Truqap Special Precautions

Hyperglycaemia: Severe hyperglycaemia, associated with diabetic ketoacidosis (DKA) and ketoacidosis, was reported in patients treated with TRUQAP (see Adverse Reactions). Some cases of DKA have been reported with fatal outcomes. DKA can occur at any time during TRUQAP treatment. In some reported cases, DKA developed in less than 10 days.
Hyperglycaemia of any grade occurred in 60 (16.9%) patients and grade 3 or 4 occurred in 8 (2.3%) patients receiving TRUQAP. In the study, dose reduction was required in 2 (0.6%) patients and 1 (0.3%) 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 10 (16.7%) patients).
Before initiating treatment with TRUQAP, inform patients about TRUQAP's potential to cause hyperglycaemia and request for them to immediately contact their healthcare professional if hyperglycaemia symptoms (e.g., excessive thirst, urinating more often than usual or greater amount of urine than usual, increased appetite with weight loss) occur. In a setting of additional co-morbidities and treatments (e.g. dehydration, malnourishment, concurrent chemotherapy/steroids, sepsis) the risk of hyperglycaemia progressing to diabetic ketoacidosis may be higher. DKA should be considered as one of the differential diagnoses in the event of additional non-specific symptoms such as nausea, vomiting, abdominal pain, difficulty breathing, fruity odour on breath, confusion, unusual fatigue, or sleepiness. In patients where DKA is suspected, TRUQAP treatment should be interrupted immediately. If DKA is confirmed, then TRUQAP should be permanently discontinued.
Patients must be tested for fasting blood glucose (FG) levels and HbA1C prior to start of treatment with TRUQAP and in accordance with the intervals stated in Table 8. Based on the severity of hyperglycaemia, TRUQAP dosing may be interrupted, reduced, or permanently discontinued (see Table 4 under Dosage & Administration).
More frequent blood glucose monitoring is recommended in patients that develop hyperglycaemia during treatment, those with baseline risk factors for DKA (including but not exclusive to diabetes mellitus, pre-diabetes, those receiving regular oral steroids) and in those that develop risk factors for DKA during treatment (e.g., infection, sepsis, raised HbA1c) (see Table 8). In addition to FG, monitoring of ketones (preferably in blood) and other metabolic parameters (as indicated) is recommended when a patient experiences hyperglycaemia.
In addition to the recommended management of hyperglycaemia described in Table 4 under Dosage & Administration, counselling on lifestyle changes is recommended for patients with baseline risk factors and those that develop hyperglycaemia during treatment with TRUQAP.
The safety of TRUQAP in patients with Type 1 and Type 2 diabetes requiring insulin has not been studied as these patients were excluded from the clinical study. Patients with history of diabetes mellitus may require intensified diabetic treatment and should be closely monitored. (See Table 8.)

Click on icon to see table/diagram/image

Diarrhoea: Severe diarrhoea associated with dehydration occurred in patients who received TRUQAP.
Diarrhoea occurred in 257 (72.4%) patients receiving TRUQAP. Grade 3 and/or 4 diarrhoea occurred in 33 (9.3%) patients. 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, antidiarrheal medication was required in 59% (151/257) of patients to manage diarrhoea symptoms.
Based on the severity of diarrhoea, TRUQAP dosing may be interrupted, reduced, or permanently discontinued (see Table 5 under Dosage & Administration). Advise patients to start anti-diarrheal treatment at the first sign of diarrhoea, increase oral fluids if diarrhoea symptoms occur while taking TRUQAP. Maintenance of normovolaemia and electrolyte balance is required in patients with diarrhoea to avoid complications related to hypovolaemia and low electrolyte levels.
Cutaneous Adverse Reactions: Cutaneous 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.
Rash (including erythema, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, and rash pruritic) was reported in 143 (40.3%) patients. Grade 3 and/or 4 occurred in 44 (12.4%) of patients who received capivasertib. Dose reduction was required in 16 (4.5%) patients and 16 (4.5%) patients discontinued TRUQAP due to rash.
Patients should be monitored for signs and symptoms of rash or dermatitis and based on severity of skin drug reactions the dosing may be interrupted, reduced, or permanently discontinued (see Table 6 under Dosage & Administration). Early consultation with a dermatologist is recommended to ensure greater diagnostic accuracy and appropriate management.
Effects on ability to drive and use machines: TRUQAP has no influence on the ability to drive and use machines. However, during treatment with capivasertib, fatigue has been reported and those patients who experience this symptom should be advised to observe caution when driving or operating machinery.