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Treatment Name: Ruxolitinib (Jakafi®)

Ruxolitinib (Jakafi®) is a Treatment Regimen for Myelofibrosis

How does ruxolitinib (Jakafi®) work?
By blocking a mutated protein in bone marrow cells known as JAK2V617F (or “JAK2"), ruxolitinib (Jakafi) is designed to slow the growth of white blood cells, red blood cells, or platelets when they are higher than the normal range.

Ruxolitinib is also designed to decrease inflammation in the body caused by myelofibrosis.

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 ruxolitinib therapy:
Ruxolitinib (Jakafi) is taken to decrease symptoms caused by myelofibrosis, which include: fatigue, low appetite, shortness of breath, weight loss, fever, excessive sweating during sleep, a large spleen or liver, or generalized bone or muscle pain. Sometimes doctors refer to fever, weight loss, and night sweats as “constitutional symptoms.”

Ruxolitinib is not usually given with the goal of cure, although in some studies, it has been shown to help people live longer when compared to other therapies.

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Schedule

Blood counts, as well as kidney and liver function should be evaluated using blood tests before beginning treatment as those results may affect the starting dose.

  • Serious infections should be treated before starting this drug

Usual ruxolitinib (Jakafi) starting dose depends upon platelet count and kidney function:

  • 20 mg oral tablet by mouth TWICE DAILY every day (platelet count more than 200 k/mcL
  • 15 mg oral tablet by mouth TWICE DAILY every day (platelet count 100 – 200 k/mcL)
  •   5 mg oral tablet by mouth TWICE DAILY every day (platelet count 50 – 99 k/mcL)
  • Avoid use of ruxolitinib when platelet count less than 50 k/mcL

Adjusted dosing:

  • If kidney function is decreased (estimated by CrCl) = 15 – 59 mL/min, AND platelet count 100 – 150 k/mcL, a ruxolitinib dosage reduction to 10 mg by mouth TWICE DAILY may be recommended
  • If kidney function is decreased (estimated by CrCl) = 15 – 59 mL/min, AND platelet count 50 – 99 k/mcL, a ruxolitinib dosage reduction to 5 mg by mouth TWICE DAILY may be recommended

Ruxolitinib is usually taken at home. On occasion, it may be given in the hospital if someone is too sick. If you are hospitalized while taking this, it is best to bring your personal supply with you as some hospitals will not provide this medicine.

Typical duration of therapy is usually until ruxolitinib no longer works, or unacceptable side effects are experienced. Although the majority of patients notice symptom improvement, ruxolitinib should be discontinued if there is no symptom improvement or spleen reduction after six months of treatment.

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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: 60 - 70% have a low platelet count] because they differed between clinical studies:

Up to 11% of patients discontinue ruxolitinib due to unacceptable side effects.

The red blood cell count and hemoglobin level are expected to decline after starting therapy with ruxolitinib, often reaching the lowest point in 8 – 12 weeks. Blood transfusion may be recommended if the hemoglobin gets too low.

Other important notes:

  • Ruxolitinib does NOT cause hair loss
  • Although fatigue is listed as a side effect of ruxolitinib, it often gets better rather than worse over time
  • Although ruxolitinib is not known to increase the risk of blood clots, myelofibrosis itself can increase the risk for blood clots. Please watch our blood clot video below to learn more

Side effect videos Side Effect Videos
AnemiaAnemiaFatigue Fatigue DiarrheaDiarrheaBleedingBleedingNausea and VomitingNausea and VomitingConstipationConstipationPainPainNeutropenic FeverNeutropenic FeverBlood 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), lactate dehydrogenase, uric acid, plus any others your doctor may order.

  • Blood counts should be monitored every 2 to 4 weeks until a stable dose has been reached
  • A cholesterol panel is recommended 8 to 12 weeks after starting therapy

How often is imaging needed?
Imaging may be checked before treatment, after 24 weeks, after 48 weeks, and again until stable. Imaging may include: Magnetic Resonance Imaging (MRI), or Computerized Tomography (CT scan) to assess spleen size. Many clinicians choose to determine spleen size by gently pressing (also called palpating) on the lower left side of the abdomen (belly), just below the last rib of the rib cage. Chest x-ray or CT scans may be recommended if there are 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, reduce the dose, delay the next dose until the side effect goes away, or switch to an alternative therapy.

