• Discard in an approved sharps disposal container immediately after use.
• If you do not have one, you may use a household container that is:
  - Made of heavy-duty plastic with a tight-fitting, puncture-resistant lid;
  - Upright and stable during use;
  - Leak-resistant; and
  - Properly labelled to warn of hazardous waste inside the container.
  
• Refer to Instructions for self injection brochure for further details about possible containers.
• Do not throw away any medicines via wastewater or household waste.
• Ask your pharmacist how to throw away medicines you no longer use.

Note: Keep the syringe or pen and sharps disposal container out of the sight and reach of children.

Tell your doctor, nurse, or pharmacist as soon as possible if you do not feel well while you are being given Remsima^®

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of possible side effects. You may not experience any of them. Most of the side effects are mild to moderate in severity. Other side effects not listed below may also occur in some patients. Some side effects may appear up to six months after the last injection.

During the injection of Remsima^® the following reactions may occur:

• fever or chills
• itchiness or hives
• chest pain
• low blood pressure
• high blood pressure
• shortness of breath

Tell your doctor immediately if you notice any of the following:

• pain or tenderness in chest, muscles, joints or jaw
• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• fever
• muscle pains
• joint pains
• tiredness
• abnormal chest sounds
• rash
• itching
• symptoms that may indicate heart failure, e.g. shortness of breath, especially with exercise or lying down, or swelling of your feet
• injection site reactions such as: redness, pain, itching, swelling, hardening of the skin, bruising, coldness, pins and needles, irritation, rash, ulcer, bleeding under the skin or scarring.

Tell your doctor or nurse as soon as possible if you notice any of the following:

• nausea or vomiting
• headache
• dizziness and lightheadedness
• fatigue
• fever
• rash
• hives
• itching
• sore throat
• coughing
• hoarseness
• shortness of breath
• chest pain
• back pain
• muscle pain
• abdominal pain
• indigestion
• diarrhoea
• weight loss, muscle wasting
• problems with urination
• changes in the way your heart beats, for example, if you notice it beating faster
• flushing
• dry skin or increased sweating
• fluid retention
• new onset of psoriasis, mainly on the soles of the feet and on palms
• worsening of rheumatoid arthritis.

There have been very rare cases where people taking infliximab have developed liver problems. Signs that you could be having a problem include:

• jaundice (skin and eyes turning yellow)
• dark-brown coloured urine
• right-sided abdominal pain
• fever
• severe fatigue (tiredness).

You should contact your doctor immediately if you develop any of these symptoms.

Infections

Remsima^® may affect the normal immune response. There is a possibility that you may be more prone to infections. You will be watched closely for signs of infection.

Cancers

In clinical studies, more cancers were seen in patients who received TNF-blockers, including Remsima^®, than patients who did not receive these treatments. In children and adults being treated with TNF-blockers, the chances of getting lymphoma or other cancers may increase. It should be noted, however, that patients with longstanding and active rheumatoid arthritis or Crohn's disease may already have a higher risk for developing cancers even without TNF-blockers, making it difficult to estimate the risk of developing cancers in these patients. Nevertheless, the role of TNF-blockers in the development of cancers cannot be excluded.

A rare type of cancer called Hepatosplenic T-Cell Lymphoma (HSTCL) has been reported rarely in adolescents and young adults with Crohn's disease or ulcerative colitis who have received Remsima^®. All of these patients were also receiving drugs known as azathioprine or 6- mercaptopurine. No cases of HSTCL have been reported in patients receiving Remsima^® only. HSTCL often results in death. The role of TNF-blockers in the development of cancers in children and adolescents remain unclear. Talk to your doctor if you are concerned about this.

Skin cancers (melanoma, Merkel cell carcinoma, basal cell carcinoma and squamous cell carcinoma) have been reported rarely in patients treated with TNF-blockers, including Remsima^®. Tell your doctor if you notice any new skin lesions during or after therapy or if existing lesions change appearance.

