PIVITO FILM COATED TABLET

Indications

• Hormone receptor-positive breast cancer
• HER2-negative breast cancer
• Advanced or metastatic breast cancer

Dosage

Children: Not established; refer to pediatric dosing guidelines or clinical resources.

Adults: Refer to the specific product information or clinical guidelines for dosing recommendations.

Mechanism of action

Aipelisib exerts its anticancer effects by selectively inhibiting the alpha isoform of phosphatidylinositol 3-kinase (PI3K), which is involved in the PI3K/AKT/mTOR signaling pathway. This pathway plays a crucial role in cell growth, proliferation, and survival. By inhibiting PI3K, aipelisib disrupts the signaling cascade, leading to decreased cellular proliferation and promoting apoptosis in cancer cells.

Pharmacodynamics

The pharmacodynamics of aipelisib involve the inhibition of the PI3K signaling pathway, resulting in reduced tumor cell growth and survival. Studies have shown that the drug can lead to cell cycle arrest and enhanced apoptosis in cancer cells that are dependent on this pathway for growth. The efficacy of aipelisib is influenced by the genetic makeup of the tumor, particularly alterations in the PI3K pathway.

Pharmacokinetics

Aipelisib is absorbed orally, with peak plasma concentrations typically achieved within 1 to 4 hours. The drug has a high protein binding capacity and is metabolized primarily by CYP3A4. The elimination half-life is approximately 5 to 8 hours. Aipelisib is excreted mainly through the feces, with a smaller fraction eliminated in the urine. The pharmacokinetics can be affected by food intake, with a high-fat meal increasing the systemic exposure of the drug.

Contra-indications

• Hypersensitivity to aipelisib or any of its components
• Severe hepatic impairment

Adverse effects

• Diarrhea
• Nausea
• Fatigue
• Rash
• Appetite loss
• Mucositis
• Hyperglycemia
• Elevated liver enzymes

Interactions

• Strong CYP3A4 inhibitors may increase the risk of toxicity
• Strong CYP3A4 inducers may decrease the efficacy of aipelisib
• Concurrent use with other antineoplastic agents should be approached with caution

Precautions

• Monitor for symptoms of diarrhea and manage appropriately
• Regularly check blood glucose levels in patients with diabetes or at risk of hyperglycemia
• Assess liver function periodically due to potential hepatotoxicity
• Use caution in patients with a history of cardiac disorders

Pregnancy

Aipelisib may cause fetal harm. It is not recommended for use during pregnancy.

Breast-feeding

It is not known whether aipelisib is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

• Oral tablets