Generic Name

Capivasertib

---

Classification

FDA Approved Indications

• Treatment of adult patients with specific types of breast cancer that have progressed after other treatments, under the designation of advanced or metastatic hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutations.

Mechanism of Action

Capivasertib selectively inhibits AKT kinase, a key component of the PI3K/AKT signaling pathway involved in tumor cell proliferation, survival, and metabolism, thereby exerting antitumor effects.

Dosage and Administration

Adult: The dosing regimen typically involves oral administration of 320 mg twice daily on schedules such as 4 days on, 3 days off in 28-day cycles, but specific regimens should be based on prescribing information.

Pediatric: Safety and efficacy in pediatric populations have not been established.

Geriatric: Use with caution; no specific dose adjustments are established, but monitor for toxicity.

Renal Impairment: Adjust dose based on severity; specific guidelines are limited.

Hepatic Impairment: No specific dosing recommendations provided; consider pharmacokinetic considerations.

Pharmacokinetics

Absorption: Well absorbed orally.

Distribution: Widely distributed in tissues, plasma protein binding approximately 89%.

Metabolism: Extensively metabolized in the liver via CYP3A4/5.

Excretion: Primarily excreted in feces; minor urinary excretion.

Half Life: Approximately 18 hours.

Contraindications

• Hypersensitivity to capivasertib or any component of the formulation.

Precautions

• Use with caution in patients with hepatic impairment, patients on concomitant medications affecting CYP3A4, or with other comorbidities. Monitor for signs of toxicity, including hyperglycemia and skin reactions. Pregnancy Category D; a risk to the fetus cannot be excluded. Effective contraception is recommended during treatment and for a period after stopping therapy.

Adverse Reactions - Common

• Nausea (Most patients)
• Diarrhea (Common)
• Hyperglycemia (Common)
• Fatigue (Common)

Adverse Reactions - Serious

• Hyperglycemic crisis (Serious but rare)
• Severe skin reactions (e.g., Stevens-Johnson syndrome) (Rare)
• QTc prolongation (Rare)

Drug-Drug Interactions

• CYP3A4 inhibitors or inducers may alter capivasertib levels.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed.
• Report any severe skin reactions, persistent diarrhea, or symptoms of hyperglycemia.
• Keep appointments for laboratory tests to monitor side effects.

Special Considerations

Black Box Warnings:

• Potential for severe hyperglycemia and new or worsening diabetes.

Genetic Factors: None specifically identified.

Lab Test Interference: May affect blood glucose monitoring; coordinate with lab testing protocols.

Overdose Management

Signs/Symptoms: Severe dehydration, hyperglycemia, gastrointestinal symptoms.

Treatment: Supportive care, manage hyperglycemia as per standard protocols, and seek immediate medical attention.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions until the expiration date.