Truqap Adverse Reactions

Summary of safety profile: The summary of safety profile of TRUQAP is based on data from 355 patients who received TRUQAP plus fulvestrant in the phase III (CAPItello-291) study. The median duration of exposure to capivasertib in CAPItello-291 was 5.42 months, with 27% patients exposed ≥12 months.
The most common adverse reactions were diarrhoea (72.4%), rash (40.3%), nausea (34.6%), fatigue (32.1%), vomiting (20.6%), stomatitis (17.2%), hyperglycaemia (16.9%), headache (16.9%) and decreased appetite (16.6%).
The most common grade 3 or 4 adverse reactions were rash (12.4%), diarrhoea (9.3%), hyperglycaemia (2.3%), hypokalaemia (2.3%), anaemia (2.0%) and stomatitis (2.0%).
Serious adverse reactions were seen in 6.8% of patients receiving TRUQAP plus fulvestrant. Most common serious adverse reactions reported in patients receiving TRUQAP plus fulvestrant included rash (2.3%), diarrhoea (1.7%) and vomiting (1.1%).
Dose reductions due to adverse reactions were reported in 17.7% of patients. The most common adverse reactions leading to dose reduction of TRUQAP were diarrhoea (7.9%) and rash (4.5%).
Treatment discontinuation due to adverse reactions occurred in 9.6% of patients. The most common adverse reactions leading to treatment discontinuation were rash (4.5%), diarrhoea (2%) and vomiting (2%).
Tabulated list of adverse reactions: Table 9 lists the adverse reactions based on pooled data from patients treated with TRUQAP plus fulvestrant in clinical studies at the recommended dose.
Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data). (See Table 9.)

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Description of selected adverse reactions: Hyperglycaemia: Hyperglycaemia of any grade occurred in 60 (16.9%) patients and grade 3 or 4 occurred in 8 (2.3%) patients receiving TRUQAP. The median time to first occurrence of hyperglycaemia was 15 days (range: 1 to 367). In the study, dose reduction was required in 2 (0.60%) patients and 1 (0.30%) patient discontinued treatment due to hyperglycaemia. In the 60 patients with hyperglycaemia, 28 (46.7%) patients were treated using anti-hyperglycaemic medication (including insulin in 16.7%). See Precautions.
Diarrhoea: Diarrhoea occurred in 257 (72.4%) patients receiving TRUQAP. Grade 3 and/or 4 diarrhoea occurred in 33 (9.3%) patients. The median time to first occurrence was 8 days (range 1 to 519). Dose reduction was required in 28 (7.9%) patients and 7 (2.0%) patients discontinued TRUQAP due to diarrhoea. In the 257 patients with diarrhoea, anti-diarrheal medication was required in 59% (151/257) of patients to manage diarrhoea symptoms.
Rash: Rash (including erythema, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, and rash pruritic) was reported in 143 (40.3%) patients. The median time to first occurrence of rash was 12 days (range 1-226). Grade 3 and/or 4 occurred in 44 (12.4%) of patients who received capivasertib. Erythema multiforme occurred in 6 (1.7%) patients and the highest grade was grade 3 in 3 (0.8%) of the patients. Dermatitis exfoliative generalised occurred in 2 (0.6%) patients, these events were grade 3 in severity. Dose reduction was required in 16 (4.5%) patients and 16 (4.5%) patients discontinued TRUQAP due to rash.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Drug Office of Department of Health and AstraZeneca.