🟩 Ribotix

Generic Name: Ribociclib
Brand Name: Ribotix
Manufacturer: Beacon Pharmaceuticals Ltd.
Dosage Form & Strength: Tablet (Available in multiple strengths such as 200 mg)
Therapeutic Class: Anticancer | CDK4/6 Inhibitor

📌 Indications:

Ribotix (Ribociclib) is indicated for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic breast cancer.

It is:

• Used in combination with an aromatase inhibitor as initial endocrine-based therapy.

• Used in combination with fulvestrant in patients with disease progression after endocrine therapy.

💊 Pharmacology:

Ribociclib is a selective cyclin-dependent kinase (CDK) 4 and 6 inhibitor.

• CDK4 and CDK6 are critical regulators of cell cycle progression.

• By inhibiting these kinases, Ribotix prevents phosphorylation of the retinoblastoma protein (Rb).

• This leads to cell cycle arrest at the G1 phase, thereby slowing down cancer cell proliferation.

• The therapy is especially effective in HR+ / HER2– breast cancers, where cell cycle dysregulation is common.

💉 Dosage & Administration:

• Recommended Dose: 600 mg orally once daily (usually 3 tablets of 200 mg each) for 21 consecutive days, followed by 7 days off-treatment (28-day cycle).

• Administered in combination with endocrine therapy (letrozole, anastrozole, or fulvestrant).

• Tablets should be swallowed whole, with or without food.

• Dose adjustments may be required based on patient tolerance and adverse effects.

⚠️ Treatment must be initiated and supervised by an oncologist.

⚠️ Precautions & Warnings:

• Neutropenia: Frequent monitoring of complete blood count (CBC) is required.

• QT interval prolongation: Regular ECG monitoring recommended.

• Hepatotoxicity: Monitor liver function tests before and during treatment.

• Infections: Patients are at increased risk due to myelosuppression.

• Drug Interactions: Ribociclib is metabolized by CYP3A4; avoid strong CYP3A inhibitors/inducers.

❌ Contraindications:

• Known hypersensitivity to Ribociclib or excipients.

• Severe uncontrolled cardiac disease.

• Patients with baseline prolonged QT interval.

🤰 Pregnancy & Lactation:

• Pregnancy: May cause fetal harm. Contraception must be used during treatment and at least 3 weeks after the last dose.

• Lactation: Not recommended; potential harm to infants.

⚕️ Side Effects:

Common:

• Neutropenia

• Leukopenia

• Fatigue, headache

• Nausea, vomiting, diarrhea

• Rash

• Alopecia

Serious:

• Severe neutropenia with infection risk

• Hepatotoxicity

• QT interval prolongation

• Pulmonary toxicity (rare cases of interstitial lung disease/pneumonitis)

🧊 Storage Conditions:

• Store below 30°C, in a cool, dry place.

• Protect from light and moisture.

• Keep out of reach of children.