Ruxolitinib oral tablets

What is this medicine?

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 acute graft-versus-host disease.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not take with grapefruit juice. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

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

• dizziness

• headache

• swelling of arms or legs

• upset stomach

• weight gain

What may interact with this medicine?

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, 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

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.

Where should I keep my medicine?

Keep out of the reach of children.

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

What should I tell my health care provider before I take this medicine?

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

• cancer of the skin

• hepatitis

• high cholesterol

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to ruxolitinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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.