15 mg and 30 mg prolonged-release tablets are
Upadacitinib

What RINVOQ is and what it is used for

RINVOQ contains the active substance upadacitinib. It belongs to a group of medicines called Januskinas inhibitors. By lowering the activity of an enzyme in the body called ‘Janus kinase’, RINVOQ helps reduce inflammation in the following diseases:

  • rheumatoid arthritis
  • psoriatic arthritis
  • ankylosing spondylitis
  • atopic dermatitis

Rheumatoid arthritis

RINVOQ is used to treat adults with rheumatoid arthritis ( rheumatoid arthritis ). Rheumatoid arthritis is a disease that causes inflamed joints. If you have moderate to severely active rheumatoid arthritis, you may first be given other medicines, which are usually methotrexate. If these medicines do not work well enough, you will receive RINVOQ either alone or in combination with methotrexate to treat your rheumatoid arthritis.

RINVOQ can help reduce pain, stiffness, and swelling in your joints, reduce fatigue and slow down damage to bones and cartilage in your joints. These effects can make it easier for you to perform everyday activities and thus improve your quality of life.

Psoriatic arthritis

RINVOQ is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a disease that causes inflamed joints and psoriasis. If you have active psoriatic arthritis, you may first be given other medicines. If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your psoriatic arthritis.

RINVOQ can help reduce pain, stiffness, and swelling in and around the joints, pain, stiffness in the spine, psoriasis rash, and fatigue. It can slow down damage to the bones and cartilage in your joints. These effects can make it easier for you to perform everyday activities and thus improve your quality of life.

Ankylosing spondylitis

RINVOQ is used to treat adults with ankylosing spondylitis. Ankylosing spondylitis is a disease that mainly causes inflammation in the spine. If you have active ankylosing spondylitis, you may first be given other medicines. If these medicines do not work well enough, you will be given RINVOQ to treat your ankylosing spondylitis.


RINVOQ can help reduce back pain, stiffness, and inflammation in the spine. These effects can make it easier for you to perform everyday activities and thus improve your quality of life.

Atopic dermatitis

RINVOQ is used to treat adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis, also called atopic eczema and flexural eczema. RINVOQ can be used with eczema medicines that you apply to the skin or use alone.

RINVOQ can improve the condition of the skin and reduce itching and flare-ups. RINVOQ can also relieve the symptoms of pain, anxiety, and depression that people with atopic dermatitis can have. RINVOQ can also reduce sleep disorders and provide an improved quality of life.

What you need to know before taking RINVOQ 

Do not take RINVOQ

  • if you are allergic to upadacitinib or any of the other ingredients of this medicine (listed in section 6).
  • if you have a serious infection (such as pneumonia or a bacterial skin infection)
  • if you have active tuberculosis (TB)
  • if you have severe liver problems
  • if you are pregnant (see section Pregnancy, breast-feeding and contraception)

Warnings and cautions

Talk to your doctor or pharmacist before and during treatment with RINVOQ about:

  • you have an infection (fever, sweating or chills, shortness of breath, have hot, red, or sore skin or sores on the body, feeling tired, coughing, burning sensation when urinating or urinating more often than normal, have a severe headache with neck stiffness), or if you have had a recurring infection – RINVOQ may reduce the body’s ability to fight infection and thus aggravate an ongoing infection or increase the risk of getting a new infection
  • you have had tuberculosis or been in close contact with someone with tuberculosis. Your doctor will test you for tuberculosis before you start taking RINVOQ and may repeat the test during treatment
  • if you have had a herpes zoster infection ( shingles ) because RINVOQ may cause it to come back. Tell your doctor if you get painful skin rashes with blisters as this may be a sign of shingles
  • you have had hepatitis B or C
  • you have recently or are planning to get vaccinated – this is because live vaccines are not recommended when using RINVOQ
  • if you have cancer – because your doctor needs to assess if you can still take RINVOQ
  • you are at high risk of developing skin cancer. Your doctor may recommend preventative measures such as regular skin examinations while you are taking RINVOQ. Tell your doctor if you develop a new skin change or see any change in the appearance of your skin. Some patients receiving RINVOQ have developed skin cancer
  • you have heart problems, high blood pressure, or high cholesterol
  • your liver is not working as well as it should
  • you have had blood clots in the veins of your legs (deep vein thrombosis ) or your lungs ( pulmonary embolism ). Tell your doctor if you get a sore, swollen leg, chest pain, or shortness of breath as this may be a sign of blood clots in the veins.
  • you have kidney problems
  • you have had diverticulitis (a type of inflammation of the colon) (see section 4).

