Introduction for Osicent 80 mg (Osimertinib):

Each tablet of Osicent 80 mg contains Osimertinib Mesylate INN equivalent to Osimertinib 80 mg. Osimertinib 80 is a protein kinase inhibitor used to treat non-small cell lung cancer. Adult individuals with specific EGFR mutations are treated with it. Osimertinib 80 mg showed anti-tumor effectiveness against non-small cell lung cancer (NSCLC) lines.

Pharmacology:

Osicent 80 mg is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to specific mutant forms of EGFR (T790M, L858R, and exon 19 deletion) found in non-small cell lung cancer (NSCLC) tumors after treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, Osimertinib 80 mg targets the gate-keeper T790M mutation, which increases ATP binding activity to EGFR and leads to a poor prognosis in late-stage illness. Furthermore, Osicent 80 mg has been proven to protect wild-type EGFR during therapy, lowering non-specific binding and minimizing toxicity.

The median time to C max for Osimertinib 80 mg was 6 hours (range 3-24 hours). Following the administration of 20 mg Osimertinib 80 mg tablets with a high-fat, high-calorie meal (containing approximately 58 grams of fat and 1000 calories), the C max and AUC of Osicent 80 mg were compared to those obtained when fasting.
Osimertinib 80 mg had a mean steady-state distribution volume (Vss/F) of 986 L. Osicent 80 mg (Osimertinib) has a plasma protein binding rate of 95%.
Osicent 80 mg plasma concentrations fell over time, with a population-estimated mean half-life of 48 hours and oral clearance (CL/F) of 14.2 L/h.
Osimertinib 80 mg ‘s primary metabolic pathways in vitro were oxidation (mostly CYP3A) and dealkylation. After the oral treatment of Osicent 80 mg , two pharmacologically active metabolites (AZ7550 and AZ5104) were detected in the plasma. The geometric mean exposure (AUC) of each metabolite (AZ5104 and AZ7550) was roughly 10% of Osimertinib 80 mg’s exposure at steady-state. Osimertinib 80 mg is predominantly removed in the feces (68%), with a minor amount in the urine (14%). Unchanged Osicent 80 mg (Osimertinib) contributed for roughly 2% of the elimination.

 Dosage & Administration:

The recommended dose of Osicent 80 mg  is 80 mg once daily until disease progression or intolerable toxicity. Osimertinib 80 can be taken with or without food, but it is best to take it at the same time every day to maximize its advantages.

Administration of Osicent 80 mg:

Dissolve the tablet with 60 ml of non-carbonated water only. Stir until the tablet is divided into small bits (it will not entirely dissolve), then consume immediately. During preparation, avoid crushing, heating, and ultrasonicating. Drink the liquid right away after rinsing the jar with 120–240 ml (4–8 ounces) of water. In the event that a nasogastric tube is required, disperse the tablet as described above in 15 ml of non-carbonated water, then add another 15 ml of water to move any leftovers to the syringe. The resulting 30 ml liquid should be administered using the nasogastric tube with enough water for flushes (about 30 ml).

Interaction:

Strong CYP3A4 inducer: If co-administration of Osimertinib 80 mg with strong CYP3A inducers is necessary, increase the dose to 160 mg daily. Resume Osicent 80 mg 3 weeks after stopping the strong CYP3A4 inducer.

 Side Effects:

The most common (>20%) adverse effects reported in Osicent 80 mg (Osimertinib)-treated individuals were diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). The most common side effects resulting in dosage reductions or suspensions were electrocardiogram QTc prolongation (2.2%) and neutropenia (1.9%). Pneumonia and pulmonary embolism were among the serious adverse responses recorded in 2% or more patients.

Pregnancy and Lactation:
Osicent 80 mg when given to a pregnant patient, it may harm the developing fetus. Administration of Osimertinib 80 mg to pregnant rats resulted in similar exposures to embryonic death, lower fetal growth, and neonatal mortality. Osicent 80 mg (Osimertinib)  is not recommended during pregnancy or for women of reproductive potential who do not use contraception.

There is no information available regarding Osicent 80 mg’s presence in human milk, how it affects breastfed infants.

Drug/Therapeutic Class:

Cytotoxic Chemotherapy.

Storage Conditions:

Osicent 80 mg should be kept between 20°C and 25°C at room temperature. When a medication is no longer needed or has expired, dispose of it safely. Keep Osimertinib 80 mg and all medicines out of the reach of children.

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