Jakavi 5 mg (Tablet)

Indications

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

Pharmacology

• Inhibition of Janus Associated Kinases (JAKs) JAK1 and JAK2
• Modulation of gene expression
• Prevention of splenomegaly
• Decrease of circulating inflammatory cytokines

Absorption

Rapid absorption after oral administration

Distribution

Mean volume of distribution at steady-state

Half-life

Mean half-life of ruxolitinib & metabolites is approximately 5.8 hours

Plasma Protein Binding

97%, mostly to albumin

Metabolism

Metabolized by CYP3A4 and to a lesser extent by CYP2C9

Excretion

Predominantly through metabolism with 74% excreted in urine

Dosage

• Starting dose based on platelet count
• Dose titration based on safety and efficacy
• Different starting doses for myelofibrosis and polycythemia vera
• Recommended starting dose for acute graft-versus-host disease

Administration

Orally with or without food

Interactions

• Interaction with fluconazole
• Concomitant administration with strong CYP3A4 inhibitors
• Concomitant administration with strong CYP3A4 inducers

Contraindications

Hypersensitivity to Ruxolitinib or any other components of this product

Side Effects

• Thrombocytopenia
• Anemia
• 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

Precautions & Warnings

• Thrombocytopenia, Anemia And Neutropenia management
• Risk of Infection management
• Tuberculosis monitoring
• Progressive Multifocal Leukoencephalopathy evaluation
• Herpes Zoster awareness
• Hepatitis B viral load monitoring
• Symptom Exacerbation following treatment interruption
• Non-Melanoma Skin Cancer periodic examinations
• Lipid Elevations management

Use in Special Populations

Safety and effectiveness in pediatric patients not established

Overdose Effects

No known antidote, associated myelosuppression

Therapeutic Class

Pyrrolopyrimidines

Storage Conditions

Store below 30°C in a dry place, away from sunlight

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