Rinvoq 30 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

RINVOQ 15 mg prolonged-release tablets

RINVOQ 30 mg prolonged-release tablets

RINVOQ 45 mg prolonged-release tablets

upadacitinib

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What RINVOQ is and what it is used for
2. What you need to know before taking RINVOQ
3. How to take RINVOQ
4. Possible side effects
5. How to store RINVOQ
6. Contents of the pack and other information

1. What RINVOQ is and what it is used for

RINVOQ contains the active substance upadacitinib. It belongs to a group of medicines called Janus kinase inhibitors. By reducing the activity of an enzyme in the body known as "Janus kinase", RINVOQ reduces inflammation in the following conditions:

• Rheumatoid arthritis
• Psoriatic arthritis
• Axial spondyloarthritis
• Non-radiographic axial spondyloarthritis
• Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
• Giant cell arteritis
• Atopic dermatitis
• Ulcerative colitis
• Crohn’s disease

Rheumatoid arthritis

RINVOQ is used to treat adults with rheumatoid arthritis. Rheumatoid arthritis is a disease that causes inflammation of the joints. If you have moderate to severe rheumatoid arthritis, you may first be prescribed other medicines, one of which is usually methotrexate. If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your rheumatoid arthritis.

RINVOQ can help reduce pain, stiffness, and inflammation in your joints, reduce fatigue, and slow down the progression of bone and cartilage damage in the joints. These effects may make daily activities easier and thereby improve your quality of life.

Psoriatic arthritis

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

RINVOQ can help reduce pain, stiffness, and inflammation in and around the joints, back pain and stiffness, skin rash due to psoriasis, and fatigue. It may also slow down damage to the bones and cartilage in the joints. These effects may make daily activities easier and thereby improve your quality of life.

Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis)

RINVOQ is used to treat adults with axial spondyloarthritis. Axial spondyloarthritis is a disease that mainly causes inflammation in the spine. If you have active axial spondyloarthritis, you will likely first be prescribed other medicines. If these medicines do not work well enough, you will be given RINVOQ to treat axial spondyloarthritis.

RINVOQ can help reduce lower back pain, stiffness, and inflammation of the spine. These effects may make daily activities easier and thereby improve your quality of life.

Giant cell arteritis

RINVOQ is used to treat adults with giant cell arteritis. Giant cell arteritis is a disease that causes inflammation of blood vessels, typically affecting medium and large arteries in the head, neck, and arms.

RINVOQ can help control the signs and symptoms of giant cell arteritis, including headache, scalp tenderness, jaw pain, and fatigue. These effects may make daily activities easier and thereby improve your quality of life. Giant cell arteritis is usually treated with medicines called steroids. These are effective but may cause side effects if used at high doses or for prolonged periods. Reducing steroid doses may also lead to a flare-up of giant cell arteritis. Adding RINVOQ to treatment allows steroids to be used for a shorter duration while still controlling giant cell arteritis.

Atopic dermatitis

RINVOQ is used to treat adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. RINVOQ can be used together with topical eczema treatments applied to the skin or used alone.

Taking RINVOQ can improve skin condition and reduce itching and flare-ups. RINVOQ may help improve symptoms of pain, anxiety, and depression that people with atopic dermatitis may experience. RINVOQ may help improve sleep disturbances and overall quality of life.

Ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine. RINVOQ is used for the treatment of adults with ulcerative colitis who have had an inadequate response to or cannot tolerate previous treatment.

RINVOQ can help reduce signs and symptoms of the disease, including bloody stools, abdominal pain, and urgency and frequency of bowel movements. These effects may make daily activities easier and reduce fatigue.

Crohn’s disease

Crohn’s disease is an inflammatory condition that can affect any part of the digestive tract, but most commonly affects the intestine. RINVOQ is used for the treatment of adults with Crohn’s disease who have had an inadequate response to or cannot tolerate previous treatment.

RINVOQ can help reduce signs and symptoms of the disease, including urgency and frequency of bowel movements, abdominal pain, and inflammation of the intestinal lining. These effects may make daily activities easier and reduce fatigue.

2. What you need to know before starting 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 skin infection caused by bacteria)
• if you have active tuberculosis (TB)
• if you have severe liver problems
• if you are pregnant (see section Pregnancy, breastfeeding, and contraception).

