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Treatment Name: Ruxolitinib (Jakafi®)

Ruxolitinib (Jakafi®) is a Treatment Regimen for Polycythemia Vera

How does ruxolitinib (Jakafi®) work?
Ruxolitinib works by blocking a mutated protein in bone marrow cells known as JAK2V617F or “JAK2”. Blocking this protein slows the growth of red blood cells in patients with polycythemia vera when red blood cells are higher than normal.

Is Jakafi chemotherapy?
Although Jakafi (ruxolitinib) often slows the growth of certain cells such as white blood cells, red blood cells, and platelets, it does not cause many of the side effects of classic chemotherapy. For example, Jakafi does not usually cause hair loss, mouth sores, nausea or vomiting, severe diarrhea, or severe constipation. However, like certain types of chemotherapy agents, Jakafi may increase the risk of infection.

Goals of therapy:
Ruxolitinib is taken to help control the symptoms of polycythemia vera such as increased spleen size, itching, night sweats, and fatigue. It can also help keep the amount of red blood cells within the normal range, without the need for phlebotomy. Ruxolitinib is also taken to reduce the risk of blood clots from polycythemia vera. It is not commonly given with the goal of curing polycythemia vera.

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Schedule

  • Usual Ruxolitinib starting dose: 10 mg oral tablet by mouth TWICE daily
  • Many patients take aspirin 81 mg by mouth ONCE daily with ruxolitinib, unless they have an aspirin allergy or their doctor recommends against aspirin therapy
  • Important note: If therapy with ruxolitinib needs to stop for any length of time, it is often recommended to decrease the dose slowly each day for several days to prevent a sudden return of symptoms, such as an enlarged spleen

Blood counts, as well as kidney and liver function, should be evaluated before beginning treatment as those results may affect the starting dose. Serious infections should also be treated before starting ruxolitinib (Jakafi®).

Ruxolitinib is usually taken at home. On occasion, it may be given in the hospital if someone is very sick. If you become hospitalized while taking ruxolitinib, it is best to bring your home supply with you, as some hospitals do not supply this medicine. Typical duration of therapy is usually until ruxolitinib no longer works, or unacceptable side effects are experienced.

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Side Effects

In clinical studies, the most commonly reported ruxolitinib (Jakafi®) side effects are shown here. Side effects sometimes have percentage ranges [example: 44 – 76% had anemia] because they differed between clinical studies:

  • Anemia [low red blood cells] (44 - 76%)
  • Increased bleeding risk [low platelets; thrombocytopenia] (25 - 44%)
  • Diarrhea (15 - 23%)
  • Fever (20%)
  • Low neutrophil count (type of white blood cells) (2 - 18%)
  • Cough (18%)
  • Back pain (17%)
  • Weight gain (17%)
  • Headache (16%)
  • Herpes zoster, or shingles infection (6 - 16%)
  • Fatigue (15%)
  • Itching (14%)
  • Vomiting (14%)
  • Muscle spasms (12%)
  • Dizziness (12%)
  • Abdominal pain (9 - 12%)
  • Weakness (7 - 12%)
  • Sinus infection (11%)
  • Shortness of breath (10%)
  • Blood clots (less than 1%)

Roughly 4% of patients discontinue treatment due to unacceptable side effects. 

Up to 42% of patients taking ruxolitinib for P. Vera may develop an infection. This is a similar rate of infection (37%) when patients are treated with other medicines for P. Vera.

Note: Ruxolitinib does NOT cause hair loss.

Side effect videos Side Effect Videos
AnemiaAnemiaBleedingBleedingDiarrheaDiarrheaNeutropenic FeverNeutropenic FeverPainPainFatigue Fatigue Nausea and VomitingNausea and VomitingBlood ClotsBlood Clots

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, then every two to four weeks until a stable dose is reached, then as needed. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order. A cholesterol panel is recommended eight to twelve weeks after starting therapy with ruxolitinib.

How often is imaging needed?
Imaging may be checked before treatment, after approximately eight months of therapy, then at your doctor’s discretion thereafter. Imaging may include: Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) scan, often to assess spleen size. Many doctors choose to determine spleen size by gently pressing (also called palpating) the lower left side of the abdomen (belly), just below the last rib of the left rib cage.

A chest X-ray may also be recommended if you develop signs or symptoms of pneumonia.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue ruxolitinib as planned, decrease the dose, increase the dose, hold therapy, or switch therapy. Your doctor may recommend a bone marrow biopsy if concerned the disease is progressing (getting worse). Depending upon the results of the bone marrow biopsy, a change in therapy may be recommended.

A complete response to ruxolitinib for polycythemia vera is defined as a hematocrit less than 45% without phlebotomy, a platelet count less than 400 k/µL (400,000 per microliter), a white blood cell count less than 10 k/µL (10,000 per microliter), no itching within the previous week, and a spleen that does not feel enlarged by pressing on the lower left belly.

