Product image of Kisqali (Ribociclib) supplied by GNH India

Kisqali

Active Ingredient:
Ribociclib
Origin:
EU

Kisqali (Ribociclib)

Ribociclib, the active ingredient in Kisqali, is a CDK4/6 inhibitor presented as an unknown strength/unknown form for oral use. It treats hormone receptor‑positive, HER2‑negative advanced or metastatic breast cancer in adults.
GNH India supplies Kisqali as a licensed, GDP-compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Kisqali is a CDK4/6 inhibitor used in the management of hormone‑driven breast cancer pathways.

  • Hormone receptor‑positive, HER2‑negative advanced breast cancer: combined with an aromatase inhibitor to delay disease progression.
  • Hormone receptor‑positive, HER2‑negative metastatic breast cancer: combined with fulvestrant to improve progression‑free survival.
  • Post‑menopausal women with HR+ HER2‑negative breast cancer: used with endocrine therapy to extend treatment benefit.

How It Works

  • Ribociclib selectively inhibits cyclin‑dependent kinases 4 and 6 (CDK4/6), preventing phosphorylation of the retinoblastoma protein and halting cell‑cycle progression from the G1 to S phase. This results in cell‑cycle arrest and reduced proliferation of tumor cells that rely on CDK4/6 signaling, particularly in hormone‑receptor positive breast cancer.

Side Effects

Common Side Effects

  • Neutropenia: reduced white blood cell count.
  • Nausea: feeling of sickness.
  • Fatigue: persistent tiredness.
  • Diarrhea: loose stools.
  • Alopecia: hair thinning or loss.
  • Vomiting: expulsion of stomach contents.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils.
  • Hepatotoxicity: liver enzyme elevations or injury.
  • QT interval prolongation: potential cardiac rhythm disturbance.
  • Interstitial lung disease: inflammation of lung tissue.
  • Severe infections: opportunistic or bacterial infections.
  • Pulmonary embolism: blood clot in lung arteries.

Precautions & Warnings

Before initiating therapy, patients should be evaluated for baseline blood counts, liver function, and cardiac status.

  • Monitor blood counts: check CBC regularly for neutropenia.
  • Assess liver function: test hepatic enzymes before and during treatment.
  • Evaluate QT interval: perform ECG if risk factors for prolongation exist.
  • Avoid strong CYP3A4 inhibitors: drugs like ketoconazole can increase ribociclib exposure.
  • Use effective contraception: ribociclib may cause fetal harm.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Ribociclib may interact with several concomitant medications.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase ribociclib levels.
  • Strong CYP3A4 inducers (e.g., rifampin, phenytoin): reduce ribociclib efficacy.
  • QT‑prolonging agents (e.g., sotalol, amiodarone): heighten risk of cardiac arrhythmia.

Moderate Interactions (Monitor Closely)

  • Antacids containing aluminum or magnesium: may affect absorption.
  • CYP2C8 substrates (e.g., paclitaxel): possible altered metabolism.
  • Warfarin: monitor INR for potential anticoagulation changes.

Frequently Asked Questions

Kisqali is indicated for the treatment of hormone receptor‑positive, HER2‑negative advanced or metastatic breast cancer. It is used in combination with endocrine therapies such as aromatase inhibitors or fulvestrant to delay disease progression and improve progression‑free survival in adult patients.

Ribociclib selectively blocks cyclin‑dependent kinases 4 and 6, which are essential for cell‑cycle transition from G1 to S phase. By preventing this phosphorylation step, the drug halts tumor cell proliferation, particularly in cancers that depend on CDK4/6 signaling, such as hormone‑driven breast cancer.

The prescribed dose of Kisqali is determined by the treating physician based on the patient’s clinical condition and treatment plan. A common regimen involves 600 mg taken orally once daily for 21 days followed by a 7‑day break in a 28‑day cycle, but exact dosing must be individualized by the prescriber.

Safety of ribociclib in pregnancy and lactation has not been established. The drug may cause fetal harm, so it is contraindicated in pregnant women. Women of child‑bearing potential should use effective contraception during treatment and for a defined period after the last dose. Breastfeeding is not recommended.

To order Kisqali, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Kisqali (ribociclib) shares the CDK4/6 inhibition mechanism with palbociclib and abemaciclib but differs in dosing schedules, side‑effect profiles, and specific drug‑interaction potentials. Ribociclib has a longer half‑life, allowing once‑daily dosing, and is associated with a higher incidence of hepatotoxicity, whereas abemaciclib is taken twice daily and may cause more gastrointestinal toxicity.

Kisqali tablets should be stored at room temperature, below 25 °C, in the original blister pack or container to protect them from moisture and light. Do not refrigerate or freeze the product. Keep it out of reach of children and store in a dry place away from direct sunlight.

Kisqali is taken orally as a tablet, usually with water. It is commonly prescribed to be taken on an empty stomach, but patients should follow the specific instructions provided by their healthcare professional regarding timing relative to meals and other medications.

The most serious risks include severe neutropenia or febrile neutropenia, liver toxicity (elevated transaminases), QT‑interval prolongation leading to cardiac arrhythmias, and serious infections. Patients should report symptoms such as fever, persistent fatigue, jaundice, palpitations, or unexplained shortness of breath to their physician promptly.

Kisqali should not be used in patients with severe hepatic impairment, uncontrolled QT prolongation, or those taking strong CYP3A4 inhibitors that cannot be discontinued. It is also contraindicated in pregnant women and not recommended for breastfeeding mothers. Patients with a history of serious cardiac arrhythmias or uncontrolled infections should avoid the drug.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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