Upadacitinib

Upadacitinib is used to treat several conditions characterized by inflammation as a primary symptom. It is an oral Janus kinase (JAK) inhibitor that works by decreasing the activity of the immune system. Upadacitinib may be used to treat:

• Rheumatoid arthritis in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s)
• Psoriatic arthritis in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s)
• Symptoms of Eczema (atopic dermatitis) 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
• Ulcerative colitis that is moderate to severe in adults who haven't responded to or can't tolerate TNF blockers. If TNF blockers aren't medically appropriate, patients must try at least one other approved therapy first.
• Crohn's disease that is moderate to severe in adults who haven't responded to or can't tolerate TNF blockers or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
• Giant cell arteritis in adults
• Ankylosing spondylitis in adults who are unable to take or who do not respond to one or more TNF inhibitor medications
• Active non-radiographic axial spondyloarthritis in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Active polyarticular juvenile idiopathic arthritis in children aged 2 years and older who have had an inadequate response or intolerance to one or more TNF blockers.

There are two formulations of upadacitinib: Rinvoq extended-release tablets and Rinvoq LQ liquid solution. These two formulations are not interchangeable.

• Upadacitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine.

Upadacitinib was FDA-approved on August 16, 2019, under the name Rinvoq. Rinvoq LQ was approved on April 26, 2024. There is no generic.

Upadacitinib is a JAK inhibitor that works by blocking Janus kinase enzymes, specifically JAK1.

• These enzymes are part of the signaling pathway that triggers inflammation in the body.
• By inhibiting JAK1, Rinvoq reduces the activity of the immune system and decreases the production of inflammatory chemicals called cytokines.
• This helps control symptoms in autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and atopic dermatitis by reducing inflammation and tissue damage.

Retail Price (Without Insurance): $5,500-$6,500 per month for all strengths

Ways to Save:

• Rinvoq (upadacitinib) Complete Savings Card: Eligible commercially insured patients may pay as little as $5/month
• Patient Assistance Program: Free medication for qualifying uninsured/underinsured patients through AbbVie Patient Assistance Foundation

Next Steps:

• Ask your doctor about savings programs
• Call AbbVie: 1-800-2RINVOQ (1-800-274-6865)
• Compare pharmacy prices

Note: Actual costs vary by insurance, pharmacy, and location.

Refer to our price guide page for more information about the cost of Rinvoq (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 only available as the brand Rinvoq.

Rinvoq tablets

Rinvoq tablets are 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 Rinvoq tablet in your stool.
• You may need frequent medical tests before and while taking Rinvoq.

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

Rinvoq LQ

Rinvoq LQ is not the same as Rinvoq tablets. Do not switch between Rinvoq LQ and Rinvoq tablets your healthcare provider has made the change.

Your healthcare provider will tell you what dose to give. This is based on your child's weight. The dosage is usually given twice daily.

• Only use the syringe provided. Do not share with other people or use with other medicines. The syringe should be clean and dry before use.
• The first time you use a new bottle of Rinvoq LQ, you will need to insert the syringe adapter. Once inserted, do not remove.
• Insert the tip of the syringe into the adapter, then turn the bottle upside down.
• Pull the plunger down and flick the syringe to get any large air bubbles out. Small air bubbles are normal.
• Measure the dose. Move the plunger until it is even with the marking for the dose.
• Turn the bottle upright, carefully remove the syringe, and place the lid back on the bottle.
• Check the dose is correct. If correct, place the syringe against the inside of your child's cheek and push the plunger to give the entire dose into the child's mouth. The solution must be given within 1 hour of filling the syringe.
• Give the child a drink of water.
• Remove the plunger from the syringe and rinse both parts in water then leave to dry.

You should not take upadacitinib if you are allergic to it.

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 this medicine, and for at least 6 days after your last dose.

Most Common Side Effects

• Flu symptoms
• Nausea
• Acne, rash, headache
• Stomach pain
• Weight gain
• Muscle pain
• Folliculitis (redness or crusting around your hair follicles)
• Cold symptoms such as a 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.

Serious side effects and warnings

Boxed Warning: Upadacitinib may increase your risk of serious infections, death, cancer, heart attack, stroke, and blood clots.

