Ruxolitinib
Ruxolitinib is a targeted therapy that works by blocking JAK1 and JAK2 enzymes involved in blood cell production and immune function. It is primarily used to treat myelofibrosis, polycythemia vera, and graft-versus-host disease in patients who have not responded to other treatments. By inhibiting these signaling pathways, it helps reduce symptoms such as enlarged spleen, night sweats, and bone pain associated with these conditions.
Ruxolitinib is a JAK inhibitor used to treat myelofibrosis and polycythemia vera by blocking signaling pathways involved in blood cell production and immune function.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- D11AH09
- RxNorm
- 1193326
- Generic
- Ruxolitinib
- Class
- atc-d11
- Brands
- Jakafi, Opzelura
- Availability
- rx
- Lactation
- unknown
- Routes
- oral, topical
- Forms
- tablet, cream
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 15mg or 20mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 10mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 1.5% cream applied twice daily
- Maximum
- consult physician
- Frequency
- twice daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid
discontinue therapy if pregnancy occurs
fetal growth monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue
do not breastfeed during treatment and for at least 2 weeks after last dose
monitor infant for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
adolescents 12 17weight-based dosing
use for GVHD in patients 12 years and older; for atopic dermatitis in patients 12 years and older
monitor growth and development
Use with caution and monitor for adverse effects.
geriatric
elderly 65 plusno specific adjustment
use with caution due to increased susceptibility to infections
monitor for infections and hematologic parameters
Use with caution and monitor for adverse effects.
renal_impairment
severereduce dose to 10mg once daily
monitor renal function regularly
check creatinine clearance and adjust dose accordingly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderatereduce dose
reduce starting dose for moderate hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid
not recommended in severe hepatic impairment
regular hepatic function assessment
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
First FDA approval for myelofibrosis under brand name Jakafi
Drug class
Mechanism of action classification
Approved indications
Therapeutic indications for Jakafi and Opzelura brands
Route of administration
Dosage form and route information
Ruxolitinib is indicated for the treatment of myelofibrosis (primary or secondary to polycythemia vera or essential thrombocythemia), polycythemia vera in patients who have an inadequate response to or are intolerant of hydroxyurea, and acute graft-versus-host disease in patients who have not responded to corticosteroid therapy.
Ruxolitinib inhibits JAK1 and JAK2 enzymes that are part of the JAK-STAT signaling pathway. This pathway normally transmits signals from cytokines and growth factors to the cell nucleus, regulating blood cell production (hematopoiesis) and immune responses. By blocking these enzymes, the medication reduces the overactive signaling that contributes to abnormal blood cell production and inflammation in myeloproliferative neoplasms and graft-versus-host disease.
Ruxolitinib is taken orally as a tablet, typically twice daily. Common side effects include anemia, thrombocytopenia, neutropenia, bruising, dizziness, and headache. Patients should be monitored for infections, as JAK inhibitors can affect immune function. The medication may increase the risk of certain cancers and should not be used during pregnancy. Dose adjustments may be needed based on blood cell counts and kidney or liver function.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy