Kisqali Generic – Ribokis Ribociclib 200mg HR+/HER2– Advanced or Metastatic Breast Cancer:
Ribociclib 200mg (Ribokis) is indicated for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in:
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Postmenopausal women in combination with an aromatase inhibitor as first-line endocrine therapy.
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Premenopausal and perimenopausal women when combined with an aromatase inhibitor plus an LHRH agonist.
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Combination with fulvestrant in women with disease progression following endocrine therapy.
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Adult men with HR+/HER2– metastatic breast cancer.
Pharmacology
Ribociclib is a selective CDK4/6 inhibitor that blocks the activity of cyclin-dependent kinases 4 and 6. These enzymes promote cell cycle progression from the G1 to S phase, enabling cancer cell division.
By inhibiting CDK4/6, Ribociclib:
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Prevents phosphorylation of Rb protein
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Causes G1 cell cycle arrest
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Reduces proliferation of HR+/HER2– breast cancer cells
This mechanism enhances the therapeutic effect of endocrine therapy.
Dosage & Administration
Oral Administration Only
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Recommended Dose: 600 mg once daily (three 200mg tablets)
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Schedule: 21 days on treatment, followed by 7 days off (28-day cycle)
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Can be taken with or without food
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Swallow tablets whole; do not crush, chew, or split
Dose Adjustments Required For:
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Grade 3–4 neutropenia
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Elevated liver enzymes
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QT interval prolongation
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Serious toxicities
Missed dose: skip and resume next scheduled dose.
Vomited dose: do not retake; resume regular dosing time.
Interaction
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Strong CYP3A4 inhibitors (ketoconazole, clarithromycin) ↑ Ribociclib levels — avoid.
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Strong CYP3A4 inducers (rifampicin, phenytoin) ↓ effectiveness — avoid.
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Avoid co-administration with QT-prolonging medications.
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Avoid grapefruit products.
Contraindications
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Hypersensitivity to Ribociclib
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Severe uncontrolled cardiac disease
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Concurrent use with strong CYP3A4 inhibitors
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Severe active infections
Side Effects
Common side effects:
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Neutropenia
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Nausea, vomiting
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Fatigue
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Alopecia
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Diarrhea
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Headache
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Elevated liver enzymes
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Rash
Serious adverse reactions:
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QT interval prolongation
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Hepatotoxicity
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Severe infections
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Pneumonitis
Seek immediate medical care for fever, chest pain, shortness of breath, or signs of infection.
Pregnancy & Lactation
Pregnancy
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Can cause fetal harm
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Not recommended during pregnancy
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Effective contraception required during treatment
Lactation
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Unknown if excreted in breast milk
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Breastfeeding is not recommended during therapy and for at least 3 weeks after the final dose
Precautions & Warnings
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CBC monitoring required regularly
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Monitor liver function in all cycles
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ECG monitoring required for QT interval
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Avoid use in patients with congenital long QT syndrome
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Discontinue temporarily in case of severe infection
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Be alert for symptoms of lung toxicity
Therapeutic Class
CDK4/6 Inhibitors — Targeted Anticancer Agents
Storage Conditions
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Store below 25°C
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Keep in original packaging
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Protect from moisture & light
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Keep out of reach of children
