Description
Upadacitinib is used to treat moderate to severely active rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis (a type of arthritis in the spine) with objective signs of swelling, moderate to severe ulcerative colitis, moderate to severe Crohn's disease, and polyarticular juvenile idiopathic arthritis (PJIA) in patients who have taken other medicines (eg, methotrexate) that did not work well. It is also used to treat moderate to severe atopic dermatitis (eczema) in patients who have taken other medicines that did not work well and whose condition is not well controlled with other treatments or in patients who cannot tolerate these treatments. This medicine is also used to treat giant cell arteritis.
Upadacitinib is a Janus kinase (JAK) inhibitor that works on the immune system.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of upadacitinib extended-release tablets to treat rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis in children, to treat psoriatic arthritis and PJIA in children younger than 2 years of age, and to treat atopic dermatitis in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of upadacitinib oral solution to treat atopic dermatitis, rheumatoid arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, Crohn's disease, and giant cell arteritis in children and to treat psoriatic arthritis and PJIA in children younger than 2 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of upadacitinib in the elderly. However, elderly patients are more likely to have serious infections and cancer, which may require caution in patients receiving upadacitinib.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ranolazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abatacept
- Aceclofenac
- Acemetacin
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alclometasone
- Aldosterone
- Amcinonide
- Amtolmetin Guacil
- Apalutamide
- Aspirin
- Avacopan
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Beclomethasone
- Betamethasone
- Boceprevir
- Bromfenac
- Budesonide
- Bufexamac
- Carbamazepine
- Cariprazine
- Celecoxib
- Cholera Vaccine, Live
- Choline Salicylate
- Ciclesonide
- Clarithromycin
- Clobetasol
- Clobetasone
- Clocortolone
- Clonixin
- Cobicistat
- Conivaptan
- Cortisone
- Deflazacort
- Dengue Tetravalent Vaccine, Live
- Desonide
- Desoximetasone
- Dexamethasone
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia (blood condition) or
- Cancer or
- Diabetes or
- Hyperlipidemia (high cholesterol in the blood) or
- Infection, history of or
- Lung disease or
- Neutropenia (blood disease) or
- Stomach or bowel problems (eg, diverticulitis, perforation, ulcers), history of—Use with caution. May make these conditions worse.
- Heart or blood vessel disease or
- Hepatitis B, history of or
- Hepatitis C, history of or
- Herpes zoster infection or
- Tuberculosis, active or history of or
- Weakened immune system—May cause side effects to become worse.
- Infection, active or
- Kidney disease, end stage or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Kidney disease, severe—Use with caution in patients with atopic dermatitis, Crohn's disease, or ulcerative colitis. The effects may be increased because of slower removal of the medicine from the body.
- Smoking, current or past—May increase risk for serious side effects.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Swallow the extended-release tablet whole with water. Do not cut, crush, break, or chew it.
To use the oral liquid:
- Use this medicine with the provided press-in bottle adapter and oral dosing syringe.
- Press down and twist the cap to remove it from the bottle. Do not throw away the cap. While holding the bottle firmly, use your thumb to push the adapter all the way down to the rim of the bottle. Do not remove the adapter after it is inserted.
- Insert the tip of the syringe into the adapter. With the syringe attached to the bottle, turn the bottle upside down.
- Slowly pull the plunger down. Check the syringe for large air bubbles. If you see air bubbles, flick the sides off the syringe to send large air bubbles to the tip. Move the plunger up and down to return air bubbles back into the bottle.
- Move the plunger until it is even with the prescribed dose. Turn the bottle upright and remove the syringe. Hold the middle of the syringe and carefully remove it from the bottle.
- Place the syringe against the inside of the child's cheek. Push the plunger to give the entire dose and give water.
Do not switch between extended-release tablet and oral liquid unless your doctor yells you to.
A part of the extended-release tablet may pass into your stools. This is normal and is nothing to worry about.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (extended-release tablets):
- For atopic dermatitis:
- Adults and children 12 years of age and older weighing at least 40 kilograms (kg)—At first, 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For Crohn's disease:
- Adults—At first, 45 milligrams (mg) once a day for 12 weeks, then 15 mg once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For giant cell arteritis:
- Adults—15 milligrams (mg) once a day in combination with a decreasing dose of a steroid medicine. Then, 15 mg once a day alone after stopping treatment with a steroid medicine.
- Children—Use and dose must be determined by your doctor.
- For polyarticular juvenile idiopathic arthritis and psoriatic arthritis:
- Adults and children 2 years of age and older weighing 30 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) once a day.
- Children 2 years of age and older weighing less than 30 kg—Use of oral liquid is recommended.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For rheumatoid arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis:
- Adults—15 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For ulcerative colitis:
- Adults—At first, 45 milligrams (mg) once a day for 8 weeks, then 15 mg once a day. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For atopic dermatitis:
- For oral dosage form (solution):
- For polyarticular juvenile idiopathic arthritis and psoriatic arthritis:
- Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 30 kilograms (kg) or more—6 milligrams (mg) or 6 milliliters (mL) 2 times a day.
- Weighing 20 kg to less than 30 kg—4 mg or 4 mL 2 times a day.
- Weighing 10 kg to less than 20 kg—3 mg or 3 mL 2 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- For polyarticular juvenile idiopathic arthritis and psoriatic arthritis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away unused oral liquid 60 days after opening.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests are needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 4 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Using this medicine together with azathioprine or cyclosporine is not recommended.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
Your body's ability to fight infections may be reduced while you are using upadacitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.
This medicine may increase your risk of serious heart or blood vessel problems (eg, heart attack, stroke), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.
This medicine may increase your risk of cancer (eg, lymphoma, lung cancer, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.
This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
Upadacitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:
- If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Before treatment with upadacitinib, while you are being treated with it, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Upadacitinib may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, talk to your doctor.
This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- itching, pain, redness, swelling, tenderness, warmth on the skin
- loss of voice
- rapid weight gain
- runny or stuffy nose
- sneezing
- sore throat
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Black, tarry stools
- burning or stinging of the skin
- chest tightness
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- painful blisters on the trunk of the body
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- ulcers, sores, or white spots in the mouth or tongue
- unusual bleeding or bruising
Rare
- Coughing or spitting up blood
- difficulty with breathing
- heartburn
- indigestion
- muscle aches
- nausea
- night sweats
- pale skin
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- severe stomach pain, cramping, or burning
- shiny bump
- sudden high fever or low-grade fever for months
- trouble breathing
- vomiting of material that looks like coffee grounds, severe and continuing
- white, yellow or waxy scar-like area
Incidence not known
- Chest pain or discomfort
- confusion
- difficulty in speaking
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- no blood pressure or pulse
- pain or discomfort in the arms, jaw, back, or neck
- slow speech
- stopping of heart
- sweating
- unconsciousness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Blemishes on the skin
- pimples
Less common
- Burning, itching, and pain in hairy areas, pus at the root of hair
- difficulty in moving
- muscle cramps, pains, or stiffness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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