Ruxolitinib

Ruxolitinib is used to treat

• myelofibrosis (a cancer of the bone marrow in which the bone marrow is replaced by scar tissue and causes decreased blood cell production)
• polycythemia vera (PV; a slow growing cancer of the blood in which the bone marrow makes too many red blood cells)
• acute graft versus host disease (aGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow] that usually develops within the first months after HSCT)
• chronic GVHD (cGVHD; a complication of HSCT that usually develops at least 3 months after HSCT)

Ruxolitinib is in a class of medications called kinase inhibitors. It works to treat myelofibrosis and PV by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. It works to treat GVHD by blocking the signals of the cells that cause GVHD.

Ruxolitinib comes as a tablet and extended-release tablet to take by mouth with or without food. Take the tablet twice daily and the extended-release tablet once daily. Take ruxolitinib at around the same times every day.

Take ruxolitinib exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of ruxolitinib and increase your dose based on your response and condition being treated. 

If you can not have food by mouth and have a nasogastric (NG) tube, your doctor may tell you to take ruxolitinib tablets through the nasogastric (NG) tube. Your doctor or pharmacist will explain how to prepare ruxolitinib to give through an NG tube.

Your doctor will order laboratory tests before and during your treatment to see how you are affected by this medication. Your doctor may increase or decrease your dose of ruxolitinib during your treatment, or may tell you to stop taking ruxolitinib for awhile. This depends on how well the medication works for you, your lab test results, and if you experience side effects. Talk to your doctor about how you are feeling during your treatment. Continue to take ruxolitinib even if you feel well. Do not stop taking ruxolitinib without talking to your doctor. 

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ruxolitinib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with ruxolitinib: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking ruxolitinib. Do not start this medication while taking ruxolitinib without talking to your healthcare provider.
• tell your doctor if you have or ever had anemia; a low white blood cell count; high cholesterol or triglycerides; a blood clot, heart attack, stroke, or other heart problems; skin cancer; or liver or kidney disease. Also tell your doctor if you are a current or past smoker or if you are on dialysis.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking ruxolitinib, call your doctor. You should not breast-feed while taking ruxolitinib and for 2 weeks after your final dose.
• you should know that ruxolitinib may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. Also tell your doctor if you have or if you have ever had hepatitis B virus infection (HBV; an ongoing liver infection) or herpes zoster (shingles). If you experience any of the following symptoms during or shortly after your treatment with ruxolitinib, call your doctor immediately: fever, sweats, or chills; sore throat; cough; warm, red, or painful skin or sores on your body; frequent, urgent, or painful urination; or other signs of infection.
• you should know that taking ruxolitinib increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Ruxolitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• headache
• weight gain
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• unusual or heavy bleeding or bruising
• burning, tingling, itching, or skin sensitivity on one side of the body or face with painful rash or blisters appearing several days later.
• new sores, bumps, or discoloration or other changes to the skin
• pale skin, tiredness, or shortness of breath (especially while exercising)
• difficulty moving or keeping your balance, weakness of the legs or arms that keeps getting worse, difficulty understanding or speaking, loss of memory, vision problems, or changes in personality
• swelling, pain, tenderness, warmth or redness in one or both legs
• shortness of breath, difficulty breathing
• pain in the chest, arms, back, neck, jaw, or stomach
• breaking out in cold sweat. nausea, vomiting, lightheadedness
• slow or difficult speech
• numbness or weakness of the face, arm, or leg on one side of your body

Ruxolitinib may increase the risk that you will develop skin cancer or other cancers. Talk to your doctor about the risks of taking this medication.

Ruxolitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• unusual bleeding or bruising
• fever, sore throat, chills, cough, and other signs of infection

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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