Important safety information to know about RINVOQ® (upadacitinib)
This page includes some of the important safety information to know about RINVOQ®. Additional information is also available in the
RINVOQ® Consumer Medicine Information (CMI).
Information on this website should be discussed with your doctor and does not replace a doctor's advice.
What should I know before I start taking RINVOQ®?
RINVOQ® and Infections
Because of the way RINVOQ® works on your immune system, you may be more likely to develop infections. Usually these infections are mild—like a cold or a sinus infection, but occasionally they can be serious or even life-threatening. While you're taking RINVOQ® your specialist and GP will monitor you closely for infections. They may encourage you to get early treatment for any infection—even minor ones like a common cold or a graze—so they don't become more serious. RINVOQ® may also increase your risk of developing shingles or cold sores. It is important to tell your doctor if you get symptoms of infections such as fever, feeling tired, persistent cough, wounds, skin sores and blisters, dental problems or burning on urination.
Your doctor may ask you to temporarily stop your RINVOQ® treatment if you develop a serious infection or if your blood test results are outside of the normal range. If this happens, your doctor will tell you when you can start taking RINVOQ® again.
RINVOQ® and Vaccinations
You should also not receive some types of vaccinations (live vaccines) whilst taking RINVOQ®. Speak to your doctor about receiving vaccines whilst taking RINVOQ®.
RINVOQ® and Cancer
Cases of skin cancer have been observed in patients taking RINVOQ®. If new skin lesions appear during or after therapy, or if you notice any change in the appearance of an area on the skin, tell your doctor as soon as possible. Speak to your doctor for more information on your specific situation.
RINVOQ® and Blood Clots
There have been cases of blood clots in the veins (venous thrombosis) in patients taking RINVOQ®. Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins.
Do not take RINVOQ® if any of the following applies:
- If you have an allergy to any medicine containing upadacitinib (RINVOQ® active ingredient)
- If you are allergic to any of the ingredients that RINVOQ® contains (see the last page of the Consumer Medicine Information for a full list of ingredients)
- After the expiry date printed on the pack or if the packaging is torn or shows signs of tampering
- If you have active tuberculosis
- If you have a serious infection.
What does my doctor need to know before I start taking RINVOQ®?
Tell your doctor if you have:
Because:
An infection, or if you have ever had an infection that keeps coming back.
RINVOQ® can reduce your body’s ability to fight infections. It may make an existing infection worse, or make it more likely for you to get a new infection.
Tuberculosis (TB), a history of TB, have been in close contact with someone with TB, or have lived or travelled overseas where TB is a problem.
You may need tests to check for TB before you start taking RINVOQ®.
Have had shingles or chicken pox.
RINVOQ® may increase your risk of getting it again. Tell your doctor if you get a painful skin rash with blisters during RINVOQ® treatment as these can be signs of shingles.
Have had hepatitis B, are a carrier of the hepatitis B virus or you think you have been a risk of contracting hepatitis B or hepatitis C.
Your doctor will factor this into their monitoring process.
Recently had or plan to have a vaccination (immunisation).
It is recommended that people be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RINVOQ® therapy. Use of some vaccines during or immediately before starting RINVOQ® is not recommended so it's important to check with your doctor before you receive any vaccination.
Had cancer, including skin cancer and lymphomas.
You should tell your doctor if you notice any new or changed spots on your skin. Your doctor will decide if you can still be given RINVOQ®.
Had blood clots, for example in the legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism).
See your doctor immediately if you experience signs of blood clots, such as a painful swollen leg, shortness of breath or chest pain.
Liver, kidney, or heart problems, or if you have high blood pressure, high cholesterol or altered blood cell counts.
You may need blood tests before you start taking RINVOQ®, or while you are taking it. This is to check if you have a low red blood cell count (anaemia), low white cell count (neutropaenia or lymphopaenia), high cholesterol or high levels of liver enzymes.
Plans to become pregnant, your partner has plans to become pregnant, or you or your partner are pregnant, breastfeeding or are planning to breastfeed.
