How does this medication work? What will it do for me?

Upadacitinib belongs to the class of medications called selective immunosuppressants, specifically Janus kinase inhibitors. It is used to treat moderately-to-severely active rheumatoid arthritis for adults who have not responded well enough to or not tolerated methotrexate. Upadacitinib is also used to treat active psoriatic arthritis and ankylosing spondylitis for people who have not responded well enough to or not tolerated other medications. In all cases, upadacitinib may be used alone or with other medications.

Upadacitinib may also be used by adults and adolescents over 12 years of age to treat moderate-to-severe atopic dermatitis when other treatments taken by mouth have not controlled the symptoms well enough or are not recommended.

This medication works by blocking an enzyme called Janus kinase, a chemical in the body that starts the immune response. This immune response causes joint swelling, redness, pain, as well as skin inflammation for people with atopic dermatitis.  Upadacitinib reduces this immune response and the inflammation that occurs with these conditions. This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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What form(s) does this medication come in?

15 mg
Each purple, biconvex, oblong, extended-release tablet, with dimensions of 14 x 8 mm and debossed with "a15" on one side, contains 15 mg of upadacitinib. Nonmedicinal ingredients: colloidal silicon dioxide, ferrosoferric oxide (E172), hypromellose, iron oxide red (E172), magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, tartaric acid, and titanium dioxide (E171).

30 mg
Each red, biconvex oblong, extended-release tablet, with dimensions of 14 x 8 mm, and debossed with "a30" on one side, contains 30 mg of upadacitinib. Nonmedicinal ingredients: hypromellose, iron oxide red (E172), macrogol/polyethylene glycol, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, silica (colloidal anhydrous)/colloidal silicon dioxide, talc, tartaric acid, and titanium dioxide (E171).

How should I use this medication?

The recommended dose of upadacitinib to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis is 15 mg taken by mouth, once daily.

For the treatment of atopic dermatitis, the recommended adult starting dose is 15 mg taken by mouth, once daily. For adults younger than 65, the dose may be increased to 30 mg daily if the lower dose does not provide an adequate response. The dose for adolescents 12 years of age and weighing at least 40 kg, is 15 mg once daily.

Upadacitinib may be taken with food or on an empty stomach. Swallow the tablet whole with something to drink. Do not split, crush, or chew the tablet.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Store this medication in its original container, at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to upadacitinib or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • acne
  • back pain
  • cold sores
  • cough
  • fatigue
  • headache
  • nausea
  • throat and nose infections
  • thrush (yeast infection of the mouth; white patches on the tongue, throat)
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • bronchitis (lung inflammation; e.g., persistent cough, fatigue, shortness of breath)
  • fever
  • flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
  • hives
  • inflammation of the hair follicles (redness, swelling)
  • pneumonia (lung infection; e.g., shortness of breath, cough, chest pain)
  • shingles infection (e.g., painful skin rash with blisters and fever)
  • signs of anemia (low number of red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
  • signs of skin cancer (e.g., open sores that do not heal, growths on the skin that are irregularly shaped or changing colour)
  • skin infection (e.g., redness, swelling, painful skin)
  • symptoms of osteoarthritis (e.g., joint pain, stiffness, swelling)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • gastrointestinal perforation (e.g., abdominal pain, nausea, vomiting, constipation, fever)
  • signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: As with other similar medications, upadacitinib may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Cancer: Although not common, upadacitinib has been associated with several different types of cancer including lymphoma and non-melanoma skin cancer. Discuss any concerns that you may have with your doctor.

Cholesterol: Upadacitinib can cause increased blood cholesterol levels. This may happen to people with normal cholesterol levels and high cholesterol levels at the beginning of treatment.

If you are at risk of developing high cholesterol or you have high cholesterol levels before starting upadacitinib, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor will monitor your cholesterol levels regularly while you are taking this medication.

Gastrointestinal perforation: Some people taking this mediation have experienced gastrointestinal perforations. People who have a history of diverticulitis or who take anti-inflammatory medications such as NSAIDs or corticosteroids while they are also taking upadacitinib may be more likely to experience a tear in the lining of the stomach, which can cause serious bleeding. This can occur without abdominal pain. If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.

Heart Disease: Serious heart complications such as heart attack or stroke have been reported in people with rheumatoid arthritis taking medications similar to upadacitinib. If you have risk factors for heart disease such as high blood pressure, high cholesterol, or are a smoker or have a history of smoking your risk may be increased.

If you experience symptoms such as chest pain, difficulty breathing, pain extending through shoulder and arm, nausea and vomiting, sweating, get immediate medical attention.

Infection: This medication can increase the risk of developing an infection, including serious infections such as sepsis, chicken pox, fungal infections, and tuberculosis. Before starting treatment with upadacitinib, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. This medication should also not be started while you have an active infection. Upadacitinib should not be used in combination with certain other medications that suppress the immune system, as this can increase the risk of severe infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections (e.g., diabetes). While you are taking upadacitinib, your doctor will monitor you for signs of infection.

Liver function: People taking upadacitinib may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking this medication. If you have severe changes in liver function, your doctor may recommend that you take a lower dose of this medication or stop taking it altogether.

If you have a history of hepatitis B infection, it is possible that this infection may flare up while taking upadacitinib. If you experience symptoms of liver problems, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

People with severely decreased liver function should not take this medication.

Muscle effects: Muscle damage has been associated with the use of upadacitinib. Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell).

Vaccines: The safety and effectiveness of vaccines may be affected by this medication. Vaccinations should be completed before starting upadacitinib.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant should use effective birth control while taking upadacitinib and for at least 4 weeks after stopping the medication. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if upadacitinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication to treat rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis have not been established for children. Upadacitinib has been shown to be safe and effective to treat atopic dermatitis for adolescents weighing at least 40 kg and who are 12 years of age and older.

Seniors: People over the age of 65 years may be more likely to experience side effects from taking upadacitinib.

What other drugs could interact with this medication?

There may be an interaction between upadacitinib and any of the following:

  • abatacept
  • anakinra
  • apalutamide
  • azathioprine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • BCG
  • bosentan
  • cancer medications (e.g., alemtuzumab, blinatumomab, carboplatin, cladribine, cyclophosphamide, doxorubicin, ifosfamide, mercaptopurine, vincristine)
  • carbamazepine
  • clarithromycin
  • clozapine
  • cobicistat
  • corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
  • cyclosporine
  • efavirenz
  • enzalutamide
  • eslicarbazepine
  • etanercept
  • etravirine
  • everolimus
  • grapefruit juice
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydroxyurea
  • lenalidomide
  • mesalamine
  • methotrexate
  • mifepristone
  • modafinil
  • monoclonal antibodies (e.g., adalimumab, belimumab, denosumab, golimumab, guselkumab, natalizumab, ocrelizumab, sarilumab, tocilizumab)
  • mycophenolate
  • phenobarbital
  • phenytoin
  • pimecrolimus
  • primidone
  • protein kinase inhibitors (e.g., baricitinib, dabrafenib, dasatinib, imatinib)
  • rifabutin
  • rifampin
  • St. John's wort
  • sirolimus
  • sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
  • sulfasalazine
  • tacrolimus
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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