Tirucap 200 mg (Capivasertib)

Adult dose

The recommended dose of this medicine is 400 mg (two 200 mg tablets) twice daily (approximately 12 hours apart), with or without food, for 4 days, followed by 3 days off treatment. * Do not administer on days 5, 6, or 7. The recommended dose of fulvestrant administered in combination with this medicine is 500 mg on days 1, 15, and 29, and once monthly thereafter. Starting dose: 400 mg twice daily for 4 days, followed by 3 days off treatment; two 200 mg tablets First dose reduction: 320 mg twice daily for 4 days, followed by 3 days off treatment; two 160 mg tablets Second dose reduction: 200 mg twice daily for 4 days, followed by 3 days off treatment; one 200 mg tablet If concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of this medicine to 320 mg twice daily (equivalent to a total daily dose of 640 mg). After discontinuing the strong or moderate CYP3A inhibitor (after 3–5 times the inhibitor’s half-life), resume this medicine at the dose used before starting concomitant treatment with the CYP3A inhibitor.

This medication should not be used in patients who have had severe allergic reactions to any ingredient or excipient of this drug. This drug is used for breast cancer treatment, and clinical trials have shown that common side effects include diarrhea, rash, nausea, fatigue, and vomiting. Diarrhea and rash occur particularly frequently, and sometimes symptoms may become severe enough to require dosage reduction or discontinuation of treatment. During treatment with this drug, hyperglycemia may occur, which in severe cases can progress to a dangerous condition called diabetic ketoacidosis. Therefore, blood sugar and glycated hemoglobin levels should be regularly checked before and during treatment, and any symptoms of hyperglycemia should be reported to healthcare providers immediately. If diarrhea occurs, it is recommended to increase fluid intake and take antidiarrheal medication if necessary, and treatment may need to be adjusted for severe symptoms. If skin rashes or other skin abnormalities occur, consult a dermatologist, and depending on symptoms, medication administration may be adjusted. This drug may harm the fetus if taken during pregnancy, so it should not be used in women who are pregnant or planning to become pregnant, and effective contraception should be implemented during and after treatment for a certain period. Women who are breastfeeding should discontinue nursing while taking this medication, as it may excrete into breast milk. This drug does not have a significant impact on the ability to drive or operate machinery, but caution should be exercised due to possible fatigue. As it may interact with other medications, particularly those that inhibit or induce CYP3A enzymes, healthcare providers should be notified if other drugs are being taken, and dosage adjustments and monitoring for side effects may be necessary. Elderly patients can use this medication, but they require careful monitoring for the higher likelihood of side effects. This drug is not recommended for patients with severely impaired kidney or liver function, while mild to moderately impaired patients may use it without dose adjustment. Safety and effectiveness in children or adolescents have not been confirmed. There is no specific antidote for overdose; typical symptomatic treatment should be implemented. Store this drug out of reach of children, and keep it in its original packaging in a cool place below 30 degrees Celsius, as transferring it to another container can adversely affect quality.

• Diarrhea
• rash
• nausea
• fatigue
• vomiting
• hyperglycemia
• hypokalemia
• anemia
• stomatitis
• urinary tract infection

This medication should be stored in a tightly closed container, protected from air and moisture, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent degradation.

Appearance

Beige, oval-shaped film-coated tablet with a convex surface on both sides

Package unit

64 tablets (16 tablets/PTP x 4)