Patients with a lung disease called Chronic Obstructive Pulmonary Disease and who have a history of heavy smoking may have an increased risk for getting cancer while being treated with Remsima^®.

Do not use Remsima^® if you

• have an allergy to mouse proteins or any of the ingredients listed in the Consumer Medicine Information leaflet.
• have severe infections such as tuberculosis and infected abscesses, a repeating infection or have had repeating infections.
• are already taking another medicine for arthritis, which contains the substance called anakinra.
• have congestive heart failure, and are not already using Remsima^®.



Before you are given Remsima^®, tell your doctor if you:

• currently have an infection, or if you are prone to infections, or if you have a history of infections. Remsima^® may affect the normal immune response. You might get infections more easily. Some cases of serious infections, including tuberculosis (TB) and sepsis have been reported in patients treated with Remsima^®.
• have ever had or been in close contact with tuberculosis (TB), even if you were treated for it.
• have ever had or had been in close contact with hepatitis B. Reactivation of hepatitis B have been reported in people treated with TNF-α blockers. However, these reports are very rare.
• have lived in or travelled to an area where fungal infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. Ask your doctor if you don't know if these infections are common in the area in which you have lived in or travelled to. These infections are caused by fungus that can affect the lungs or other parts of your body.
• have had cancer. A type of blood cancer called lymphoma has been reported in patients receiving TNF-blockers. The reports are rare but are more frequent than expected for people in general. Cancers, other than lymphoma, have also been reported.
• have a long history of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis, especially if you have a highly active disease and/or have been taking medicine that reduces the activity of the body's natural defences. You may be more likely to develop infections and lymphomas than people in general, even without receiving TNF-blockers such as Remsima^®.
• are pregnant or plan to become pregnant. Like most medicines, Remsima^® is not recommended in pregnancy. You must use adequate contraception to avoid falling pregnant.
• are breast-feeding. Like most medicines, Remsima^® is not recommended while breast-feeding. It is not known whether Remsima^® passes into breastmilk.
• have or have had a disease that affects the nervous system such as multiple sclerosis and seizures, or if you experience any numbness, weakness, tingling, or sight disturbances.
• suffer from congestive heart failure. Steps must be taken to monitor any changes to your condition during treatment with Remsima^®.
• have ongoing blood disorders or a history of blood disorders
• are scheduled to receive any vaccines. Patients receiving Remsima^® should not receive some types of vaccines.



Tell your doctor if you are taking any other medicines, including those you buy without a prescription from your pharmacy, supermarket or health food shop.

• Contact your doctor, nurse or the emergency department immediately if you inject more than the prescribed amount of Remsima^®.

If you remember within 7 days from the original scheduled dose,

• Take the missed dose immediately.
• Take your next dose on the originally scheduled date and thereafter fortnightly.
• Do not take a double dose on the same day to make up for a missed dose.

If you remember after 8 days or more after the original scheduled dose,

• Do not take the missed dose.
• Take your next dose on the next originally planned date and thereafter fortnightly.
• Do not take a double dose on the same day to make up for a missed dose.

• You can store your medicine in the original package outside of the refrigerator at up to a maximum of 25°C for up to 28 days.
• Write the new expiry date on the carton including day/month/year. The new expiry date is 28 days after the day you take it out of the refrigerator (as long as that is before the original expiry date).
• Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
• Upon removal from refrigerated storage, Remsima^® must not be returned to refrigerated storage.

Please contact your doctor or other healthcare professional for more information about your condition or treatment.

Celltrion Healthcare is providing a patient support program for people prescribed Remsima^®.
Through this program, you can get further support from a healthcare professional on the use of subcutaneous Remsima^®.

You can contact the program co-ordinator on 1800 782 288 on weekdays, excluding public holidays, between 9.00am - 5.00pm AEST.

Note. The Patient Support Program is not authorised or approved by the Australian regulator of medicines, the TGA.