Tirucap 160 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. Take this medicine at the same time each day. Continue treatment until disease progression or unacceptable toxicity occurs. 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. In premenopausal or perimenopausal women, this medicine should be administered with a luteinizing hormone-releasing hormone (LHRH) agonist when used in combination with fulvestrant. For men, consider administration of an LHRH agonist in accordance with current clinical guidelines. 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 The dose of this medicine may be reduced up to 2 times. If the patient cannot tolerate the dose after the second reduction, permanently discontinue this medicine. 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 a severe allergic reaction to the ingredients or excipients of this medication. During the course of this medication, side effects such as diarrhea, rash, nausea, fatigue, and vomiting may commonly occur, and if symptoms appear, the healthcare provider should be consulted. Particularly, hyperglycemia may occur frequently, so regular monitoring of blood sugar levels and careful attention to blood sugar control is necessary. If diarrhea becomes severe, there is a risk of dehydration, so it is recommended to maintain sufficient fluid intake and use antidiarrheal medications if necessary. If skin rashes or pruritus occur, it is important to inform the healthcare provider immediately and seek appropriate treatment. This medication is only effective in patients with certain genetic mutations; therefore, genetic testing should confirm appropriateness before treatment. Women who are pregnant or potentially pregnant must use effective contraception during and for a period after taking this medication, and this medication should not be used during pregnancy. It is safe for breastfeeding women to discontinue breastfeeding while taking this medication. Elderly patients or those with impaired kidney or liver function should consult with their healthcare provider to adjust dosing or exercise caution if necessary. There may be interactions when taking this medication with other drugs, especially those that may inhibit or induce certain liver enzymes, so caution is advised. In case of overdose, as there is no specific antidote, patients must go to a medical facility immediately for appropriate treatment. When storing, keep this medication out of reach of children, and store it in its original packaging at a cool place below 30 degrees Celsius to protect it from air and moisture. This will help maintain its effectiveness and safety for a longer time.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness and safety of the medication for an extended period.

Appearance

A film-coated tablet that is beige, biconvex, and round.

Package unit

64 tablets (16 tablets per PT of 4)