Rinvoq ®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

Why am I taking Rinvoq?

Rinvoq contains the active ingredient upadacitinib. Rinvoq is used to treat moderate to severe active rheumatoid arthritis, moderate to severe active psoriatic arthritis, active ankylosing spondylitis and moderate to severe atopic dermatitis.
For more information, see Section 1. Why am I taking Rinvoq? in the full CMI.

What should I know before I take Rinvoq?

Check the list of ingredients at the end of the CMI. Do not take Rinvoq if you have ever had an allergic reaction to any of them.
Do not take Rinvoq if you are already using a biological medicine or a medicine that depress or strongly suppresses the immune system including azathioprine, ciclosporin and tacrolimus. Talk to your doctor before you take this medicine if you have any other medical conditions, take any other medicines or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take Rinvoq? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Rinvoq and affect how it works or Rinvoq may interfere with other medicines and affect how they work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I take Rinvoq?

the usual dose is one tablet once every day.
do not split, crush, or chew the tablets. Swallow them whole with a full glass of water with or without food.
More instructions can be found in Section 4. How do I take Rinvoq? in the full CMI.

What should I know while taking Rinvoq?

Things you should do
remind any doctor or dentist you visit that you are taking Rinvoq.
keep all your appointments, including blood tests.
tell your doctor if you develop an infection, or pain or swelling in the leg, or pain in your chest and/or have difficulty breathing.
Things you should not do
do not stop taking this medicine or change the dose unless your doctor tells you to.
Driving or using machines
it is unlikely that Rinvoq will have an effect on your ability to drive or use machines.
Drinking alcohol
there is no information on the effects of taking Rinvoq with alcohol.
Looking after your medicine
store Rinvoq in a cool dry place, below 30°C, away from moisture, heat and sunlight.
keep your tablets in the pack until it is time to take them.
For more information, see Section 5. What should I know while taking Rinvoq? in the full CMI.

Are there any side effects?

The more serious side effects include serious infections, e.g., tuberculosis, pneumonia, shingles, and blood clots. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient: upadacitinib (yu-pa-da-si-ti-nib)
Consumer Medicine Information (CMI)
This leaflet provides important information about taking Rinvoq. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Rinvoq.
Where to find information in this leaflet:

Why am I taking Rinvoq?

Rinvoq contains the active ingredient upadacitinib, which is a Janus Kinase (JAK) inhibitor. JAK enzymes create signals in the body's immune system that result in inflammation. Rinvoq works to block these signals, thereby reducing inflammation and the production of immune cells within the body. Rinvoq is used to treat:
- moderate to severe, active rheumatoid arthritis by helping to reduce signs and symptoms of inflammation, including joint pain, tenderness, stiffness and swelling in your joints.
- moderate to severe, active psoriatic arthritis by helping to reduce pain, stiffness, swelling in and around joints, pain and stiffness in your spine, psoriatic skin rash and tiredness. It helps to slow damage to the bone and cartilage in your joints.
-active ankylosing spondylitis by helping to reduce back pain including night back pain, stiffness and inflammation in your spine.
- moderate to severe atopic dermatitis by improving the condition of your skin and reducing itching and flares. Rinvoq has also been shown to improve symptoms of pain, anxiety, and depression associated with atopic dermatitis. Rinvoq can also help improve your sleep disturbance and overall quality of life.

What should I know before I take Rinvoq?

Warnings

Do not take Rinvoq if:

1. you are already using a biological medicine, including etanercept, adalimumab

2. you are taking other medicine used to strongly suppress your immune system, e.g., azathioprine, ciclosporin and tacrolimus

3. you are allergic to upadacitinib, or any of the ingredients listed at the end of this CMI.

Check with your doctor if you:

have allergies to any other medicines, foods, preservatives, or dyes.
have an infection or have had an infection that keeps coming back. RINVOQ can reduce your body's ability to fight infections, may make an infection you already have worse, or make it more likely for you to get a new infection.
have or have had tuberculosis, have been in close contact with someone who has had tuberculosis, or you have lived or travelled overseas where tuberculosis is a problem. You may need to have a test to check if you have previously been exposed to tuberculosis.
have or have had shingles or chicken pox
have or have had hepatitis B, are a carrier of the hepatitis B virus or you think you may be at risk of contracting hepatitis B or hepatitis C
have been recently vaccinated or are scheduled for any immunisations such as against herpes zoster. Live vaccines should not be given while you are taking Rinvoq.
have had blood clots, for example in the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism)
have or have had cancer including skin cancer and lymphomas
have or have had an abnormal blood cell count such as low red blood cell count, low haemoglobin, low white cell count
have or have had high blood pressure or high cholesterol
have or have had kidney or liver problems
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Make sure your doctor is aware if you are pregnant or plan to become pregnant. Use effective contraception to avoid becoming pregnant while taking Rinvoq and for at least 4 weeks after your last dose of Rinvoq. Rinvoq should not be used during pregnancy. Based on animal studies, Rinvoq may harm your unborn baby.
Make sure your doctor is aware if you are breastfeeding or plan to do so. You should not take Rinvoq while you are breastfeeding as it is not known if this medicine passes into breast milk.

Use in children

Rinvoq is not recommended for use in children under 12 years of age or adolescents weighing less than 40 kg with atopic dermatitis. This is because it has not been studied in this age group.
Rinvoq is not recommended for use in children and adolescents under 18 years of age with rheumatoid arthritis. This is because it has not been studied in this age group.

