Osimertinib Tablets 80 mg (Osimertinib Mesylate)

Adult dose

Monotherapy: The recommended dose of this medicine is osimertinib 80 mg once daily. Combination therapy: The recommended dose of this medicine when used in combination with pemetrexed and platinum-based chemotherapy is osimertinib 80 mg once daily. Take this medicine at the same time each day, with or without food. Patients receiving adjuvant treatment should continue taking this medicine until disease recurrence or unacceptable toxicity. Treatment durations exceeding 3 years have not been studied. Patients with locally advanced or metastatic lung cancer should continue taking this medicine until disease progression or unacceptable toxicity. Take this medicine orally and swallow it whole with water. Do not crush, split, or chew the tablets. If the patient is unable to swallow the tablet, first disperse it in 50 mL of noncarbonated water. Add the tablet to the water without crushing it, stir until it disperses, and drink immediately. Then add approximately 100 mL of water to ensure no residue remains, and drink immediately. Do not add any other liquids. If administration through a nasogastric tube is required, follow the same procedure, using 15 mL of water for the initial dispersion and 15 mL to rinse any residue. The dispersed medicine and the rinse solution must be administered within 30 minutes after the tablet is placed in water. If a dose of this medicine is missed, take it as soon as possible if at least 12 hours remain before the next dose. Treatment interruption and/or dose reduction may be necessary based on each patient's safety and tolerability. If dose reduction is necessary, reduce the dose of this medicine to 40 mg once daily. Interstitial lung disease (ILD)/pneumonitis: Permanently discontinue this medicine. ILD/pneumonitis following definitive platinum-based chemoradiation therapy: asymptomatic (Grade 1): Continue this medicine as appropriate, or interrupt and resume treatment. ILD/pneumonitis following definitive platinum-based chemoradiation therapy: Grade 2 or higher: Permanently discontinue this medicine. QTc interval greater than 500 msec on at least 2 separate ECGs: Withhold this medicine until the QTc interval is less than 481msec, or returns to baseline if the baseline QTc is 481msec or greater, then restart at a reduced dose (40mg). QTc interval prolongation with signs/symptoms of serious arrhythmia: Permanently discontinue this medicine. Asymptomatic decrease in left ventricular ejection fraction of 10 percentage points or more from baseline and below 50%: Withhold this medicine for up to 4 weeks. If it returns to baseline, resume treatment. If it does not return to baseline, permanently discontinue this medicine. Symptomatic congestive heart failure: Permanently discontinue this medicine. Stevens-Johnson syndrome and toxic epidermal necrolysis: Permanently discontinue this medicine. Aplastic anemia: Permanently discontinue this medicine. Grade 3 or higher adverse reactions: Withhold this medicine for up to 3 weeks. Grade 3 or higher adverse reactions that improve to Grade 0-2 after withholding this medicine for up to 3 weeks: Treatment may be resumed at the same dose (80 mg) or a lower dose (40 mg). Grade 3 or higher adverse reactions that do not improve to Grade 0-2 after withholding this medicine for up to 3 weeks: Permanently discontinue this medicine. Combination therapy: If adverse reactions occur when this medicine is administered in combination with pemetrexed and platinum-based chemotherapy, adjust the administration of any of the medicines as appropriate. Refer to Table 1 for dose modifications of this medicine. Withhold, reduce the dose of, or permanently discontinue pemetrexed, cisplatin, or carboplatin according to the prescribing information for each medicine.

This medication can cause serious lung disease known as interstitial lung disease; if symptoms such as difficulty breathing, cough, or fever occur, the patient must immediately stop taking the medication and seek medical attention. If symptoms such as Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis, which can cause severe skin reactions, occur, the medication must be stopped, and medical professionals should be consulted immediately. It may affect the heart and prolong the QT interval, so patients with heart disease or those taking related medications should undergo regular ECG checks. Symptoms of heart function deterioration or heart failure may also occur, thus patients with a risk of heart disease should have cardiac function tests before and during treatment and be vigilant for symptoms. Keratitis, which causes inflammation of the eyes, has been reported rarely; if symptoms such as eye pain, redness, or blurred vision occur, the patient should immediately consult an ophthalmologist. A rare blood condition known as aplastic anemia can occur, so if persistent fever, bruising, bleeding, or pallor appears, the patient must inform the healthcare provider immediately. Patients with a known allergy to this medication must not take it, and if unusual symptoms arise during treatment, they should consult their physician at once. Pregnant women or those with the potential for pregnancy should not take this medication and must employ effective contraception for a certain period after discontinuation. Breastfeeding can affect the infant through breast milk, so mothers should stop breastfeeding when taking this medication. The safety and efficacy in pediatric patients have not been established; hence it should not be administered to children. Elderly patients may experience adverse reactions more frequently, necessitating careful monitoring. The safety of this medication has not been established in patients with severe hepatic or renal impairment, so it should be used cautiously. This drug does not significantly affect driving or operating machinery, but caution may be needed depending on the individual's condition. If taking this medication with other drugs, interactions may occur; thus, patients must inform healthcare providers about all medications they are taking. In case of overdose, there is no specific antidote; immediate medical attention for general emergency treatment is advisable. This medication should be stored out of reach of children and should not be transferred to another container.

• Interstitial lung disease
• pulmonary inflammation
• shortness of breath
• cough
• fever
• Stevens-Johnson syndrome
• erythema multiforme
• toxic epidermal necrolysis
• prolonged QTc interval
• heart failure

This medication should be stored in a tightly closed container to prevent air or moisture from entering, at room temperature between 1 and 30 degrees Celsius. Proper storage ensures the longevity of the drug's effectiveness.

Appearance

Beige oval film-coated tablet

Package unit

5 tablets/box [(5 tablets/PTP×1)]