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Dasatinib (Sprycel)

Trade Name : SPRYCEL

E.R. Squibb & Sons, L.L.C.

TABLET

Strength 70 mg/1

DASATINIB Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 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 Dasatinib (Sprycel) which is also known as SPRYCEL and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 70 mg/1 per ml. Read more

Dasatinib (Sprycel) 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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
  • SPRYCEL (dasatinib) is indicated for the treatment of adult patients with
  • SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with
  • SPRYCEL is a kinase inhibitor indicated for the treatment of
  • (1n- 14)
  • (1n- 14)
  • (1n- 14)
  • (1n- 14)
  • (1n- 14)
  • u00a0
  • SPRYCEL (dasatinib) Tablets are available as 20-mg, 50-mg, 70-mg, 80-mg, 100-mg, and 140-mg white to off-white, biconvex, film-coated tablets .
  • Tablets: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. , n
  • None.
  • None. n
  • No data
  • Myelosuppression and Bleeding Events:
  • Fluid Retention:
  • Cardiac Dysfunction:
  • Pulmonary Arterial Hypertension (PAH):
  • QT Prolongation:
  • Severe Dermatologic Reactions:
  • Tumor Lysis Syndrome:
  • Embryo-Fetal Toxicity:
  • Effects on Growth and Development in Pediatric Patients:
  • The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (u226515%) in patients receiving SPRYCEL as single-agent therapy included myelosuppression, fluid retention events, diarrhea, headache, skin rash, hemorrhage, dyspnea, fatigue, nausea, and musculoskeletal pain. n
  • Most common adverse reactions (u226530%) in pediatric patients receiving SPRYCEL in combination with chemotherapy included mucositis, febrile neutropenia, pyrexia, diarrhea, nausea, vomiting, musculoskeletal pain, abdominal pain, cough, headache, rash, fatigue, constipation, arrhythmia, hypertension, edema, infections (bacterial, viral and fungal), hypotension, decreased appetite, hypersensitivity, dyspnea, epistaxis, peripheral neuropathy, and altered state of consciousness. n
  • To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or .
  • Strong CYP3A4 Inhibitorsn
  • [see ]
  • [see
  • ]
  • Strong CYP3A4 Inducers
  • [see ]
  • Gastric Acid Reducing Agentsn
  • Do not administer H antagonists or proton pump inhibitors with SPRYCEL. Consider the use of antacids in place of H antagonists or proton pump inhibitors. Administer the antacid at least 2 hours prior to or 2 hours after the dose of SPRYCEL. Avoid simultaneous administration of SPRYCEL with antacids.
  • Strong CYP3A4 Inhibitors:
  • Strong CYP3A4 Inducers:
  • Antacids:
  • H Antagonists and Proton Pump Inhibitors:
  • No data
  • u2022
  • Lactation:
  • (8.2)
  • Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe myelosuppression and bleeding. Since SPRYCEL is associated with severe myelosuppression , monitor patients who ingest more than the recommended dosage closely for myelosuppression and give appropriate supportive treatment.
  • Acute overdose in animals was associated with cardiotoxicity. Evidence of cardiotoxicity included ventricular necrosis and valvular/ventricular/atrial hemorrhage at single doses u2265100 mg/kg (600 mg/m) in rodents. There was a tendency for increased systolic and diastolic blood pressure in monkeys at single doses u226510 mg/kg (120 mg/m).
  • SPRYCEL (dasatinib) is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is CHClNOS u2022 HO, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure:
  • Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol.
  • SPRYCEL tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol.
  • No data
  • In a 2-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day. The highest dose resulted in a plasma drug exposure (AUC) level approximately 60% of the human exposure at 100 mg once daily. Dasatinib induced a statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and prostate adenoma in low-dose males.
  • Dasatinib was clastogenic when tested in Chinese hamster ovary cells, with and without metabolic activation. Dasatinib was not mutagenic when tested in an bacterial cell assay (Ames test) and was not genotoxic in an rat micronucleus study.
  • Dasatinib did not affect mating or fertility in male and female rats at plasma drug exposure (AUC) similar to the human exposure at 100u00a0mg daily. In repeat dose studies, administration of dasatinib resulted in reduced size and secretion of seminal vesicles, and immature prostate, seminal vesicle, and testis. The administration of dasatinib resulted in uterine inflammation and mineralization in monkeys, and cystic ovaries and ovarian hypertrophy in rodents.
  • No data
  • 1. n
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • This Patient Information has been approved by the U.S. Food and Drug Administration.n
  • See section for a complete list of available packages of SPRYCEL.
  • 60 Tablets NDC 0003-0527-11SPRYCELn (dasatinib)Tablets20 mgRx onlyDo not crush, cut or chew tablets.Swallow tablets whole.Bristol-Myers Squibb
  • 60 Tablets NDC 0003-0528-11 SPRYCELn (dasatinib)Tablets50 mgRx onlyDo not crush, cut or chew tablets.Swallow tablets whole.Bristol-Myers Squibb
  • 60 Tablets NDC 0003-0524-11SPRYCELn (dasatinib)Tablets70 mgRx onlyDo not crush, cut or chew tablets.Swallow tablets whole.Bristol-Myers Squibb
  • 30 Tablets NDC 0003-0855-22SPRYCELn (dasatinib)Tablets80 mgRx onlyDo not crush, cut or chew tablets.Swallow tablets whole.Bristol-Myers Squibb
  • 30 Tablets NDC 0003-0852-22 SPRYCELn (dasatinib)Tablets100 mgRx onlyDo not crush, cut or chew tablets.Swallow tablets whole.Bristol-Myers Squibb
  • No data

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