Big Bear Capivasertib CAPIVADX 200mg

Product Information

• Product name: Capivasertib CAPIVADX 200mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Capivasertib
• Current strength: 200mg
• SKU: BB-ITEM-77
• Site category: AKT1 target, PIK3CA target, other cancer

Product Summary

Capivasertib CAPIVADX 200mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Capivasertib is the active ingredient used for this product page. Public prescribing information for Capivasertib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Capivasertib is an inhibitor of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2 and AKT3) and inhibits phosphorylation of downstream AKT substrates. AKT activation in tumors is a result of activation of upstream signaling pathways, mutations in AKT1 , loss of phosphatase and tensin homolog (PTEN) function and mutations in the catalytic subunit alpha of phosphatidylinositol 3-kinase ( PIK3CA ).

Reference 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 with one or more PIK3CA/AKT1/PTEN -alteration 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.

Reference Dosage and Administration

Recommended Dosage: 400 mg orally twice daily, with or without food, for 4 days followed by 3 days off.

With this 200mg product, that corresponds to 2 x 200mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Hyperglycemia: Capivasertib can cause hyperglycemia. Evaluate blood glucose levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue Capivasertib based on severity. ( 2.2 , 2.4 , 5.1 ) Diarrhea: Capivasertib caused diarrhea in most patients. Advise patients to increase oral fluids, start antidiarrheal treatment, and consult with a healthcare provider if diarrhea occurs while taking Capivasertib. Withhold, reduce dose, or permanently discontinue Capivasertib based on severity. Withhold, reduce dose, or permanently discontinue Capivasertib based on severity. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity: Capivasertib can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. Refer to the of fulvestrant for pregnancy and contraception information.

Common Adverse Reactions and Monitoring

Among the 355 patients who received Capivasertib, 52% were exposed for 6 months or longer, and 27% were exposed for greater than one year. CAPItello-291 The safety of Capivasertib was evaluated in CAPItello-291, a clinical trial including 288 adult patients (155 patients in Capivasertib with fulvestrant arm and 133 patients in placebo with fulvestrant arm) whose breast cancer had one or more PIK3CA/AKT1/PTEN -alterations . Among patients who received Capivasertib, 61% were exposed for 6 months or longer and 30% were exposed for greater than one year. Permanent Capivasertib discontinuation due to an adverse reaction occurred in 10% of patients.

Drug Interactions and Special Populations

Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce Capivasertib dose. ( 2.5 , 7.1 ) Moderate CYP3A Inhibitors: Reduce Capivasertib dose. ( 2.5 , 7.1 ) Strong and Moderate CYP3A Inducers: Avoid concomitant use. Prevention or Management Avoid concomitant use with a strong CYP3A inhibitor. Moderate CYP3A Inhibitors Clinical Impact Capivasertib is a CYP3A substrate. Strong and Moderate CYP3A Inducers Clinical Impact Capivasertib is a CYP3A substrate. Strong and moderate CYP3A inducers decrease capivasertib exposure , which may reduce the effectiveness of Capivasertib. Prevention or Management Avoid concomitant use of Capivasertib with strong or moderate CYP3A inducers. Lactation: Advise not to breastfeed. Refer to the of fulvestrant for pregnancy information.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: TRUQAP public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.