![]() Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Withhold, dose reduce, or permanently discontinue TRUQAP based on severity.īased on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Early consultation with a dermatologist is recommended. Monitor patients for signs and symptoms of cutaneous adverse reactions. ![]() EM occurred in 1.7% of patients and DRESS occurred in 0.3% of patients. Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.Ĭutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia, and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients who received TRUQAP (n=355).Ĭutaneous adverse reactions occurred in 58% of patients. Advise patients to increase oral fluids and start antidiarrheal treatment at the first sign of diarrhea while taking TRUQAP. Monitor patients for signs and symptoms of diarrhea. In patients with Grade ≥ 2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154). Dose reductions were required in 8% of patients and 2% of patients permanently discontinued TRUQAP due to diarrhea. In the 257 patients with diarrhea, 59% required antidiarrheal medications to manage symptoms. The median time to first occurrence was 8 days (range: 1 to 519). Grade 3 or 4 diarrhea occurred in 9% of patients. Severe diarrhea associated with dehydration occurred in patients who received TRUQAP (n=355).ĭiarrhea occurred in 72% of patients. Withhold, dose reduce, or permanently discontinue TRUQAP based on severity. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes. During treatment with anti-hyperglycemic medication, continue monitoring FG at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. If a patient experiences hyperglycemia after initiating treatment with TRUQAP, monitor FG as clinically indicated, and at least twice weekly until FG decreases to normal levels. 1 In the trial, TRUQAP in combination with fulvestrant reduced the risk of disease progression or death by 50% versus fulvestrant alone in patients with tumors harboring PI3K/AKT/PTEN pathway biomarker alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65 p=160 mg/dL (>8.9 mmol/L), HbA1C at or above the upper limit of normal, use of concomitant systemic corticosteroids, or intercurrent infections. The approval by the Food and Drug Administration (FDA) was based on the results from the CAPItello-291 Phase III trial published earlier this year in The New England Journal of Medicine. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. fulvestrant alone in the biomarker-altered populationĪstraZeneca’s TRUQAP™ (capivasertib) in combination with fulvestrant has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations ( PIK3CA, AKT1 or PTEN). First-in-class AKT inhibitor has potential to reshape treatment forīreast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN)Īpproval based on CAPItello-291 results which showed this combination reduced the risk ofĭisease progression or death by 50% vs.
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