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.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
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, active non-radiographic axial spondyloarthritis, moderate
to severe atopic dermatitis, moderate to severe active ulcerative colitis and moderate
to severe active Crohn's disease.
For more information, see Section 1. Why am I taking Rinvoq? in the full CMI.
For more information, see Section 1. Why am I taking Rinvoq? in the full CMI.
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 depresses 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, you are a current or past long-time smoker, 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.
Do not take Rinvoq if you are already using a biological medicine or a medicine that depresses 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, you are a current or past long-time smoker, 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.
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.
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.
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Things you should do
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remind any doctor, pharmacist 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, or severe stomach pain especially
accompanied by fever, nausea and vomiting.
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Things you should not do
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do not stop taking this medicine or change the dose unless your doctor tells you to.
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Driving or using machines
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do not drive or use machines if you experience a spinning sensation (vertigo) when
taking Rinvoq until it resolves.
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Drinking alcohol
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there is no information on the effects of taking Rinvoq with alcohol.
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Looking after your medicine
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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.
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For more information, see Section 5. What should I know while taking Rinvoq? in the full CMI.
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 .
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WARNINGS:
Speak with your doctor and refer to Section 2 for more information if:
You have a history of cardiovascular disease (such as heart attack, stroke or blood
vessel disease) or factors that increase your risk of cardiovascular disease.
You are a current or past long-time smoker.
You have or have had cancer including skin cancer and cancer of the lymph glands.
You are 65 years of age and older.
Your doctor has prescribed RINVOQ because they believe it is the most suitable option
for your condition and they have thought carefully about your specific needs and other
ways to treat it.
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Rinvoq®
(rin voke)
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:
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.
- active non-radiographic axial spondyloarthritis in adults, a disease that primarily
causes inflammation in the spine. Rinvoq helps to reduce back pain including back
pain at night, stiffness, and inflammation in your spine. These effects can help you
to do normal daily activities and may improve your health-related quality of life.
- moderate to severe active ulcerative colitis by helping to control inflammation
and reduce the signs and symptoms of ulcerative colitis, including bloody stools,
abdominal pain and the need to rush to and the number of times you go to the toilet,
helping you do normal daily activities, reduce fatigue and improve your health-related
quality of life.
- moderate to severe active Crohn's disease by helping to control inflammation and
reduce the signs and symptoms of Crohn's disease, including frequent and loose stools,
abdominal pain and the inflammation of your intestinal lining. Rinvoq can also help
improve your ability to do your normal daily activities, reduce fatigue and improve
your health-related quality of life.
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. Symptoms of an allergic reaction (such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat), have been seen in people taking Rinvoq. Some of these reactions may be serious. If any of these symptoms occur during treatment with Rinvoq, stop taking Rinvoq and get emergency medical help right away.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives, or dyes.
take any medicines for any other condition.
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. If you have diabetes, or are
65 years of age or older, you may have an increased chance of getting infections.
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) or have an increased risk for developing blood clots (for example:
if you had recent major surgery, if you use hormonal contraceptives / hormonal replacement
therapy, if a blood clotting disorder is identified in you or your close relative).
are a current or past long-time smoker.
have or have had cancer including skin cancer and lymphomas (cancer of the lymph glands).
If you are at high risk of developing skin cancer, your doctor may recommend preventative
measures or monitoring, such as regular skin examinations while taking Rinvoq. Talk
to your doctor if you develop a new skin lesion or any change in the appearance of
an area on the skin.
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 heart problems, high blood pressure or high cholesterol.
have or have had kidney or liver problems.
have unexplained stomach (abdominal) pain, have or have had diverticulitis (painful
inflammation of small pockets in the lining of your intestine) or ulcers in your stomach
or intestines, or are taking non-steroidal anti-inflammatory medicines.
Repeatedly see a tablet or tablet pieces in your stool.
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
on side effects including signs and symptoms 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. It is not known if this medicine passes
into your 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 these patients.
Rinvoq is not recommended for use in children and adolescents under 18 years of age
with rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis,
ankylosing spondylitis, ulcerative colitis, and Crohn's disease. This is because it
has not been studied in these patients.
Use in the elderly
Patients 65 years of age and older may be at increased risk of infections, heart problems
including heart attack, stroke and some types of cancer.
