Lucicapiva Capivasertib 200mg Tablets 64's

Capivasertib 200 mg tablets contain the active ingredient capivasertib, an oral targeted anticancer medicine belonging to the class of AKT kinase inhibitors.

Capivasertib works by inhibiting AKT, a key protein involved in signaling pathways that regulate cancer cell growth, survival, and proliferation. Abnormal activation of the PI3K/AKT pathway can contribute to the development and progression of cancer. By blocking AKT signaling, capivasertib helps inhibit tumor cell growth.

The 200 mg strength is available as a film-coated tablet. The approved recommended dosage is generally 400 mg twice daily for 4 days, followed by 3 days without treatment, although dosage modifications may be required depending on tolerability and drug interactions.

HR-positive, HER2-negative advanced or metastatic breast cancer

In combination with fulvestrant for adults with hormone receptor (HR)-positive, HER2-negative, locally advanced, or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence during/within 12 months of completing adjuvant therapy.

PTEN-deficient metastatic prostate cancer

In combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or androgen pathway modulation-sensitive prostate cancer that is PTEN-deficient, as identified by an FDA-authorized test. This indication was approved by the FDA in June 2026.

Capivasertib is a selective AKT inhibitor.

It works by:

• Inhibiting AKT1, AKT2 and AKT3 signaling.
• Blocking signaling pathways involved in cancer cell growth and survival.
• Reducing proliferation of tumor cells.
• Interfering with abnormal PI3K/AKT pathway activity.
• Helping slow tumor progression in cancers driven by relevant molecular alterations.

For breast cancer, treatment selection is based on the presence of PIK3CA, AKT1, or PTEN alterations. For the newly approved prostate-cancer indication, treatment selection is based on PTEN deficiency.

• Capivasertib is taken orally twice daily, approximately 12 hours apart.
• The recommended dose is 400 mg twice daily—equivalent to two 200 mg tablets per dose.
• Take for 4 consecutive days, followed by 3 days off treatment.
• It may be taken with or without food.
• Swallow tablets whole with water.
• Do not crush, chew, or split the tablets.
• Continue treatment as prescribed until disease progression or unacceptable toxicity.

If a dose is missed by 4 hours or less, it may be taken when remembered. If it is more than 4 hours late, the missed dose should be skipped and the next dose taken at the normal time.

If vomiting occurs after taking a dose, do not take an additional dose; take the next dose at its scheduled time.

Serious:

• Severe hyperglycemia, including diabetic ketoacidosis
• Severe diarrhea and dehydration
• Serious cutaneous adverse reactions
• Severe hypersensitivity, including anaphylactic reactions
• Renal injury
• Pneumonia
• Significant abnormalities in blood cell counts
• Serious infection/sepsis

Capivasertib can cause clinically significant increases in blood glucose, and fasting glucose and HbA1C should be evaluated before treatment and monitored regularly.

Common:

• Diarrhea
• Skin reactions/rash
• Nausea
• Fatigue
• Vomiting
• Stomatitis (mouth sores)
• Decreased appetite
• Headache
• Increased blood glucose
• Decreased lymphocyte count
• Decreased hemoglobin
• Decreased white blood cells
• Increased triglycerides
• Increased creatinine
• Decreased neutrophils

In the CAPItello-291 breast-cancer study, diarrhea occurred in approximately 77%, cutaneous adverse reactions in 56%, fatigue in 38%, nausea in 35%, and vomiting in 21% of patients receiving capivasertib with fulvestrant.

Patients should inform their healthcare provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements they are taking.

Capivasertib is metabolized primarily through CYP3A4, making CYP3A interactions clinically important.

Medicines requiring particular attention include:

• Strong CYP3A inhibitors—concomitant use should generally be avoided; if unavoidable, capivasertib dosage reduction and monitoring are required.
• Moderate CYP3A inhibitors—capivasertib dosage reduction is recommended.
• Strong and moderate CYP3A inducers—concomitant use should generally be avoided because they can reduce capivasertib exposure and potentially decrease its effectiveness.
• Capivasertib can also affect the exposure of certain medicines metabolized through CYP3A and other transport/metabolic pathways.

Patients should not start or stop taking medicines without consulting their treating physician.

Grapefruit and grapefruit juice should be avoided during treatment.

• Store at 20°C–25°C (68°F–77°F).
• Temperature excursions between 15°C and 30°C (59°F and 86°F) are permitted.
• Keep tablets in the original packaging.
• Protect from excessive heat and moisture.
• If tablets are dispensed outside the original packaging as permitted by the labeling, unused tablets should be discarded after 45 days.
• Keep out of reach of children.

• Monitor fasting blood glucose and HbA1C regularly, particularly because significant hyperglycemia can occur.
• Report excessive thirst, frequent urination, blurred vision, confusion, difficulty breathing, or unexplained weight loss promptly.
• At the first sign of significant diarrhea, maintain adequate fluid intake and contact your healthcare provider regarding appropriate antidiarrheal treatment.
• Report new or worsening skin rash, peeling, blistering, or other serious skin reactions immediately.
• Avoid grapefruit and grapefruit juice during treatment.
• Inform your physician about all medicines and supplements because capivasertib has important CYP3A drug interactions.
• Follow the 4-days-on/3-days-off dosing schedule exactly.
• Regular blood tests may be required to monitor glucose, blood counts, liver function, kidney function, and other laboratory parameters.
• Do not alter or discontinue treatment without consulting your oncologist.
• For breast cancer, appropriate molecular testing for PIK3CA/AKT1/PTEN alterations is important before treatment.
• For PTEN-deficient metastatic prostate cancer, appropriate PTEN testing is required to identify eligible patients.