Jakafi

Primary Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera + 10 more

Treatment

19 FDA approvals

18 Active Studies for Jakafi

What is Jakafi

Ruxolitinib

The Generic name of this drug

Treatment Summary

Ruxolitinib, also known as Jakafi, is a drug used to prevent cell growth and treat certain types of blood cancer and other immune system diseases. It was first approved by the FDA in 2011 and is used to treat myelofibrosis and polycythemia vera. In 2019, it was also approved for use in adults and children with steroid-refractory acute graft-versus-host disease, and in 2021 for mild to moderate atopic dermatitis. Ruxolitinib works by blocking the JAK1 and JAK2 tyrosine kinases responsible for cytokine signalling and he

Jakafi

is the brand name

image of different drug pills on a surface

Jakafi Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Jakafi

Ruxolitinib

2011

6

Approved as Treatment by the FDA

Ruxolitinib, otherwise called Jakafi, is approved by the FDA for 19 uses like Post Polycythemia Vera Myelofibrosis and intermediate risk Myelofibrosis .

Post Polycythemia Vera Myelofibrosis

Helps manage Post Polycythemia Vera Myelofibrosis

intermediate risk Myelofibrosis

Helps manage intermediate risk Myelofibrosis

Acute Graft-Versus-Host Disease (GVHD)

Helps manage Acute Graft-Versus-Host Disease (GVHD)

refractory Polycythemia vera

Helps manage refractory Polycythemia vera

Chronic Graft Versus Host Disease

Helps manage Chronic Graft Versus Host Disease

Post Essential Thrombocythaemia Myelofibrosis

Helps manage Post Essential Thrombocythaemia Myelofibrosis

high risk Myelofibrosis

Helps manage high risk Myelofibrosis

Primary Myelofibrosis (PMF)

Helps manage Primary Myelofibrosis (PMF)

resistant to or intolerant of hydroxyurea

Helps manage resistant to or intolerant of hydroxyurea

Polycythemia

Helps manage Post Polycythemia Vera Myelofibrosis

Polycythemia Vera

Helps manage refractory Polycythemia vera

Primary Myelofibrosis

Helps manage high risk Myelofibrosis

Disease

Helps manage Chronic Graft Versus Host Disease

Primary Myelofibrosis

Helps manage Primary Myelofibrosis (PMF)

Primary Myelofibrosis

Helps manage intermediate risk Myelofibrosis

Disease

Helps manage failure of at least one prior systemic therapy

Primary Myelofibrosis

Helps manage Post Essential Thrombocythaemia Myelofibrosis

Steroid Refractory

Helps manage Steroid Refractory

Graft-vs-Host Disease

Helps manage Acute Graft-Versus-Host Disease (GVHD)

Effectiveness

How Jakafi Affects Patients

Ruxolitinib is a medicine used to treat different kinds of blood cancer. It works by stopping cells from growing and dividing, killing cancer cells, and lowering inflammation in the body. In clinical trials, ruxolitinib was found to reduce the size of the spleen and improve symptoms of myelofibrosis. Studies on mice have also shown that it can help extend the lifespan of those with myeloproliferative neoplasms. Ruxolitinib works by blocking a protein called JAK2, which is found in both normal cells and cancer cells. However, some cancers, such as those with

How Jakafi works in the body

The Janus kinase (JAK) family of proteins helps control the way the body responds to growth factors and cytokines. These proteins are important for lymphocyte development and help regulate gene expression of pro-inflammatory cytokines. Ruxolitinib is a drug that blocks certain JAK proteins, thus preventing the body from responding in an excessive way to these cytokines and growth factors. In cancer cells, this can lead to cell death. This drug is also used to treat graft-versus-host-disease, an immune complication of allogeneic hematopoietic cell transplantation.

When to interrupt dosage

The advised dosage of Jakafi is contingent upon the recognized condition, including reluctance to or insensitivity to hydroxyurea, Steroid Refractory and Primary Myelofibrosis. Dosage varies according to the technique of administration (e.g. Cream - Topical or Oral) noted in the table below.

Condition

Dosage

Administration

Primary Myelofibrosis

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Primary Myelofibrosis

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Dermatitis, Atopic

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Polycythemia Vera

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Dermatitis, Atopic

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Steroid Refractory

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Disease

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Primary Myelofibrosis

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Primary Myelofibrosis

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Polycythemia

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Disease

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

resistant to or intolerant of hydroxyurea

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Graft-vs-Host Disease

, 5.0 mg, 10.0 mg, 15.0 mg, 20.0 mg, 25.0 mg, 0.015 mg/mg

, Tablet, Tablet - Oral, Oral, Cream - Topical, Cream, Topical

Warnings

There are 20 known major drug interactions with Jakafi.

Common Jakafi Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Ruxolitinib is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Acteoside

Major

The risk or severity of adverse effects can be increased when Ruxolitinib is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Ruxolitinib is combined with Antilymphocyte immunoglobulin (horse).

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Ruxolitinib.

Baricitinib

Major

The risk or severity of adverse effects can be increased when Ruxolitinib is combined with Baricitinib.

Jakafi Toxicity & Overdose Risk

The lowest toxic dose of ruxolitinib in rats is 250mg/kg. Taking a single dose of up to 200mg is generally safe, but taking more than the recommended dose may lead to a decrease in white blood cells, red blood cells, and platelets. There is no known antidote for an overdose, so supportive treatment is advised. Hemodialysis will not help eliminate the drug from the body.

image of a doctor in a lab doing drug, clinical research

Jakafi Novel Uses: Which Conditions Have a Clinical Trial Featuring Jakafi?

