Ruxolitinib oral tablets

What is this medication?

RUXOLITINIB (RUX oh LI ti nib) is a medicine that targets proteins in cells and stops them from growing. It is used to treat myelofibrosis, polycythemia vera, and graft-versus-host disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Jakafi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• blood clots
• cancer
• heart attack
• heart disease
• hepatitis
• high cholesterol
• infection such as tuberculosis (TB) or other bacterial, fungal, or viral infections
• kidney disease or if you are on dialysis
• liver disease
• low blood counts (white cells, platelets, or red blood cells)
• smoke tobacco cigarettes
• stroke
• an unusual or allergic reaction to ruxolitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. You can take it with or without food. If it upsets your stomach, take it with food. Do not take with grapefruit juice. Take it as directed on the prescription label at the same time every day. Your health care provider may change your dose or tell you stop taking this medicine if you get side effects. Do not change your dose or stop taking it unless your health care provider tells you to.

If you are giving this medicine into a feeding tube, flush the tube with water before and after the dose.

Talk to your health care provider about the use of this medicine in children. While it may be given to children as young as 12 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medication may interact with the following medications:

• antiviral medicines for HIV or AIDS
• apalutamide
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
• certain antibiotics like clarithromycin, chloramphenicol, erythromycin, telithromycin, and dalfopristin; quinupristin
• certain medicines for seizures like carbamazepine, phenobarbital, fosphenytoin/phenytoin, and primidone
• conivaptan
• enzalutamide
• grapefruit juice
• idelalisib
• lumacaftor; ivacaftor
• mifepristone
• mitotane
• nefazodone
• ribociclib
• rifampin
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

You may need blood work done while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your doctor right away. If you cannot reach your doctor, urgently seek other source of medical care.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not breast-feed an infant while taking this medicine or for at least 2 weeks after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• anemia (trouble breathing; feeling faint; lightheaded; falls, unusually weak or tired)
• blood clot (chest pain; shortness of breath; pain, swelling, or warmth in the leg)
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• muscle cramps
• swelling of arms or legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.