RINVOQ 15 mg Extended-Release Tablet

Зміст інструкції

1. RINVOQ 15 mg prolonged-release tablets, 30 mg prolonged-release tablets, 45 mg prolonged-release tablets
   1. What is RINVOQ and what is it used for
   2. What you need to know before you take RINVOQ
   3. How to take RINVOQ
   4. How to pierce the foil
   5. Possible side effects
   6. How to store RINVOQ
   7. Contents of the pack and other information

RINVOQ 15 mg prolonged-release tablets, 30 mg prolonged-release tablets, 45 mg prolonged-release tablets

upadacitinib

Read this leaflet carefully before you start taking this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What RINVOQ is and what it is used for
• 2. What you need to know before you take 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 is RINVOQ and what is it used for

RINVOQ contains the active ingredient upadacitinib and belongs to a group of medicines called
Janus kinase inhibitors. By reducing the activity of an enzyme present in the body called
“Janus kinase”, RINVOQ reduces inflammation in the following diseases:

• 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 active rheumatoid arthritis, you may have been prescribed other medicines first, one of which will usually be
methotrexate. If these medicines do not work adequately, you will be prescribed RINVOQ alone or in combination with methotrexate for the treatment of rheumatoid
arthritis.
RINVOQ can help reduce joint pain, stiffness and swelling, reduce
fatigue and may also slow down damage to the bones and cartilage of the joints. These
effects can make normal daily activities easier and therefore improve quality of life.
Psoriatic arthritis
RINVOQ is used to treat adults with psoriatic arthritis. Psoriatic arthritis is a
disease that causes inflammation of the joints and psoriasis. If you have active psoriatic arthritis, you may have been prescribed other medicines first. If these medicines do not
work adequately, you will be prescribed RINVOQ alone or in combination with methotrexate
for the treatment of psoriatic arthritis.
RINVOQ can help reduce pain, stiffness and swelling inside and around the
joints, back pain and stiffness, psoriasis rash and
fatigue, as well as slowing down damage to the bones and cartilage of the joints. These effects
can make normal daily activities easier and therefore improve 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 causes inflammation mainly in the spine. If you have
active axial spondyloarthritis, you may have been prescribed other medicines first. If these
medicines do not work adequately, you will be prescribed RINVOQ for the treatment
of axial spondyloarthritis.
RINVOQ can help reduce back pain, stiffness and inflammation of the spine. These effects can make normal daily activities easier and therefore improve 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; it generally affects the arteries of
medium and large size 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 can
make normal daily activities easier and therefore improve quality of life. Giant cell
arteritis is often treated with medicines called steroids which are usually effective, but can
have undesirable effects if used at high doses or if used for a long period of time. Reducing
the dose of steroids can also cause a flare-up of giant cell arteritis.
Adding RINVOQ to treatment allows for the possibility of using steroids for a
shorter period of time, while maintaining control of giant cell arteritis.
Atopic dermatitis
RINVOQ is used for the treatment of adults and adolescents aged 12 years and over with
moderate to severe atopic dermatitis, also known as atopic eczema. RINVOQ can be used
together with medicines for the treatment of eczema that can be applied to the skin or it can be used alone.
Taking RINVOQ can improve skin conditions and reduce itching and
flare-ups. RINVOQ can help improve symptoms of pain, anxiety and depression that may
manifest in people with atopic dermatitis. RINVOQ can also help improve
sleep disturbances and overall quality of life.
Ulcerative colitis
Ulcerative colitis is an inflammatory bowel disease of the large intestine. RINVOQ is used for the
treatment of adults with ulcerative colitis who have not responded sufficiently well or have not
tolerated previous therapy.
RINVOQ can help reduce the signs and symptoms of the disease, including bloody stools, abdominal pain and urgency and frequency of bowel movements. These effects can make normal
activities easier and reduce fatigue.
Crohn’s disease
Crohn’s disease is an inflammatory disease 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 not responded sufficiently well or have not tolerated the
previous therapy.
RINVOQ can help reduce the signs and symptoms of the disease, including urgency and frequency
of bowel movements, abdominal pain and inflammation of the lining of the intestine. These
effects can make normal daily activities easier and reduce fatigue.