Use in the elderly

There is a higher rate of infection in patients aged 65 years and older. Tell your doctor as soon as you notice any signs or symptoms of an infection.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Rinvoq and affect how it works.
Do not take Rinvoq if you are taking any of the following medicines:
biological medicines.
Medicines that may increase the effect of Rinvoq include:
medicines used to treat or prevent fungal infections, e.g., ketoconazole, itraconazole, posaconazole or voriconazole
medicines used to treat infections caused by bacteria (antibiotic), e.g., clarithromycin.
Medicines that may reduce the effect of Rinvoq include:
medicines used to treat tuberculosis and other bacterial infections, e.g., rifampicin
medicines used to treat neurological disorders, e.g., phenytoin.
Medicines that may increase the risk of infection when taken with Rinvoq include:
other JAK inhibitors, e.g., tofacitinib and baricitinib
biological medicines, e.g., etanercept, adalimumab, see above list of medicines to avoid while taking Rinvoq
medicines used for suppressing the immune system, e.g., azathioprine, ciclosporin, tacrolimus.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Rinvoq.

How do I take Rinvoq?

How much to take

If you have rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:
take one 15 mg tablet once every day.
If you have atopic dermatitis:
take one 15mg or 30 mg tablet once every day as prescribed by your doctor.
your doctor may increase or decrease your dose depending on how well the medicine is working.
if you are 65 years of age or older, the recommended dose is 15 mg a day.
if you are an adolescent aged 12 years of age or older, the recommended dose is 15 mg a day.

How to take Rinvoq

Do not split crush or chew the tablets. Swallow them whole with a full glass of water.

it does not matter if you take this medicine before or after food.
follow the instructions provided and use Rinvoq until your doctor tells you to stop.
in some instances, Rinvoq needs to be taken with other medicines. Your doctor will let you know which medicines, how to take them and how long to take them.

When to take Rinvoq

take Rinvoq at about the same time each day.

If you forget to take Rinvoq

It is important that you do not skip doses of Rinvoq.
If you miss a dose, take it as soon as you remember as long as it is at least 10 hours before your next dose.
If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
Do not take a double dose to make up for the dose you missed.

If you take too much Rinvoq

You should immediately:
phone the Poisons Information Centre in Australia
( by calling 13 11 26), in New Zealand the National Poisons Centre (by calling 0800 POISON or 0800 764 766) or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.

What should I know while taking Rinvoq?

Things you should do

keep all your appointments so your progress can be checked.
keep your appointments for blood tests to make sure the medicine is working and as some side effects are seen in blood results before you have any symptoms.
get regular skin checks, and wear sunscreen and a hat when outdoors.
remind any doctor, pharmacist or dentist you visit that you are taking Rinvoq.
call your doctor straight away if you become pregnant while taking Rinvoq

Things you should not do

do not stop taking this medicine or change the dose without checking with your doctor.

Driving or using machines

It is unlikely that Rinvoq will have an effect on your ability to drive or use machines.

Drinking alcohol

There is no information of the effects of taking Rinvoq with alcohol.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight, for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on windowsills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
 
 
 

Less serious side effects

Less serious side effects
What to do
Upper airways:
sore or scratchy throat
blocked or runny nose
flu
Gut:
feeling sick in the tummy
pain in your belly
Body as a whole:
fever
weight gain
feeling unusually tired or weak
anaemia
headache
Skin:
acne
cold sores
redness and swelling of the hair follicles
hives
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
Signs of a serious infection:
fever, sweating or chills
feeling short of breath
feeling tired or lacking energy
muscle aches
diarrhoea
tummy pain
cough
weight loss
burning when passing urine or passing urine more often
Signs of a blood disorder:
swelling of the glands in your neck, armpits or groin
Skin:
painful skin rash with blisters
new skin spots or sores
changes to any skin spots or sores
cluster of warm, red or painful skin sores or blisters on your body
Call your doctor straight away if you notice any of these serious side effects.
Signs of an allergic reaction:
difficulty breathing or swallowing
swelling of face, lips, tongue, or throat
severe itching of skin, with a red rash or raised bumps
Signs of tuberculosis:
fever, night sweats
chills
difficulty breathing
a bad cough that won't go away
blood in your phlegm
weight loss
Signs of the effect of a blood clot:
pain, redness or swelling of the leg
chest pain or difficulty breathing
Signs of pneumonia:
fever, chills
cough sometimes with phlegm
feeling tired or lacking energy
shortness of breath
chest pain
Go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

Product details

This medicine is only available with a doctor's prescription.

What Rinvoq contains

Active ingredient
(main ingredient)
Upadacitinib
Other ingredients
(inactive ingredients)
microcrystalline cellulose
hypromellose
mannitol
tartaric acid
colloidal anhydrous silica
magnesium stearate
polyvinyl alcohol
macrogol 3350
talc
titanium dioxide
iron oxide black (15 mg only)
iron oxide red.
Do not take this medicine if you are allergic to any of these ingredients.
Rinvoq does not contain gluten or lactose.

What Rinvoq looks like

Rinvoq 15 mg tablets are purple oblong tablets, 14 x 8 mm and marked 'a15' on one side (AUST R 312687).
Rinvoq 30 mg tablets are red oblong tablets, 14 x 8 mm and marked ‘a30’ on one side (AUST R 346215).
Rinvoq is supplied in blister packs inside a carton containing 7 or 28 tablets.

Who distributes Rinvoq?

AbbVie Pty Ltd
ABN 48 156 384 262
241 O'Riordan Street
MASCOT NSW 2020
This leaflet was prepared in September 2021.
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