Truqap Special Precautions

Hyperglycaemia: The safety and efficacy of TRUQAP in patients with pre-existing Type 1 diabetes or Type 2 diabetes requiring insulin and/or in patients with HbA1C ˃8.0% (63.9 mmol/mol) has not been studied as these patients were excluded from the phase III clinical study. This study included 21 (5.9%) patients in the TRUQAP plus fulvestrant arm with HbA1C ≥6.5%. Hyperglycaemia was more frequently reported in patients with a baseline HbA1C ≥6.5% (28.6% of patients) than those with a baseline HbA1C <6.5% (15.4%). Severe hyperglycaemia, associated with ketoacidosis, occurred in patients treated with TRUQAP. Patients with history of diabetes mellitus may require intensified anti-diabetic treatment and should be closely monitored. Consultation with a diabetologist or a healthcare professional experienced in the treatment of hyperglycaemia is recommended for patients with diabetes.
Before initiating treatment with TRUQAP, patients should be informed about TRUQAP's potential to cause hyperglycaemia (see Adverse Reactions) and 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, or increased appetite with weight loss) occur. Patients should be tested for fasting blood glucose (FG) levels and HbA1C prior to treatment with capivasertib and at regular intervals during treatment (see Table 8).

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Diarrhoea: Diarrhoea has been reported in the majority of the patients treated with TRUQAP (see Adverse Reactions). Clinical consequences of diarrhoea may include dehydration, hypokalaemia and acute kidney injury which have all, together with cardiac arrhythmias (with hypokalaemia as risk factor) been reported during treatment with TRUQAP. Based on the severity of diarrhoea, TRUQAP dosing may be interrupted, reduced, or permanently discontinued (see Dosage & Administration, Table 5). Advise patients to start anti-diarrhoeal treatment at the first sign of diarrhoea, increase oral fluids if diarrhoea symptoms occur while taking TRUQAP. Maintenance of normovolemia and electrolyte balance is required in patients with diarrhoea to avoid complications related to hypovolemia and low electrolyte levels.
Rash and other skin drug reactions: Skin drug reactions, including erythema multiforme and dermatitis exfoliative generalised, were reported in patients receiving TRUQAP (see Adverse Reactions). 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 (Dosage & Administration, Table 6). Early consultation with a dermatologist is recommended to ensure greater diagnostic accuracy and appropriate management.
Patients excluded from the study: The efficacy and safety of this medicinal product have not been studied in patients with symptomatic visceral disease. The patients with history of clinically significant cardiac disease including QTcF >470 msec, any factors that increased the risk of QTc prolongation or risk of arrhythmic events or risk of cardiac function impairment, or patients with pre-existing Type 1 diabetes and Type 2 diabetes requiring insulin, and patients with HbA1C ˃8.0% (63.9 mmol/mol) were excluded from CAPItello-291. This should be considered if TRUQAP is prescribed in these patients.
Other medicinal products: Co-administration of strong or moderate CYP3A4 inhibitors with TRUQAP may lead to increased capivasertib exposure and consequently a higher risk of toxicity. Refer to Dosage & Administration regarding TRUQAP dose modification when co-administered with CYP3A4 inhibitors.
On the contrary, co-administration of strong and moderate CYP3A4 inducers may lead to decreased capivasertib exposure. Concomitant administration of strong and moderate CYP3A4 inducers and TRUQAP should be avoided.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: TRUQAP may have a minor influence on the ability to drive and use machines because fatigue, dizziness and syncope have been reported during treatment with capivasertib (see Adverse Reactions).