Tofacitinib Oral Solution (TOFACITINIB - ORAL)

Instructions

Drink the medicine.

Measure the dose of liquid medicine carefully. Use the measuring device that comes with the medicine. If you do not have one, please ask your pharmacist for help.

This medicine may be taken with or without food.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Store in original bottle, tightly closed and upright.

Discard any unused medicine 60 days after opening.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

This medicine is associated with an increased risk of blood clots, heart attack, and stroke. Contact your doctor immediately if you experience leg pain or swelling, difficulty breathing, chest or jaw pain, severe headache, one-sided weakness or slurred speech.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 18 hours after stopping treatment.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• headaches

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• wheezing or difficulty breathing
• chest pain
• cough that does not go away
• fever or chills
• rapid heartbeat
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• muscle pain
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• skin sores
• sore throat
• severe stomach pain that spreads to the back
• light colored stool
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• sweating at night
• difficulty or discomfort urinating

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.