Lumiclib — Ribociclib 200 mg Tablets, 21 Tablets

Lumiclib 200 mg is supplied as film-coated tablets for oral administration[cite: 7].

Qualitative and Quantitative Composition per Tablet:[cite: 7]

• • Active Ingredient: Ribociclib — 200 mg[cite: 7].
• • Excipients: Microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate; film-coating contains Titanium Dioxide I.P. and other excipients[cite: 7].

Packaging Configuration: 200 mg tablets are packaged in blister strips[cite: 7]. The commercial box contains 21 tablets, providing a 1-week supply for the standard 600 mg/day dose or a full cycle for reduced maintenance regimens[cite: 7]. The package features official Azista branding, storage instructions, and prescribing information[cite: 7].

Pharmacodynamics:
Ribociclib is a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). These enzymes are activated upon binding to D-cyclins and play a central role in signaling pathways leading to cell cycle entry and cellular proliferation. Blockade of the CDK4/6-cyclin D complex prevents phosphorylation of the retinoblastoma (Rb) protein, blocking G1 to S phase progression and inhibiting DNA synthesis in HR+ breast cancer cells.

Pharmacokinetics:

• • Absorption: Time to peak plasma concentration ($T_{max}$) ranges between 1 and 4 hours post-dose. Food intake has no clinically relevant effect on absorption.
• • Distribution: Binding to human plasma proteins is approximately 70%. The mean steady-state volume of distribution ($V_{ss}$) is approximately 1090 L.
• • Metabolism: Primarily metabolized in the liver by the CYP3A4 enzyme system.
• • Elimination: Terminal elimination half-life ($T_{1/2}$) ranges from 30 to 55 hours. Excreted mainly via feces and urine as metabolites and unchanged drug.

Lumiclib 200 mg is indicated for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer:

• • In combination with an aromatase inhibitor (letrozole, anastrozole) as initial endocrine-based therapy.
• • In combination with fulvestrant in women who have received prior endocrine therapy.
• • In pre- or perimenopausal women, endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Therapy with Lumiclib 200 mg should be initiated and supervised by a physician experienced in the use of anticancer therapies[cite: 7].

Dosing Administration Rules:

• • Take tablets orally once daily at approximately the same time each day, preferably in the morning.
• • May be taken with or without food.
• • Swallow tablets whole with water. Do not chew, crush, or split tablets before swallowing.
• • Avoid consumption of grapefruit or grapefruit juice during treatment.

Dosage Regimen and Schedule:

• • Recommended Starting Dose: 600 mg (three 200 mg tablets) once daily.
• • Dosing Schedule (28-day cycle): Take daily for 21 consecutive days followed by 7 days off treatment. This 28-day cycle should be repeated continuously.
• • Dose Modification: Based on individual safety and tolerability, dose reduction to 400 mg daily (two 200 mg tablets) or 200 mg daily (one 200 mg tablet) may be required.

Missed Dose: If the patient vomits after taking the dose or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time the following day.

Administration of Lumiclib 200 mg is contraindicated in:

• • Hypersensitivity: Hypersensitivity to ribociclib or any excipients in the formulation[cite: 7].
• • Pregnancy and Lactation: Contraindicated during pregnancy and breastfeeding due to potential fetal harm.
• • Pediatric Population: Safety and efficacy in patients under 18 years have not been established.
• • Severe Baseline QTc Prolongation: Patients with long QT syndrome or baseline prolonged QTc interval.

Ribociclib is primarily metabolized by CYP3A4 and acts as a strong time-dependent inhibitor of CYP3A4.

Key Drug Interactions:

• • Strong CYP3A4 Inhibitors (ketoconazole, itraconazole, grapefruit): Significantly increase ribociclib plasma exposure. Concomitant use should be avoided.
• • Strong CYP3A4 Inducers (rifampin, St. John's Wort, phenytoin): Decrease ribociclib plasma exposure and reduce efficacy.
• • QT-Prolonging Drugs (antiarrhythmics, clarithromycin): Co-administration increases the risk of severe cardiac arrhythmias.

Pregnancy:
Ribociclib can cause fetal harm when administered to pregnant women. Lumiclib is contraindicated during pregnancy. Females of reproductive potential must use effective contraception during treatment and for at least 3 weeks after the last dose.

Lactation:
It is unknown whether ribociclib is excreted in human milk. Breastfeeding is contraindicated during treatment and for at least 3 weeks after the final dose.

Treatment with Lumiclib 200 mg requires routine monitoring of complete blood counts, liver function tests, and ECGs.

Adverse Reactions:

• • Hematologic (Very Common): Neutropenia, leukopenia, anemia, lymphopenia, thrombocytopenia. Complete blood counts should be monitored regularly.
• • Infections: Increased susceptibility to infections secondary to neutropenia.
• • Gastrointestinal: Nausea, diarrhea, vomiting, stomatitis, decreased appetite, constipation.
• • Cardiovascular: Prolongation of the QTc interval on ECG.
• • Hepatobiliary: Elevated serum transaminases (ALT, AST) and bilirubin.
• • General & Dermatologic: Fatigue, alopecia, rash, pruritus.

Symptoms:
Experience with ribociclib overdose is limited. Exacerbation of known adverse events such as severe neutropenia, QTc prolongation, and nausea may occur.

Treatment:
There is no known specific antidote. General supportive measures, regular hematologic and ECG monitoring should be implemented.

Storage Requirements for Lumiclib 200 mg:[cite: 7]

• 🌡️ Temperature: Store below 30°C[cite: 7].
• ☀️ Moisture & Light Protection: Protect from light and moisture[cite: 7]. Keep in original packaging[cite: 7].
• 👶 Safety: Keep out of reach of children[cite: 7].
• ⏳ Shelf Life: Stated on the packaging[cite: 7]. Caution: Prescription Only (Rx Only)[cite: 7].

To verify the authenticity of original Lumiclib 200 mg manufactured by Azista, check the following packaging details[cite: 7]:

• ✅ Azista Corporate Logo: Bright multi-colored Azista flower/pinwheel logo on the bottom right corner[cite: 7].
• ✅ Product Branding: Brand name "Lumiclib" in dark red/maroon stylized font with an elongated "L" curve[cite: 7].
• ✅ Packaging Design: Dark blue and gold geometric accents framing the edges of the box[cite: 7].
• ✅ Composition Labeling: Clear composition statement on the side panel detailing Ribociclib 200 mg[cite: 7].
• ✅ Batch Identification: Printed Lot Number (LOT), Manufacturing Date (MFG), and Expiration Date (EXP) on the carton flap.