Imatinib Mesylate (Gleevec)

Trade Name : Gleevec

Novartis Pharmaceuticals Corporation

TABLET

Strength 100 mg/1

IMATINIB MESYLATE 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 Imatinib Mesylate (Gleevec) which is also known as Gleevec and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 100 mg/1 per ml. Read more

Imatinib Mesylate (Gleevec) 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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Gleevec is a kinase inhibitor indicated for the treatment of:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase () n
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy ()n
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) ()n
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy ()n
Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test ()n
Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown ()n
Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRu03b1 fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRu03b1 fusion kinase negative or unknown ()n
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) ()u00a0n
Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) ()n
Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST ()

All doses of Gleevec should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered onceu00a0daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Gleevec can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400 mg tablet to reduce exposure to iron.

Adults with Ph+ CML CP ():nttu00a0u00a0u00a0u00a0u00a0nt400 mg/dayn
Adults with Ph+ CML AP or BC ():nttu00a0u00a0u00a0u00a0u00a0nt600 mg/dayn
Pediatrics with Ph+ CML CP ():nttu00a0u00a0u00a0u00a0u00a0nt340 mg/m/day n
Adults with Ph+ ALL ():nttu00a0u00a0u00a0u00a0u00a0nt600 mg/dayn
Pediatrics with Ph+ ALL ():nttu00a0u00a0u00a0u00a0u00a0nt340 mg/m/dayn
Adults with MDS/MPD ():nttu00a0u00a0u00a0u00a0u00a0nt400 mg/dayn
Adults with ASM ():nttu00a0u00a0u00a0u00a0u00a0nt100 mg/day or 400 mg/dayn
Adults with HES/CEL ():nttu00a0u00a0u00a0u00a0u00a0nt100 mg/day or 400 mg/dayn
Adults with DFSP ():nttu00a0u00a0u00a0u00a0u00a0nt800 mg/dayn
Adults with metastatic and/or unresectable GIST ():nttu00a0u00a0u00a0u00a0u00a0nt400 mg/dayn
Adjuvant treatment of adults with GIST ():nttu00a0u00a0u00a0u00a0u00a0nt 400 mg/dayn
Patients with mild to moderate hepatic impairment ():nttu00a0u00a0u00a0u00a0u00a0nt400 mg/dayn
Patients with severe hepatic impairment ():nttu00a0u00a0u00a0u00a0u00a0nt300 mg/day

100 mg film coated tablets
Very dark yellow to brownish orange, film-coated tablets, round, biconvex with bevelled edges, debossed with u201cNVRu201d on one side, and u201cSAu201d with score on the other side
400 mg film coated tablets
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with u201c400u201d on one side with score on the other side, and u201cSLu201d on each side of the score
400 mg film coated tablets
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with u201cgleevecu201d on one side and score on the other side.
Tablets (scored): 100 mg and 400 mg

None.u00a0
None. ()

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Edema and severe fluid retention have occurred. Weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics. (, )n
Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction, dose interruption, or discontinuation of treatment. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter. () n
Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in patients with comorbidities and risk factors. Monitor and treat patients with cardiac disease or risk factors for cardiac failure. (n n
Severe hepatotoxicity including fatalities may occur. Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction. () n
Grade 3/4 hemorrhage has been reported in clinical studies in patients with newly diagnosed CML and with GIST. GI tumor sites may be the source of GI bleeds in GIST. ()n
Gastrointestinal perforations, some fatal, have been reported. ()n
Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Gleevec in patients with conditions associated with high eosinophil levels (e.g., HES, MDS/MPD and ASM). ()n
Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of Gleevec. ()n
Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients. ()n
Fetal harm can occur when administered to a pregnant woman. Apprise women of the potential harm to the fetus, and to avoid pregnancy when taking Gleevec. (, )n
Growth retardation occurring in children and pre-adolescents receiving Gleevec has been reported. Close monitoring of growth in children under Gleevec treatment is recommended. (, )n
Tumor lysis syndrome. Close monitoring is recommended. ()n
Reports of motor vehicle accidents have been received in patients receiving Gleevec. Caution patients about driving a car or operating machinery. ()
Renal toxicity. A decline in renal function may occur in patients receiving Gleevec. Evaluate renal function at baseline and during therapy, with attention to risk factors for renal dysfunction. ()

The following serious adverse reactionsu00a0are described elsewhere in the labeling:u00a0
The most frequently reported adverse reactions (greater than or equal to 30%) were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue and abdominal pain. ()

No data

CYP3A4 inducers may decrease Gleevec C and area under curve (AUC). (, , )n
CYP3A4 inhibitors may increase Gleevec C and AUC. (, )n
Gleevec is an inhibitor of CYP3A4 and CYP2D6 which may increase the C and AUC of other drugs. (, , )n
Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin. ()

