Ruxolitinib phosphate

What is Ruxolitinib phosphate?[edit | edit source]

Ruxolitinib phosphate (Jakafi) is a kinase inhibitor used to treat:

myelofibrosis (MF)
polycythemia vera
acute graft-versus-host-disease (aGVHD) who have taken corticosteroids
chronic graft-versus-host-disease (cGVHD)

Ruxolitinib Structural formula V1

Ruxolitinib2DACS

What are the uses of this medicine?[edit | edit source]

Ruxolitinib phosphate (Jakafi) is used to treat:

adults with certain types of myelofibrosis (MF).
adults with polycythemia vera (PV) who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.
adults and children 12 years of age and older with acute graft-versus-host-disease (aGVHD) who have taken corticosteroids and they did not work well enough.
adults and children 12 years of age and older with chronic graft-versus-host-disease (cGVHD) who have taken one or two types of treatments and they did not work well enough.

How does this medicine work?[edit | edit source]

The phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities.
Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation.
The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies.

Who Should Not Use this medicine ?[edit | edit source]

This medicine have no usage limitations.

What drug interactions can this medicine cause?[edit | edit source]

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed above and any of the following:

antifungal medications including itraconazole (Sporanox), ketoconazole, and voriconazole (Vfend)
carbamazepine (Carbatrol, Equetro, Tegretol, others)
clarithromycin
efavirenz (Sustiva, in Atripla, Symfi)
erythromycin (E.E.S, Eryc, Ery-tab)
fluconazole (Diflucan)
HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Viekira Pak), and saquinavir (Invirase)
nefazodone
nevirapine (Viramune)
phenytoin (Dilantin, Phenytek)
pioglitazone (Actos, in Oseni, Duetact)
rifabutin (Mycobutin)
rifampin (Rifadin, Rimactane, in Rifamate, Rifater)
telaprevir (Incivik)
St. John's wort

Is this medicine FDA approved?[edit | edit source]

In November 2011, ruxolitinib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis.
In 2014, it was approved in polycythemia vera (PCV) when there has been an inadequate response to or intolerance of hydroxyurea.

How should this medicine be used?[edit | edit source]

Recommended dosage: Myelofibrosis: The starting dose of Jakafi is based on patient’s baseline platelet count:

Greater than 200 x 109/L: 20 mg given orally twice daily
100 x 109/L to 200 x 109/L: 15 mg given orally twice daily
50 x 109/L to less than 100 x 109/L: 5 mg given orally twice daily

Monitor complete blood counts every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
Modify or interrupt dosing for thrombocytopenia.

Polycythemia Vera:

The starting dose of Jakafi is 10 mg given orally twice daily.

Acute Graft-Versus-Host Disease:

The starting dose of Jakafi is 5 mg given orally twice daily.

Chronic Graft-Versus-Host Disease:

The starting dose of Jakafi is 10 mg given orally twice daily.

Administration:

You can take Jakafi with or without food.
Jakafi may also be given through certain nasogastric tubes.
If you miss a dose of Jakafi, take your next dose at your regular time. Do not take 2 doses at the same time.
You will have regular blood tests during your treatment with Jakafi. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests.

What are the dosage forms and brand names of this medicine?[edit | edit source]

This medicine is available in fallowing doasage form:

As Tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

This medicine is available in fallowing brand namesː

Jakafi

What side effects can this medication cause?[edit | edit source]

The most common side effects of Jakafi in adults with certain types of myelofibrosis (MF) and polycythemia vera include:

low platelet counts
low red blood cell counts
bruising
dizziness
headache
diarrhea

The most common side effects of Jakafi in people with acute graft-versus-host-disease (aGVHD) include:

low red blood cell counts
low platelet counts
low white blood cell counts
infections
swelling

The most common side effects of Jakafi in people with chronic graft-versus-host-disease (cGVHD) include:

low red blood cell counts
low platelet counts
infections, including viral infections

Jakafi can cause serious side effects including:

Low blood cell counts
Infection
Cancer
Cholesterol increases
Increased risk of
blood clots
Possible increased risk of new (secondary) cancers

What special precautions should I follow?[edit | edit source]

Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. Manage by dose reduction, or interruption, or transfusion.
Serious bacterial, mycobacterial, fungal and viral infections have occurred. Assess patients for signs and symptoms of infection and initiate appropriate treatment promptly. Serious infections should have resolved before starting therapy with Jakafi.
Following discontinuation of Jakafi, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Manage with supportive care and consider resuming treatment with Jakafi.
Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred in patients treated with Jakafi. Perform periodic skin examinations.
Treatment with Jakafi has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Assess lipid levels 8-12 weeks from start of therapy and treat as needed.
Another JAK-inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Monitor for development of MACE.
Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Evaluate and treat symptoms of thrombosis promptly.
Monitor for development of secondary malignancies, particularly in patients who are current or past smokers.

What to do in case of emergency/overdose?[edit | edit source]

Symptoms of overdosage may include:

Management of overdosage:

Appropriate supportive treatment should be given.
Hemodialysis is not expected to enhance the elimination of Jakafi.

Can this medicine be used in pregnancy?[edit | edit source]

It is not known if Jakafi will harm your unborn baby.

Can this medicine be used in children?[edit | edit source]

It is not known if Jakafi is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

What are the active and inactive ingredients in this medicine?[edit | edit source]

Active ingredient: ruxolitinib phosphate
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, sodium starch glycolate, povidone and hydroxypropyl cellulose

Who manufactures and distributes this medicine?[edit | edit source]

Manufactured for:

Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE
Jakafi is a registered trademark of Incyte.

What should I know about storage and disposal of this medication?[edit | edit source]

Store Jakafi at room temperature 68°F to 77°F (20°C to 25°C).

Ruxolitinib phosphate Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.