Rinvoq

Rinvoq is a prescription medication used to treat a variety of inflammatory diseases including ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, eczema, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Rinvoq is a JAK inhibitor that works inside your cells to block certain signals that are thought to cause inflammation.

This medication comes in tablet form. It is taken once-daily with or without food. Swallow Rinvoq tablets whole. Do not crush, chew or split tablets.

Common side effects include common cold, sinus infections, shingles, herpes simplex virus infections (including cold sores), bronchitis and nausea.

Rinvoq is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has 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, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) 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.

This medication may be prescribed for other uses. Ask your healthcare provider or pharmacist for more information.

Rinvoq may cause serious side effects. See "Rinvoq Precautions".

Common side effects 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 
• 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 healthcare provider 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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider 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 healthcare provider 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 healthcare provider or pharmacist.

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 healthcare provider (healthcare provider) 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 healthcare provider tells you it is okay. If you get a serious infection, your healthcare provider 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 healthcare provider’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 healthcare provider should do blood tests before you start taking Rinvoq and while you take it. Your healthcare provider 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. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Grapefruit and grapefruit juice may interact with Rinvoq and lead to potentially dangerous effects. Discuss the use of grapefruit products with your healthcare provider.

Before taking Rinvoq, tell your healthcare provider about all of your medical conditions. Especially tell your healthcare provider 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 healthcare provider.
• 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 healthcare provider 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 non-prescription medicines, vitamins, and herbal supplements.

After starting Rinvoq:

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

Tell your healthcare provider if you are pregnant or plan to become pregnant. Based on animal studies, Rinvoq may harm your unborn baby. Your healthcare provider 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.

Tell your healthcare provider if you 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.

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

If you take too much Rinvoq, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Rinvoq at 36°F to 77°F (2°C to 25°C).

• Store Rinvoq in the original bottle to protect it from moisture.

• Keep Rinvoq and all medicines out of the reach of children.

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS

SERIOUS INFECTIONS

Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt RINVOQ until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ use.

• Invasive fungal infections, including cryptococcosis and pneumocystosis.

• Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

  The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

  Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

  MORTALITY

  In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.

  MALIGNANCIES

  Lymphoma and other malignancies have been observed in patients treated with RINVOQ. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

  MAJOR ADVERSE CARDIOVASCULAR EVENTS