Serious infections

Rinvoq/Rinvoq LQ can lower the immune system's ability to fight infections. Serious infections, including tuberculosis (TB), bacterial, fungal, and viral infections that can spread throughout the body, have occurred. Some have been fatal. The most frequently reported serious infections with Rinvoq include pneumonia and cellulitis.

Before starting Rinvoq/Rinvoq LQ, your healthcare provider should test you for TB and viral hepatitis. Do not start Rinvoq/Rinvoq LQ if you have an active infection unless your healthcare provider says it is safe to do so. You may be at higher risk of developing shingles (herpes zoster).

Tell your healthcare provider before starting Rinvoq/Rinvoq LQ if you:

• Are being treated for an infection or have recurring infections
• Have diabetes, chronic lung disease, HIV, or a weakened immune system
• Have or have had TB, shingles, or hepatitis B or C
• Live in or have traveled to areas where certain fungal infections (such as histoplasmosis) are common, including the Ohio and Mississippi River valleys and the Southwest United States
• Have symptoms of infection: fever, chills, muscle aches, cough, shortness of breath, tiredness, weight loss, painful skin sores, diarrhea, stomach pain, or burning on urination

Increased risk of death

A large postmarketing safety study found a higher rate of all-cause mortality, including sudden cardiovascular death, in patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor compared to TNF blockers.

Cancer and immune system problems

Rinvoq/Rinvoq LQ may increase the risk of certain cancers, including lymphoma, lung cancer, and non-melanoma skin cancer (NMSC). The risk is higher in current or past smokers. Periodic skin examinations are recommended. Limit sun exposure, use sunscreen with SPF 30 or higher, wear protective clothing, and avoid tanning beds.

Increased risk of major cardiovascular events (MACE)

There is an increased risk of heart attack, stroke, and cardiovascular death in patients 50 years of age and older with at least one cardiovascular risk factor, particularly in current or past smokers. Discontinue Rinvoq/Rinvoq LQ if you have a heart attack or stroke. Seek emergency help immediately if you develop:

• Chest discomfort, tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw
• Pain or discomfort in the arms, back, neck, jaw, or stomach
• Shortness of breath, cold sweat, nausea, vomiting, lightheadedness, weakness on one side, or slurred speech

Blood clots (thrombosis)

Deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis have occurred in patients treated with Rinvoq. Some events have been fatal. The risk is higher in patients aged 50 and older with at least one cardiovascular risk factor. Stop taking Rinvoq/Rinvoq LQ and get medical help immediately if you have:

• Leg swelling, pain, or tenderness
• Sudden unexplained chest or upper back pain
• Shortness of breath or difficulty breathing

Serious side effects

See the warnings above. Other serious side effects include:

• Severe allergic reactions (hypersensitivity): Anaphylaxis and angioedema have been reported. Symptoms include rash (hives), trouble breathing, feeling faint or dizzy, or swelling of the lips, tongue, or throat. Stop taking upadacitinib and get emergency medical help immediately if these occur.
• Gastrointestinal (GI) perforation: Tears in the stomach or intestines have been reported, most often in people taking NSAIDs or corticosteroids or with a history of diverticulitis. Seek medical help immediately if you develop stomach pain, fever, chills, nausea, or vomiting.
• Retinal detachment: Separation or tears to the lining at the back of the eye have been reported in patients with atopic dermatitis. Contact your healthcare provider immediately if you notice any sudden vision changes.
• Eczema herpeticum: Eczema herpeticum (Kaposi's varicelliform eruption) has been reported in patients with atopic dermatitis treated with upadacitinib. Contact your healthcare provider if you develop widespread blistering or painful skin sores.
• Low blood sugar (hypoglycemia): Hypoglycemia, including severe cases, has been reported after starting upadacitinib, mainly in people with diabetes. If you have diabetes, your healthcare provider may recommend checking your blood sugar more often during treatment. Contact your healthcare provider if you develop signs or symptoms of low blood sugar.
• Changes in laboratory test results: Upadacitinib can affect blood counts and liver tests. Your healthcare provider will monitor for: Low neutrophil counts (neutropenia) Low lymphocyte counts (lymphopenia) Low red blood cell counts (anemia) Increased cholesterol levels (check around 12 weeks after starting) Elevated liver enzymes Upadacitinib should not be started or continued if counts are too low (absolute lymphocyte count below 500 cells/mm3, absolute neutrophil count below 1000 cells/mm3, or hemoglobin below 8 g/dL).
• Medication residue in stool: Some people may see whole tablets or tablet fragments in their stool, most often in those with shortened GI transit times or conditions such as ileostomy or colostomy. Contact your healthcare provider if this occurs repeatedly, as it may indicate inadequate drug absorption.

