ORENCIA 125 MG

Warnings and precautions
Talk to your doctor, pharmacist or nurse:
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if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or
lightheadedness, swelling or skin rash tell your doctor immediately.
if you have any kind of infection, including long-term or localised infection, if you often get
infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is
important to tell your doctor. ORENCIA can lower your body’s ability to fight infection and
the treatment can make you more likely to get infections or make any infection you have worse.
if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight
loss, listlessness, mild fever) tell your doctor. Before you use ORENCIA, your doctor will
examine you for tuberculosis or do a skin test.
if you have viral hepatitis tell your doctor. Before you use ORENCIA, your doctor may
examine you for hepatitis.
if you have cancer, your doctor will decide if you can still be given ORENCIA.
if you recently had a vaccination or are planning to have one, tell your doctor. Some vaccines
should not be given while you are receiving ORENCIA. Check with your doctor before you
are given any vaccines. Certain vaccinations may cause infections from the vaccine. If you
received ORENCIA while you were pregnant, your baby may be at a higher risk for getting
such an infection for up to approximately 14 weeks after the last dose you received during
pregnancy. It is important that you tell your baby’s doctors and other health care professionals
about your ORENCIA use during your pregnancy so they can decide when your baby should
receive any vaccine.

Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.

Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.

Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.

Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.

Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist.

Your doctor may also do tests to examine your blood values.
Children and adolescents
ORENCIA solution for injection in pre-filled syringe has not been studied in children and adolescents
under 2 years of age. Therefore, ORENCIA solution for injection in pre-filled syringe is not
recommended for use in this patient population.
Other medicines and ORENCIA
Tell your doctor if you are taking, have recently taken or might take any other medicines.
ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNF
blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its
being given with anakinra and rituximab.
ORENCIA can be used with other medicines commonly used to treat rheumatoid arthritis, such as
steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Pregnancy and breast-feeding
The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant
unless your doctor specifically recommends it.
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if you are a woman who could become pregnant, you must use reliable contraception (birth
control) while using ORENCIA and up to 14 weeks after the last dose. Your doctor will advise
you on suitable methods.
if you become pregnant while using ORENCIA, tell your doctor.
If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an
infection. It is important that you tell your baby’s doctors and other health care professionals about
your ORENCIA use during your pregnancy before the baby receives any vaccine (for more
information see section on vaccination).
It is not known whether ORENCIA passes into human milk. You must stop breast-feeding if you are
being treated with ORENCIA and for up to 14 weeks after the last dose.
Driving and using machines
The use of ORENCIA is not expected to affect the ability to drive, cycle or use machines. However, if
you are feeling tired or unwell after receiving ORENCIA, you should not drive, cycle or operate any
machinery.
ORENCIA contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium
free’.