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Rx Item-Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare

Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare  item No.:RX490052 NDC No.310134930 UPC No.:303101349307 NDC No.00310-1349-30 00310134930 0310134930 UPC/GTIN No.3-03101-34930-7 MPN 45759BRAND: TAGRISSO  NDC: 00310-1349-30,310134930 UPC: 3-03101-34930-7,303101349307 This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,VeterinariaThis Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare

$18250.16$17381.11

Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare Item No.: RX490052 NDC No.310134930 UPC No.:303101349307 NDC No.00310-1349-30 00310134930 0310134930 UPC/GTIN No.3-03101-34930-7 MPN 45759 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx490052 Tagrisso (OSIMERTINIB) 40mg Tab 30 by Ast

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For: Non-Small Cell Lung Cancer

Tagrisso (osimertinib) is a tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) indicated for the treatment of patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. TAGRISSO- osimertinib tablet, film coated
AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE

TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.



This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection
Confirm the presence of a T790M EGFR mutation in tumor or, in the absence of tumor, plasma specimens prior to initiation of treatment with TAGRISSO [see Indications and Usage (1) and Clinical Studies (14)]. Testing for the presence of the mutation in plasma specimens is recommended only in patients for whom a tumor biopsy cannot be obtained. ​If this mutation is not detected in a plasma specimen, re-evaluate the feasibility of biopsy for tumor tissue testing. Information on FDA-approved tests for the detection of T790M mutations is available at https://www.fda.gov/companiondiagnostics.

2.2 Recommended Dosage Regimen
The recommended dose of TAGRISSO is 80 mg tablet once a day until disease progression or unacceptable toxicity. TAGRISSO can be taken with or without food.

If a dose of TAGRISSO is missed, do not make up the missed dose and take the next dose as scheduled.

2.3 Administration to Patients Who Have Difficulty Swallowing Solids
Disperse tablet in 60 mL (2 ounces) of non-carbonated water only. Stir until tablet is dispersed into small pieces (the tablet will not completely dissolve) and swallow immediately. Do not crush, heat, or ultrasonicate during preparation. Rinse the container with 120 mL to 240 mL (4 to 8 ounces) of water and immediately drink.
DOSAGE FORMS AND STRENGTHS

80 mg tablets: beige, oval and biconvex tablet marked with "AZ 80" on one side and plain on the reverse.

40 mg tablets: beige, round and biconvex tablet marked with "AZ 40" on one side and plain on the reverse.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Interstitial Lung Disease/Pneumonitis
Across clinical trials, interstitial lung disease (ILD)/pneumonitis occurred in 3.3% (n=27) of TAGRISSO treated patients (n=813); 0.5% (n=4) were fatal.

Withhold TAGRISSO and promptly investigate for ILD in any patient who presents with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
DESCRIPTION

Osimertinib is a kinase inhibitor for oral use. The molecular formula for osimertinib mesylate is C28 H33 N7 O2 �CH4 O3 S, 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.
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.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Osimertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) at approximately 9-fold lower concentrations than wild-type. In cultured cells and animal tumor implantation models, osimertinib exhibited anti-tumor activity against NSCLC lines harboring EGFR-mutations (T790M/L858R, L858R, T790M/exon 19 deletion, and exon 19 deletion) and, to a lesser extent, wild-type EGFR amplifications. Two pharmacologically-active metabolites (AZ7550 and AZ5104 circulating at approximately 10% of the parent) with similar inhibitory profiles to osimertinib have been identified in the plasma after oral administration of osimertinib. AZ7550 showed a similar potency to osimertinib, while AZ5104 showed greater potency against exon 19 deletion and T790M mutants (approximately 8-fold) and wild-type (approximately 15-fold) EGFR. In vitro, osimertinib also inhibited the activity of HER2, HER3, HER4, ACK1, and BLK at clinically relevant concentrations.

Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare  item No.:RX490052 NDC No.310134930 UPC No.:303101349307 NDC No.00310-1349-30 00310134930 0310134930 UPC/GTIN No.3-03101-34930-7 MPN 45759
RX ITEM-Tagrisso (Osimertinib) 40Mg Tab
Tagrisso (Osimertinib) 40Mg Tab 30 By Astra Zeneca Healthcare item No.:RX490052 NDC No.310134930 UPC No.:303101349307 NDC No.00310-1349-30 00310134930 0310134930 UPC/GTIN No.3-03101-34930-7 MPN 45759

BRAND: TAGRISSO  NDC: 00310-1349-30,310134930 UPC: 3-03101-34930-7,303101349307 This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinaria
Tagrisso (Osimertinib) 40Mg Tab 30 By As
BRAND: TAGRISSO NDC: 00310-1349-30,310134930 UPC: 3-03101-34930-7,303101349307 This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinaria

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
OSIMERTINIB MESYLATE ORAL
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.