No data

Experience with doses greater than 800 mg is limited. Isolated cases of Gleevec overdose have been reported. In the event of overdosage, observe the patient and give appropriate supportive treatment.
Adult Overdose
1,200 to 1,600 mg (duration varying between 1 to 10 days)
1,800 to 3,200 mg (as high as 3,200 mg daily for 6 days)
6,400 mg (single dose)
8 to 10 g (single dose):
A patient with myeloid blast crisis experienced Grade 1 elevations of serum creatinine, Grade 2 ascites and elevated liver transaminase levels, and Grade 3 elevations of bilirubin after inadvertently taking 1,200 mg of Gleevec daily for 6 days. Therapy was temporarily interrupted and complete reversal of all abnormalities occurred within 1 week. Treatment was resumed at a dose of 400 mg daily without recurrence of adverse reactions. Another patient developed severe muscle cramps after taking 1,600 mg of Gleevec daily for 6 days. Complete resolution of muscle cramps occurred following interruption of therapy and treatment was subsequently resumed. Another patient that was prescribed 400 mg daily, took 800 mg of Gleevec on Day 1 and 1,200 mg on Day 2. Therapy was interrupted, no adverse reactions occurred and the patient resumed therapy.
Pediatric Overdose
One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhea.

Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets contain imatinib mesylate equivalent to 100u00a0mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is:
Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is CHNO u2022 CHSO and its molecular weight is 589.7. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile.
Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); hydroxypropyl methylcellulose (USP); magnesium stearate (NF); and microcrystalline cellulose (NF). Tablet coating: ferric oxide, red (NF); ferric oxide, yellow (NF); hydroxypropyl methylcellulose (USP); polyethylene glycol (NF) and talc (USP).

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Each film-coated tablet contains 100 mg or 400 mg of imatinib free base.
100 mg Tablets
Very dark yellow to brownish orange, film-coated tablets, round, biconvex with bevelled edges, debossed with u201cNVRu201d on one side, and u201cSAu201d with score on the other side.
Bottles of 90 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0401-34
400 mg Tablets
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with u201c400u201d on one side with score on the other side, and u201cSLu201d on each side of the score.
Bottles of 30 tabletsu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0438-15
400 mg Tablets
Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with u201cgleevecu201d on one side and score on the other side.
Unit Dose (blister pack of 30) u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0649-30
Storage and Handling
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight container, USP.
Do not crush Gleevec tablets. Avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. Avoid exposure to crushed tabletsn

Dosing and Administration
Advise patients to take Gleevec exactly as prescribed, not to change their dose or to stop taking Gleevec unless they are told to do so by their doctor. If the patient missed a dose of Gleevec, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Advise patients to take Gleevec with a meal and a large glass of water .
Fluid Retention and Edema
Inform patients of the possibility of developing edema and fluid retention. Advise patients to contact their health care provider if unexpected rapid weight gain occurs .
Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising .
Pregnancy and Breastfeeding
Advise patients to inform their doctor if they are or think they may be pregnant. Advise women of reproductive potential to avoid becoming pregnant while taking Gleevec. Female patients of reproductive potential taking Gleevec should use highly effective contraception during treatment and for fourteen days after stopping treatment with Gleevec . Avoid breastfeeding during treatment and for 1 month after the last dose .
Drug Interactions
Gleevec and certain other medicines such as warfarin, erythromycin, and phenytoin, including over-the-counter medications such as herbal products, can interact with each other. Advise patients to tell their doctor if they are taking or plan to take iron supplements. Avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking Gleevec .
Pediatric
Advise patients that growth retardation has been reported in children and pre-adolescents receiving Gleevec. The long term effects of prolonged treatment with Gleevec on growth in children are unknown. Therefore, closely monitor growth in children under Gleevec treatment .
Driving and Using Machines
Advise patients that they may experience side effects such as dizziness, blurred vision or somnolence during treatment with Gleevec. Therefore, caution patients about driving a car or operating machinery .
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2018-102

PRINCIPAL DISPLAY PANEL
Package Label u2013 100 mg Tablets
Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0401-34
GLEEVECu00ae (imatinib mesylate)
90 Tablets
100 mg
Each tablet contains 100 mg of imatinib free base

PRINCIPAL DISPLAY PANEL
Package Label u2013 400 mg Tablets
Rx Only nttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0649-30
GLEEVECu00ae (imatinib mesylate)
400 mg per tablet
Each tablet contains 400 mg of imatinib free base
30 Tablets

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Imatinib Mesylate (Gleevec)

Trade Name : Gleevec

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Imatinib Mesylate (Gleevec)

Trade Name : Gleevec

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

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