Upadacitinib Extended-Release Tablets

What is this medication?

UPADACITINIB (ue PAD a SYE ti nib) treats autoimmune conditions, such as arthritis, eczema, and ulcerative colitis. It is often used when other medications have not worked well enough or cannot be tolerated. It works by slowing down an overactive immune system. This decreases inflammation.

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:

• Cancer
• Current or past tobacco use
• Diabetes
• Have had a heart attack or stroke
• Have had blood clots
• Have been in close contact with someone who has tuberculosis (TB)
• Heart disease
• High blood pressure
• High cholesterol
• HIV or AIDS
• Infection or have had an infection that does not go away, such as tuberculosis (TB), shingles, hepatitis, herpes
• Kidney disease
• Live or have traveled to the Southwest US or the Ohio or Mississippi River valleys
• Liver disease
• Low blood cell levels (white cells, red cells, and platelets)
• Lung or breathing disease, such as asthma or COPD
• Recent or upcoming vaccine
• Stomach or intestine problems
• Taking NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Taking steroid medications, such as prednisone or cortisone
• Weakened immune system
• An unusual or allergic reaction to upadacitinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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.

Do not take this medication with grapefruit juice.

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 2 years for selected 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?

• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Clarithromycin
• Grapefruit and grapefruit juice
• Live virus vaccines
• Medications that lower your chance of fighting infection, such as abatacept, adalimumab, azathioprine, cyclosporine, etanercept, infliximab, rituximab
• Rifampin
• Supplements, such as St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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.

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.

Your care team will screen you for tuberculosis (TB) before you start this medication. If they think you are at risk, you may be treated with medication for TB. You should start taking the medication for TB before you start this medication. Make sure to finish the full course of TB medication.

Talk to your care team about your vaccination history. To lower your risk of infection, you may need certain vaccines before you start this medication.

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. Tobacco use may increase your risk of cancer. Talk to your care team about having your skin checked for cancer while taking this medication. Limit the amount of time you spend in the sun. Wear protective clothing and sunscreen when you are in the sun. Do not use sun lamps, tanning beds, or tanning booths.

This medication may increase the risk of blood clots, heart attack, stroke, or death. High blood pressure, high cholesterol, diabetes, increased age, excess weight, and tobacco use increase this risk. Call emergency services right away if you have symptoms of a heart attack or stroke.

This medication can increase bad cholesterol and fats (such as LDL, triglycerides) and decrease good cholesterol (HDL) in your blood. You may need blood tests to check your cholesterol. Ask your care team what you can do to lower your risk of high cholesterol while taking this medication.

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

Talk to your care team if you often see part of the tablet in your stool.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 4 weeks after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 6 days after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team 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 level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Stomach pain that is severe, does not go away, or gets worse
• 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 care team if they continue or are bothersome):

• Acne
• Cough
• Headache
• Nausea
• Runny or stuffy nose

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). Protect from moisture. Keep the container tightly closed. Keep this medication in the original container until you are ready to take it. 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.