Warnings and precautions

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

• you have an infection or get infections frequently. Inform your doctor if you experience symptoms such as fever, sores, feeling more tired than usual, or dental problems, as these could be signs of infection. RINVOQ may reduce your body's ability to fight infections and may worsen an existing infection or increase the likelihood of getting a new infection. If you have diabetes or are 65 years of age or older, you may be at higher risk of infections

• you have had tuberculosis or have been in close contact with someone who has tuberculosis. Your doctor will perform a test for tuberculosis before you start taking RINVOQ and may repeat the test during treatment

• you have had herpes infection (herpes zoster), as RINVOQ may cause it to reappear. Inform your doctor if you develop a painful rash with blisters, as these may be signs of herpes zoster

• you have ever had hepatitis B or C

• you have recently been vaccinated or are planning to get vaccinated (immunization) – this is because live vaccines are not recommended while you are taking RINVOQ

• you have or have had cancer in the past, smoke or have smoked in the past, because your doctor will assess whether RINVOQ is suitable for you

• non-melanoma skin cancer has been observed in patients taking RINVOQ. Your doctor may recommend regular skin examinations while you are taking RINVOQ. Inform your doctor if new skin lesions appear during or after treatment, or if existing lesions change in appearance

• you have or have had heart problems, because your doctor will assess whether RINVOQ is suitable for you

• your liver is not functioning as well as it should

• you have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), or are at increased risk of developing them (for example: if you have recently had major surgery, use hormonal contraceptives/hormone replacement therapy, or if you or your close relatives have been identified as having a clotting disorder). Your doctor will assess whether RINVOQ is suitable for you. Inform your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in an arm or leg, pain or tenderness upon touch in the leg, or redness or discoloration in an arm or leg, as these may be signs of blood clots in the veins

• you experience sudden changes in vision. Seek immediate medical attention if you have sudden symptoms such as blurred vision or partial or complete loss of vision, as these may indicate a blockage of blood flow in the eyes

• you have kidney problems

• you have abdominal pain of unknown origin, have or have had diverticulitis (painful inflammation of small pouches in the intestinal lining), stomach or intestinal ulcers, or are taking non-steroidal anti-inflammatory drugs (NSAIDs)

• you repeatedly notice a tablet or parts of a tablet in your stools.

If you notice any of the following serious side effects, inform your doctor immediately:

• symptoms such as rash (hives), difficulty breathing, or swelling of your lips, tongue, or throat, as you may be experiencing an allergic reaction. Some people taking RINVOQ have had serious allergic reactions. If you experience any of these symptoms while taking RINVOQ, stop taking RINVOQ and seek immediate emergency medical help
• severe stomach pain, especially if accompanied by fever, nausea, and vomiting.

Blood tests

You will need to have blood tests before starting RINVOQ and while taking it. These tests check for low red blood cell count (anemia), low white blood cell count (neutropenia or lymphopenia), high levels of fat in the blood (cholesterol), or high levels of liver enzymes. These tests are performed to ensure that RINVOQ treatment is not causing problems.

Elderly patients

There is a higher rate of infections in patients aged 65 years and older. Inform your doctor immediately if you notice any signs or symptoms of infection.

Patients aged 65 years and older may have an increased risk of infections, heart problems (including heart attack), and certain types of cancer. Your doctor will assess whether RINVOQ is suitable for you.

Children and adolescents

The use of RINVOQ is not recommended in children under 12 years of age or adolescents weighing less than 30 kg with atopic dermatitis. It has not been studied in these patients.

The use of RINVOQ is not recommended in children and adolescents under 18 years of age with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis), ulcerative colitis, or Crohn's disease. It 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 need to take any other medicines. Some medicines may reduce the effectiveness of RINVOQ or increase the risk of side effects. It is very important that you inform your doctor or pharmacist if you are taking any of the following:

• medicines to treat fungal infections (such as itraconazole, posaconazole, or voriconazole)
• medicines to treat bacterial infections (such as clarithromycin)
• medicines to treat Cushing's syndrome (such as ketoconazole)
• medicines to treat tuberculosis (such as rifampicin)
• medicines to treat seizures or epilepsy (such as phenytoin)
• medicines that affect your immune system (such as azathioprine, 6-mercaptopurine, cyclosporine, and tacrolimus)
• medicines that may increase the risk of gastrointestinal perforation or diverticulitis, such as non-steroidal anti-inflammatory drugs (commonly used to treat painful and/or inflammatory conditions of muscles or joints), and/or opioids (used to treat severe pain), and/or corticosteroids (commonly used to treat inflammatory conditions)
• medicines to treat diabetes or if you have diabetes. Your doctor may decide that you need less antidiabetic medication while taking upadacitinib.

If any of these situations apply to you or if you are unsure, consult your doctor or pharmacist before taking RINVOQ.

Pregnancy, breastfeeding, and fertility

Pregnancy

RINVOQ must not be used during pregnancy.

