Jakavi

Brand Name

Jakavi

Common Name

ruxolitinib

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Ruxolitinib belongs to the group of medications called antineoplastics, or anti-cancer medications. More specifically, it is a protein kinase inhibitor.

It is used to treat people with an enlarged spleen and other symptoms of myelofibrosis (MF), a rare type of blood cancer. It is also used to control the amount of red blood cells in the blood (hematocrit) for people with the condition polycythemia vera (PV), who have not responded to other medications.

Ruxolitinib is also used to reduce the symptoms of graft-versus-host disease (GVHD), a potential complication of stem cell transplants. In GVHD, the transplanted cells recognize recipient's cells as foreign and try to destroy them. Ruxolitinib may be used for GVHD that has not responded to other medications or chronic (long-term) GVHD.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended starting dose of ruxolitinib when treating myelofibrosis or polycythemia vera depends on the condition being treated and baseline levels of certain blood cells (e.g., platelets, hemoglobin, neutrophils). Your doctor will adjust your dose based on how you respond to and tolerate this medication. Doses range between 5 mg and 20 mg taken twice daily. The maximum dose of ruxolitinib is 25 mg taken twice daily.

When treating acute GVHD, the usual starting dose is 5 mg taken by mouth twice a day. Depending on your blood counts, your doctor may recommend increasing the dose to 10 mg twice a day after 3 days.

When treating chronic GVHD, the usual starting dose is 10 mg taken by mouth twice daily. Your doctor will adjust your dose based on blood tests and side effects.

This medication can be taken with or without food. Swallow the tablets whole with a glass of water. Do not break, cut, crush, or chew the tablets. It is important to take this medication around the same time every day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original package at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

5 mg
Each round, curved, white-to-almost-white tablet, with "NVR" debossed on one side and "L5" debossed on the other side, contains 5 mg of ruxolitinib. Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

10 mg
Each round, curved, white-to-almost-white tablet with "NVR" debossed on one side and "L10" debossed on the other side contains 10 mg of ruxolitinib. Nonmedicinal ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

15 mg
Each ovaloid, curved, white-to-almost-white tablet, with "NVR" debossed on one side and "L15" debossed on the other side, contains 15 mg of ruxolitinib. Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

20 mg
Each elongated, curved, white-to-almost-white tablet with "NVR" debossed on one side and "L20"debossed on the other side, contains 20 mg of ruxolitinib. Nonmedicinal ingredients: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (Type A), and povidone.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to ruxolitinib or any ingredients of the medication
• have a history of an illness called progressive multifocal leukoencephalopathy

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• anxiety
• constipation
• diarrhea
• dizziness
• flu-like symptoms (e.g., sore throat, cough)
• headache
• muscle spasms
• nausea
• passing gas (flatulence)
• ringing in the ears
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• back pain
• high blood pressure
• numbness
• fast, pounding heartbeat
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
• symptoms of an infection (e.g., fever, chills, cough, difficult or painful urination)
• symptoms of anemia (e.g., unusual tiredness, shortness of breath, pale skin)
• symptoms of heart problems (e.g., low heartbeat, chest pain, dizziness, fainting, palpitations)
• symptoms of pneumonia (e.g., fever, cough, difficulty breathing, wheezing, chest pain)
• symptoms of shingles (e.g., painful skin rash with blisters)
• symptoms of tuberculosis (e.g., chronic cough with blood-tinged sputum, fever, night sweats, weight loss)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• symptoms of cytomegalovirus infection (e.g., fever, pain, redness, difficulty breathing)
• unexpected bruising or bleeding (e.g., nose bleeds, blood in urine, black stools, bleeding gums, cuts that won't stop bleeding)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the brain (e.g., sudden altered level of consciousness, persistent headache, numbness, tingling, weakness, or paralysis)
• signs of bleeding in the stomach or intestine (e.g., passing black or bloodstained stools, or vomiting blood)
• signs of progressive multifocal leukoencephalopathy (PML) (e.g., memory loss, vision loss, difficulty thinking or walking)
• signs of a serious allergic reaction (e.g., abdominal cramps, hives, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of JC virus (e.g., weakness, confusion, difficulty thinking or walking)
• symptoms of sepsis (blood infection; e.g., fast heart rate, fever, confusion, rapid breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Ruxolitinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the amounts of specific types of blood cells in your blood.

Bleeding: Ruxolitinib can reduce the number of platelet cells in the blood. Platelets help the blood to clot and if there aren't enough, you may bleed more easily. If you notice signs of unusual bruising or bleeding (e.g., blood in urine, cuts that won't stop bleeding, black stools, bleeding gums), contact your doctor.

Blood clots: Similar medications have been associated with an increased chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Cancer: Although not common, ruxolitinib has been associated with several different types of cancer including skin cancer and lymphoma. If you have risk factors for developing cancer, including a history of smoking, make sure your doctor is aware. Report any skin changes or sores that do not heal to your doctor. Discuss any concerns that you may have with your doctor.

Cholesterol: Ruxolitinib can cause increases in cholesterol and other lipids in the blood. Your doctor will do blood tests to monitor your cholesterol levels.

Grapefruit juice: Grapefruit juice affects how ruxolitinib is removed from the body. It may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at any time while taking this medication for treatment.

Heart rhythm: Ruxolitinib can cause changes to the normal rhythm of the heart, including a decrease in heart rate and an irregular heartbeat.

If you are at risk for heart rhythm problems (e.g., have a slow heart rate, an abnormal heart rhythm, heart failure, or heart disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: Ruxolitinib can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood. Inform your doctor if you have a history of tuberculosis or hepatitis B before you start treatment.

Kidney function: Decreased kidney function or kidney disease may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactose intolerance: This medication contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency), you should not take this medication.

Liver function: Decreased liver function or liver disease causes this medication to build up in the body and may cause side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication can affect your liver function. Your doctor may want to regularly test your liver function with blood tests while you are taking this medication. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using ruxolitinib. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately. People taking ruxolitinib should use an effective method of birth control (e.g., birth control pill, condoms) during treatment.

Breast-feeding: It is not known if ruxolitinib passes into breast milk. People taking ruxolitinib should not breast-feed during treatment and for at least 2 weeks after the final dose.

Children: The safety and effectiveness of this medication have not been established for children less than 12 years of age for treatment of GVHD or for children less than 18 years of age for other conditions.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over the counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Jakavi