Osicent 80 mg Tablet

Description

Osicent 80 mg is a prescription oral tablet made by Incepta Pharmaceuticals that contains osimertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is used to treat non-small cell lung cancer (NSCLC) whose tumours carry specific EGFR mutations: exon 19 deletions, the exon 21 L858R substitution, or the T790M resistance mutation. Osimertinib binds irreversibly to these mutant forms of EGFR and blocks the growth signals they send, which can slow or stop the progression of the cancer. It also reaches the brain, so it is active against brain metastases.

Osicent must be prescribed and supervised by an oncologist, and the EGFR mutation has to be confirmed by a validated test before treatment starts. Each pack contains 30 tablets of 80 mg, one month of treatment at the standard dose.

Indications and Usage

Osicent 80 mg Tablet (osimertinib 80 mg) is indicated for:

• Adjuvant treatment after complete surgical removal of early-stage NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation
• First-line treatment of locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation, alone or with pemetrexed and platinum chemotherapy
• Locally advanced or metastatic NSCLC with the EGFR T790M mutation that has progressed on or after another EGFR-TKI
• Unresectable stage III EGFR-mutated NSCLC that has not progressed after chemoradiation

How it Works

Osimertinib blocks the epidermal growth factor receptor (EGFR), a protein on the surface of cells that controls growth and division.

In EGFR-mutated lung cancer, the mutant receptor is permanently switched on and drives uncontrolled cell growth. Osimertinib binds irreversibly to the mutant receptor, including the T790M form that makes earlier EGFR inhibitors stop working, while largely sparing normal EGFR. As a result:

• Tumour cell growth signals are switched off
• Cancer cells stop dividing and die
• Tumour growth slows, including in the brain

Dosage & Administration

• Recommended dose: 80 mg (one tablet) once daily
• Route: Oral (by mouth)
• Form: Tablet

Take Osicent at about the same time each day, with or without food. Swallow the tablet whole with water. If you cannot swallow it, you can disperse it in 50 ml of plain (non-carbonated) water, stir until dispersed, drink it straight away, then rinse the glass with more water and drink that too.

If you miss a dose, skip it and take the next dose at the usual time. Do not take two doses to make up for a missed one. Your doctor may pause treatment or reduce the dose to 40 mg if side effects occur. Do not stop or change the dose on your own.

Side Effects

Like all anti-cancer medicines, osimertinib can cause side effects, although not everybody gets them.

Common side effects

• Diarrhoea
• Skin rash, acne-like spots or dry, itchy skin
• Nail changes (redness, swelling or infection around the nails)
• Mouth sores (stomatitis)
• Tiredness
• Reduced appetite
• Low white blood cell or platelet counts in blood tests

Serious side effects: contact your doctor immediately

• New or worsening cough, shortness of breath or fever (possible lung inflammation)
• Fast or irregular heartbeat, dizziness or fainting (possible heart rhythm problem)
• Swelling of the legs, breathlessness or unusual tiredness (possible heart muscle problem)
• Eye pain, redness, watering or blurred vision
• Severe skin reactions with blisters or peeling

Warning and Precaution

Before starting Osicent 80 mg Tablet, tell your doctor about all your medical conditions.

Lung problems

Osimertinib can rarely cause interstitial lung disease or pneumonitis, which can be serious. Report any history of lung disease and any new breathing symptoms.

Heart monitoring

Osimertinib can prolong the QTc interval and can affect heart function. Your doctor may check an ECG, blood electrolytes and heart function, especially if you have heart disease or take other medicines that affect heart rhythm.

Eyes and skin

Report eye symptoms (keratitis) and any severe skin reaction promptly.

Pregnancy and breastfeeding

• Osimertinib can harm an unborn baby. Women should use effective contraception during treatment and for 6 weeks after the last dose; men with female partners should use it for 4 months after the last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.

Other medicines

Avoid strong CYP3A inducers such as rifampicin, carbamazepine, phenytoin and St John’s wort, which lower osimertinib levels. Tell your doctor about all medicines and supplements you take.