Nilotinib (Tasigna)

Trade Name : Tasigna

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 200 mg/1

NILOTINIB Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nilotinib (Tasigna) which is also known as Tasigna and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 200 mg/1 per ml. Read more

Nilotinib (Tasigna) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • WARNING: QT PROLONGATION and SUDDEN DEATHS
  • See full prescribing information for complete boxed warning.
  • Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. (n n- ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. (n- Arrayn- , n- Arrayn- , n- Arrayn- , n- Array
  • Sudden deaths have been reported in patients receiving Tasigna. (n- Arrayn- Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome. (n- Arrayn- , n- Array
  • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. (, n
  • Avoid food 2 hours before and 1 hour after taking the dose. ()
  • 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. ()
  • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ()nttttttttt
  • Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ()nttttttttt
  • No data
  • 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. ()n
  • Recommended Pediatric Dose: Newly Diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI therapy: 230 mg/m orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg). ()n
  • See Dosage and Administration for full dosing instructions and dose-reduction instructions for toxicity. ()
  • Reduce starting dose in patients with baseline hepatic impairment. ()n
  • 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. (, , )n
  • 50 mg red opaque cap and light-yellow opaque body hard gelatin capsules with black radial imprint u201cNVR/ABL.u201d
  • 150 mg red opaque hard gelatin capsules with black axial imprint u201cNVR/BCR.u201d
  • 200 mg light-yellow opaque hard gelatin capsules with a red axial imprint u201cNVR/TKI.u201d
  • Capsules: 50 mg, 150 mg, and 200 mg ()
  • Tasigna is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndromen
  • Tasigna is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ()
  • No data
  • Myelosuppression:
  • Cardiac and Arterial Vascular Occlusive Events:
  • Pancreatitis and Elevated Serum Lipase:
  • Hepatotoxicity:
  • Electrolyte Abnormalities:
  • Tumor Lysis Syndrome:
  • Hemorrhage:
  • Fluid Retention:
  • Effects on Growth and Development in Pediatric Patients:
  • Embryo-Fetal Toxicity:
  • Treatment Discontinuation:
  • The following clinically significant adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of labeling:
  • The most commonly reported non-hematologic adverse reactions (u2265 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. ()
  • No data
  • Strong CYP3A Inhibitors:
  • Strong CYP3A Inducers:
  • Proton Pump Inhibitors:
  • nttu00a0u00a0u00a0u00a0u00a0ntttttttt
  • Lactation: Advise women not to breastfeed.u00a0()
  • 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, observe the patient and provide appropriate supportive treatment.
  • Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors.
  • Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of CHFNOu2022HCl u2022 HO and 584 (corresponding molecular formula and weight of nilotinib base, anhydrous are CHFNO and 529 respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK1 was determined to be 2.1; pK2 was estimated to be 5.4.
  • The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below:
  • Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.
  • No data
  • A 2-year carcinogenicity study was conducted orally in rats at nilotinib doses of 5, 15, and 40 mg/kg/day. Exposures in animals at the highest dose tested were approximately 2- to 3-fold the human exposure (based on AUC) at the nilotinib dose of 400 mg twiceu00a0daily. The study was negative for carcinogenic findings.u00a0A 26-week carcinogenicity study was conducted orally in Tg.rasH2 mice, a model genetically modified to enhance susceptibility to neoplastic transformation,u00a0at nilotinib doses of 30, 100, and 300u00a0mg/kg/day. Nilotinib induced in the skin and subcutis statistically significant increases in the incidence of papillomas in females and of papillomas and combined papillomas and carcinomas in males at 300 mg/kg/day.u00a0The no-observed-adverse-effect-level (NOAEL) for skin neoplastic lesions was 100u00a0mg/kg/day.u00a0
  • Nilotinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, did not induce DNA damage (comet assay) in L5178Y mouse lymphoma cells, nor was it clastogenic in an in vivo rat bone marrow micronucleus assay with two oral treatments at doses up to 2000 mg/kg/dose.
  • There were no effects on male or female rat and female rabbit mating or fertility at doses up to 180 mg/kg in rats (approximately 4- to 7-fold for males and females, respectively, the AUC in patients at the dose of 400 mg twiceu00a0daily) or 300 mg/kg in rabbits (approximately one-half the AUC in patients at the dose of 400 mg twiceu00a0daily)The effect of Tasigna on human fertility is unknown. In a study where male and female rats were treated with nilotinib at oral doses of 20 to 180 mg/kg/day (approximately 1- to 6.6-fold the AUC in patients at the dose of 400 mg twiceu00a0daily) during the pre-mating and mating periods and then mated, and dosing of pregnant rats continued through gestation Day 6, nilotinib increased post-implantation loss and early resorption, and decreased the number of viable fetuses and litter size at all doses tested.
  • No data
  • Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint u201cNVR/ABL.u201d Tasigna (nilotinib) 150 mg capsules are red opaque hard gelatin capsules, size 1 with black axial imprint u201cNVR/BCR.u201d Tasigna (nilotinib) 200 mg capsules are light yellow opaque hard gelatin capsules, size 0 with the red axial imprint u201cNVR/TKI.u201d Tasigna 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.
  • 50 mg