2. What you need to know before you take 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, breastfeeding and contraception)

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

• you have an infection or if you get infections often. Tell your doctor if you develop symptoms such as fever, sores, feeling more tired than usual, or dental problems, as these may be signs of infection. RINVOQ can reduce the body's ability to fight infections and may therefore cause or worsen an existing infection or increase the likelihood of contracting a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to get infections
• you have had tuberculosis or have been in close contact with someone who has tuberculosis. Your doctor will test you for tuberculosis before starting treatment with RINVOQ and may repeat the test during treatment
• you have had a herpes zoster virus infection (shingles), because RINVOQ may allow it to reappear. Tell your doctor if you develop a painful rash with blisters, as these may be signs of herpes zoster virus infection
• you have ever had hepatitis B or C
• you have recently had or are planning to have a vaccination (immunization) - this is because live vaccines are not recommended during the use of RINVOQ
• you have or have had cancer in the past, smoke or have smoked in the past, because your doctor will need to discuss with you whether RINVOQ is an appropriate therapy in your case
• non-melanoma skin cancer has been observed in patients taking RINVOQ. Your doctor may recommend that you undergo periodic skin examinations while taking RINVOQ. If new skin lesions appear during or after therapy, or if existing lesions change in appearance, tell your doctor.
• you have or have had heart problems, because your doctor will need to discuss with you whether RINVOQ is an appropriate therapy in your case
• your liver is not working properly
• you have had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism) in the past, or have an increased risk of developing them (for example, if you have recently undergone major surgery, if you are using hormonal contraceptives/hormone replacement therapy, if a blood clotting disorder has been found in you, or if it has been found in a close relative). Your doctor will discuss with you whether RINVOQ is an appropriate therapy in your case. Tell your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain, or pain in the upper back, swelling of a leg or arm, pain or tenderness in a leg, or

redness or color change in a leg or arm, as these may be
signs of blood clots in the veins

• you experience sudden changes in vision. You should see a doctor immediately if you experience symptoms such as blurred vision, partial or complete loss of vision, as these may be signs of blocked blood flow to the eyes
• you have kidney problems
• you have unexplained abdominal pain, have or have had diverticulitis (inflammation of the pouches in the intestine) or ulcers in the stomach or intestine, or are taking nonsteroidal anti-inflammatory drugs
• you repeatedly notice a tablet or tablet residue in your stool.

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

• symptoms such as rash (urticaria), difficulty breathing, or swelling of the lips, tongue, or throat, as you may be having 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 go to the emergency room immediately.
• severe stomach pain, especially accompanied by fever, nausea, and vomiting.

Blood tests
You will need to have blood tests before starting to take RINVOQ or during therapy.
The purpose of these tests is to check for a low number of red blood cells (anemia), a
low number of white blood cells (neutropenia or lymphopenia), a high level of fats in the blood
(cholesterol), or high levels of liver enzymes. The tests are intended to ensure that treatment
with RINVOQ does not cause problems.

Elderly
In patients aged 65 years or older, there is a higher rate of infections. Tell your doctor
as soon as you notice signs or symptoms of an infection.
Patients aged 65 years or older may have a higher risk of infections, heart problems, including heart attack, and some types of cancer. Your doctor will discuss with you whether
RINVOQ is an appropriate therapy in your case.