If you notice any of the following serious side effects, tell your doctor straight away:

  • severe abdominal pain, especially if accompanied by fever, nausea, and vomiting.

Blood tests

You will have a blood test before you start taking RINVOQ or while you are taking it. This is to check if you have a low red blood cell count ( anemia ), low white blood cell count ( neutropenia or lymphopenia), high blood fats ( cholesterol ), or high levels of liver enzymes. These tests are to check that the treatment with RINVOQ does not cause any problems.

Older

Infection rates are higher in patients 65 years of age and older. Tell your doctor as soon as you notice any signs or symptoms of an infection.

Children and young people

RINVOQ is not recommended for children under 12 years of age or adolescents weighing less than 30 kg with atopic dermatitis. This is because the drug has not been studied in these patients.

RINVOQ is not recommended for children and adolescents under 18 years of age with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. This is because the drug has not been studied in this age group.

Other medicines and RINVOQ

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because some medicines may reduce the effect of RINVOQ or increase the risk of side effects. You must tell your doctor or pharmacist if you are taking any of the following:

  • medicines for fungal infections (eg itraconazole, posaconazole or voriconazole)
  • drugs against bacterial infections (eg clarithromycin)
  • medicines for Cushing’s syndrome (eg ketoconazole )
  • drugs against tuberculosis (eg rifampicin)
  • medicines for seizures and seizures (eg phenytoin )
  • medicines that affect your immune system (eg azathioprine, cyclosporin, and tacrolimus)
  • drugs that may increase the risk of diverticulitis, such as non-steroidal anti-inflammatory drugs (often used as painkillers and/or to treat inflammation in muscles or joints) and/or opioids (used for severe pain), and/or corticosteroids (often used to treat inflammation ) (see section 4).

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking this medicine.

Pregnancy, breastfeeding, and contraception

Pregnancy

RINVOQ should not be used if you are pregnant.

Breast-feeding

If you are breastfeeding or planning to start breastfeeding, talk to your doctor before using this medicine. You should not take RINVOQ while breastfeeding as it is unknown if this medicine passes into breast milk. You and your doctor should decide whether to breastfeed or take RINVOQ. You should not do both.

Contraceptive

If you are a woman of childbearing potential, you must use an effective contraceptive to avoid pregnancy while you are being treated with RINVOQ and for at least 4 weeks after the last dose of RINVOQ. If you become pregnant during this time, you must tell your doctor immediately.

If your child gets her first period while taking RINVOQ, tell your doctor.

Driving and using machines

RINVOQ does not affect the ability to drive and use machines.

How to take RINVOQ

Always take this medicine exactly as your doctor or pharmacist has told you.

Ask your doctor or pharmacist if you are unsure.

How much to take

If you have rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

The recommended dose is one 15 mg tablet once a day.

If you have atopic dermatitis

Adults :

The recommended dose is 15 mg or 30 mg as prescribed by your doctor, which is taken as a tablet once a day.

Your doctor may increase or decrease your dose depending on how well the medicine works.

Older:

If you are 65 years of age or older, the recommended dose is 15 mg once daily.

Adolescents (from 12 to 17 years) weighing at least 30 kg:

The recommended dose is one 15 mg tablet once a day.

How to take the medicine

  • Swallow the tablet whole with water. The tablet should not be split, crushed, chewed, or broken before swallowing as it may affect the amount of RINVOQ in your body.
  • To help you remember to take RINVOQ, take it at the same time each day.
  • The tablets can be taken with or without food.

