Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 5 mg, 10 mg, 15 mg, 20 mg, 25 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
- Indicated for treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
- Indicated for treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.
- Indicated for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Latest News
Summary
- Jakafi (ruxolitinib) is indicated for the treatment of intermediate or high-risk myelofibrosis, including primary, post-polycythemia vera, and post-essential thrombocythemia myelofibrosis in adults. It is also used for treating polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. Additionally, Jakafi is indicated for the treatment of steroid-refractory acute graft-versus-host disease and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in patients 12 years and older.
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Ruxolitinib demonstrated superior efficacy in steroid-refractory acute GvHD, showing higher overall and complete response rates, improved durable responses, and longer failure-free survival compared to other treatments.
- In myelofibrosis, earlier initiation of ruxolitinib was associated with better spleen volume response rates and improved overall survival.
- For steroid-refractory GvHD in the general population, the overall response rates were 77% for acute and 78% for chronic, with the highest response observed in oral manifestations.
- Pediatric Population with SR-GvHD: Treatment-related toxicities occurred in 20% of patients, with increased incidence of cytopenia, liver toxicity, and infections; higher toxicity rates were observed in acute GvHD (aGvHD) patients.
- General Population with SR-GvHD: Common adverse events included cytopenia and infections, with infection rates comparable between children and adults.
- Myelofibrosis (MF): Increased risk of herpes zoster infection was noted, with odds ratios of 7.39 and 5.23 for early and extension phases, respectively; fewer thrombocytopenia and anemia events were reported in patients who started ruxolitinib earlier.
- Pediatric patients with SR-GvHD experienced higher treatment-related toxicities, adults with myelofibrosis showed improved outcomes with earlier initiation of ruxolitinib, and various efficacy and safety profiles were noted among different JAK inhibitors for myelofibrosis.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jakafi (ruxolitinib) Prescribing Information. | 2023 | Incyte Corporation, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ERS/EBMT clinical practice guideline on treatment of pulmonary chronic graft-versus-host disease in adults. | 2024 | European Respiratory Journal |
Management of Patients with Early Myelofibrosis: A Discussion of Best Practices. | 2024 | Current Hematologic Malignancy Reports |
Myeloproliferative Neoplasms, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. | 2022 | Journal of the National Comprehensive Cancer Network |
Graft-Versus-Host Disease. | 2021 | Journal of the National Comprehensive Cancer |
A guideline for the management of specific situations in polycythaemia vera and secondary erythrocytosis. A British Society for Haematology Guideline. | 2019 | British Journal of Haematology |