Breastfeeding

If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. You must not use RINVOQ while breastfeeding, as it is unknown whether this medicine passes into breast milk. You and your doctor must decide whether to breastfeed or take RINVOQ. You must not do both.

Fertility

If you are a woman of childbearing potential, you must use an effective method of contraception to prevent pregnancy while taking RINVOQ and for at least 4 weeks after the last dose of RINVOQ. If you become pregnant during this time, inform your doctor immediately.

Inform your doctor if your daughter starts menstruating while taking RINVOQ.

Driving and using machines

Do not drive or operate machinery if you feel dizzy or experience vertigo (spinning sensation) while taking RINVOQ until these symptoms resolve.

3. How to take RINVOQ

Follow exactly the dosing instructions for this medicine as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

If you have rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis), or giant cell arteritis:

The recommended dose is one 15 mg tablet once daily.

If you have atopic dermatitis:

Adults (aged 18 to 64 years):

The recommended dose is 15 mg or 30 mg, as prescribed by your doctor, as one tablet once daily.

Your doctor may increase or decrease your dose depending on your response to treatment.

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

The recommended dose is one 15 mg tablet once daily. Your doctor may increase your dose to one 30 mg tablet once daily depending on your response to treatment.

Elderly patients:

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

If you have ulcerative colitis:

The recommended dose is one 45 mg tablet once daily for 8 weeks. Your doctor may decide to extend the initial 45 mg dose for an additional 8 weeks (a total of 16 weeks), followed by one 15 mg or 30 mg tablet once daily for long-term treatment. Your doctor may increase or decrease your dose depending on your response to the medication.

Elderly patients:

If you are 65 years of age or older, the recommended dose for long-term treatment is 15 mg once daily.

Your doctor may reduce your dose if you have renal impairment or if you are prescribed other medications.

If you have Crohn's disease:

The recommended dose is one 45 mg tablet once daily for 12 weeks. This will be followed by one 15 mg or 30 mg tablet once daily for long-term treatment. Your doctor may increase or decrease your dose depending on your response to the medication.

Elderly patients:

If you are 65 years of age or older, the recommended dose for long-term treatment is 15 mg once daily.

Your doctor may reduce your dose if you have renal impairment or if you are prescribed other medications.

How to take the medicine

• Swallow the tablet whole with water. Do not split, crush, chew, or break the tablet before swallowing, as this may alter the amount of medicine entering your body.
• To help you remember to take RINVOQ, take it at the same time each day.
• Tablets may be taken with or without food.
• Do not ingest the desiccant.
• Avoid foods or drinks containing grapefruit while taking (or being treated with) RINVOQ, as they may increase the likelihood of adverse effects by increasing the amount of medicine in your body.

If you take more RINVOQ than you should

If you take more RINVOQ than prescribed, consult your doctor. You may experience some of the adverse effects described in section 4.

If you forget to take RINVOQ

• If you forget to take a dose, take it as soon as you remember.
• If you forget to take your dose for an entire day, simply skip the missed dose and take a single dose the next day as usual.
• Do not take a double dose to make up for missed doses.

If you stop taking RINVOQ

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

How to open the bottle

	Aluminum seal cutting device - on the bottle cap
	How to puncture the aluminum seal 1a. Remove the cap from the bottle by pressing downward and, while continuing to press, turn the cap counterclockwise. 1b. Turn the cap over and place the cutting device near the edge of the aluminum seal.
	Press down to puncture the aluminum and move the cutting device around the edge of the seal to continue cutting.
	After removing the tablet, replace the cap and close the bottle.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Tell your doctor or seek medical help immediately if you experience any signs of:

• infection, such as shingles or a painful skin rash with blisters (herpes zoster) – common (may affect up to 1 in 10 people).
• lung infection (pneumonia), which may cause difficulty breathing, fever, and cough with mucus – common (may affect up to 1 in 10 people).
• blood infection (sepsis) – uncommon (may affect up to 1 in 100 people).
• allergic reaction (chest tightness, wheezing, swelling of the lips, tongue or throat, hives) – uncommon (may affect up to 1 in 100 people).

