What information does the detailed instructions for Carpiseti/Tunicate include?

1. Name: Capivasertib, Capivasertib

Product name: Truqap, Tsuenkode

Other names: capositinib, AZD5363

2. Indications

Capivasertib/Capivasertib is used in combination with fulvestrant to treat the following patients:

Adults with hormone receptor (HR)-positive breast cancer.

Human epidermal growth factor receptor2 (HER2) negative.

Patients with locally advanced or metastatic breast cancer.

The breast cancer must have one or more PIK3CA, AKT1, or PTEN gene alterations confirmed by an FDA-approved test. Patients must have progressed on at least one endocrine-based regimen or relapse within 12 months of completing adjuvant therapy.

3. Usage and dosage

1. Preparation before medication: Before starting to use Carpisete Tablets and during treatment, patients need to regularly detect fasting blood glucose (FG) and glycated hemoglobin (HbA1C). Doctors will decide whether to use Truqap based on the presence of genetic changes in the tumor tissue.

2. Recommended dose: The recommended dose of Capisete tablets combined with fulvestrant is 400 mg, administered orally twice a day (approximately 12 hours apart), with or without food, for 4 consecutive days and then 3 days off. Patients need to continue to use Carpizote tablets until the disease worsens or adverse reactions occur.

3. Dosage adjustment:

If a patient develops an adverse reaction while taking Capisete Tablets , the dose needs to be adjusted based on its severity. The initial dose can be reduced to 320 mg twice a day for 4 consecutive days, followed by 3 days of discontinuation; if still intolerable, it can be reduced to 200 mg twice a day for 4 consecutive days with 3 days of discontinuation. If the second dose is still not tolerated, permanent discontinuation is requiredCarpiset tablets.

4. Adverse reactions

In clinical studies of Capisete tablets, common adverse reactions (incidence rate ≥20%) include: diarrhea, skin adverse reactions, random increase in blood sugar, decrease in lymphocytes, decrease in hemoglobin, increase in fasting blood glucose, nausea, fatigue, leukopenia, increase in triglycerides, neutropenia, increase in creatinine, vomiting, and stomatitis.

5. Storage

Carpiseti tablets should be stored in the original bottle at 20°C to 25°C (68°F to 77°F), with a permitted temperature deviation of 15°C to 30°C (59°F to 86°F).

6. Taboo

Capivasertib tablets are contraindicated in patients with severe allergic reactions toCapivasertib or any of its components. Capivasertib tablets are contraindicated.

7. Special groups

1. Women: According to animal research results, Carpisete Tablets may cause fetal harm to pregnant women. It is recommended to avoid breastfeeding during use. It is recommended that females of reproductive potential use effective contraception during treatment and for 1 month after the last dose.

2. Males: Male patients of reproductive potential need to take effective contraceptive measures during treatment and within 4 months after the last dose.

8. Mechanism of action

Capivasertib Active ingredientCapivasertib is an inhibitor of the serine/threonine kinase AKT, which can effectively inhibit the activity of all three isoforms (AKT1, 2, and 3). By inhibiting the phosphorylation of AKT substrates, carpisetin can slow tumor growth. In experiments, carpisetin was shown to reduce the proliferation of breast cancer cell lines, even those with PIK3CA or AKT1 mutations or PTEN alterations. In animal models, carpisetin can effectively inhibit tumor growth, both alone and in combination with fulvestrant, especially in estrogen receptor-positive breast cancer models with altered PIK3CA, AKT1, and PTEN.

Reference materials:https://www.drugs.com/mtm/capivasertib.html