Upadacitinib Extended-Release Tablets

What is this medication?

UPADACITINIB (ue PAD a SYE ti nib) treats rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitits. It is also used to treat ulcerative colitis. It works on the immune system. It belongs to a group of medications called JAK inhibitors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): RINVOQ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood clots
• Cancer
• Diabetes (high blood sugar)
• Heart disease
• High blood pressure
• High cholesterol
• Immune system problems
• Infection, especially a viral infection such as chickenpox, cold sores, or herpes
• Infection such as tuberculosis (TB) or other bacterial, fungal or viral infection
• Kidney disease
• Liver disease
• Low blood counts (white cells, platelets, or red blood cells)
• Lung or breathing disease (asthma, COPD)
• Organ transplant
• Recent or upcoming vaccine
• Skin cancer/melanoma
• Smoke tobacco cigarettes
• Stomach or intestine problems
• Stroke
• An unusual or allergic reaction to upadacitinib, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for select conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following medications:

• Baricitinib
• Tofacitinib

This medication may also interact with the following medications:

• Azathioprine
• Certain antivirals for hepatitis or HIV
• Biologic medications such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab
• Certain medications for fungal infections like ketoconazole, itraconazole, posaconazole, or voriconazole
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Clarithromycin
• Cyclosporine
• Live vaccines
• Medications that lower your chance of fighting infection
• Mifepristone
• Nefazodone
• Rifampin
• Supplements, such as St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medication. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Women should use a form of birth control while taking this medication. Women will also need to take it for 4 weeks after stopping this medication. There is potential for serious harm to an unborn child. Talk to your care team for more information.

Do not breast-feed an infant while taking this medication or for 6 days after stopping it.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Talk to your care team about your risk of skin cancer. You may be more at risk for skin cancer if you take this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

Tell your care team right away if you have any change in your eyesight.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Change in vision
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell count—unusually weakness or fatigue, dizziness, headache, trouble breathing
• Stomach pain
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• Runny or stuffy nose
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.