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Nilotinib (Tasigna) 200 mg capsules
28, 56 pills
Nilotinib brand, Tasigna generic
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(trade names include Tasigna, Tasinga, Nilotib
) is an anti cancer medication from protein kinase inhibitors pharmacological group. This medicine is used for the treatment of Philadelphia chromosome (Ph+)-positive chronic myelogenous leukaemia. It is also in research phases for the therapy of Parkinson's disease, Alzheimer's disease, Amyotrophic lateral sclerosis, dementia, Huntington's disease, gastrointestinal stromal tumor. It works by inhibiting various enzymes called kinases.
Abemaciclib (Verzenio, Verzenios)
Nintedanib (Ofev, Vargatef)
Pharmacological and medical categories:
Anti cancer drugs
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XE - Protein kinase inhibitors
L01XE08 - Nilotinib
Malignant neoplasm of other connective and soft tissue - C49
Gastrointestinal stromal tumor, unspecified site - C49.A0
Myeloid leukemia - C92
Mental disorders due to known physiological conditions - F01-F09
Huntington's disease - G10
Spinal muscular atrophy and related syndromes - G12
Amyotrophic lateral sclerosis - G12.21
Parkinson's disease - G20
Alzheimer's disease - G30
Indications and usage:
Tasigna (Nilotinib) is a kinase inhibitor indicated forthe treatment of:
Adult and pediatric patientsgreater than or equal to 1 year of agewith newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
Pediatric patients greater than or equal to 1 year of agewith Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
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 orallytwice daily.
Recommended Pediatric Dose: Newly Diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI therapy: 230 mg/m2orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).
See Dosage and Administration for full dosing instructions and dose-reduction instructions for toxicity.
Reduce starting dose in patients with baseline hepatic impairment.
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.
Overdose with nilotinib has been reported, where an unspecified number of Tasigna capsules were ingested in combination with alcohol and other drugs. Events included neutropenia, vomiting, and drowsiness. In the event of overdose, the patient should be observed and appropriate supportive treatment given.
Dosage forms and strengths:
Tasigna (Nilotinib) capsules: 50 mg, 150 mg, and 200 mg
Nilotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.
Warnings and precautions:
Myelosuppression: Monitor complete blood count (CBC) during therapy and manage by treatment interruption or dose-reduction.
Cardiac and Arterial Vascular Occlusive Events: Evaluate cardiovascular status, monitor and manage cardiovascular risk factors during Tasigna therapy.
Pancreatitis and Elevated Serum Lipase: Monitor serum lipase; if elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis.
Hepatotoxicity: Monitor hepatic function tests monthly or as clinically indicated.
Electrolyte Abnormalities: Tasigna can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating Nilotinib and monitor periodically during therapy.
Tumor Lysis Syndrome: Maintain adequate hydration and correct uric acid levels prior to initiating therapy with Tasigna.
Hemorrhage: Hemorrhage from any site may occur. Advise patients to report signs and symptoms of bleeding and medically manage as needed.
Fluid Retention: Monitor patients for unexpected rapid weight gain, swelling, and shortness of breath. Manage medically.
Effects on Growth and Development in Pediatric Patients: Growth retardation hasbeen reported in pediatric patients treated with Tasigna. Monitor growth and development in pediatric patients.
Embryo-Fetal Toxicity: Advise patients of potential risk to a fetus and to use effective contraception.
Treatment Discontinuation: Patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detection limit below MR4.5 must be used to determine eligibility for discontinuation. Patients must be frequently monitored by the FDA authorized testto detect possible loss of remission.
Adverse reactions, side effects:
The most commonly reported non-hematologic adverse reactions ( >= 20%) in adult and pediatric patients were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats. Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia, and anemia.
Strong CYP3A Inhibitors: Avoid concomitant use with Tasigna, or reduce Tasigna dose if co-administration cannot be avoided.
Strong CYP3A Inducers: Avoid concomitant use with Tasigna.
Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors.
Use in specific populations:
Sexually active female patients should use effective contraception during treatment.
Should not breast-feed.
No data to support use in pediatrics.
A lower starting dose of nilotinib is recommended in patients with hepatic impairment.
D - Australia
D - United States (Positive evidence of risk)
Salts and other forms:
Nilotinib Hydrochloride Dihydrate
Nilotinib Hydrochloride Monohydrate
Synonyms, international and chemical names:
Brands, generics, trade names:
Tasigna - Novartis
Tasinga - Novartis
Nilotib - Caprane Pharmaceutical
Nilotinib - Actiza Pharmaceutical
Nilotinib main article on Wikipedia: https://en.wikipedia.org/wiki/Nilotinib
Nilotinib compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Nilotinib
Nilotinib Hydrochloride compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Nilotinib-hydrochloride
Nilotinib Hydrochloride Monohydrate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/16757572
Nilotinib Hydrochloride Dihydrate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Nilotinib-hydrochloride-dihydrate
Nilotinib on DrugBank: https://www.drugbank.ca/drugs/DB04868
Nilotinib Hydrochloride Monohydrate on DrugBank: https://www.drugbank.ca/salts/DBSALT001325
Nilotinib FAQ on MedlinePlus (revised 04/15/2018): https://medlineplus.gov/druginfo/meds/a608002.html
Tasigna (Nilotinib) capsules drug label info on DailyMed (revised December 8, 2020): https://dailymed.nlm.nih.gov/dailymed/lookup...
Nilotinib for sale on Pharma Doctor: https://pharma-doctor.com/nilotinib.html
Tasigna (Nilotinib) 150 mg, 200 mg capsules official website for U.S. residents only: https://www.us.tasigna.com/
Tasigna (Nilotinib) official website for non-U.S. residents: http://www.tasigna.com/
Tasigna (Nilotinib) capsules official prescribing information and medication guide from the U.S. FDA (revised 06/2010): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Tasigna (Nilotinib) capsules product monograph on Novartis pharmaceutical company website (revised 12/2020): https://www.novartis.us/sites/www.novartis.us/files/tasigna...
Tasigna (Nilotinib) 150 mg hard capsules patient information leaflet on Medicines.org.uk (revised November 2020): https://www.medicines.org.uk/emc/files/pil.5852.pdf
Tasigna (Nilotinib) 200 mg hard capsules patient information leaflet on Medicines.org.uk (revised November 2020): https://www.medicines.org.uk/emc/files/pil.6251.pdf
Revised: June 2021