Truqap

Treatment with TRUQAP should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. 3 Patients with ER-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 which should be assessed by a CE-marked IVD with the corresponding intended purpose.

If the CE-marked IVD is not available, an alternative validated test should be used. Posology The recommended dose of TRUQAP is 400 mg (two 200 mg tablets) twice daily, approximately 12 hours apart (total daily dose of 800 mg), 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 on Days 1, 15, and 29, and once monthly thereafter. Refer to the Summary of Product Characteristics (SmPC) of fulvestrant for more information. Missed dose If a dose of TRUQAP is missed, it can be taken within 4 hours after the time it is usually taken.

After more than 4 hours, 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. Vomiting If the patient vomits, an additional dose should not be taken. The next dose of TRUQAP should be taken at the usual time.

Treatment duration 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 TRUQAP 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. 9 mmol/L No TRUQAP dose adjustment required.

Consider initiation or intensification of oral anti-diabetic treatmente. 9 mmol/L Withhold TRUQAP and initiate or intensify oral anti-diabetic treatment. 9 mmol/L) is reached within 28 days, restart TRUQAP at the same dose level and maintain initiated or intensified anti-diabetic treatment.

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. 2% patients exposed ≥ 12 months. 6%). 3%). Serious adverse reactions were seen in 9% of patients receiving TRUQAP plus fulvestrant.

1%). 9% of patients. 5%). 4% of patients. 3%) and vomiting (2%). Tabulated list of adverse reactions Table 8 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).

13 Table 8 Adverse drug reactions observed in patients treated with TRUQAP MedDRA SOC MedDRA term Any grade (%) Infections and infestations Urinary tract infection1 Very common Blood and lymphatic system disorders Anaemia Very common Immune system disorders Hypersensitivity2 Common Metabolism and nutrition disorders Hyperglycaemia3 Very common Decreased appetite Very common Hypokalaemia4 Common Diabetic ketoacidosis5 Uncommon Nervous system disorders Headache Very common Dysgeusia Common Dizziness Common Syncope Common Gastrointestinal disorder Diarrhoea2 Very common Nausea Very common Vomiting Very common Stomatitis6 Very common Dyspepsia Common Dry Mouth Common Abdominal pain Common Skin and subcutaneous tissue disorders Rash7 Very common Pruritus Very common Dry skin Common Erythema multiforme Common Drug eruption Uncommon Dermatitis Uncommon 14 MedDRA SOC MedDRA term Any grade (%) Dermatitis exfoliative generalised Uncommon Toxic skin eruption Uncommon Renal and urinary disorders Acute kidney injury Common General disorders and administration site conditions Fatigue8 Very common Mucosal inflammation Common Pyrexia9 Common Investigations Blood creatinine increased Common Weight Decreased Common Glycosylated haemoglobin increased Common 1 Urinary tract infection includes urinary tract infection and cystitis.

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). 5 Metformin is currently the preferred oral antidiabetic recommended for the management of hyperglycaemia occurring in patients participating in studies of capivasertib. Dosing and management of patients receiving the metformin and capivasertib combination requires caution.

g. OCT2] involved in the excretion of metformin), when taking both capivasertib and metformin concurrently, it is recommended weekly monitoring of creatinine after initiation of metformin, for up to 3 weeks and then on Day 1 of each cycle thereafter.

Metformin should only be given on the days when capivasertib is also administered (the half-life of capivasertib is approximately 8 hours) and should be withdrawn when treatment with capivasertib is withdrawn, unless otherwise clinically indicated.

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, monitor the patient and if clinically indicated interrupt TRUQAP dose for up to 28 days until recovery to ≤ Grade 1 and resume TRUQAP dosing at same dose, or one lower dose level as clinically indicated.

If Grade 2 diarrhoea is persistent or recurring, maintain appropriate medical therapy and restart TRUQAP at the next lower dose level, as clinically indicated. Grade 3 Interrupt TRUQAP. Initiate or intensify appropriate anti-diarrhoeal treatment and monitor as clinically indicated.

1.