Description:
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 deletions) at approximately 9-fold lower concentrations than wild-type. In cultured cells and animal tumour implantation models, osimertinib exhibited anti-tumour activity against non-small cell lung cancer (NSCLC) lines harbouring EGFR-mutations (T790M/L858R, L858R, T790M/exon 19 deletions, and exon 19 deletions) and, to a lesser extent, wild-type EGFR amplifications.
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Presentation
Osicent 80: Each tablet contains Osimertinib Mesylate INN equivalent to Osimertinib 80 mg.
Indications
Osimertinib is a kinase inhibitor 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 therapy.
NCI Cancer Drugs
Drug: Osimertinib
FDA Approval: Yes
Osimertinib mesylate is approved to treat: Non-small cell lung cancerin adults whose tumor shave certain EGFR gene mutations. It use: As adjuvant therapy after surgery to remove the tumor,
As first-line therapy for metastatic disease, or For metastatic disease that got worse during or after treatment with another EGFR tyrosine kinase inhibitor.
Osimertinib mesylate is also being studied in the treatment of other types of cancer.
Dosage & Administration
80 mg orally once daily, with or without food.
Clearance: Oral clearance is 14.2 L/hr.
Metabolism/Metabolites
Osimertinib is metabolized to at least two pharmacologically active metabolites, AZ7550 and AZ5104, that circulate at approximately 10% of the concentration of the parent compound. Biochemical assays have shown that AZ7550 has similar potency and efficacy to osimertinib, while AZ5104 is more potent against mutant and wild-type EGFR. The main metabolic pathways are oxidation (predominantly by CYP3A) and dealkylation.
Toxicity
Across clinical trials, interstitial lung disease (ILD)/pneumonitis occurred in 3.3% of treated patients with 0.5% of these being fatal. There is also a change of QTc interval prolongation; electrocardiogram and electrolytes monitor in patients with a history or predisposition for QTc prolongation. Cardiomyopathy occur in 1.4% of patients, therefore left ventricular ejection fraction (LVEF) measure at baseline and then every 3 months during treatment. Osimertinib can cause embryo-fetal toxicity, requiring female patients to take effective birth control during therapy and for 6 weeks after final dose.
Side Effects
The most common (>20%) adverse reactions (all grades) observe in Osimertinib-treat patients were diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). The most frequent adverse reactions that led to dose reductions or interruptions were: electrocardiogram QTc prolonged (2.2%) and neutropenia (1.9%). Serious adverse reactions reported in 2% or more patients pneumonia and pulmonary embolus.
Precautions
Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.3% of patients. Osimertinib permanently discontinue in patients diagnose with ILD/Pneumonitis.
QTc Interval Prolongation: Electrocardiograms and electrolytes monitor in patients who have a history or predisposition for QTc prolongation, or those who taking medications that are known to prolong the QTc interval. Osimertinib withheld then restarted at a reduce dose or permanently discontinue.
Cardiomyopathy: Occur in 1.4% of patients. Left ventricular ejection fraction (LVEF) assess before treatment and then every 3 months thereafter.
Embryo-Fetal Toxicity: Osimertinib can cause fetal harm. Females advise of potential risk to the fetus and to use effective contraception during treatment with Osimertinib and for 6 weeks after final dose. Males advise to use effective contraception for 4 months, after the last dose of Osimertinib.
Contraindications
None.
Use in Pregnancy & Lactation
Based on its mechanism of action and animal data, Osimertinib can cause fetal harm when administer to a pregnant woman. There are no available data on Osimertinib use in pregnant women. Pregnant women advise of the potential risk to a fetus.
There are no data on the presence of Osimertinib in human milk, the effects of Osimertinib on the breastfed infant or on milk production. Lactating woman advise not to breastfeed during treatment.
Pediatric Use
The safety and effectiveness of Osimertinib in pediatric patients have not established.
Geriatric Use
No overall differences in safety observe between patients 65 years and older and those younger than 65 years.
Drug Interaction
Strong CYP3A Inhibitors
Concomitant administration of Osimertinib avoid with strong CYP3A inhibitors, including macrolide antibiotics (e.g., telithromycin), antifungals (e.g., itraconazole), antivirals (e.g., ritonavir), nefazodone, as concomitant use of strong CYP3A inhibitors may increase Osimertinib plasma concentrations. If no other alternative exists, patients monitor more closely for adverse reactions.
Strong CYP3A Inducers
Concomitant administration of Osimertinib avoid with strong CYP3A inducers (e.g., phenytoin, rifampicin, carbamazepine, St. John’s Wort) as strong CYP3A inducers may decrease Osimertinib plasma concentrations.
Commercial Packaging
Osicent 80 Container Pack: Each bottles contains 30 tablets.
Osicent 80: Each box contains 1 blister strip of 10 tablets.
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