Drugplain

Imatinib mesylate 400 mg 400 mg/1

imatinib mesylate · TABLET, FILM COATED · Armas Pharmaceuticals Inc.

No Recall History
Plain English

Imatinib mesylate is a prescription tablet taken by mouth used to treat certain types of cancer, including chronic myeloid leukemia and gastrointestinal stromal tumors. Your doctor will determine the right dose for your condition and monitor you while taking this medication.

Key Facts

Brand Name
Imatinib mesylate 400 mg
Generic Name
imatinib mesylate
NDC Code (Product)
72485-203
Manufacturer
Armas Pharmaceuticals Inc.
Strength
400 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA208302
Marketing Start
03/15/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death505 reports
nausea256 reports
diarrhoea234 reports
drug ineffective196 reports
fatigue188 reports
vomiting154 reports
dyspnoea152 reports
neoplasm malignant141 reports
abdominal pain132 reports
pyrexia131 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE Imatinib mesylate 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 ( 1.1 ) 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 ( 1.2 ) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) ( 1.3 ) 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 ( 1.5 ) 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 ( 1.6 ) Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who ar…

Dosage & Administration

2 DOSAGE & ADMINISTRATION Adults with Ph+ CML CP ( 2.2 ): 400 mg/day Adults with Ph+ CML AP or BC ( 2.2 ): 600 mg/day Pediatrics with Ph+ CML CP ( 2.3 ): 340 mg/m 2 /day Adults with Ph+ ALL ( 2.4 ): 600 mg/day Adults with MDS/MPD ( 2.6 ): 400 mg/day Adults with ASM ( 2.7 ): 100 mg/day or 400 mg/day Adults with HES/CEL ( 2.8 ): 100 mg/day or 400 mg/day Adults with DFSP ( 2.9 ) 800 mg/day Patients with mild to moderate hepatic impairment ( 2.12 ): 400mg/day Patients with severe hepatic impairment ( 2.12 ): 300 mg/day All doses of Imatinib mesylate tablets should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib mesylate tablet 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. 2.1 Drug Administration The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg t…

Contraindications

4 CONTRAINDICATIONS None None (4)

Drug Interactions

7 DRUG INTERACTIONS CYP3A4 inducers may decrease imatinib mesylate C max and area under curve (AUC). ( 2.12 , 7.1 , 12.3 ) CYP3A4 inhibitors may increase imatinib mesylate C max and AUC. ( 7.2 , 12.3 ) Imatinib mesylate is an inhibitor of CYP3A4 and CYP2D6 which may increase the C max and AUC of other drugs. ( 7.3 , 7.4 , 12.3 ) Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin ( 7.3 ) 7.1 Agents Inducing CYP3A Metabolism Concomitant administration of imatinib mesylate tablet and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents [see Clinical Pharmacology ( 12.3 )]. 7.2 Agents Inhibiting CYP3A Metabolism Concomitant administration of imatinib mesylate tablet and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase. Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice [see Clinical Pharmacology ( 12.3 )] . 7.3 Interactions with Drugs Metabolized by CYP3A4 Imatinib mesylate tablet will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, cer…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Fluid Retention and Edema [see Warnings and Precautions ( 5.1 )] Hematologic Toxicity [see Warnings and Precautions ( 5.2 )] Congestive Heart Failure and Left Ventricular Dysfunction [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Hemorrhage [see Warnings and Precautions ( 5.5 )] Gastrointestinal Disorders [see Warnings and Precautions ( 5.6 )] Hypereosinophilic Cardiac Toxicity [see Warnings and Precautions ( 5.7 )] Dermatologic Toxicities [see Warnings and Precautions ( 5.8 )] Hypothyroidism [see Warnings and Precautions ( 5.9 )] Growth Retardation in Children and Adolescents [see Warnings and Precautions ( 5.11 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.12 )] Impairments Related to Driving and Using Machinery [see Warnings and Precautions ( 5.13 )] Renal Toxicity [see Warnings and Precautions ( 5.14 )] 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 ( 6.1 ) To report SUSPECTED ADVERS…

Frequently Asked Questions

What is Imatinib mesylate 400 mg used for?

Imatinib mesylate is a prescription tablet taken by mouth used to treat certain types of cancer, including chronic myeloid leukemia and gastrointestinal stromal tumors. Your doctor will determine the right dose for your condition and monitor you while taking this medication.

Is Imatinib mesylate 400 mg a controlled substance?

Imatinib mesylate 400 mg is not classified as a controlled substance by the DEA.

What is the generic name for Imatinib mesylate 400 mg?

The generic name for Imatinib mesylate 400 mg is imatinib mesylate. There are 11 other brand versions of imatinib mesylate.

What is the NDC code for Imatinib mesylate 400 mg 400 mg/1?

The NDC (National Drug Code) for Imatinib mesylate 400 mg 400 mg/1 is 72485-203, listed by Armas Pharmaceuticals Inc..

Product NDC

72485-203

Package NDC

72485-203-30

Other Imatinib Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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