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Capivasertib(Truqap)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

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Formulation:

TABLET

Validity period:

The expiration date is specified on the packaging. Do not use the medication beyond this date.

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

TRUQAP® (capivasertib) is an oral, small-molecule kinase inhibitor targeting all three isoforms of serine/threonine kinase AKT (AKT1, AKT2, AKT3). By blocking AKT phosphorylation and downstream signaling, TRUQAP disrupts oncogenic pathways driven by *PIK3CA/AKT1/PTEN* alterations, which are implicated in resistance to endocrine therapies. Approved by the U.S. FDA in 2023, it is administered in combination with fulvestrant, an estrogen receptor antagonist, to enhance antitumor efficacy in HR-positive/HER2-negative advanced breast cancer.

The approval is based on the CAPItello-291 trial, a randomized Phase III study demonstrating significant improvement in progression-free survival (PFS) versus placebo-fulvestrant (median PFS: 7.3 vs. 3.1 months; HR=0.50, p<0.0001) in the biomarker-positive subgroup. Common adverse reactions include hyperglycemia (57%), diarrhea (72%), cutaneous reactions (58%), and cytopenias. Rigorous glucose monitoring, proactive management of diarrhea, and dermatologic assessments are critical due to risks of diabetic ketoacidosis, dehydration, and severe skin toxicities. Dose adjustments or discontinuation may be required based on severity.

Generic name

Capivasertib(Truqap)

English name

Capivasertib

Alternative Names

Truqap

Drug prices

Indications

TRUQAP is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adult patients. This includes those 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.

Therapeutic Target

AKT pathway

Active Ingredients

Capivasertib

Dosage form

TABLET

specifications

Description

TRUQAP (Capivasertib) is an oral kinase inhibitor designed to target and inhibit the activity of AKT, a protein kinase involved in critical signaling pathways associated with cancer cell survival, growth, and proliferation. It is used in combination with fulvestrant for the treatment of specific types of breast cancer that harbor PIK3CA, AKT1, or PTEN alterations. The drug has demonstrated effectiveness in patients with HR-positive, HER2-negative breast cancer who have progressed on endocrine-based therapy or experienced recurrence within 12 months after completing adjuvant therapy.

Dosage and Administration

The recommended dose of TRUQAP is 240 mg once daily, taken orally in combination with fulvestrant, unless otherwise directed by a healthcare provider. The treatment should be continued until disease progression or unacceptable toxicity.

Key Points for Dosage Administration:

Administer TRUQAP with or without food.

If a dose is missed, take the dose as soon as possible, unless it is almost time for the next dose. Do not take two doses at once.

Adjust the dosage based on tolerability and clinical response.

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