Tagrisso 80 mg (Osimertinib Mesylate)

Adult dose

Monotherapy The recommended dose of this drug is 80 mg of osimertinib once daily. Combination therapy When administered in combination with pemetrexed and platinum-based chemotherapy, the recommended dose of this drug is 80 mg of osimertinib once daily. For dosage information for pemetrexed and either cisplatin or carboplatin, refer to the prescribing information for the respective drugs (see 13. Information for Healthcare Professionals). Take this drug at the same time each day, with or without food. Duration of treatment Patients receiving adjuvant therapy should continue taking this drug until disease recurrence or unacceptable toxicity occurs. Treatment durations exceeding 3 years have not been studied. Patients with locally advanced or metastatic lung cancer should continue taking this drug until disease progression or unacceptable toxicity occurs. Method of administration This drug is administered orally and should be swallowed whole with water. Do not crush, split, or chew the tablets. If a patient is unable to swallow the tablet, first disperse it in 50 mL of non-carbonated water. Place the tablet in the water without crushing it, stir until dispersed, 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 dispersion and the rinse used to clear any residue must be administered within 30 minutes after the tablet is placed in water. Missed dose If a dose of this drug is missed, take it immediately if 12 hours or more remain before the next dose. Dose adjustment Treatment interruption and/or dose reduction may be necessary based on the safety and tolerability of each patient. If dose reduction is necessary, reduce the dose of this drug to 40 mg once daily. Dose reduction guidelines for adverse reaction toxicity are presented in Table 1. Table 1. Recommended dose modifications Lungb Interstitial lung disease (ILD)/pneumonitis Permanently discontinue this drug. ILD/pneumonitis following definitive platinum-based chemoradiation: asymptomatic (Grade 1) Continue this drug as appropriate, or temporarily interrupt and resume treatment. ILD/pneumonitis following definitive platinum-based chemoradiation: Grade 2 or higher Permanently discontinue this drug. Cardiacb QTc interval greater than 500 msec on at least 2 separate ECGs Interrupt this drug until the QTc interval is below 481msec, or until it returns to baseline if the baseline QTc is 481msec or greater, then resume at a reduced dose (40mg). QTc interval prolongation accompanied by signs/symptoms of serious arrhythmia Permanently discontinue this drug. Asymptomatic, with a decrease in left ventricular ejection fraction of 10 percentage points or more from baseline and to below 50% Interrupt this drug for up to 4 weeks. If it returns to baseline, resume treatment. If it does not return to baseline, permanently discontinue this drug. Symptomatic congestive heart failure Permanently discontinue this drug. Skinb Stevens-Johnson syndrome and toxic epidermal necrolysis Permanently discontinue this drug. Blood and lymphatic systemb Aplastic anemia Permanently discontinue this drug. Other Grade 3 or higher adverse reaction Interrupt this drug for up to 3 weeks. Grade 3 or higher adverse reaction improves to Grade 0-2 after interruption of this drug 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 reaction that does not improve to Grade 0-2 after interruption of this drug for up to 3 weeks Permanently discontinue this drug. Combination therapy: If an adverse reaction occurs when this drug is administered in combination with pemetrexed and platinum-based chemotherapy, the administration of any of the drugs may need to be adjusted appropriately. Refer to Table 1 for dose adjustments of this drug. Pemetrexed, cisplatin, or carboplatin should be interrupted, dose-reduced, or permanently discontinued according to their respective prescribing information.

This drug may cause inflammation in the lungs or interstitial lung disease, so if symptoms such as shortness of breath, cough, or fever occur, it should be discontinued immediately, and medical consultation is required. If severe skin rashes, blisters, or mucosal damage occur during treatment with this drug, use should be stopped immediately and healthcare professionals should be notified. Since it may affect heart rhythm, patients with heart disease or abnormal findings on ECG should be cautious and undergo regular cardiac examinations. Heart function may decline, so if symptoms of heart failure appear, consult a doctor immediately, and the drug may be discontinued if necessary. Inflammation may occur in the eyes, so if pain, redness, or blurred vision occurs, consult an ophthalmologist. A rare blood disorder known as aplastic anemia may occur, so if there are persistent fever, bruising, bleeding, or pallor, notify the healthcare professionals immediately and get tested. Patients with severe allergic reactions to any ingredient in this drug should not be treated with it. Common side effects may include diarrhea, skin rash, fingernail or toenail inflammation, dry skin, stomatitis, pruritus, alopecia, increased blood creatine phosphokinase levels, increased blood creatinine, nosebleeds, decreased platelet count, decreased white blood cells, decreased lymphocytes, decreased neutrophils, hematological leukopenia, lymphopenia, neutropenia, thrombocytopenia, pain, weakness, fatigue, and. There may be interactions with other medications, so inform healthcare professionals of any medications being taken, especially those that affect enzymes that break down drugs in the liver. Women who are pregnant or may become pregnant should not take this drug and should continue contraception for a certain period even after taking it. Women who are breastfeeding should stop breastfeeding while taking this drug. Safety in children and adolescents has not been established, so it is advisable not to use it for this population. Elderly patients are at a higher risk for side effects, so they should be closely monitored when taking this drug under the guidance of a doctor. For patients with severely impaired liver or kidney function, consultation with a doctor is essential before using this drug. There is no specific antidote for overdose, so seek immediate medical care for appropriate treatment. This drug should be kept out of reach of children and should not be transferred to other containers.

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

This drug should be stored at room temperature between 1 and 30 degrees Celsius, and it is important to keep it in a tightly closed container to prevent air and moisture ingress.

Appearance

Beige, oval-shaped, biconvex film-coated tablet

Package unit

28 tablets (7 tablets/PTP x 4)