Treatment with Truqap should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patients with HR-positive, HER2-negative advanced breast cancer should be selected for treatment with Truqap based on the presence of one or more PIK3CA/AKT1/PTEN-alterations using a validated test.
Posology The recommended dose of Truqap in combination with fulvestrant is 400 mg (two 200 mg tablets) taken orally twice daily approximately 12 hours apart (total daily dose of 800 mg) with or without food, for 4 days followed by 3 days off treatment.
See Table 1. Table 1 Truqap dosing schedule for each week Day 1 2 3 4 5* 6* 7* Morning 2 x 200 mg 2 x 200 mg 2 x 200 mg 2 x 200 mg Evening 2 x 200 mg 2 x 200 mg 2 x 200 mg 2 x 200 mg * No dosing on day 5, 6 and 7 Truqap should be co-administered with fulvestrant.
The recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, and 29, and once monthly thereafter. Refer to the approved Summary of Product Characteristics (SmPC) of fulvestrant for more information. In pre/perimenopausal women, Truqap plus fulvestrant should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
For men, consider administering a LHRH agonist according to current clinical practice standards. Refer to the approved Summary of Product Characteristics (SmPC) of fulvestrant for more information. If a dose of Truqap is missed, it can be taken within 4 hours after the time it is usually taken.
If a dose is missed and more than 4 hours have passed, the dose should be skipped. The next dose of Truqap should be taken at the usual time. There should be at least 8 hours between doses. If the patient vomits, an additional dose should not be taken.
The next dose of Truqap should be taken at the usual time. Treatment with capivasertib should continue until disease progression or unacceptable toxicity occurs. Dose adjustments Treatment with Truqap may be interrupted to manage adverse reactions and dose reduction can be considered.
Dose reductions for capivasertib should be carried out as described in Table 2. The dose of capivasertib can be reduced up to two times. Dose modification guidance for specific adverse reactions is presented in Tables 3-5. Table 2 Truqap dose reduction guidelines for adverse reactions Truqap Dose and Schedule Number and Strength of 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. 9 mmol/L or HbA1C > 7% No Truqap dose adjustment required. Consider initiation or intensification of oral anti- diabetic treatmente.
9 mmol/L Initiate or intensify oral anti-diabetic treatment. 9 mmol/L). If recovery occurs in ≤28 days, resume Truqap at the same dose and maintain initiated or intensified anti-diabetic treatment. 9 mmol/L) is reached in more than 28 days restart at one lower dose level and maintain initiated or intensified anti-diabetic treatment.
9 mmol/L) and consult a diabetologist. Initiate or intensify oral anti-diabetic treatment. Consider additional anti-diabetic medicinal products such as insulinf, as clinically indicated. Consider intravenous hydration and provide appropriate clinical management as per local guidelines.
9 mmol/L) within 28 days, restart Truqap at one lower dose level and maintain initiated or intensified anti- diabetic treatment. 9 mmol/L) within 28 days following appropriate treatment permanently discontinue Truqap. 8 mmol/L) Withhold Truqap and consult with a diabetologist.
Initiate or intensify appropriate anti-diabetic treatment. Consider insulinf, (dosing and duration as clinically indicated), intravenous hydration and provide appropriate clinical management as per local guidelines. 8 mmol/l) within 24 hours, then follow the guidance in the table for the relevant grade.
8 mmol/l) after 24 hours, permanently discontinue Truqap treatment. 4. 03. c Considerations should be also given to increases in HbA1C. 4 for further recommendations on monitoring of glycaemia and other metabolic parameters. e Consultation with a diabetologist should be considered when selecting the anti-diabetic medicinal product.
A potential for hypoglycaemia with anti-diabetic medicinal product administration on non-Truqap dosing days should be taken into account. 4). f There is limited experience in patients receiving insulin when being treated with Truqap.
4). Table 4 Recommended dose modification for Truqap for diarrhoea CTCAE Gradea Recommendations Grade 1 No Truqap dose adjustment required. Initiate appropriate anti-diarrhoeal therapy, maximise supportive care and monitor as clinically indicated.
Grade 2 Initiate or intensify appropriate anti-diarrhoeal treatment and monitor as clinically indicated. […]