capivasertib: clinical use

Prescribing considerations

• Confirm HR-positive, HER2-negative disease and a qualifying PIK3CA, AKT1 or PTEN alteration using a validated test.
• Treatment should be initiated and supervised by a clinician experienced in anticancer therapy and co-administered with fulvestrant.
• Review glucose status, diabetes history, infection, diarrhoea, skin disease, renal and hepatic function, corticosteroids and interacting medicines.
• Safety and pharmacokinetics have not been established in severe renal or hepatic impairment; moderate hepatic impairment requires careful benefit-risk assessment and close observation.
• Consider additional monitoring in older patients because severe adverse events and treatment changes were more frequent in trial participants aged 65 years or older.

Contraindications and cautions

• Hypersensitivity to capivasertib or any tablet excipient.

Monitoring

• Fasting blood glucose and HbA1c before and during treatment, with intensified glucose and ketone monitoring when risk factors occur.
• Assess promptly for diarrhoea, dehydration and electrolyte disturbance.
• Monitor for rash and dermatitis; seek early dermatology input for significant reactions.
• Monitor renal and hepatic parameters as clinically indicated.
• Monitor oral and jaw symptoms in patients receiving bisphosphonates or RANK-ligand inhibitors.
• Review pregnancy status and contraception where relevant.

Clinical pharmacology

Capivasertib is an oral, selective pan-AKT kinase inhibitor. It is rapidly absorbed, primarily metabolised by CYP3A4 and UGT2B7, and has no identified active metabolites; elimination is mainly metabolic.

Formulation and product differences

• The selected product is a beige, round, biconvex film-coated tablet marked “CAV” above “160”.
• Tablets must remain intact and must not be divided, crushed, chewed or dissolved.
• The formulation is essentially sodium-free and requires no special storage conditions.

Tablet

Route: Oral

Strengths: 160 mg, 200 mg