brain have problems with decreased blood flow to your legs 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 a severe problem with lactose (milk sugar) or other sugars.

Tasigna capsules contain lactose. Most people who have mild or moderate lactose intolerance can take Tasigna. have bleeding problems had a surgical procedure involving the removal of the entire stomach (total gastrectomy) are pregnant or plan to become pregnant. Tasigna can harm your unborn baby.

Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with Tasigna. In females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with…