Rulicent 10 | 1 Strip | 7pcs Tablet

✔️ Dosage and Administration | Rulicent 10

Route: Oral
Administration: Can be taken with or without food. If a dose is missed, resume with the next scheduled dose without doubling.

For Myelofibrosis (MF):

Dosing is based on baseline platelet count:

≥200 × 10⁹/L: 20 mg twice daily

100–199 × 10⁹/L: 15 mg twice daily

50–99 × 10⁹/L: 5 mg twice daily

Frequent monitoring (CBC every 2–4 weeks) is required to guide dose adjustments.

For Polycythemia Vera (PV):

Starting dose: 10 mg twice daily

Consider reducing to 5 mg twice daily if hemoglobin is between 8–12 g/dL or platelets fall below 75 × 10⁹/L.

For Acute GVHD:

Initial dose: 5 mg twice daily

May increase to 10 mg twice daily after 3 days if ANC and platelet counts remain stable.

• Pediatric Use: Approved for acute GVHD in patients aged 12 years and older. Not established for other indications.
• Elderly: No specific dose adjustments, but greater susceptibility to adverse effects like infections and cytopenias may require cautious use.

✔️ Overdose Management | Rulicent 10

No specific antidote exists.

Single doses up to 200 mg have been tolerated; repeated high doses may cause significant myelosuppression (low WBC, RBC, and platelets).

Supportive measures are recommended. Hemodialysis is ineffective in drug clearance.

✔️ Side Effects | Rulicent 10

Common adverse effects include:

Hematologic: Thrombocytopenia, anemia, neutropenia

General: Headache, dizziness, bruising

Infectious risk: Opportunistic bacterial, fungal, and viral infections

Discontinuation symptoms: Disease rebound, including fever, hypotension, respiratory distress

Skin cancers: Reports of non-melanoma skin cancers (e.g., basal cell, squamous cell, Merkel cell carcinoma)

✔️ Drug Interactions

Fluconazole (>200 mg/day): Inhibits Ruxolitinib metabolism via CYP3A4/CYP2C9, increasing drug levels. Avoid high doses of fluconazole except in acute GVHD.

Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole): Elevate Ruxolitinib exposure. Reduce the Rulicent dose and monitor blood counts closely.

Strong CYP3A4 Inducers: May lower drug levels; frequent monitoring is recommended to adjust dose based on clinical response.

✔️ Contraindications

Patients with known hypersensitivity to Ruxolitinib or any formulation component must avoid this medication.

✔️ Precautions & Warnings

• Bone Marrow Suppression: Monitor CBCs regularly. Thrombocytopenia may require dose reduction or drug interruption. Severe neutropenia is usually reversible upon drug cessation.
• Serious Infections: Delay treatment until active infections are resolved. Monitor throughout therapy.
• Tuberculosis (TB): Screen for TB risk before initiation. Treat latent TB prior to Rulicent initiation if required.
• Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection; discontinue immediately if suspected.
• Herpes Zoster: Educate patients about signs and encourage early medical attention.
• Hepatitis B Reactivation: Regular HBV monitoring is advised in patients with chronic HBV.
• Discontinuation Reactions: Sudden withdrawal may lead to disease flare, systemic symptoms, and serious complications. Taper gradually if feasible.
• Skin Cancer: Conduct periodic skin assessments during long-term use.
• Lipid Monitoring: Check cholesterol and triglyceride levels 8–12 weeks after starting therapy. Manage according to guidelines.
• Store at below 30°C in a dry, light-protected place.
• Keep out of reach of children.