Momelotinib

Momelotinib is used to treat certain types of myelofibrosis (a cancer of the bone marrow in which the bone marrow is replaced by scar tissue and causes decreased blood cell production) in adults who have anemia. Momelotinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Momelotinib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take momelotinib at around the same time 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 momelotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

Your doctor will order blood tests before and during your treatment to see how you are affected by this medication. Your doctor may decrease your dose of momelotinib during your treatment, or may tell you to stop taking momelotinib temporarily or permanently. 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.

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 momelotinib,

• tell your doctor and pharmacist if you are allergic to momelotinib, any other medications, or any of the ingredients in momelotinib tablets. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects
• tell your doctor if you smoke or if you have ever smoked. Also tell your doctor if you have or have ever had a low number of white blood cells or platelets; bleeding problems; cancer; blood clots, including a pulmonary embolism (PE; a blood clot in the lung); a stroke; a heart attack or other heart problems; or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking momelotinib and for 1 week after your last dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking momelotinib, call your doctor immediately. Momelotinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking momelotinib and for 1 week after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking momelotinib.
• you should know that momelotinib 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. Also tell your doctor if you have or if you have ever had hepatitis B virus infection (HBV; an ongoing liver infection). If you experience any of the following symptoms during or shortly after your treatment with momelotinib, 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.

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.

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

• diarrhea
• headache
• numbness and tingling of the arms, hands, legs, or feet
• new or increasing fatigue
• dizziness
• back, arm, or leg pain
• swelling of the arms, legs or other parts of the body
• rash
• itching
• blurry vision

Some side effects can be serious. If you experience any of these symptoms or those listed in the SEPCIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• unusual or heavy bleeding or bruising
• black or tarry stools
• yellowing of the skin or eyes, loss of appetite, pain in upper right side of stomach, dark (tea-colored) urine, or extreme tiredness
• crushing chest pain or chest heaviness
• 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
• nausea or vomiting
• feeling light-headed
• slow or difficult speech
• numbness or weakness in face, arm, or leg on one side of your body

Momelotinib may increase the risk that you will develop other cancers, such as lymphoma (cancer that begins in the cells that fight infection). Talk to your doctor about the risks of taking this medication.

Momelotinib 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 (http://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).

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

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.

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.

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.

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