If you take more RINVOQ than you should

If you take more RINVOQ than you should, contact your doctor. You may experience some of the side effects described in section 4.

If you forget to take RINVOQ

  • If you miss a dose, take it as soon as you remember.
  • If you have missed your dose for an entire day, skip the missed dose and take your usual dose, as usual, the next day.
  • Do not take a double dose to make up for a forgotten tablet.

If you stop taking RINVOQ

Do not stop taking RINVOQ unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Contact your doctor or seek medical help immediately if you get any signs/symptoms of infection eg:

  • shingles or painful skin rash with blisters ( herpes zoster) – common (may affect up to 1 in 10 people)
  • lung infection ( pneumonia ) which can cause shortness of breath, fever, and cough – uncommon (may affect up to 1 in 100 people)

Other side effects are

Tell your doctor if you get any of the following side effects:

Very common (may affect more than 1 user in 10)

  • the infection you in the throat and nose
  • acne

Common (may affect up to 1 in 10 people)

  • cough
  • fever
  • cold sores ( herpes simplex)
  • nausea
  • increase in an enzyme called creatine kinase, which is shown in blood tests
  • the low number of white blood cells shown in blood samples
  • elevated cholesterol levels (a type of blood fat) shown in blood tests
  • elevated levels of liver enzymes, which appear on blood tests (signs of liver problems)
  • weight gain
  • inflammation (swelling) of the hair follicles
  • influenza
  • anemia
  • abdominal pain
  • fatigue
  • headache
  • hives
  • urinary tract infection

Uncommon (may affect up to 1 in 100 people)

  • fungus in the mouth (white spots in the mouth)
  • elevated triglyceride levels (a type of blood fat) shown in blood tests
  • diverticulitis (painful inflammation in small pockets in the intestinal mucosa)

How to store RINVOQ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.

No special temperature instructions.

Store in original blister. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is upadacitinib.

RINVOQ 15 mg prolonged-release tablet is

  • Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.
  • Other ingredients are:
    • Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silicon colloidal, anhydrous, magnesium stearate
    • Film coating: poly (vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

RINVOQ 30 mg prolonged-release tablet is

  • Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg upadacitinib.
  • Other ingredients are:
    • Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silicon colloidal, anhydrous, magnesium stearate
    • Film coating: poly (vinyl alcohol), macrogol, talc, titanium dioxide (E171), red iron oxide (E172).

What the medicine looks like and the contents of the pack

RINVOQ 15 mg prolonged-release tablet is

RINVOQ 15 mg prolonged-release tablets are purple, oval, biconvex tablets debossed with “a15” on one side.

The tablets are available in blister packs or jars.

RINVOQ is available in packs of 28 or 98 prolonged-release tablets and multipacks of 84, consisting of 3 cartons containing 28 prolonged-release tablets each.

Each calendar blister contains 7 tablets.

RINVOQ is available in cans of desiccant containing 30 prolonged-release tablets, each pack contains 1 can (pack of 30 tablets) or 3 cans (pack of 90 tablets).

RINVOQ 30 mg prolonged-release tablet is

RINVOQ 30 mg prolonged-release tablets are red, oval, biconvex tablets debossed with “a30” on one side.

The tablets are available in blister packs or jars.

RINVOQ is available in packs of 28 or 98 prolonged-release tablets.

Each calendar blister contains 7 tablets.

RINVOQ is available in cans of desiccant containing 30 prolonged-release tablets, each pack contains 1 can (pack of 30 tablets) or 3 cans (pack of 90 tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Srl

SR 148 Pontina, km 52 SNC

04011 Campoverde di Aprilia (Latina)

Italy

AbbVie Logistics BV

Zuiderzeelaan 53

Zwolle, 8017 JV, The Netherlands

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

AbbVie AB

Tel: +46 (0) 8 684 44 600

Muhammad Nadeem

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