23 active clinical trials are currently being conducted to determine the efficacy of Jakafi in managing Polycythemia, Primary Myelofibrosis and Related Disorders.

Condition

Clinical Trials

Trial Phases

Polycythemia

2 Actively Recruiting

Phase 3, Phase 1

Disease

7 Actively Recruiting

Phase 1, Phase 2, Not Applicable

resistant to or intolerant of hydroxyurea

0 Actively Recruiting

Primary Myelofibrosis

1 Actively Recruiting

Phase 2

Disease

0 Actively Recruiting

Primary Myelofibrosis

0 Actively Recruiting

Graft-vs-Host Disease

8 Actively Recruiting

Phase 3, Phase 2, Phase 1, Not Applicable

Dermatitis, Atopic

0 Actively Recruiting

Steroid Refractory

0 Actively Recruiting

Dermatitis, Atopic

0 Actively Recruiting

Primary Myelofibrosis

0 Actively Recruiting

Polycythemia Vera

0 Actively Recruiting

Primary Myelofibrosis

1 Actively Recruiting

Phase 1

Jakafi Reviews: What are patients saying about Jakafi?

5

Patient Review

11/18/2013

Jakafi for Myelofibrosis

Jakavi has been great a reducing the size of my spleen, but I unfortunately still experience all the other symptoms that come with myelofibrosis.

4.3

Patient Review

10/31/2013

Jakafi for Myelofibrosis

I felt a significant difference within one week of starting this treatment regimen.

4

Patient Review

9/8/2016

Jakafi for Myelofibrosis

Jakavi has been great in reducing the size of my spleen, but it hasn't done much for my platelet or hemoglobin counts. I get transfusions every month as a result. It's not ideal, but it's manageable.

3.3

Patient Review

6/7/2012

Jakafi for Myelofibrosis

3

Patient Review

5/28/2019

Jakafi for Myelofibrosis

This treatment was great for the first month, but then my spleen grew back to its original size and I gained 16 kg in 5 months.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about jakafi

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Jakafi prescribed for?

"Jakafi is a medication used to treat adults with polycythemia vera who have already taken hydroxyurea but it was not effective enough or they could not tolerate it. Jakafi is also used to treat adults with certain types of myelofibrosis."

Answered by AI

What type of drug is Jakafi?

"Jakafi can either be used by itself or with other medications. It is classified as a Hematologic, a Kinase Inhibitor, and an Antineoplastic. It is not known if Jakafi is safe and effective for children under the age of 12."

Answered by AI

How long can you take Jakafi for?

"If you are taking Jakafi, your Healthcare Professional may allow up to 6 months to see if it is working for you. If you do not see an improvement after 6 months of treatment, your Healthcare Professional may have you stop taking Jakafi."

Answered by AI

Is Jakafi considered chemotherapy?

"Although Jakafi is not technically classified as chemotherapy, it does work to target and control the production of blood cells in a similar way."

Answered by AI

Clinical Trials for Jakafi

Have you considered Jakafi clinical trials?

We made a collection of clinical trials featuring Jakafi, we think they might fit your search criteria.
Go to Trials
Image of Fred Hutch/University of Washington Cancer Consortium in Seattle, United States.

Fecal Microbiota Transplantation for Graft-versus-Host Disease

18+
All Sexes
Seattle, WA

This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.

Phase 2
Recruiting

Fred Hutch/University of Washington Cancer Consortium

Armin Rashidi

Image of Ruttenberg Treatment Center in New York, United States.

Reparixin for Myelofibrosis

18+
All Sexes
New York, NY

This is an open label, phase II study to assess the efficacy, safety, and tolerability of Reparixin in patients with DIPSS intermediate-2, or high-risk primary myelofibrosis (PMF), post essential thrombocythemia/polycythemia vera related MF (Post ET/PV MF) after prior treatment, and those who are ineligible or refuse treatment, with a Janus kinase inhibitor (JAKi). 26 patients will be enrolled. Eligible patients will receive oral reparixin three times daily on a 4-week cycle for a core study period of 6 cycles (24 weeks). After cycle 6, patients may continue receiving reparixin once daily on a 4-week cycle if at least stable disease (SD) is met by IWG-MRT criteria until loss of response, disease progression, unacceptable toxicity, patient/physician withdrawal, or termination of study by sponsor.

Phase 2
Recruiting

Ruttenberg Treatment Center (+10 Sites)

Marina Kremyanskaya, PhD, MD

Dompé Farmaceutici S.p.A

Have you considered Jakafi clinical trials?

We made a collection of clinical trials featuring Jakafi, we think they might fit your search criteria.
Go to Trials
Image of City of Hope Medical Center in Duarte, United States.

Leflunomide + Steroids for Graft-versus-Host Disease

18+
All Sexes
Duarte, CA

This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.

Phase 1
Recruiting

City of Hope Medical Center

Monzr M. Al Malki

Image of University of Alabama at Birmingham in Birmingham, United States.

Luspatercept for Myelofibrosis

18+
All Sexes
Birmingham, AL

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

Phase 3
Waitlist Available

University of Alabama at Birmingham (+22 Sites)

Bristol-Myers Squibb

Celgene

Have you considered Jakafi clinical trials?

We made a collection of clinical trials featuring Jakafi, we think they might fit your search criteria.
Go to Trials