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Jakafi

ruxolitinib
JAK1/JAK2 InhibitorFDA Approved 2011Incyte
Route
Oral
Half-Life
3 hrs
FDA Approved
2011
Manufacturer
Incyte
1. Indications and Usage

Intermediate or high-risk myelofibrosis. Polycythemia vera with inadequate response to hydroxyurea. Steroid-refractory acute GVHD. Chronic GVHD after failure of 1-2 lines of therapy.

2. Dosage and Administration

Myelofibrosis: 15-20 mg BID based on platelet count. PV: 10 mg BID. Acute GVHD: 5 mg BID. Chronic GVHD: 10 mg BID. All oral.

3. Dosage Forms and Strengths

Tablets: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Cytopenias: Manage by dose reduction. Monitor CBCs.
  • Infection Risk: Serious infections reported. Assess for TB before starting.
  • Symptom Exacerbation on Discontinuation: Gradually taper in myelofibrosis.
  • Non-Melanoma Skin Cancer: Monitor.
  • Lipid Elevations: Monitor lipids 8-12 weeks after initiation.
6. Adverse Reactions
Most Common Adverse Reactions

Thrombocytopenia (70%), Anemia (64%), Bruising (23%), Neutropenia (18%), Dizziness (18%), Headache (15%)

Thrombocytopenia
70%
Anemia
64%
Bruising
23%
Neutropenia
18%
Dizziness
18%
Headache
15%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Reduce dose by 50%.
Fluconazole <=200 mg: Reduce dose by 50%.
Strong CYP3A4 Inducers: May require dose increase.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Ruxolitinib selectively inhibits JAK1 and JAK2, key mediators of cytokine signaling in hematopoiesis. In myelofibrosis, dysregulated JAK-STAT signaling drives myeloproliferation and constitutional symptoms.

Pharmacokinetics

Tmax: 1-2 hours. Protein binding: ~97%. Half-life: ~3 hours (parent); ~5.8 hours (active metabolites). Elimination: urine 74%, feces 22%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Ruxolitinib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Ruxolitinib Clinical Trials ↗
FDA-Approved Tumor Types

Consult the prescribing information for complete indication details and associated tumor types.

External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Jakafi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Jakafi (ruxolitinib) approved for?

Jakafi (ruxolitinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Jakafi (ruxolitinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Jakafi (ruxolitinib) work?

Ruxolitinib selectively inhibits JAK1 and JAK2, key mediators of cytokine signaling in hematopoiesis. In myelofibrosis, dysregulated JAK-STAT signaling drives myeloproliferation and constitutional symptoms.

What are the most common side effects?

Thrombocytopenia (70%), Anemia (64%), Bruising (23%), Neutropenia (18%), Dizziness (18%), Headache (15%) Thrombocytopenia 70% Anemia 64% Bruising 23% Neutropenia 18% Dizziness 18% Headache 15%

← All TherapiesFull Prescribing Information ↗