Capivasertib

What it is and how it works

Capivasertib is an oral, potent inhibitor of all three AKT isoforms (AKT1, AKT2, AKT3). By blocking signalling through the PI3K/AKT/PTEN pathway, which is frequently activated in hormone receptor-positive breast cancer, it inhibits tumour-cell proliferation and survival.

Indications

In combination with fulvestrant for adults with oestrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1 or PTEN alterations, following recurrence or progression on or after an endocrine-based regimen.

Dosage and administration (summary)

Oral: 400 mg twice daily (about 12 hours apart) for 4 days, followed by 3 days without treatment, in each weekly cycle, with fulvestrant; dose reductions for adverse reactions per label.

Contraindications

Hypersensitivity to capivasertib or any excipient.

Warnings and precautions

Hyperglycaemia, including diabetic ketoacidosis, may occur; check fasting glucose and HbA1c before and during treatment. Diarrhoea and cutaneous adverse reactions (including erythema multiforme and drug reaction with eosinophilia) are common and may require interruption or dose reduction. Avoid strong CYP3A4 inhibitors (or reduce the dose) and strong CYP3A4 inducers.

Pregnancy

Not recommended in pregnancy; effective contraception is required during treatment and for a period after the last dose.

Storage and supply

No special storage conditions; store in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.