What is Jakafi?

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. This medicine is also used to treat polycythemia vera in patients who have had received hydroxyurea without success.

This medicine is available only with your doctor's prescription.

Your doctor will tell you how much of this medicine 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.

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

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

Take this medicine with or without food.

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

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

The dose of this medicine 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 this medicine. 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, 5 to 20 milligrams (mg) two times a day, depending on your blood test results. 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.
  • For polycythemia vera:
    • Adults—At first, 10 milligrams (mg) two times a day, depending on your blood test results. 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.

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

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.

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 this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

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.

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

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.

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 this medicine, 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 this medicine 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
• Cobicistat
• Conivaptan
• Fluconazole
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Voriconazole

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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

• Anemia (low number of red blood cells) or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Neutropenia (low number of white blood cells) or
• Skin cancer, history of or
• Thrombocytopenia (low number of platelets) or
• Tuberculosis, or history of—Use with caution. May make these conditions worse.

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

• Kidney disease, moderate or severe 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—This medicine should be taken after your dialysis treatment.

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

If your condition does not improve within 6 months, or if it becomes worse, check with your doctor.

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.

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

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have weakness on one side of your body, loss of coordination, clumsiness, memory problems, trouble thinking clearly, or loss of interest in things.

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).

This medicine may cause non-melanoma skin cancer. Tell your doctor if you have any new or changing skin lesions.

Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as a fever, chest tightness, trouble breathing, lightheadedness, dizziness, or fainting.

This medicine may increase the level of cholesterol and fat in your blood. If this occurs, your doctor may give you medicine to lower the cholesterol and fat. Talk to your doctor if you have concerns.

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

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.