Upadacitinib (ue-pad-a-SYE-ti-nib)

Treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, Crohn's disease, non-radiographic axial spondyloarthritis, and polyarticular juvenile idiopathic arthritis.

Brand Name(s):

Rinvoq, Rinvoq LQ

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it.
• If you take the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
• Oral liquid:
  • Use this medicine with the provided press-in bottle adapter and oral dosing syringe.
  • Press down and twist the cap to remove it from the bottle. Do not throw away the cap. While holding the bottle firmly, use your thumb to push the adapter all the way down to the rim of the bottle. Do not remove the adapter after it is inserted.
  • Insert the tip of the syringe into the adapter. With the syringe attached to the bottle, turn the bottle upside down.
  • Slowly pull the plunger down. Check the syringe for large air bubbles. If you see air bubbles, flick the sides off the syringe to send large air bubbles to the tip. Move the plunger up and down to return air bubbles back into the bottle.
  • Move the plunger until it is even with the prescribed dose. Turn the bottle upright and remove the syringe. Hold the middle of the syringe and carefully remove it from the bottle.
  • Place the syringe against the inside of the child's cheek. Push the plunger to give the entire dose and give water.
• Do not switch between extended-release tablet and oral liquid unless your doctor yells you to
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away unused oral liquid 60 days after opening.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how upadacitinib works. Tell your doctor if you are using any of the following:
  • Atorvastatin, azathioprine, bupropion, caffeine, cyclosporine, dextromethorphan, ethinylestradiol, levonorgestrel, methotrexate, midazolam, omeprazole, rifampin, rosuvastatin, warfarin
  • Medicine that weaken the immune system
  • Medicine to treat infections (including clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole)
  • NSAID pain medicine
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines during treatment with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 4 weeks after the last dose.
• Do not breastfeed during treatment with this medicine and for at least 6 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B or C), blood problems, cancer or a history of cancer, diabetes, lung disease, HIV, stomach or bowel problem (including diverticulitis), or a history of tuberculosis. Tell your doctor if you have a current infection or an infection that keeps coming back, or if you smoke or have smoked in the past.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of cancer (including lymphoma, lung cancer, skin cancer)
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease
  • Stomach or bowel perforation (tear or hole)
  • High cholesterol in the blood
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain that may spread, trouble breathing, coughing up blood, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, night sweats, body aches
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain, redness, swelling, or tenderness in the arms or legs
• Skin or mole changes, sores that do not heal
• Stomach pain, cramping, bloody stools
• Sores, reddish patch or irritated area, shiny bump, or pink growth on the skin
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Blemishes on the skin, pimples
• Muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088