  • Bottle of 120 capsulesu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0951-66
  • 150 mg
  • Carton of 4 blister packs of (4x28)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0592-87
  • Blisters of 28 capsulesu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0592-51
  • 200 mg
  • Carton of 4 blister packs of (4x28)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0526-87
  • Blisters of 28 capsulesu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0526-51
  • Tasigna (nilotinib) capsules should be stored at 25u00b0C (77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • 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 attentionu00a0if symptoms suggestive ofu00a0low blood countsu00a0occur, such as fever, chills or other signs of infection, unexplained bleeding or bruising, or unexplained weakness or shortness of breathu00a0n n .
  • QT Prolongation
  • Advise patients that Tasigna can cause possibly life-threatening, abnormal heart beat. Advise patients tou00a0seek immediate medical attention if symptoms of abnormal heart beat occur, such as feelingu00a0light-headed, faint or experiencing an irregular heartbeatu00a0n n .
  • Cardiac and n- Arterial n- Vascular n- Occlusive n- 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 ifu00a0any symptoms suggestive of a cardiovascular eventu00a0occur, such as chest or leg pain, numbness or weakness, or problems walking or speaking occur suddenly .
  • Pancreatitis and Elevated Serum Lipase
  • Advise patients that Tasigna can increase the risk of pancreatitis and thatu00a0patients with a previous history of pancreatitis may be at greater risk.u00a0Advise patients to seek immediate medical attentionu00a0if symptoms suggestive of pancreatitis occur, such as sudden stomach area pain with accompanying nausea and vomitingu00a0n n n .
  • 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 .
  • Taking Tasigna
  • Advise patients to take Tasigna doses twiceu00a0daily approximately 12 hours apart. The capsules should be swallowed whole with water.
  • Advise patients to take Tasigna 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. Patients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at anyu00a0time during Tasigna treatmentn n n n n n .
  • If the patient missed a dose of Tasigna, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time.u00a0
  • Should patients be unable to swallow capsules, the contents of each capsule may be dispersed in one teaspoon of applesauce and the mixture swallowed immediately (within 15 minutes).
  • Tumor Lysis Syndrome
  • Advise patients that Tasigna can cause tumor lysis syndrome and to seek immediate medical attentionu00a0if any symptoms suggestive of tumor lysis syndrome occur such as an abnormal heartbeat or less urine production n n n .
  • 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 surroundingsu00a0n n n .
  • Fluid Retention
  • Advise patients that Tasigna can cause fluid retention and to seek immediate medical attentionu00a0ifu00a0any symptoms suggestive of fluid retention such asu00a0shortness of breath, rapid weight gain,u00a0or swelling occur n n n .
  • 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 .
  • Treatment Free Remissionn- (TFR)
  • Advise patients that frequent monitoring is required to detect possible loss of remission if TFR is attempted.u00a0Advise patients that musculoskeletal symptoms such asu00a0muscle pain, pain in extremity, joint pain, bone pain, or spinal pain, may occur more frequently than before treatment discontinuation n n n n
  • Drug Interactions
  • Advise patients that Tasigna and certain other medicines, including over the counter medications or herbal supplements (such as St. Johnu2019s Wort), can interact with each other.
  • Embryo-Fetal Toxicity
  • Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy .
  • Advise females of reproductive potential to use effectiveu00a0contraception during treatment and for at leastu00a014 days after receiving the last dose of Tasigna .ntttttt
  • Lactation
  • Advise lactating women not to breastfeed during treatment with Tasigna and for at least 14 days after the last dose n n
  • Compliance
  • Advise patients of the following:
  • u00a9 Novartisn T2019-108
  • No data
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 50 mg
  • NDC 0078-0951-66
  • 120 Capsules
  • Rx Only
  • TASIGNAu00ae (nilotinib) capsules
  • 50 mg
  • Dispense with Medication Guide
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 150 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0592-87
  • TASIGNAu00ae (nilotinib) capsules
  • Contents: 4 individual blister packs containing 28 capsules each.
  • For oral use.
  • Dosage: See package insert
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F).
  • 1 capsule contains 150 mg nilotinib
  • Keep this and all drugs out of the reach of children.
  • For more information, visit www.US.TASIGNA.com or call 1-866-411-Tasigna
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ATTACHED OR PROVIDED SEPARATELY.
  • Take Tasigna on empty stomach. Avoid food for at least 2 hours before taking a dose of Tasigna and at least 1 hour after the dose is taken.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 200 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0526-87
  • TASIGNAu00ae (nilotinib) capsules
  • Contents: 4 individual blister packs containing 28 capsules each.
  • For oral use.
  • Dosage: See package insert
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F).
  • 1 capsule contains 200 mg nilotinib
  • Keep this and all drugs out of the reach of children.
  • For more information, visit www.US.TASIGNA.com or call 1-866-411-Tasigna
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ATTACHED OR PROVIDED SEPARATELY.
  • Take Tasigna on empty stomach. Avoid food for at least 2 hours before taking a dose of Tasigna and at least 1 hour after the dose is taken.

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