Rutinib 5 mg (Tablet)

Indications

• Treatment of myelofibrosis
• Treatment of polycythemia vera
• Treatment of acute graft-versus-host disease
• For adults only
• For pediatric patients 12 years and older

Pharmacology

• Inhibits Janus Associated Kinases (JAKs)
• Modulates gene expression
• Prevents splenomegaly
• Decreases JAK2V617F mutant cells
• Rapid oral absorption
• Plasma protein binding of 97%
• Metabolized by CYP3A4 and CYP2C9
• Predominantly eliminated through metabolism

Dosage

• Starting dose based on platelet count
• Dose titration based on safety and efficacy
• Oral administration
• Dose adjustment for polycythemia vera based on hemoglobin count and platelet count

Administration

• Oral administration
• With or without food
• No additional dose if missed

Interaction

• Concomitant administration of fluconazole
• Avoid concomitant use of fluconazole in certain patients
• Concomitant administration of strong CYP3A4 inhibitors
• Consider dose reduction with strong CYP3A4 inhibitors
• Concomitant administration of strong CYP3A4 inducers

Contraindications

• Hypersensitivity to Ruxolitinib or any components

Side Effects

• Thrombocytopenia, Anemia and Neutropenia
• Risk of Infection
• Bruising, dizziness, headache
• Symptom Exacerbation Following Interruption or Discontinuation of treatment
• Non-Melanoma Skin Cancer

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Discontinue breastfeeding during treatment and for two weeks after the final dose

Precautions & Warnings

• Manage thrombocytopenia, anemia and neutropenia
• Monitor for signs and symptoms of infection
• Evaluate for tuberculosis risk factors
• Observe for signs and symptoms of active tuberculosis
• Stop treatment and evaluate if Progressive Multifocal Leukoencephalopathy is suspected
• Advise patients about early signs and symptoms of herpes zoster
• Monitor and treat hepatitis B viral load
• Exacerbation of symptoms following discontinuation of treatment
• Perform periodic skin examinations
• Assess and monitor lipid parameters

Use in Special Populations

• Safety and effectiveness not established in pediatric patients

Overdose Effects

• No known antidote
• Single doses up to 200 mg given with acceptable tolerability
• Supportive treatment for myelosuppression

Therapeutic Class

• Pyrrolopyrimidines

Storage Conditions

• Store below 30°C
• In a dry place
• Away from sunlight
• Keep out of reach of children

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