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Nilotinib (Tasigna™)

Last Updated: 09/27/18

Ended: Trial Resulted in Death

Chemical Structure, Nilotinib

Trade Name: Tasigna™
Synonym: AMN107
Legal Status: ℞ - Prescription Only
Administered By: Pill - Oral
Tumor Target: Intracranial Schwannoma
Protein Target: TKI Inhibitors
Formula: C28H22F3N7O
IUPAC 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)- 5-(trifluoromethyl)
phenyl]-3- [(4-pyridin-3-ylpyrimidin-2-yl) amino]benzamide
NF2 Trials: Terminated: NCT01201538
ChemSpider 559260
PubChem CID 644241

Special Precautions

  • Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.
  • Tell your doctor and pharmacist if you are allergic to nilotinib or any other medications.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section.
  • Tell your doctor what herbal products you are taking, especially St. John's wort.
  • Tell your doctor if you have or have ever had any heart problems, pancreatitis (swelling of the pancreas, a gland behind the stomach that produces substances to help with digestion), or any condition that makes it difficult for you to digest lactose (milk sugar) or other sugars.
  • Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking nilotinib.
  • Tell your doctor if you are breast-feeding. You should not breast-feed while you are taking nilotinib.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nilotinib


  • A Study of Nilotinib in Growing Vestibular Schwannomas - www.ClinicalTrials.gov
  • Trial of Tasigna (Nilotinib) 400 mg Twice Daily Alone or With Gleevec (Imatinib Mesylate) 400 mg Daily for Patients With Advanced Gastrointestinal Stromal Tumor (GIST) - www.ClinicalTrials.gov
  • Imatinib Mesylate (Glivec) as Maintenance Therapy After Cytogenetic Response With Nilotinib (AMN107, Tasigna) First Line in Newly Diagnosed Chronic Myelogenous Leukemia - www.ClinicalTrials.gov
  • Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia - www.ClinicalTrials.gov
  • An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment - www.ClinicalTrials.gov

Side Effects


  • Back, Bone, Joint, Limb, Or Muscle Pain
  • Constipation
  • Diarrhea
  • Difficulty Falling Asleep Or Staying Asleep
  • Dizziness
  • Dry Or Reddened Skin
  • Gas
  • Hair Loss
  • Headache
  • Heartburn
  • Itching
  • Loss Of Appetite
  • Muscle Cramps
  • Nausea
  • Night Sweats
  • Numbness, Burning, Or Tingling In The Hands Or Feet
  • Rash
  • Tiredness
  • Vomiting

Serious - Contact doctor if you experience any of the following:

Major side effects are uncommon. Since people with NF2 are taking these medications at a low dose, only minimal side effects are common. However, long term use is primarily where these major side effects take place. Monthly Blood and Urine Tests can usually point to an issue before it's a real problem. Talk to your doctor.

  • Unexplained Bleeding Or Bruising
  • Blood In Urine Or Stool
  • Unexplained Weakness
  • Fever, Sore Throat, Chills, Or Other Signs Of Infection
  • Shortness Of Breath
  • Swelling Of Hands, Ankles, Feet, Or Face
  • Sudden Stomach Area Pain
  • Yellowing Of The Skin And Eyes
  • The Drug Carries A Black Box Warning For Possible Heart Complications

Other Known Uses

  • TASIGNA is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults who:
    • Are newly diagnosed with Ph+ CML in chronic phase (CP). The study is ongoing and further data will be required to determine long-term outcomes
    • Are in chronic phase (CP) or accelerated phase (AP) Ph+ CML and are resistant or intolerant to prior therapy that included imatinib
  • It is not known if TASIGNA is safe or effective in children.
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