  • Lower doses should be used in patients with poor kidney function to reduce the occurrence of side effects
  • This drug may cause low platelet counts, which could increase the risk for bruising or bleeding. Ruxolitinib can be temporarily stopped when platelets drop below 25 or 50 k/mcL, and resumed at a lower dose when platelets rise about 35 or 50 k/mcL. Platelet transfusions may be required to prevent bleeding if the platelet count drops too low
  • If the good white blood cells (known as neutrophils) drop below 500/mcL, ruxolitinib therapy may need to be temporarily stopped until these cells recover to a safe level (above 750/mcL)
  • Depending upon blood tests and response to treatment, your doctor may recommend a bone marrow biopsy if concerned the disease is progressing. Depending upon the results, a change in therapy may be recommended.
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ChemoExperts Tips

  • If dizziness is experienced, a dose reduction in ruxolitinib (Jakafi) should be considered
  • Headache is a common side effect and does not often respond to typical headache medications. A dose reduction may help to decrease the number of headaches and their severity
  • The requirement for red blood cell transfusions may increase during the first several months of treatment, however anemia usually lessens with continued treatment for most patients
  • If ruxolitinib is stopped, symptoms of myelofibrosis can return within a period of one week
  • Regular skin examinations should be scheduled as ruxolitinib can increase the risk of non-melanoma skin cancers. These skin cancers are usually not serious and are easily removed
  • If you have a large spleen or liver that shrinks after starting therapy, it is recommended to not abruptly stop treatment as they could become large again quickly, causing abdominal pain
  • 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 or valacyclovir (Valtrex®) may be considered in patients with a history of shingles infection
  • Lemons, limes, and other types of oranges are okay to eat and do not interact with ruxolitinib. Try to avoid grapefruit and grapefruit juice, pomegranate, starfruit, and seville oranges (found in marmalade) as they may increase the concentration of ruxolitinib in your blood leading to a greater risk of side effects
  • Ruxolitinib should be temporarily stopped for any bleeding event. Once bleeding has resolved, consider resuming at a lower dose
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately. For example, ruxolitinib should NOT be taken with fluconazole (an antifungal medication) at doses of 200 mg or greater as this can increase the side effects
  • Ruxolitinib may be used for patients receiving hemodialysis for kidney disease. The starting dose for dialysis is either one 15 mg dose (if platelet count between 100 – 200 k/mcL) or one 20 mg dose (if platelet count above 200 k/mcL) after each dialysis session
  • Clinical trials may exist for myelofibrosis. 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) Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366:799-807.

2) Harrison C, Kiladjian JJ, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366:787-798.

3) Mesa RA, Komrokji RS, Verstovsek S. Ruxolitinib dose management as a key to long-term treatment success. Int J Hematol. 2016 Aug 27. [Epub ahead of print]

4) Cervantes F, Vannucchi AM, Kiladjian JJ, et al. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013;122:4047-4053.

5) Harrison CN, Mesa RA, Kiladjian JJ, et al. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol. 2013;162:229-239.

Created: September 15, 2016 Updated: July 21, 2017

What is Myelofibrosis?

A disease of the bone marrow where fibrous tissue, known as reticulin, replaces normal healthy bone marrow cells, such as white blood cells, red blood cells, or platelets. If the bone marrow cannot make enough red blood cells, the spleen or liver may make red blood cells which causes the spleen or liver to get bigger. An enlarged spleen or liver can cause abdominal discomfort and may push on the stomach making it difficult to eat an entire meal. Patients with myelofibrosis can also have excessive, or too much growth of certain cells such as white blood cells, red blood cells, or platelets. Myelofibrosis may increase the risk of a blood clot, bleeding, or infection, or cause “constitutional symptoms” such as fatigue, fever, weight loss, or night sweats.

Myelofibrosis is a rare condition. There are no known causes of myelofibrosis, however it can result when patients with other bone marrow disorders, such as polycythemia vera or essential thrombocythemia, get worse. Very rarely, these as well as other types of cancer can cause fibrosis of the marrow. This is known as “secondary myelofibrosis.” The stage of myelofibrosis can vary at diagnosis and throughout treatment. Prognostic scoring systems for myelofibrosis take into account the degree of fibrous tissue (reticulin) in the marrow, age, white blood cell count, hemoglobin, platelet count, presence of “blast cells” in the blood, and symptoms. The effectiveness of the treatment may depend upon the prognostic score.

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.

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Clinical Studies

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

1) Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366:799-807.

2) Harrison C, Kiladjian JJ, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366:787-798.

3) Cervantes F, Vannucchi AM, Kiladjian JJ, et al. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013;122:4047-4053.

4) Harrison CN, Mesa RA, Kiladjian JJ, et al. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol. 2013;162:229-239.

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 k/mcL ?

k/mcL is an abbreviation for thousand per microliter.

What is CrCl ?

CrCl is an abbreviation for creatinine clearance, which is a measure of kidney function.