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.
Medicines that may
increase
your risk of GI perforations:
Medicines that may increase your risk of gastrointestinal perforation such as a non-steroidal
anti-inflammatory medicine (usually used to treat painful and/or inflammatory conditions
of muscle or joints), and/or opioids (used to treat severe pain), and/or corticosteroids
(usually used to treat inflammatory conditions).
Medicines that may
increase
the risk of hypoglycaemia when taken with Rinvoq:
Rinvoq may affect your blood sugar levels when you are taking medicines to treat diabetes.
It is very important to talk to your doctor or pharmacist if you are taking medicines
to treat diabetes or if you have diabetes. Your doctor may decide if you need less
anti-diabetic medicine while taking Rinvoq.
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 much to take
If you have rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis
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.
If you have ulcerative colitis:
When starting treatment (Induction):
take one 45 mg tablet once every day for 8 weeks, as prescribed by your doctor. This
can be continued for another 8 weeks, for a total of 16 weeks (induction dose).
Continuing treatment (Maintenance):
then take one 15 mg or 30 mg tablet once every day, as prescribed by your doctor (maintenance
dose).
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 maintenance dose is 15 mg a day.
If you have Crohn's disease:
When starting treatment (Induction):
take one 45 mg tablet once every day for 12 weeks, as prescribed by your doctor (induction
dose).
Continuing treatment (Maintenance):
then take one 15 mg or 30 mg tablet once every day, as prescribed by your doctor (maintenance
dose).
Your doctor may increase or decrease your dose depending on how well the medicine
is working.
If you are 65 years of age and older, the recommended maintenance 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.
Avoid food or drink containing grapefruit during treatment with Rinvoq as these may
interact and increase the risk of side effects.
When to take Rinvoq
take Rinvoq at about the same time each day.
Please look for the QR code on the medicine pack. Scan this code for more information
on Rinvoq.
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.
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.
Things you should not do
do not stop taking this medicine or change the dose without checking with your doctor.
Driving or using machines
Do not drive or use machines if you experience a spinning sensation (vertigo) when
taking Rinvoq until it resolves.
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, and
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.
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
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Less serious side effects
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What to do
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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
a spinning sensation (vertigo)
Skin:
acne
cold sores
redness and swelling of the hair follicles
hives
rash
warts (skin papilloma)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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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, or changes to any skin spots, sores, or lesions
cluster of warm, red or painful skin sores or blisters on your body
Signs of GI perforation (hole in the bowel):
sudden onset of stomach pain
fever or chills
nausea or vomiting
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Call your doctor straight away if you notice any of these serious side effects.
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Signs of an allergic reaction:
difficulty breathing or swallowing
chest tightness
wheezing
severe dizziness or light-headedness
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:
leg pain or tenderness
redness or discolouration in the leg or arm
swelling of the leg or arm
chest pain or pain in the upper back
sudden shortness of breath or difficulty breathing
Signs of pneumonia:
fever, chills
cough sometimes with phlegm
feeling tired or lacking energy
shortness of breath
chest pain
Signs of a heart attack:
chest pain or discomfort
lightheadedness, nausea, or vomiting
pain in jaw, neck or back
pain or discomfort in arm or shoulder
shortness of breath
Signs of a stroke:
trouble speaking or difficulty understanding speech
sudden numbness, weakness or paralysis in the face, arm or leg of one side of the
body
problems seeing in one or both eyes
headache
trouble walking
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Go straight to the Emergency Department at your nearest hospital if you notice any
of these very serious side effects.
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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.
This medicine is only available with a doctor's prescription.
What Rinvoq contains
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Active ingredient
(main ingredient)
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Upadacitinib
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
hypromellose
mannitol
tartaric acid
colloidal anhydrous silica
magnesium stearate
polyvinyl alcohol
macrogol 3350
talc
titanium dioxide
iron oxide red
iron oxide black (15 mg only)
iron oxide yellow (45 mg only)
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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 45 mg tablets are yellow to mottled yellow oblong tablets, 14 x 8 mm and marked
‘a45’ on one side (AUST R 375857).
Rinvoq is supplied in blister packs inside a carton containing 7 or 28 tablets.