Seek Emergency Care Immediately for:

• Allergic reaction: Hives, difficulty breathing, swelling of face/lips/tongue/throat
• Heart attack: Chest pain or pressure, pain spreading to jaw or shoulder, nausea, sweating
• Stroke: Sudden numbness or weakness (especially on one side), severe headache, slurred speech, vision or balance problems
• Blood clot: Chest pain, sudden shortness of breath, coughing up blood, dizziness, or pain/swelling/warmth in one leg

Call Your Doctor Right Away for:

• Infection signs: Fever, chills, sore throat, night sweats, swollen glands, unusual tiredness
• Respiratory issues: Wheezing, trouble breathing, severe or worsening cough, chest pain
• Digestive problems: Severe stomach pain, persistent diarrhea, changes in bowel habits, vomiting, weight loss
• Urinary symptoms: Burning, pain, or blood when urinating; decreased urination
• Liver problems: Loss of appetite, dark urine, clay-colored stools, yellowing of skin or eyes, upper right stomach pain
• Skin changes: New lesions, moles that have changed, blistering rash, shingles, or herpes symptoms
• Other concerns: Mental status changes, weakness on one side of body, low blood glucose levels, abnormal blood tests, lumps in neck/armpits/groin

Note: Hepatitis B may reactivate. Treatment may be delayed or stopped if serious side effects occur.

Report side effects: Call your doctor or the FDA at 1-800-FDA-1088.

Adult Dose of Upadacitinib for Rheumatoid Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis

• 15 mg orally once a day

Upadacitinib may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

• Not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) of less than 1000 cells/mm3, or a hemoglobin level of less than 8 g/dL.

Dose of Upadacitinib for Psoriatic Arthritis

• Adults: 15 mg orally once daily
• Children aged 2 to less than 18 years weighing at least 10 kg: the dosage is based on body weight.

Dose of Upadacitinib for Atopic Dermatitis

• Adults less than 65 years and children 12 years and older weighing at least 40kg: Initiation dose: 15 mg orally once daily Maximum dose: 30 mg orally once daily (if no response with the initial dose).
• Adults 65 years and older: 15 mg once daily.
• Severe renal impairment: 15 mg once daily.

Use the lowest dose to maintain response.

• Not recommended to use in combination with other JAK inhibitors, biological immunomodulators, or other immunosuppressants.

Adult Dose of Upadacitinib for Ulcerative Colitis

• Induction dose: 45 mg once daily for 8 weeks.
• Maintenance dose: 15 mg once daily. A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response. Dosage modification may be needed for kidney or liver impairment or withdrug interactions.

Adult Dose of Upadacitinib for Crohn's disease

• Induction dose: 45 mg once daily for 12 weeks.
• Maintenance dose: 15 mg once daily. A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response. Dosage modification may be needed for kidney or liver impairment or withdrug interactions.

Dose of Upadacitinib for Polyarticular Juvenile Idiopathic Arthritis

• The recommended dosage is based on body weight.

Adult Dose of Upadacitinib for Giant Cell Arteritis

• 15 mg orally once daily in combination with a tapering dose of corticosteroids.
• Can be used as monotherapy following discontinuation of corticosteroids.

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.

If you take too much upadacitinib, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room.

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 and cause side effects. Avoid consuming grapefruit products.

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, 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. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store Rinvoq tablets between 36°F to 77°F (2°C to 25°C) in the original bottle to protect from moisture.

Store Rinvoq LQ between 36°F to 86°F (2°C to 30°C). Throw away (discard) any remaining Rinvoq LQ 60 days after opening the bottle.

Keep out of the reach of children.

Active ingredient: upadacitinib

Inactive ingredients, Rinvoq 15 mg tablets: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide.

Inactive ingredients, Rinvoq 30 mg 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 45 mg 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.

Inactive ingredients, Rinvoq LQ: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose.

Upadacitinib is manufactured by AbbVie Inc., under the brand name Rinvoq. AbbVie is a biopharmaceutical company and their global headquarters are located in North Chicago, Illinois, USA.