Capivasertib Application Scope

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 with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Capivasertib Characteristics

Ingredients: Capivasertib
Properties: Serine/threonine kinase inhibitor
Packaging Specification: 160 mg and 200 mg tablets
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Expiry Date: As per manufacturer labeling
Executive Standard: As per FDA and EMA guidelines
Approval Number: FDA: 218197; EMA: EMA/CHMP/1084/2024
Date of Revision: As per latest labeling updates
Manufacturer: AstraZeneca

Guidelines for the Use of Truqap

Dosage and Administration:
- Recommended Dose: 400 mg orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off. Continue until disease progression or unacceptable toxicity.
- Administration: Oral tablets
- Missed Dose: If a dose is missed, administer as soon as possible. Resume the dosing schedule from the most recently administered dose.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Injection site reactions (19%)
  - Decreased platelet count (12%)
  - Arthralgia (9%)
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.
Contraindications: Patients with a history of serious hypersensitivity to it or any of the excipients in Truqap.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Capivasertib Interactions

Drug Interactions: It is metabolized by CYP3A4. Co-administration with strong CYP3A4 inhibitors or inducers may alter it plasma concentrations.
Food Interactions: It can be taken with or without food.
Laboratory Test Interactions: It may affect laboratory tests, including liver function tests.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.