Children and adolescents
The use of RINVOQ is not recommended in children under 12 years of age or adolescents of
less than 30 kg weight with atopic dermatitis, as 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, as 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 take
any other medicines. This is because some medicines may reduce the effectiveness of RINVOQ
or increase the risk of side effects. It is very important to tell your doctor or pharmacist
if you are taking any of the following medicines:

• medicines for the treatment of fungal infections (such as itraconazole, posaconazole, or voriconazole)
• medicines for the treatment of bacterial infections (such as clarithromycin)
• medicines for the treatment of Cushing's syndrome (such as ketoconazole)
• medicines for the treatment of tuberculosis (such as rifampicin)
• medicines for the treatment of seizures or epilepsy (such as phenytoin)
• medicines that affect the immune system (such as azathioprine, 6-mercaptopurine, cyclosporine, and tacrolimus)
• medicines that can increase the risk of gastrointestinal perforation or diverticulitis such as non-steroidal anti-inflammatory drugs (commonly used to treat muscle or joint pain and/or inflammation), and/or opioids (used to treat severe pain), and/or corticosteroids (commonly used to treat inflammatory conditions).
• medicines for the treatment of diabetes or if you have diabetes. Your doctor may decide to reduce the dose of antidiabetic medicine while taking upadacitinib. If you are taking any of the medicines listed above or are unsure, talk to your doctor or pharmacist before taking RINVOQ.

Pregnancy, breastfeeding and contraception
Pregnancy
RINVOQ must not be used during pregnancy.
Breastfeeding
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this
medicine. You should not use RINVOQ while breastfeeding as it is not known whether this medicine
passes into breast milk. You and your doctor should decide whether to breastfeed or take RINVOQ. You should not
do both.
Contraception
If you are a woman of childbearing potential, you must use an effective method of contraception to avoid
pregnancy while taking RINVOQ and for at least 4 weeks after the last dose of
RINVOQ. If you become pregnant during this period, you should tell your doctor immediately.
If the girl has her first menstrual period during treatment with RINVOQ, tell
your doctor.

Driving and using machines
If you experience dizziness or a sensation of spinning (vertigo) while taking RINVOQ, do not
drive vehicles or use machines until it resolves.

3. How to take RINVOQ

Always take this medicine exactly as your doctor or pharmacist has told you.If you have any doubts, ask your doctor or pharmacist.

How much medicine to take
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 a day.
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, in the form of one tablet
once a day.
Your doctor may increase or decrease the dose depending on how you respond to the medicine.

Adolescents (aged 12 to 17 years) weighing at least 30 kg:
The recommended dose is one 15 mg tablet once a day. Your doctor may increase the
dose to one 30 mg tablet once a day depending on how you respond to the medicine.

Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day.
If you have ulcerative colitis
The recommended dose is one 45 mg tablet once a day for 8 weeks. Your doctor
may decide to extend the initial 45 mg dose for another 8 weeks (16 weeks in total).
This phase will be followed by taking one 15 mg or 30 mg tablet once a day for
long-term treatment. Your doctor may increase or decrease the dose depending on how
you respond to the medicine.

Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day for long-term treatment.
Your doctor may decrease the dose if you have kidney problems or if you have been prescribed other
medicines.
If you have Crohn’s disease
The recommended dose is one 45 mg tablet once a day for 12 weeks. This phase
will be followed by taking one 15 mg or one 30 mg tablet once a day
for long-term treatment. Your doctor may increase or decrease the dose depending on
how you respond to the medicine.

Elderly:
If you are 65 years of age or older, the recommended dose is 15 mg once a day for long-term treatment.
Your doctor may decrease the dose if you have kidney problems or if you have been prescribed some other
medicines.

How to take the medicine

• Swallow the tablet whole with water. Do not split, crush, chew or break the tablet before swallowing, as this could change the amount of medicine that gets into your body.
• To help you remember to take RINVOQ, take it every day at the same time.
• The tablets can be taken with or without food.
• Do not ingest the desiccant.
• Avoid grapefruit or grapefruit juice while taking (or being treated with) RINVOQ as these can increase the likelihood of side effects by increasing the amount of medicine in your body.

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 listed in section 4.

If you forget to take RINVOQ

• If you forget a dose, take it as soon as you remember.
• If you forget the dose for a whole day, skip the missed dose and, the next day, take only one single dose as usual.
• Do not take a double dose to make up for a missed dose.

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

How to open the bottle
Film tear-off tool- on the bottle cap

1. How to pierce the foil

1a.Remove the cap from the vial by pressing down and, continuing to press, rotate the cap counterclockwise.

