Oshimertinib Tablets 40 mg (Oshimertinib 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. Refer to the prescribing information for the dosage information for pemetrexed and either cisplatin or carboplatin (see section 13. Information for healthcare professionals). Take this medicine at the same time each day, with or without food. Duration of treatment 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. Method of administration 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. Missed dose If a dose of this medicine is missed, take it as soon as possible if at least 12 hours remain before the next dose. Dose adjustment 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. Dose-reduction guidelines for adverse reaction toxicity are provided in Table 1. Table 1. Recommended dose modifications Lungb 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. Cardiacb 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. Skinb Stevens-Johnson syndrome and toxic epidermal necrolysis Permanently discontinue this medicine. Blood and lymphatic systemb Aplastic anemia Permanently discontinue this medicine. Other 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 may cause serious side effects such as interstitial lung disease, characterized by inflammation in the lungs; if symptoms like breathlessness, cough, or fever occur, usage should be stopped immediately, and medical attention sought. Additionally, severe skin reactions like Stevens-Johnson Syndrome, erythema multiforme, or toxic epidermal necrolysis can occur rarely, so if symptoms such as skin rash, blisters, or mucosal pain arise, immediate cessation of the drug and consultation with a specialist is required. The drug can affect the heart and may lead to reduced cardiac output or heart failure symptoms; regular cardiac function tests are necessary for those with heart disease or related symptoms. Corneal inflammation may occur, so if there is eye pain, redness, or blurred vision, an evaluation by an ophthalmologist is required. This medication can reduce blood cell counts, leading to symptoms like anemia, increased risk of infection, or bleeding; any unusual symptoms should be promptly reported to a doctor. It may be harmful to the fetus during pregnancy; hence, women who are pregnant or planning to conceive should not use this medication and effective contraception is needed during treatment. While this medication does not require dose adjustment for patients with certain liver or kidney diseases, caution is necessary as its safety has not been established in patients with severe liver or end-stage renal disease. Interactions with other medications may occur, so inform healthcare professionals about any concurrently used medications. Lastly, this drug is not recommended for use in children, and if used, it should be kept out of reach of children.

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

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best kept at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Beige circular film-coated tablet

Package unit

5 tablets/box [(5 tablets/PTP×1)]