Piciclib 125mg Capsule

About

Piciclib 125mg Capsule is an oral cyclin-dependent kinase (CDK) 4 and 6 inhibitor, primarily used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It works by selectively inhibiting CDK4 and CDK6, enzymes that play a crucial role in regulating cell cycle progression from the G1 to S phase. By blocking these kinases, Piciclib prevents cancer cells from dividing and proliferating, thereby slowing tumor growth.

This targeted therapy is often used in combination with an aromatase inhibitor or fulvestrant in postmenopausal women, or men, with HR+/HER2- breast cancer as initial endocrine-based therapy or after disease progression on prior endocrine therapy. The inhibition of CDK4/6 leads to G1 arrest, allowing for a more effective and sustained anti-tumor response, improving progression-free survival in eligible patients. Regular monitoring of blood counts is essential due to potential myelosuppression.

Uses

• Treatment of HR+/HER2- advanced or metastatic breast cancer.
• Used in combination with an aromatase inhibitor as initial therapy.
• Used with fulvestrant after progression on prior endocrine therapy.
• Management of specific hormone-sensitive malignancies.

Directions For Use

Take Piciclib 125mg Capsule orally once daily for 21 consecutive days, followed by 7 days off, to complete a 28-day cycle. Take with food at approximately the same time each day.

Benefits

• Significantly improves progression-free survival in breast cancer.
• Targets specific cell cycle regulators.
• Effective in combination with endocrine therapy.
• Oral administration for patient convenience.
• Offers a new treatment option for HR+/HER2- breast cancer.
• Helps to delay disease progression.

Side Effects

• Neutropenia (low white blood cell count)
• Leukopenia
• Fatigue
• Nausea
• Diarrhea
• Stomatitis
• Hair thinning or loss
• Infections
• Thrombocytopenia (low platelet count)
• Anemia
• Rash
• Abnormal liver function tests

Safety Measures

• Alcohol - Moderate alcohol intake is generally permissible, but excessive consumption may worsen side effects like nausea or fatigue.
• Pregnancy - Piciclib is embryofetal toxic. Women of reproductive potential must use effective contraception during treatment and for at least 3 weeks after the last dose.
• Breastfeeding - It is unknown if Piciclib is excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is not recommended.
• Liver - Dose adjustments are required for patients with moderate or severe hepatic impairment. Monitor liver function tests regularly.
• Kidney - Dose adjustments are required for patients with severe renal impairment. Monitor kidney function throughout treatment.
• Lung - Monitor for signs of interstitial lung disease (ILD) or pneumonitis, such as dyspnea, cough, or fever. Discontinue if ILD is confirmed.

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