The Tagrix

Beacon Pharmaceuticals Limited is the number 1 oncology company of Bangladesh has introduced revolutionary lung cancer drug, osimertinib in the brand name Tagrix.

Tagrix is the 1st global generic of osimertinib. This drug is a third generation EGFR inhibitor. Osimertinib (Tagrix) is the 1st and only drug of its kind approved by USFDA for the treatment of epidermal growth factor receptor (EGFR) positive Non- Small Cell Lung Cancer (NSCLC) patient with T790M  mutation.

Mutations in the EGFR receptor can lead to uncontrolled cell growth and tumour formation. Tagrix (Osimertinib) targets both the EGFR mutation that triggers cancer development and T790M, a mutation that makes tumours resistant to existing treatment with EGFR-TKIs.

Mechanism of Action

Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M.

Pharmaceutical Form

TAGRIX 40 mg tablets: Each tablet contains 40 mg osimertinib (as mesylate).

TAGRIX80 mg tablets: Each tablet contains 80 mg osimertinib (as mesylate).

Therapeutic indications

TAGRIX is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

Dose and Method of Administration

Treatment with TAGRIX should be initiated by a physician experienced in the use of anticancer therapies. When considering the use of TAGRIX as a treatment for locally advanced or metastatic NSCLC, it is necessary that EGFR T790M mutation status is determined.

Dose

The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity. If a dose of TAGRIX is missed, the dose should be made up unless the next dose is due within 12 hours. TAGRIX can be taken with or without food at the same time each day.

Mode of Administration

Tagrix is for oral use. The tablet should be swallowed whole with water and it should not be crushed, split or chewed.

Dose adjustments for different disease conditions

Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.

Special populations: No dosage adjustment is required due to patient age, body weight, gender, ethnicity and smoking status.

Hepatic impairment: No dose adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤upper limit of normal (ULN) and aspartate amino transferase but caution should be used when administering TAGRIX to these patients.

Renal impairment: No dose adjustment is recommended in patients with mild and moderate renal impairment. Limited data are available in patients with severe renal impairment.

Contraindications

Hypersensitivity to the active substance or to any of the excipients used in the tablet. St. John’s wort should not be used together with Tagrix.

Special warnings and precautions for use

Prolongation of QTc interval

QTc interval prolongation occurs in patients treated with TAGRIX. QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias (e.g. torsade de pointes) or sudden death.

Use in Pregnancy

There are no or limited amount of data from the use of osimertinib in pregnant women. Studies in animals have shown reproductive toxicity (embryolethality, reduced foetal growth.

Common Side Effects

Hematologic like Lymphopenia, thrombocytopenia, anemia, neutropenia, Gastrointestinal disorder including Diarrhea, nausea, decreased appetite, constipation, stomatitis, Dermatologic like Rash, dry skin, nail toxicity, pruritus, Dry skin included eczema, Nail toxicity including nail and nail bed disorders, Metabolic like Hyponatremia, hypermagnesemia, Ocular like Eye disorders including dry eye, blurred vision, keratitis etc. Other side effects are Cough, Back pain, Headache, Cardiomyopathy, Venous thromboembolism etc.