Upadacitinib Oral Solution (UPADACITINIB SOLUTION - ORAL)

Instructions

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.

Drink medicine immediately after measuring in the syringe. If not taken within 1 hour, throw away and prepare a new dose.

This medicine may be taken with or without food.

Drink some water after the medicine to make sure it is completely swallowed.

This medicine will work best if you take it at about the same time every day.

Store at room temperature or in refrigerator. Do not freeze. Protect from light.

Store in original bottle, tightly closed and upright.

Discard any unused medicine 60 days after opening.

Avoid grapefruit and grapefruit juice while on this medicine.

Avoid prolonged or excessive sunlight exposure. Use sunscreen lotion with SPF 15 or higher.

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.

Your doctor should check you for tuberculosis (TB) before you start this medicine and while you are using it. Tell your doctor if you are being treated for TB or any other infection.

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.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

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 6 days after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while using this medicine and for 28 days after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

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.

• headaches
• nausea

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

• severe or persistent abdominal pain
• chest or jaw pain
• cough that does not go away
• dizziness or lightheadedness
• fainting
• 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)
• unusual growth or lump on the neck
• pale or blue skin, lips or fingernails
• rapid breathing
• shortness of breath
• change in the size or color of a skin mole
• skin sores
• sore throat
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• excessive or unusual sweating
• yeast infection of mouth
• increased urinary frequency
• difficulty or discomfort urinating
• blurring or changes of vision
• severe or persistent vomiting
• unexpected or extreme weight loss

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.