Ribokis 200 mg Tablet

Generic Name: Ribociclib
Brand Name: Ribokis
Strength: 200 mg
Form: Film-coated Oral Tablet
Pack Size: Commonly 21 tablets per pack
Manufacturer: Everest Pharmaceuticals
Distributed by: NP Molecule

Indications:

Ribokis (Ribociclib) is indicated for the treatment of:

• Hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer
  In combination with:

  • An aromatase inhibitor as initial endocrine-based therapy

  • Fulvestrant in patients with disease progression following endocrine therapy

Applicable for both pre/perimenopausal and postmenopausal women, and in men.

Pharmacology:

Ribociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor.
It inhibits CDK4 and CDK6, proteins that regulate cell cycle progression.
By blocking these kinases, Ribokis prevents the proliferation of cancer cells, especially in HR+ breast cancers which are dependent on cell cycle signaling.

Dosage & Administration:

• Recommended dose: 600 mg once daily (i.e., 3 tablets of 200 mg)

• Administered for 21 consecutive days, followed by 7 days off, in a 28-day cycle

• Taken with or without food

• Tablets should be swallowed whole, not crushed or chewed

Dose modifications may be necessary based on side effects and blood counts.

Drug Interactions:

• Avoid strong CYP3A4 inhibitors and inducers

• QT interval–prolonging drugs should be used with caution

• Monitor ECG and electrolytes if used with interacting medications

Contraindications:

• Hypersensitivity to Ribociclib or any tablet component

• Use with caution in patients with known QT prolongation

Side Effects:

• Common: Neutropenia, nausea, fatigue, diarrhea, hair loss, liver enzyme elevations

• Serious: QT prolongation, hepatotoxicity, severe neutropenia, infections

Pregnancy & Lactation:

• Contraindicated during pregnancy due to potential fetal harm

• Breastfeeding should be avoided during treatment and for at least 3 weeks after the last dose

Precautions & Warnings:

• Perform baseline and periodic ECG and liver function tests

• Regularly monitor complete blood count (CBC)

• Advise contraception for women of reproductive potential during and after therapy

Overdose Effects:

• Increased risk of hematologic toxicities and QT prolongation

• Symptomatic treatment and close monitoring required

Therapeutic Class:

• CDK 4/6 Inhibitor

• Targeted Therapy for HR+/HER2– Breast Cancer

Storage Conditions:

• Store below 30°C in a dry place

• Protect from light and moisture

• Keep out of reach of children