Valamor Tablets — Ribociclib 200 mg (63 Tabs) Farmanova

Prescribed by an oncologist for the treatment of women with:

• 🔹 Breast Cancer: Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
• 🔹 Combination Therapy: Used as initial endocrine-based therapy or following disease progression, in combination with an aromatase inhibitor (e.g., letrozole) or fulvestrant.

Sales Unit: Carton containing 63 film-coated tablets. Strength: 200 mg per tablet.

⚠️ APPLICATION INSTRUCTIONS:

• 28-Day Cycle Schedule: The recommended dose is 600 mg (three 200 mg tablets) taken once daily for 21 consecutive days, followed by a mandatory 7-day treatment-free period.
• Administration: Take at approximately the same time each day (preferably in the morning), with or without food. Tablets must be swallowed whole; do not chew, crush, or break them.
• ✋ Dietary Warning: Strictly avoid consuming grapefruit, grapefruit juice, and pomegranates during treatment, as they can increase the drug's toxicity in the blood.

• ⛔ Cardiac Conditions: Patients with congenital long QT syndrome or a significant prolongation of the QTcF interval on an ECG.
• Concomitant use with strong CYP3A4 inhibitors (certain antibiotics, antifungals).
• Severe hepatic impairment.
• Pregnancy and breastfeeding (highly teratogenic). Women of childbearing potential must use highly effective contraception during treatment and for at least 21 days after the last dose.

Treatment requires rigorous monitoring of complete blood counts, liver function tests, and ECGs. Potential side effects include:

• 🩸 Blood Counts: Neutropenia (very common, requires routine blood tests), leukopenia, anemia.
• 🫀 Cardiac: QT interval prolongation (risk of irregular heartbeat, requires ECG monitoring).
• 🟡 Liver: Elevated liver enzymes (ALT/AST), hepatotoxicity.
• 🤢 Gastrointestinal: Nausea, diarrhea, vomiting, decreased appetite.
• 💤 General: Severe fatigue, hair thinning (alopecia).