Rinvoq is a prescription medicine that is a Janus kinase (JAK) inhibitor. It works inside your cells to block certain signals that are thought to cause inflammation.

Rinvoq is used to treat adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, moderate to severe ulcerative colitis, moderately to severely active Crohn’s disease, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis.

It is used when medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.

Rinvoq is also used to treat adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

It is not known if Rinvoq is safe and effective in children with juvenile idiopathic arthritis, with psoriatic arthritis, with ulcerative colitis, with Crohn’s disease, with ankylosing spondylitis, or with non-radiographic axial spondyloarthritis.

It is not known if Rinvoq is safe and effective in children under 12 years of age with atopic dermatitis.

Rinvoq affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

Taking Rinvoq may increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer.

Tell your doctor if you have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis, shingles, or HIV. Also tell your doctor if you've ever had diverticulitis, an ulcer in your stomach or intestines, cancer, heart problems, or a history of smoking, heart attack, stroke, or blood clots.

Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.

Seek emergency medical help if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.

Take Rinvoq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Take Rinvoq tablets with a full glass of water.

Take the medicine at the same time each day, with or without food.

Swallow the Rinvoq extended release tablet whole and do not crush, chew, or break a tablet.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've ever had shingles (herpes zoster) or hepatitis B or C, using Rinvoq can cause these viruses to become active or get worse.

Store Rinvoq in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Rheumatoid Arthritis

15 mg orally once a day

Comments:
-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Psoriatic Arthritis

15 mg orally once a day

Comments:
-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult and Pediatric Dose for Atopic Dermatitis

15 mg orally once a day

Comments:
- for pediatric patients 12 years of age and older weighing at least 40 kg and adults less than 65 years of age: Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily.
- for adults 65 years of age and older: Recommended dosage is 15 mg once daily
- This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of adult and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

Usual Adult Dose for Ulcerative Colitis

Induction dosage: 45 mg orally once a day for 8 weeks. Maintenance dosage: 15 mg orally once a day (30 mg once daily may be considered for patients with refractory, severe, or extensive disease.)

Comments:
- discontinue treatment if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Crohn’s Disease

Induction dosage: 45 mg orally once a day for 12 weeks. Maintenance dosage: 15 mg orally once a day.

Comments:
- a maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
- discontinue treatment if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
- This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Ankylosing Spondylitis

15 mg orally once a day

Comments:
- This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

15 mg orally once a day

Comments:
- This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) less than 1000 cells/mm³, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

Taking Rinvoq can increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:

• a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);

• any type of cancer;

• kidney disease, a kidney transplant, or if you are on dialysis;

• diverticulitis, an ulcer in your stomach or intestines;

• heart problems;

• a heart attack, stroke, or blood clot;

• high cholesterol; or

• if you've ever smoked.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Tell your doctor if you've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Rinvoq is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B or C);

• chronic lung disease;

• diabetes;

• low red or white blood cells; or

• if you are scheduled to receive any vaccine.

Using Rinvoq may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

Upadacitinib may harm an unborn baby. Use effective birth control while using Rinvoq and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using Rinvoq and for at least 6 days after your last dose.

Rinvoq is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving a "live" vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction to Rinvoq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking Rinvoq have developed heart attacks, strokes, or serious blood clots. Stop taking Rinvoq and seek emergency medical attention if you have:

• sudden shortness of breath;

• chest pain or pressure that may spread to your jaw, shoulder, arms, or back;

• nausea, vomiting, cold sweat;

• a light-headed feeling, like you might pass out;

• weakness on one side of your body;

• slurred speech, drooping on one side of your mouth; or

• pain, swelling, or redness in an arm or a leg.

Call your doctor at once if you have:

• fever, chills, night sweats, constant tiredness;

• wheezing, trouble breathing, severe or worsening cough;

• increased urination, pain or burning when you urinate;

• unexplained weight loss;

• lumps in your neck, armpits, or groin;

• signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body;

• a hole (perforation) in your digestive tract - fever, severe stomach pain, diarrhea or changes in bowel habits; or

• signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Rinvoq side effects may include:

• fever;

• cough;

• nausea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with upadacitinib, especially:

• phenytoin;

• an antibiotic - clarithromycin, rifampin;

• antifungal medicine - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

• drugs that weaken the immune system - azathioprine, cyclosporine, and others;

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine - dexamethasone, prednisone, and others.

This list is not complete and many other drugs may interact with upadacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.