Introduction for Tagrix 80 mg (Osimertinib):

Tagrix is the first global generic for osimertinib. Tagrix 80 is a third-generation EGFR inhibitor. Osimertinib is the first and only medicine of its kind approved by the US FDA for the treatment of EGFR-positive Non-Small Cell Lung Cancer (NSCLC) patients with the T790M mutation and whose disease has progressed during or after EGFR tyrosine kinase inhibitor (TKI) treatment.

Therapeutic Indications:

TAGRIX is used to treat adult patients who have locally progressed or metastatic non-small cell lung cancer (NSCLC) with the epidermal growth factor receptor (EGFR) T790M mutation.

Drug/Therapeutic Class:

Cytotoxic Chemotherapy.

Pharmacodynamics:

Tagrix is an anticancer drug that inhibits EGFR tyrosine kinase. EGFR is the epidermal growth factor receptor. Tagrix 80 is used to treat non-small cell lung cancers with EGFR mutations. These mutations cause unregulated cell proliferation in cancer cells. Tagrix binds to the growth factors and inhibits their signaling. As a result, it inhibits the growth and spread of cancer cells.

Pharmacology:

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

Tagrix Dosage & Administration:

Tagrix 80 mg should be taken once per day as the recommended dose of tagrix 80 mg is 80 mg once daily until the condition progresses or there is intolerable toxicity. Osimertinib 80 mg may be taken with or without food. If you miss a dose of  Tagrix 80 mg, do not make it up; instead, take the next dose as scheduled.

Administration of Tagrix 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).

Mode of Administration:
Tagrix 80 mg  is intended for oral usage. The Tagrix 80 mg tablet should be eaten whole with water, not crushed, divided, or chewed. 

Side Effects & Precautions:
Tagrix (Osimertinib Mesylate) may cause the following most common adverse effects (reported in over 10% of cases): symptoms may include diarrhea, rash, dry skin, fragile nails, nausea, decreased appetite, coughing, fatigue, headaches, and stomatitis. Tagrix (Osimertinib Mesylate) may also cause more rare (reported in fewer than 2% of instances) serious reactions, such as: Neutropenia, pulmonary embolism, interstitial lung diseases, QTc interval lengthening in ECG, and cerebrovascular dysfunction. Prolonged use of Tagrix 80 mg can cause lung and cardiac problems. Please see your physician if you have any of the following linked symptoms: such as difficulty breathing, shortness of breath, coughing, fever, elevated heart rate, leg swelling, and dizziness.
Depending on the severity of the patient’s symptoms, doctor will change the dosage or stop the treatment.

Pregnancy and Lactation:
Tagrix 80 mg when given to a pregnant patient, it may harm the developing fetus. Administration of Tagrix 80 mg (osimertinib) to pregnant rats resulted in similar exposures to embryonic death, lower fetal growth, and neonatal mortality. Tagrix 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 Tagrix 80 mg (osimertinib)’s presence in human milk, how it affects breastfed infants.

Storage Conditions:

Tagrix 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 Tagrix 80 mg and all medicines out of the reach of children.

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