Do not use RUXIENCE if you:

• are allergic to rituximab or proteins of similar origin or any other non-medicinal ingredient in RUXIENCE.
• have ever had a rare infection of the brain called progressive multifocal leukoencephalopathy (PML).

RUXIENCE is not recommended for use among patients with severe active infections. 

RUXIENCE is not recommended unless patients’ moderate-to-severe rheumatoid arthritis has not been controlled with medicines called tumour necrosis factor (TNF) antagonists.

Talk about any health conditions or problems you may have, including if you: 

• have ever had a bad reaction to rituximab or any of the non-medicinal ingredients.
• are allergic to other medications, food, or dyes.
• have a history of heart disease, heart attack, or stroke.
• are taking any other medicines (including those not prescribed by the doctor).
• are taking or took another biologic medicine called a TNF antagonist or a DMARD (disease modifying anti-rheumatic drug). 
• are taking medication to reduce blood pressure. 
• are planning to be immunized with a vaccine during or after the completion of your RUXIENCE therapy.
• have a pre-existing lung disease as you may have a greater chance of breathing difficulties during your RUXIENCE treatment infusion.
• have a history of hepatitis B or current hepatitis B infection.
• have a history of chronic or recurrent infection.
• are pregnant, plan on becoming pregnant, or are breastfeeding a child. 

This information will help your doctor and you decide whether you should use RUXIENCE and what extra care may need to be taken while you are on the medication. 

These are not all the possible side effects you may feel when taking RUXIENCE. If you experience any side effects not listed here, contact your healthcare professional. Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well while you are receiving treatment with RUXIENCE.

The most common possible unwanted effects are infusion-related events:

• Fever and chills;
• Nausea, vomiting, fatigue (feeling tired or weak), headache, skin rash, redness of the skin, itchiness, wheezing or tightness in the chest, shortness of breath, difficulty breathing, sensation of the tongue or throat swelling, throat irritation, rhinitis (runny nose), temporary low blood pressure, high blood pressure, flushing, dizziness on standing up, fast heartbeat, chest pain, pain in the mouth/throat, and swelling of the hands and feet.

If these unwanted effects occur, it is most common within 30 minutes to 2 hours after starting the first infusion but may also occur after the infusion has finished. The symptoms are usually mild to moderate, which can be easily treated. Rarely, these reactions can be severe. These unwanted side effects are less common after the first treatment.

These unwanted effects can be prevented or managed by: 

Additionally:

• Your doctor may instruct you not to take your blood pressure medication 12 hours before and delay taking until after your infusion of RUXIENCE is complete. Please ask your doctor for specific instructions. 
• Because some of the medications given with RUXIENCE may cause some dizziness or sleepiness, you should arrange for someone else to drive you home after each treatment. 

In addition to the unwanted effects described above, there are certain adverse events identified that are specific to granulomatosis with polyangiitis/microscopic polyangiitis (GPA/MPA) patients, namely muscle spasms, increases in liver enzymes, and nose bleeds.

There are also possible unwanted effects that could be serious, but occur less commonly.

Some patients get infections after treatment. Often these are colds, but could be pneumonia or urinary infections. Some other effects might occur, but are less likely, including pain in the tummy, back, chest, muscles and/or joints, or at the infusion site, feeling unwell, changes in blood pressure, changes in heart rate, diarrhea, indigestion, cramp, dizziness, tingling or numbness, anxiety or nervousness, cough, watery or itchy eyes, runny or itchy nose, sweating, or sinusitis.

Some patients also have some changes to blood tests, including a fall in the number of red cells, white cells, or both. Severe but rare reactions, in particular severe breathing difficulties and severe skin reactions including blistering, could be fatal. This is why your doctor should watch you closely, and why it is important for you to tell your doctor immediately if you experience any difficulty in breathing and any skin reactions.

Some patients also have increasing weakness on one side of the body, clumsiness or falls, trouble with thinking or memory, changes in mood, or change in vision. You should report these to your doctor immediately.

If you are receiving RUXIENCE in combination with other medicines, some of the side effects you may experience may be due to the other medicine(s).

For more information on possible side effects of RUXIENCE, please refer to the patient information leaflet provided by your healthcare team.

Talk to your healthcare professional if you have a troublesome symptom or side effect that is not listed here or if it becomes bad enough to interfere with your daily activities.

Several side effects are associated with RUXIENCE, and some may be severe and life-threatening. This drug should only be used by health professionals experienced in treating rheumatoid arthritis in a setting where medication and supportive care measures are immediately available in the event of an allergic reaction during administration.