Momelotinib

Momelotinib

Momelotinib

What is momelotinib?

Momelotinib may also be used for purposes not listed in this medication guide.

Side effects of momelotinib

If necessary, get emergency medical helpSigns of an allergic reaction:Hives, difficulty breathing, swelling of the face, lips, tongue or throat.

Momelotinib can cause serious side effects. Call your doctor immediately if you have:

• Signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• Liver problems - loss of appetite, nausea, vomiting, stomach pain (top right), fatigue, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• Heart attack symptoms – chest pain or feeling of pressure, pain spreading to the jaw or shoulder, nausea, sweating;

• Signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;

• Signs of a blood clot in the lungs – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;

• Signs of a blood clot deep in the body – pain, swelling or warmth in one leg; or

• unusual bleeding, bruising, black or tarry stools.

If you experience certain side effects, your cancer treatment may be delayed or permanently stopped.

Common side effects of momelotinib may include:

• diarrhea, nausea;

• signs of infection;

• Dizziness;

• Fatigue; or

• easy bruising, unusual bleeding, purple or red spots under the skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

Use only as directed. Tell your doctor if you are taking other medicines or have any other medical conditions or allergies.

Before you take this medicine

Tell your doctor if you have or have ever had:

• an infection;

• a heart attack, other heart problems or stroke;

• a blood clot;

• any other cancer;

• if you are taking medicines to treat rheumatoid arthritis;

• if you smoke or have smoked in the past;

• hepatitis B; or

• Liver disease.

May harm an unborn child.Use effective contraception while using momelotinib and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breast-feed while using momelotinib.and for at least 1 week after your last dose.

How should I take momelotinib?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

Do not change your dose or stop taking this medication without your doctor's advice.

Take momelotinib orally once daily with or without food.

Swallow the tablet whole and do not crush, chew or break it.

If you have had hepatitis B, the disease may come back or get worse. Liver function tests and other blood tests may be needed before, during, and after you stop using this medication.

Store tightly closed at room temperature, protected from moisture and heat. Store the medicine in the original container along with the package or canister containing the moisture-absorbing preservative.

Momelotinib dosage information

Usual Adult Dose for Myelofibrosis:

200 mg orally once daily

Comment:
- Treatment should be discontinued in patients who cannot tolerate 100 mg once daily.

Use: For the treatment of intermediate or high risk myelofibrosis (MF), including primary or secondary MF (post-polycythemia vera and post-essential thrombocythemia) in patients with anemia

What happens if I miss a dose?

Skip the missed dose and take the next dose at the regular time. Do not use two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking momelotinib?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect momelotinib?

Sometimes it is not safe to use certain medicines together. Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective.

Other medications may affect momelotinib, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.