RINVOQ® should not be taken during pregnancy or breastfeeding. Based on animal studies, RINVOQ® may harm your unborn baby. You should not take RINVOQ® while you are breastfeeding as it is not known if RINVOQ® passes into breast milk.
Smoked in the past or currently smoke.
Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer.
Unexplained stomach (abdominal) pain, had or have diverticulitis (painful inflammation of small pockets in the lining of your intestine) or ulcers in your stomach or intestines, or are taking nonsteroidal anti-inflammatory medicines.
RINVOQ® should be used with caution in people who may be at risk for gastrointestinal perforations. Tell your doctor if you have any new stomach (abdominal) pain or other gastrointestinal symptoms during RINVOQ® treatment.
Can I take RINVOQ® with other medicines?
Some medicines may interfere with RINVOQ® and affect how well it works.
You should not take RINVOQ® if you are taking a biological medicine that suppresses your immune system unless instructed by your doctor to do so.
Some medicines can affect the way RINVOQ® works:
- Medicines to treat or prevent fungal infections (such as ketoconazole, itraconazole, posaconazole or voriconazole)
- Antibiotics to treat bacterial infection (such as clarithromycin or rifampicin)
- Medicines used to treat neurological disorders (such as phenytoin).
- Medicines that may increase your risk of gastrointestinal perforation (such as non-steroidal anti-inflammatory medicines that are usually used to treat painful and/or inflammatory conditions of muscles or joints, and/or opioids that are used to treat severe pain, and/ or corticosteroids that usually used to treat inflammatory conditions)
Some medicines can increase the risk of infection when taken with RINVOQ®:
- Other JAK inhibitors (such as tofacitinib)
- Biological medicines which suppress your immune system (such as etanercept and adalimumab)
- Medicines used to suppress the immune system (such as azathioprine, cyclosporin and tacrolimus).
Check with your doctor before taking these medicines with RINVOQ®. Tell your doctor, nurse or pharmacist if you are taking any other medicines, including any vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
What are the possible side effects of RINVOQ®?
All medicines can have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Some side effects may require medical attention.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Speak to your doctor if you have any of these less serious side effects and they are worrying you
- Symptoms that may suggest an infection in the nose or throat
- Cough
- Fever
- Feeling sick in the stomach
- Infection of the lung, which may cause breathlessness, raised temperature and a cough with mucus.
- Weight gain
- Acne
Call your doctor as soon as possible if you notice any of the following:
RINVOQ® can reduce your body’s ability to fight infections, making an infection, that you already had worse, or making it more likely to get a new infection. In some cases, the infection can be life-threatening.
Tell your doctor as soon as possible if you notice any of the following:
Signs of a serious infection:
- Fever, sweating or chills
- Feeling short of breath
- Cough
- Warm, red or painful skin sores on your body
- Feeling tired
- Muscle aches
- Diarrhoea or stomach pain
- Blood in your phlegm, or mucous
- Weight loss
- Burning when passing urine or passing urine more often
Signs of tuberculosis:
- Persistent cough
- Weight loss
- Night sweats
- Fever
What are the common side effects of RINVOQ®?
It is not uncommon to experience the following when you are taking RINVOQ®:
- Symptoms that may suggest an infection in the nose or throat
- Cough
- Fever
- Feeling sick in the stomach
- Weight gain
- Acne
- Cold sores
- Painful skin rash with blisters
- Inflammation (swelling) of the hair follicles
- Flu (influenza)
- Anaemia
- Pain in your belly (abdomen)
- Fatigue (feeling unusually tired and weak)
- Headache
- Hives (urticaria)
- Some types of skin cancers (non-melanoma types)
Tell your doctor or pharmacist as soon as possible if you do not feel well while taking RINVOQ® or if you have any problems taking it. Do this even if you do not think the problems are related to the medicine or are not listed in the CMI.
Safety information on this website includes some of the important information to know about RINVOQ®. Additional information is also available in the Consumer Medicine Information (CMI) which is available on the Medsafe New Zealand website. Find links to the RINVOQ® CMI at the bottom of this page.
Information on this website should be discussed with your doctor and does not replace a doctor’s advice.