Jakafi - Ruxolitinib Tablets

What is this medication?

RUXOLITINIB (RUX oh LI ti nib) treats blood and bone marrow cancers. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells. It may also be used to treat a condition that can occur after a stem cell or bone marrow transplant (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), bacterial, fungal, viral infections
• Kidney disease or if you are on dialysis
• Liver disease
• Low blood counts, such as low white cells, platelets, red blood cells
• Stroke
• Tobacco use
• An unusual or allergic reaction to ruxolitinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking this medication unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

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

Talk to your care team about the use of this medication 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?

• Antiviral medications for HIV or AIDS
• Apalutamide
• Certain antibiotics, such as clarithromycin, chloramphenicol, erythromycin, telithromycin, dalfopristin; quinupristin
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, fosphenytoin, phenytoin, 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?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

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

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

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual bruising or bleeding

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

• Diarrhea
• Dizziness
• Headache
• Muscle spasms
• Swelling of the ankles, hands, or feet

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 at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication 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.