Jakafi (Ruxolitinib Phosphate)

(rux'' oh li' ti nib)

Ruxolitinib is used to treat myelofibrosis (a condition in which the bone marrow is replaced by scar tissue and causes decreased blood cell production). Ruxolitinib is in a class of medications called kinase inhibitors. It works by blocking an enzyme that causes scar tissue to form in the bone marrow.

Ruxolitinib comes as a tablet to take by mouth. It is usually taken with or without food two times a day. Take ruxolitinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ruxolitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may start you on a low dose of ruxolitinib for the first four weeks of treatment, and gradually increase your dose after that time, not more than once every 2 weeks. If you are unable to swallow, your doctor may tell you to take ruxolitinib through a nasogastric (NG) tube. If so, your doctor or pharmacist will explain how to prepare ruxolitinib to give through an NG tube. Your doctor will order blood 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 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. If your treatment with ruxolitinib is stopped, your doctor may decrease your dose gradually. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking ruxolitinib,
• tell your doctor and pharmacist if you are allergic to ruxolitinib, any other medications, or any of the ingredients in ruxolitinib. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungal medications including itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); boceprevir (Victrelis); clarithromycin (Biaxin, in Prevpac); conivaptan (Vaprisol); HIV protease inhibitors including indinavir (Crixivan), lopinavir/ritonavir combination (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); mibefradil (Posicor); nefazodone (Serzone); rifampin (Rifadin, Rifamate, Rimactane, others); telaprevir (Incivik); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ruxolitinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have anemia, an infection, or are on dialysis. Also tell your doctor if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ruxolitinib, call your doctor. You should not breast-feed while taking ruxolitinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ruxolitinib.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication. 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
• tiredness
• weakness
• shortness of breath
• weight gain
• gas

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

• unusual bleeding or bruising
• fever, sore throat, chills, cough, and other signs of infection
• burning, tingling, itching, or skin sensitivity on one side of the body or face with painful rash or blisters appearing several days later.

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

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). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ruxolitinib. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.