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ChemoExperts Tips

  • Do not abruptly discontinue ruxolitinib as signs and symptoms of polycythemia vera can quickly return. Speak with your doctor before stopping therapy as patients typically need to be weaned off of ruxolitinib over a period of a few days or weeks
  • If you have a history of tuberculosis (TB), have been in close contact with a person with TB, or have traveled to a country with a high prevalence of TB, you may need to be tested for TB prior to starting therapy with ruxolitinib
  • Regular skin examinations should occur as ruxolitinib can increase the risk of non-melanoma skin cancers. These skin cancers are usually not serious and are easily removed
  • Herpes zoster, or shingles infection, can occur. It is important to know the signs and symptoms of shingles and to seek treatment immediately if suspected. Preventative antiviral therapy with acyclovir (Zovirax®) or valacyclovir (Valtrex®) may be considered in patients with a history of shingles infection or those at high risk
  • Ruxolitinib may reduce the risk of blood clots to less than 1% versus roughly 5% when compared to placebo
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions with ruxolitinib (Jakafi®) are prevented or managed appropriately
  • Clinical trials may exist for polycythemia vera. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Ruxolitinib (Jakafi®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Ruxolitinib (Jakafi®). Depending upon your income, they may be able to help cover the cost of:

  • Ruxolitinib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Ruxolitinib (Jakafi®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Ruxolitinib (Jakafi®)

Individual Drug Label Information

Ruxolitinib (Jakafi®)

  • Ruxolitinib is an oral tablet available in strengths of 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg
  • Signs and symptoms of tuberculosis infection should be continually assessed in patients taking ruxolitinib who have traveled to countries where tuberculosis is common
  • Ruxolitinib can be taken with or without food, and swallowed whole with a large glass of water
  • If unable to swallow the tablet, ruxolitinib may be dissolved in roughly 40 milliliters of water (a little over one ounce) by stirring for 10 minutes. The suspension can then be administered by a nasogastric tube within six hours of preparation
  • If you miss a dose, do not take an extra dose. Resume taking ruxolitinib at the next scheduled time 
  • Ruxolitinib should be stored at room temperature (68°F to 77°F)
  • Dosage adjustments may be required kidney or liver disease
  • May interact with anti-fungal medications such as fluconazole in doses greater than 200 mg and many other medications. Ask your pharmacist to ensure that other medicines you take are safe to take with ruxolitinib
  • Avoid grapefruit and grapefruit juice, pomegranate, starfruit, and seville oranges (found in marmalade) while taking ruxolitinib as they may increase the concentration of this drug in your blood leading to a greater risk of side effects. Lemons, limes, and other types of oranges ARE okay to have and do NOT interact with ruxolitinib
  • Women of child-bearing potential should avoid becoming pregnant while taking ruxolitinib as it may harm the unborn baby. Women wanting to become pregnant should consult their doctor regarding the safest way to balance this with ruxolitinib therapy. Ruxolitinib should only be used during pregnancy if the benefits outweigh the risk to the unborn baby (fetus)
  • It is unknown if ruxolitinib is excreted in human breast milk. The “pump and dump” method of discarding breast milk is generally recommended, when applicable. A decision to either stop nursing or stop taking ruxolitinib should be discussed if the “pump and dump” method is not used
General side effects from ruxolitinib (Jakafi)
  • Bruising
  • Dizziness
  • Headache
  • Anemia (low red blood cells), which may require blood transfusion to correct 
  • Urinary tract infections
  • Other infections from bacteria, fungi, or viruses such as herpes zoster (shingles). Ask your doctor about signs and symptoms of herpes zoster and progressive multifocal leukoencephalopathy
  • Weight gain
  • Flatulence/passing gas
  • Click on the ruxolitinib (Jakafi) package insert below for reported side effects, possible drug interactions, and other ruxolitinib prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic FeverBlood ClotsBlood Clots

See DailyMed package insert.

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References

1) Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372:426-435.

2) Verstovsek S, Passamonti F, Rambaldi A, et al. A Phase 2 Study of ruxolitinib, an oral JAK1 and JAK2 Inhibitor, in patients with advanced polycythemia vera who are refractory or intolerant to hydroxyurea. Cancer. 2014;120:513-520.

Created: November 5, 2016 Updated: October 5, 2018

What is Polycythemia Vera?

Polycythemia refers to an increased production of red blood cells. There can be many causes of this, including smoking, sleep apnea, or living at high altitudes.

Polycythemia Vera, or "P. Vera", also causes increased red blood cell production, and is almost always the result of a gene mutation known as "JAK2V617F."

P. Vera may increase the risk of a blood clot, such as a heart attack or stroke. Very rarely, it may transform into another disease such as myelofibrosis or acute myeloid leukemia, however this often takes several decades.

Peginterferon alfa-2a (Pegasys®) and ruxolitinib (Jakafi®) are common treatments for polycythemia vera. Please click on the treatment options below to learn more.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1) Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372:426-435.

2) Verstovsek S, Passamonti F, Rambaldi A, et al. A Phase 2 Study of ruxolitinib, an oral JAK1 and JAK2 Inhibitor, in patients with advanced polycythemia vera who are refractory or intolerant to hydroxyurea. Cancer. 2014;120:513-520.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is Phlebotomy?

Phlebotomy is when a specific amount of blood is purposefully removed by vein from your body to lower your red blood cell count, hemoglobin, and hematocrit.