Capivasertib is a kinase inhibitor developed by AstraZeneca, which was first approved for marketing in the United States in 2023. When used in combination with fulvestrant, this medication is indicated for specific types of patients with advanced or metastatic breast cancer.
What Are the Indications of Capivasertib?
Indications
Capivasertib, in combination with fulvestrant, is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.
These patients must harbor at least one genetic alteration in PIK3CA, AKT1, or PTEN, and have experienced disease progression following at least one endocrine therapy regimen, or recurrence within 12 months after completing adjuvant therapy.
Patient selection must be based on confirmation of the aforementioned genetic alterations in tumor tissue using a detection method approved by the U.S. FDA.
Dosage Form, Strength and Properties of Capivasertib
Strength
160 mg tablet: Round, biconvex, beige film-coated tablet, engraved with "160" above "CAV" on one side, and blank on the other side.
200 mg tablet: Capsule-shaped, biconvex, beige film-coated tablet, engraved with "CAV200" on one side, and blank on the other side.
Properties
The active ingredient of Capivasertib is capivasertib, with the chemical name 4-amino-N-[(1S)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide.
Its molecular formula is C₂₁H₂₅ClN₆O₂, and its molecular weight is 428.92 g/mol.
At room temperature, this medication exists as a white to off-white powder. Its solubility varies with pH: it is freely soluble in water at pH below 1.2, and practically insoluble at pH above 6.8.
Ingredients
The tablets also contain the following excipients: croscarmellose sodium, calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, etc.
The film coating layer contains copovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, medium-chain triglycerides, polydextrose, polyethylene glycol 3350, and titanium dioxide.
Storage Method of Capivasertib
Storage Temperature
The medication should be kept in its original packaging and stored at 20°C to 25°C (68°F to 77°F).
Brief deviations to the range of 15°C to 30°C (59°F to 86°F) are permitted.
Handling After Opening
If the medication is repackaged from the original bottle into another container, a tight container meeting USP standards should be used.
The repackaged medication should be stored at 20°C to 25°C and used up within 45 days; any unused medication beyond this period should be discarded.
Precautions
Keep the packaging protected from moisture and light.
Store it out of the reach of children, as its packaging is designed with child-resistant features.
Do not take any tablets that are broken, cracked, or incomplete.