1b.Turn the cap upside down and position the cutting tool near the edge of the foil.

2. Press down to make a hole in the foil and move the cutting tool along the edge of the foil to continue cutting it.

• 3.After taking the tablet, replace the cap and close the vial.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
See your doctor or seek immediate medical attention if you experience any of the following:

• infection such as shingles or painful blistering rash (herpes zoster virus) - common (may affect up to 1 in 10 people)
• lung infection (pneumonia), which can cause shortness of breath, fever and a productive 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 (feeling of tightness in the chest, wheezing, swelling of the lips, tongue or throat, hives) - uncommon (may affect up to 1 in 100 people)

Other side effects
See your doctor if you notice any of the following side 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 virus)
• feeling sick to the stomach (nausea)
• increase in an enzyme called creatine kinase, detected by blood tests
• low number of white blood cells, detected by blood tests
• increase in cholesterol levels (a type of fat in the blood), detected by blood tests
• increase in liver enzymes, detected by blood tests (a sign of liver problems)
• weight gain
• inflammation (swelling) of the hair follicles
• flu
• anemia
• stomach (abdominal) pain
• fatigue (feeling unusually tired and weak)
• headache (very common in giant cell arteritis)
• hives
• urinary tract infection
• skin rash
• feeling of spinning (dizziness)
• lightheadedness
• lung infection (bronchitis)
• swelling of the feet and hands (peripheral edema)

Uncommon(may affect up to 1 in 100 people)

• thrush in the mouth (white patches in the mouth)
• increase in triglyceride levels (a type of fat) in the blood, detected by blood tests
• diverticulitis (painful inflammation of the lining of small pockets in the intestine)
• gastrointestinal perforation (a hole in the intestine)

Additional side effects in adolescents with atopic dermatitis
Common

• warts (skin papilloma)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex V. By reporting
side effects you can help provide more information on the safety of this
medicine.

5. 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 after “EXP”
on the label and on the carton after “Scad.”
This medicine does not require any particular storage temperature.
Store in the original blister or in the bottle with the cap tightly closed to protect the medicine
from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RINVOQ contains
The active ingredient is upadacitinib.
RINVOQ 15 mg prolonged-release tablets

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

Description of the appearance of RINVOQ and contents of the pack
RINVOQ 15 mg prolonged-release tablets
RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets with
‘a15’ imprinted on one side.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in
multipacks of 84 comprising 3 boxes, each containing 28 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with a desiccant containing 30 prolonged-release tablets, 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 with
‘a30’ imprinted on one side.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with a desiccant containing 30 prolonged-release tablets, 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 yellowish mottled tablets,
oblong, biconvex with ‘a45’ imprinted on one side.
The tablets are provided in blisters or bottles.
RINVOQ is available in packs containing 28 prolonged-release tablets.
Each calendar blister contains 7 tablets.
RINVOQ is available in bottles with a desiccant containing 28 prolonged-release tablets, each
pack containing 1 bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l.
S.R. 148 Pontina, km 52 SNC
04011 Campoverde di Aprilia (Latina)
Italy
AbbVie Logistics B.V.
Zuiderzeelaan 53
Zwolle, 8017 JV,
Netherlands
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie 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

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor
Sími: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu.
Detailed and up-to-date information on this product is also available by scanning the QR code below or on the outer packaging. The same information is also available at the following URL: www.rinvoq.eu.
QR code to be included

printing> or
authorisation holder.
ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for upadacitinib, the PRAC’s scientific conclusions are as follows:
Considering the available data on retinal vein occlusion, the reported cases with at least a reasonable possibility of a correlation between the event of retinal vein occlusion and treatment with upadacitinib, the severity of the condition, the plausible mechanism of action and the potential class effect, the PRAC considers that the information on the medicinal product containing upadacitinib must be appropriately updated.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with the overall conclusions and with the justification for the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on upadacitinib, the CHMP considers that the benefit-risk balance of the medicinal product containing upadacitinib remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.