Upadacitinib

Generic name: upadacitinib [ ue-PAD-a-SYE-ti-nib ]
Brand name: Rinvoq
Drug class: Antirheumatics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jan 16, 2024.

What is upadacitinib?

Upadacitinib is used alone or with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s).

Upadacitinib is also used to treat psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s).

Upadacitinib is also used to treat symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition or whose eczema has not responded to other medications.

Upadacitinib is also used to treat ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s).

Upadacitinib is also used to treat Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s).

Upadacitinib is used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s).

Upadacitinib is also used to treat active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling), but without changes seen on X-ray, in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s).

Upadacitinib belongs to a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

Upadacitinib side effects

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

Upadacitinib affects your immune system, and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

• fever, swollen glands, night sweats;

• vomiting, diarrhea, weight loss;

• a new skin lesion, or a mole that has changed in size or color;

• weakness on one side of your body, problems with speech or vision;

• changes in your mental state;

• blood in your urine, burning when you urinate, little or no urination; or

• tenderness near the transplanted kidney.

Some people taking upadacitinib have developed heart attacks, strokes, or serious blood clots. Seek emergency medical attention if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung - chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or

• signs of a blood clot deep in the body - pain, swelling, or warmth in one leg.

upadacitinib may cause serious side effects. Call your doctor at once if you have:

• wheezing, trouble breathing, severe or worsening cough;

• increased urination, pain or burning when you urinate;

• fever, chills, cough with mucus, chest pain, feeling short of breath;

• abnormal blood tests;

• signs of tuberculosis - fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired;

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

• symptoms of herpes virus - cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• a hole (perforation) in your digestive tract - fever, severe stomach pain, change 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).

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common upadacitinib side effects may include:

• flu symptoms;

• nausea;

• acne, rash, headache;

• stomach pain;

• weight gain;

• muscle pain;

• folliculitis (redness or crusting around your hair follicles);

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

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough; or

• low red blood cells (anemia) - pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

Warnings

Taking upadacitinib 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.

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 attention 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.

If you've had hepatitis B, it may come back or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not take this medicine if you are allergic to upadacitinib.

Before you start taking upadacitinib, tell your doctor if you have any signs of infection such as fever, sweating, chills, cough, body aches, tiredness, open sores or skin wounds, shortness of breath, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

To make sure upadacitinib is safe for you, tell your doctor if you have ever had:

• a weak immune system or HIV;

• an active or chronic infection;

• tuberculosis (or if anyone in your household has tuberculosis);

• herpes zoster (also called shingles);

• any type of cancer;

• diverticulitis, an ulcer in your stomach or intestines;

• heart problems, heart attack, stroke, or blood clot;

• high cholesterol;

• chronic lung disease;

• eye problems (especially a problem with your retina);

• diabetes;

• low red or white blood cell counts;

• recently received or scheduled to receive any vaccine;

• are a current or past smoker;

• liver disease (especially hepatitis B or C); or

• kidney disease.

Make sure you are current on all vaccines before you start using upadacitinib.

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

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

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

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

How should I take upadacitinib?

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

Upadacitinib is usually taken once per day, with or without food.

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

Call your doctor if you see part of the upadacitinib tablet in your stool.

You may need frequent medical tests before and while taking upadacitinib.

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

Dosing Information

Usual Adult Dose of Upadacitinib 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 disease modifying antirheumatic drugs (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.
-Limitations of use: This drug is not recommended in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

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

Usual Adult Dose of Upadacitinib for Psoriatic Arthritis:

15 mg orally once daily

Comments:
-Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Use: Adults with active psoriatic arthritis with inadequate response or intolerance to TNF blockers

Usual Adult Dose for Atopic Dermatitis:

Initiation dose: 15 mg orally once daily
Maximum dose: 30 mg orally once daily (if no response with initial dose)
Duration of therapy: Discontinue if no response is achieved with 30 mg/day dose.

Usual Geriatric Dose for Atopic Dermatitis:

Adults 65 years of age and older: 15 mg orally once daily.

Usual Pediatric Dose for Atopic Dermatitis:

Patients 12 years of age and older weighing at least 40 kg:
Initiation dose: 15 mg orally once daily
Maintenance dose: 30 mg orally once daily (if no response with initial dose)
Maximum dose: 30 mg orally once daily
Duration of therapy: Discontinue if no response is achieved with 30 mg dose

Comments:
-Use the lowest dose to maintain response
-Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

Use: Pediatric patients older than 12 years old and weighing at least 40 kg with refractory, moderate to severe atopic dermatitis that has not been adequately controlled with other systemic drug products, including biologics, or when other therapies are inadvisable

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while taking upadacitinib?

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

Upadacitinib may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit may interact with upadacitinib and cause side effects. Avoid consuming grapefruit products.

What other drugs will affect upadacitinib?

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

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

• phenytoin;

• an antibiotic - clarithromycin, rifampin;

• antifungal medicine - 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.

Ingredients

Active ingredient: upadacitinib
Inactive ingredients, Rinvoq 30mg tablets: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide.
Inactive ingredients, Rinvoq 45mg tablets: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide.

Manufacturer

AbbVie Inc., North Chicago, IL 60064, USA

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use upadacitinib only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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