Other adverse effects

Tell your doctor if you experience any of the following adverse effects:

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

• throat and nose infections
• acne

Common (may affect up to 1 in 10 people)

• non-melanoma skin cancer
• cough
• fever
• cold sores (herpes simplex)
• feeling of discomfort in the stomach (nausea)
• increased levels of an enzyme called creatine kinase, observed in blood tests
• low number of white blood cells in blood tests
• high levels of cholesterol (a type of fat in the blood), observed in blood tests
• high levels of liver enzymes, observed in blood tests (a sign of liver problems)
• weight gain
• inflammation (swelling) of hair follicles
• flu (influenza)
• anemia
• stomach pain (abdominal pain)
• fatigue (unusual tiredness and weakness)
• headache (headache was very common in giant cell arteritis)
• hives (urticaria)
• urinary tract infection
• rash
• sensation of spinning (dizziness)
• dizziness
• lung infection (bronchitis)
• swelling of hands and feet (peripheral edema)

Uncommon (may affect up to 1 in 100 people)

• oral candidiasis (white patches in the mouth)
• elevated levels of triglycerides (a type of fat) in the blood, observed in blood tests
• diverticulitis (painful inflammation of small pouches in the intestinal lining)
• gastrointestinal perforation (a hole in the intestine)

Additional adverse effects in adolescents with atopic dermatitis

Common:

• warts (cutaneous papilloma)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of RINVOQ

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton following "EXP".

This medicine does not require any special storage temperature.

Store in the original blister or bottle with the cap firmly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of RINVOQ

The active substance is upadacitinib.

RINVOQ 15 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.

• Other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.

• Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).

RINVOQ 30 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg of upadacitinib.

• Other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.

• Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), red iron oxide (E172).

RINVOQ 45 mg prolonged-release tablets

• Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 45 mg of upadacitinib.

• Other components are:

• Tablet core: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, anhydrous colloidal silica, magnesium stearate.

• Film coating: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and contents of the container

RINVOQ 15 mg prolonged-release tablets

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

The tablets are available in blister packs or bottles.

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

Each calendar blister contains 7 tablets.

RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, with each pack containing 1 bottle (pack of 30 tablets) or 3 bottles (pack of 90 tablets).

RINVOQ 30 mg prolonged-release tablets

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

The tablets are available in blister packs or bottles.

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

Each calendar blister contains 7 tablets.

RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, with each pack containing 1 bottle (pack of 30 tablets) or 3 bottles (pack of 90 tablets).

RINVOQ 45 mg prolonged-release tablets

RINVOQ 45 mg prolonged-release tablets are yellow to mottled yellow, oblong, biconvex tablets, engraved with “a45” on one side.

The tablets are available in blister packs or bottles.

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

Each calendar blister contains 7 tablets.

RINVOQ is available in bottles with desiccant containing 28 prolonged-release tablets, with each pack containing 1 bottle.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer responsible

AbbVie S.r.l.

S.R. 148 Pontina, km 52 SNC

04011 Campoverde di Aprilia (Latina)

Italy

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium AbbVie SA Tel/Tel: +32 10 477811	Lithuania AbbVie UAB Tel: +370 5 205 3023
	Luxembourg/Luxemburg AbbVie SA Belgique/Belgien Tél/Tel: +32 10 477811
Czech Republic AbbVie s.r.o. Tel: +420 233 098 111	Hungary AbbVie Kft. Tel.: +36 1 455 8600
Denmark AbbVie A/S Tlf: +45 72 30-20-28	Malta V.J.Salomone Pharma Limited Tel: +356 2122017
Germany AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (toll-free) Tel: +49 (0) 611 / 1720-0	Netherlands AbbVie B.V. Tel: +31 (0)88 322 2843
Estonia AbbVie OU Tel: +372 623 1011	Norway AbbVie AS Tlf: +47 67 81 80 00
Greece AbbVie PHARMACEUTICAL COMPANY S.A. Tel: +30 214 4165 555	Austria AbbVie GmbH Tel: +43 1 20589-0
Spain AbbVie Spain, S.L.U. Tel.: +34 91 384 09 10	Poland AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
France AbbVie Tél: +33 (0) 1 45 60 13 00	Portugal AbbVie, Lda. Tel: +351 (0)21 1908400
Croatia AbbVie d.o.o. Tel + 385 (0)1 5625 501	Romania AbbVie S.R.L. Tel: +40 21 529 30 35
Ireland AbbVie Limited Tel: +353 (0)1 4287900	Slovenia AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
Iceland Vistor Tel: +354 535 7000	Slovakia AbbVie s.r.o. Tel: +421 2 5050 0777
Italy AbbVie S.r.l. Tel: +39 06 928921	Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200
Cyprus Lifepharma (Z.A.M.) Ltd Tel.: +357 22 34 74 40	Sweden AbbVie AB Tel: +46 (0)8 684 44 600
Latvia AbbVie SIA Tel: +371 67605000

Date of latest review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

You can also access detailed and up-to-date information about this product by scanning the QR code below or on the outer packaging with a smartphone. The same information is also available at the following URL: www.rinvoq.eu.

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