Orencia 125 mg Solution

ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T cells involved in the immune system's inflammatory response.

ORENCIA is a medicine that is used to treat adults with active rheumatoid arthritis (RA). Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. ORENCIA 125 mg is not suitable for use in children younger than 18 years.

ORENCIA 125 mg should not be administered to you:

• if you are hypersensitive (allergic) to abatacept or any of the other ingredients of ORENCIA.
• if you have active or untreated tuberculosis (TB)
• if you are pregnant, plan to become pregnant, or are breastfeeding your baby (see Pregnancy, breastfeeding and fertility)

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you are taking a TNF (tumour necrosis factor) blocker such as etanercept or infliximab to treat RA, as you have a greater chance of getting a serious infection if you use ORENCIA with other biologic medicines for RA.
• if you are taking anakinra
• if you have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from ORENCIA. If you are unsure, please ask your doctor.
• if you have had tuberculosis (TB), a positive skin test for TB, or if you recently have been in close contact with someone who has had TB.
• if you develop any of the symptoms of TB (a dry cough that doesn’t go away, weight loss, fever, night sweats) call your doctor right away. Before you start ORENCIA, your doctor should examine you for TB and perform a skin test.
• if you have a history of chronic obstructive pulmonary (lung) disease (COPD).
• if you are scheduled to have surgery.
• if you have cancer, your doctor will decide if you can still be given ORENCIA.
• if you recently received a vaccination or are scheduled for any vaccination.
• if you have viral hepatitis. Before you start ORENCIA, your doctor may examine you for hepatitis.
• if you have human immunodeficiency virus (HIV) infection.

Allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling or skin rash have been reported with Orencia.

Children and adolescents

ORENCIA 125 mg is not suitable for use in children younger than 18 years.

Other medicines and ORENCIA 125 mg

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) ORENCIA should not be used with biologic medications for RA, including TNF-blockers such as etanercept and infliximab. There is not enough evidence to recommend ORENCIA being given with anakinra. ORENCIA can be used with other medicines commonly used to treat RA, such as cortisone or painkillers, including non-steroidal anti-inflammatory medicines such as ibuprofen or diclofenac.

Do not share medicines prescribed for you with any other person. Always use Orencia 125 mg exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is: You will receive ORENCIA as an injection under your skin (SC or subcutaneous). You will receive an injection once a week. Your doctor may start your treatment with a dose of ORENCIA lyophilisate for solution for intravenous infusion given to you in a vein in your arm over a period of 30 minutes. Your doctor will tell you how long your treatment with ORENCIA will last. In the beginning, your doctor or healthcare professional may inject your ORENCIA solution for subcutaneous injection. However, you and your healthcare professional may decide that you may inject ORENCIA yourself. In this case you will receive training on how to inject ORENCIA yourself. You will find detailed “Instructions for preparing and giving a subcutaneous injection of ORENCIA” at the end of this leaflet. ORENCIA solution for subcutaneous injection under the skin is not suitable for use in children younger than 18 years. Your doctor will tell you how long your treatment with ORENCIA will last. Do not stop treatment early. If you have the impression that the effect of ORENCIA is too strong or too weak, tell your doctor or pharmacist.

If you receive more ORENCIA 125 mg than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use ORENCIA 125 mg

If you miss your dose of ORENCIA, ask your doctor when to schedule your next dose.

ORENCIA can have side effects. Not all side effects reported for ORENCIA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving ORENCIA, please consult your health care provider for advice.

If any of the following happens, stop receiving ORENCIA and tell your doctor immediately, or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

Serious infections. Patients receiving ORENCIA are at increased risk for developing infections including pneumonia, and other infections caused by viruses, bacteria, or fungi, including tuberculosis. These are all very serious side effects. If you have them, you may have had a serious reaction to ORENCIA. You may need urgent medical attention or hospitalisation.

Cancer (malignancies). There have been cases of certain kinds of cancer in patients receiving ORENCIA. The role of ORENCIA in the development of cancer is not known. The more frequent side effects with ORENCIA are headache, upper respiratory tract infection, sore throat, and nausea.

Tell you doctor or healthcare professional as soon as possible if you notice any of the following:

• feeling generally unwell, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing

The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:

Frequent side effects:

• infections of the upper airway (including infections of the nose and throat)
• infections of lungs, urinary infections, painful skin blisters (herpes), rhinitis, painful sores on the lips and in the mouth
• headache, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhoea, nausea, upset stomach
• mouth ulcers
• rash
• fatigue, weakness
• injection site reactions
• abnormal liver function tests

Less frequent side effects:

• tooth infection, nail fungal infection, collection of pus under the skin
• vaginal or oral thrush
• infection in and around your womb
• infection in your bladder
• skin cancer
• low blood platelet count, low white blood cells count
• depression, anxiety
• numbness
• reduced vision, eye inflammation
• palpitation, rapid heart rate, low heart rate
• low blood pressure, hot flush, flushing
• gastrointestinal infections
• increased tendency to bruise, dry skin, hair loss
• painful joints, pain in extremities
• absence of menstruation
• flu-like illness, increased weight
• ear and kidney infection

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ORENCIA.

Store all medicines out of reach of children. Protect the prefilled syringes from light by storing in the original package until time of use. ORENCIA must be refrigerated at 2 °C to 8 °C. Do not freeze ORENCIA. Do not use after the expiry date stated on the container. Return unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets). Refer to the “Instructions for preparing and giving a subcutaneous injection of ORENCIA” at the end of this leaflet, for advice on how to dispose of prefilled syringes and needles.