ruxolitinib

rux-oh-LI-ti-nib

Commonly used brand name(s)

In the U.S.

• Jakafi

Available Dosage Forms:

• Tablet

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For ruxolitinib

Ruxolitinib is used to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness.

ruxolitinib is available only with your doctor's prescription.

Before Using ruxolitinib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ruxolitinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ruxolitinib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ruxolitinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ruxolitinib in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ruxolitinib, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ruxolitinib with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir


• Clarithromycin


• Conivaptan


• Indinavir


• Itraconazole


• Ketoconazole


• Lopinavir


• Mibefradil


• Nefazodone


• Nelfinavir


• Posaconazole


• Ritonavir


• Saquinavir


• Telaprevir


• Telithromycin


• Voriconazole

Using ruxolitinib with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ruxolitinib with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ruxolitinib, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of ruxolitinib. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low number of red blood cells) or


• Neutropenia (low number of white blood cells) or


• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, requiring dialysis—ruxolitinib should be taken after your dialysis treatment.

Proper Use of ruxolitinib

Your doctor will tell you how much of ruxolitinib to use and how often. Your dose depends on your platelet count and needs to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

Keep using ruxolitinib for as long as your doctor has told you to. Do not change your dose or stop taking ruxolitinib without first talking with your doctor.

Take ruxolitinib with or without food.

If you cannot swallow the tablets, tell your doctor right away. Your doctor will decide if you can take ruxolitinib through a nasogastric tube. Your doctor will give you certain instructions on how to take ruxolitinib through a tube.

ruxolitinib comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of ruxolitinib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ruxolitinib. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For myelofibrosis:
    
    • Adults—At first, 15 to 20 milligrams (mg) two times a day. Your doctor will adjust your dose as needed. However, the dose is usually not more than 25 mg two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ruxolitinib, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ruxolitinib

If you will be taking ruxolitinib for a long time, it is very important that your doctor check you at regular visits for any problems that may be caused by ruxolitinib. Blood tests will be needed to check for unwanted effects.

If your condition does not improve after 6 months, or if it become worse, stop using ruxolitinib and check with your doctor right away.

Ruxolitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

ruxolitinib may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using ruxolitinib. Wash your hands often. Tell your doctor if you have any kind of infection before you start using ruxolitinib. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Check with your doctor right away if you have painful blisters on the trunk of the body. These may be symptoms of herpes zoster (shingles).

Do not stop using ruxolitinib suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

If you take too much of ruxolitinib, call your doctor or go to the nearest hospital emergency department right away. Take the bottle of ruxolitinib with you.

Do not eat grapefruit or drink grapefruit juice while you are using ruxolitinib. Grapefruit and grapefruit juice may change the amount of ruxolitinib that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ruxolitinib Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bladder pain


• bleeding gums


• blood in the urine or stools


• bruising


• chills


• cloudy urine


• collection of blood under the skin


• cough


• deep, dark purple bruise


• difficult, burning, or painful urination


• fever


• frequent urge to urinate


• itching, pain, redness, or swelling


• large, flat, blue or purplish patches in the skin


• lower back or side pain


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• pus in the urine


• shortness of breath


• small, red or purple spots on the skin


• sore throat


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Painful blisters on the trunk of the body

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated


• dizziness or lightheadedness


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• full feeling


• headache


• passing gas


• sensation of spinning


• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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