Abbreviated Prescribing Information
TRUQAP

Presentation: TRUQAP 160 mg or 200 mg film-coated tablets. Indications: TRUQAP in combination with fulvestrant is used to treat adult patients with oestrogen receptor (ER)-positive, HER2 negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. Dosage: 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. TRUQAP should be co‑administered with fulvestrant. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: Contraception: Women of childbearing potential should be advised to avoid becoming pregnant while receiving TRUQAP. Effective contraception should be used during the use of TRUQAP and for at least 4 weeks (females) or 16 weeks (males) after completion of treatment with TRUQAP. Pregnancy: TRUQAP is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding: breast-feeding should be discontinued during treatment with TRUQAP. Driving and using machines: TRUQAP may have a minor influence on the ability to drive and use machines. Interactions: Strong or moderate CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, substrates of CYP3A, CYP2D6 substrates with a narrow therapeutic index, CYP2B6 substrates with a narrow therapeutic index, UGT1A1 substrates with a narrow therapeutic index, hepatic and renal transporters. Undesirable effects: urinary tract infection, anaemia, hypersensitivity, hyperglycaemia, decreased appetite, hypokalaemia, headache, dysgeusia, dizziness, syncope, acute kidney injury, dry mouth, abdominal pain, diarrhoea, nausea, vomiting, stomatitis, dyspepsia, rash, pruritis, dry skin, erythema multiforme, dermatitis, dermatitis exfoliative generalized, toxic skin eruption, fatigue, mucosal inflammation, pyrexia, blood creatinine increased and glycosylated haemoglobin increased. Full local prescribing information is available upon request. API.HK.TRU.0924

HK-13085 02/06/2026