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Osimertinib (Tagrisso)

Trade Name : TAGRISSO

AstraZeneca Pharmaceuticals LP

TABLET, FILM COATED

Strength 40 1-Jan

OSIMERTINIB Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Osimertinib (Tagrisso) which is also known as TAGRISSO and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 40 1-Jan per ml. Read more

Osimertinib (Tagrisso) 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.

Read more
  • No data
  • Dosage and Administration u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a012/2019
  • Warnings and Precautions u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a012/2019
  • TAGRISSO is a kinase inhibitor indicated for
  • 1.1n- 2.1
  • 1.2n- 2.1
  • Recommended dosage: 80 mg orally once daily, with or without food. ()
  • 80 mg tablets: beige, oval and biconvex tablet marked with u201cAZ 80u201d on one side and plain on the reverse.
  • 40 mg tablets: beige, round and biconvex tablet marked with u201cAZ 40u201d on one side and plain on the reverse.
  • Tablets: 80 mg and 40 mg. ()
  • None.
  • None. ()
  • No data
  • Interstitial Lung Disease (ILD)/Pneumonitis
  • QTc Interval Prolongation
  • Cardiomyopathy
  • Keratitis
  • Erythema Multiforme and Stevens-Johnson Syndrome:
  • Embryo-Fetal Toxicity
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Interstitial Lung Disease/Pneumonitis n
  • QTc Interval Prolongation n
  • Cardiomyopathy n
  • Keratitisn
  • Erythema multiforme and Stevens-Johnson syndrome n n n
  • Most common adverse reactions (u226520%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite. ()
  • Strong CYP3A Inducers
  • 2.4
  • 7.1
  • Lactation: Do not breastfeed. ()
  • Osimertinib is a kinase inhibitor for oral use. The molecular formula for osimertinib mesylate is CHNOu2022CHOS, and the molecular weight is 596 g/mol. The chemical name is N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide mesylate salt. Osimertinib has the following structural formula (as osimertinib mesylate):
  • TAGRISSO tablets contain 40 or 80 mg of osimertinib, equivalent to 47.7 and 95.4 mg of osimertinib mesylate, respectively. Inactive ingredients in the tablet core are mannitol, microcrystalline cellulose, low-substituted hydroxpropyl cellulose and sodium stearyl fumarate. The tablet coating consists of polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black.
  • No data
  • Carcinogenicity studies have not been performed with osimertinib. Osimertinib did not cause genetic damage in and assays.
  • Based on studies in animals, male fertility may be impaired by treatment with TAGRISSO. Degenerative changes were present in the testes in rats and dogs exposed to osimertinib for 1 month or more with evidence of reversibility in the rat. Following administration of osimertinib to rats for approximately 10 weeks at a dose of 40 mg/kg, at exposures 0.5 times the AUC observed at the recommended clinical dose of 80 mg once daily, there was a reduction in male fertility, demonstrated by increased pre-implantation loss in untreated females mated to treated males.
  • Based on studies in animals, female fertility may be impaired by treatment with TAGRISSO. In repeat dose toxicity studies, histological evidence of anestrus, corpora lutea degeneration in the ovaries and epithelial thinning in the uterus and vagina were seen in rats exposed to osimertinib for 1 month or more at exposures 0.3 times the AUC observed at the recommended clinical dose of 80 mg once daily. Findings in the ovaries seen following 1 month of dosing exhibited evidence of reversibility. In a female fertility study in rats, administration of osimertinib from 2 weeks prior to mating through Day 8 of gestation at a dose of 20 mg/kg/day (approximately 1.5 times the C at the recommended dose of 80 mg once daily) had no effects on oestrus cycling or the number of females becoming pregnant, but caused early embryonic deaths. These findings showed evidence of reversibility when females were mated 1 month after treatment discontinuation.
  • No data
  • 80 mg tablets: beige, oval and biconvex tablet marked with u201cAZ 80u201d on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1350-30).
  • 40 mg tablets: beige, round and biconvex tablet marked with u201cAZ 40u201d on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1349-30).
  • Store TAGRISSO bottles at 25u00b0C (77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Interstitial Lung Disease/Pneumonitis
  • QTc Interval Prolongation
  • Cardiomyopathy
  • Keratitis
  • Embryo-Fetal Toxicity
  • Females and Males of Reproductive Potential
  • Lactation
  • Distributed by:AstraZeneca Pharmaceuticals LPWilmington, DE 19850
  • TAGRISSO is a registered trademark of the AstraZeneca group of companies.
  • No data
  • NDC 0310--30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • Tagrisso
  • osimertinib
  • 40 mg per tablets
  • Rx only
  • AstraZeneca
  • NDC 0310--30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • Tagrisso
  • osimertinib
  • 80 mg per tablets
  • Rx only
  • AstraZeneca

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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