Rinvoq (Oral)
Upadacitinib is used in adults to treat rheumatoid arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Upadacitinib is used in adults and children at least 2 years old and weighing at least 22 lbs (10 kg) to treat psoriatic arthritis.
Upadacitinib is also used to treat polyarticular juvenile idiopathic arthritis who are at least 2 years old.
Upadacitinib may also be used in adults and children aged 12 years and older (weighing at least 40 kg or 88 lbs) with moderate to severe eczema (atopic dermatitis).
Upadacitinib is given after other treatments did not work or stopped working.
Upadacitinib may also be used for purposes not listed in this medication guide.
uses
What is Rinvoq (Oral) used for?
- Ankylosing Spondylitis
- Atopic Dermatitis
- Crohn's Disease -- Acute
- Crohn's Disease -- Maintenance
- Rheumatoid Arthritis
- Ulcerative Colitis -- Active
- Ulcerative Colitis -- Maintenance
- Collagen Vascular Disease
- Autoimmune Disorder
- Felty's Syndrome
- Rheumatoid Lung
- Psoriatic Arthritis
- Axial Spondyloarthritis
warnings
What is the most important information I should know about Rinvoq (Oral)?
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.
Tell your doctor if you have or have ever had:
- a weak immune system or HIV;
- an active or chronic infection;
- herpes zoster (also called shingles);
- any type of cancer;
- diverticulitis, an ulcer in your stomach or intestines;
- stomach pain or other stomach problems;
- a heart attack, stroke, blood clot, or other heart problems;
- high cholesterol;
- chronic lung disease;
- diabetes;
- low red or white blood cell counts;
- if you smoke or have smoked in the past;
- liver disease (especially hepatitis B or C); or
- kidney disease.
Tell your doctor if you've had or been exposed to tuberculosis or other infections, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.
Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine. 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.
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. 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.
Side Effects
What are the side effects of Rinvoq (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Upadacitinib can affect 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, or other unusual symptoms.
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; or
- signs of a blood clot--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance, chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg.
Call your doctor at once if you have:
- vision changes, right-sided upper stomach pain, vomiting, yellowing of your skin or eyes, and not feeling well;
- signs of tuberculosis or bronchitis--cough, night sweats, weight loss, and feeling very tired, runny or stuffy nose, chest discomfort, wheezing, headache, body aches, or sore throat;
- signs of shingles or herpes virus--flu-like symptoms, tingly or painful blistering rash on one side of your body, cold sores around your mouth, skin sores or blisters, itching, burning pain in your thigh or lower back; or
- a hole (perforation) in your digestive tract--severe stomach pain, change in bowel habits.
Your treatment may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- fever, cough, tiredness, nausea;
- acne, rash, headache;
- abnormal lab tests;
- weight gain, muscle pain, stomach pain;
- folliculitis (redness or crusting around your hair follicles);
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- low red or white blood cell counts.
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.
Pregnancy & Breastfeeding
Can I take Rinvoq (Oral) if I’m pregnant or breastfeeding?
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. 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.
Interactions
What drugs and food should I avoid while taking Rinvoq (Oral)?
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.
Dosage Guidelines & Tips
How to take Rinvoq (Oral)?
Use Rinvoq (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.
Your dose may change if you gain or lose weight.
Upadacitinib is usually taken either once or twice a day depending on the brand form of this medicine. Follow your doctor's instructions.
You may take upadacitinib with or without food.
Swallow the tablet whole and do not crush, chew, or break it.
Measure liquid medicine with the supplied measuring device (not a kitchen spoon).
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Call your doctor if you see a whole or part of a tablet in your stool.
You will need frequent medical tests before and during treatment with upadacitinib.
Follow all storage instructions provided with upadacitinib. Your pharmacist can provide more information about how to store this medicine.
Throw away any unused oral solution 60 days after opening the bottle.
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.
Overdose Signs
What happens if I overdose on Rinvoq (Oral)?
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