What is Rinvoq?

Rinvoq is a prescription medicine used:

• To treat adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumour necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
• To treat adults with active psoriatic arthritis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• To treat adults with moderate to severe ulcerative colitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, or ulcerative colitis.
• To treat adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
• Rinvoq is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if Rinvoq is safe and effective in children under 12 years of age with atopic dermatitis.

What is the most important information I should know about Rinvoq?

Rinvoq may cause serious side effects, including:

Serious infections. Rinvoq can lower your ability to fight infections. Serious infections have happened while taking Rinvoq, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your Doctor should test you for TB before starting Rinvoq and check you closely for signs and symptoms of TB during treatment with Rinvoq. You should not start taking Rinvoq if you have any kind of infection unless your Doctor tells you it is okay. If you get a serious infection, your Doctor may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.

Cancer and immune system problems. Rinvoq may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your Doctor's advice about having your skin checked for skin cancer during treatment with Rinvoq. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.

Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with Rinvoq. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.

Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking Rinvoq. Some of these reactions were serious. If any of these symptoms occur during treatment with Rinvoq, stop taking Rinvoq and get emergency medical help right away.

Tears in the stomach or intestines and changes in certain laboratory tests. Your Doctor should do blood tests before you start taking Rinvoq and while you take it. Your Doctor may stop your Rinvoq treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if:

• You are allergic to upadacitinib or any of the ingredients in Rinvoq.

What should I tell my Doctor before starting Rinvoq?

Tell your Doctor if you:

Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection, such as:

• Fever, sweating, or chills
• Shortness of breath
• Warm, red, or painful skin or sores on your body
• Muscle aches
• Feeling tired
• Blood in phlegm
• Diarrhea or stomach pain
• Cough
• Weight loss
• Burning when urinating or urinating more often than normal
• Have TB or have been in close contact with someone with TB.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
• Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
• Have recently received or are scheduled to receive a vaccine. People who take Rinvoq should not receive live vaccines.
• Are pregnant or plan to become pregnant. Based on animal studies, Rinvoq may harm your unborn baby. Your Doctor will check whether or not you are pregnant before you start Rinvoq. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with Rinvoq and for 4 weeks after your last dose.
• Are breastfeeding or plan to breastfeed. Rinvoq may pass into your breast milk. Do not breastfeed during treatment with Rinvoq and for 6 days after your last dose.

Tell your Doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rinvoq and other medicines may affect each other, causing side effects.

Especially tell your Doctor if you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your Doctor or pharmacist.

What should I do or tell my Doctor after starting Rinvoq?

Tell your Doctor right away if you have any symptoms of an infection. Rinvoq can make you more likely to get infections or make any infections you have worse.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Rinvoq, including:

• Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
• Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• Pain or discomfort in your arms, back, neck, jaw, or stomach
• Shortness of breath with or without chest discomfort
• Breaking out in a cold sweat
• Nausea or vomiting
• Feeling lightheaded
• Weakness in one part or on one side of your body
• Slurred speech

Tell your Doctor right away if you have any signs or symptoms of blood clots during treatment with Rinvoq, including:

• Swelling
• Pain or tenderness in one or both legs
• Sudden unexplained chest or upper back pain
• Shortness of breath or difficulty breathing

Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of Rinvoq?

These include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with Rinvoq. Call your Doctor right away if you have any sudden changes in your vision during treatment with Rinvoq.

These are not all the possible side effects of Rinvoq, discuss with your Doctor or Pharmacist for more on the side effects.

How should I take Rinvoq?

Rinvoq is taken once a day with or without food. Do not split, crush, or chew the tablet. Take Rinvoq exactly as your Doctor tells you to use it. Rinvoq is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of upadacitinib from your body, which may affect how upadacitinib works. Examples include rifampin, phenytoin, among others.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in original bottle in the refrigerator or at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

References

https://www.rxlist.com/rinvoq-drug.htm#clinpharm

https://www.rinvoq.com/

https://www.medicines.org.uk/emc/product/10972/smpc#gref

https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq

https://www.drugs.com/rinvoq.html

https://www.rinvoqhcp.com/

https://www.webmd.com/drugs/2/drug-177760/rinvoq-oral/details