This leaflet answers some common questions about RENFLEXIS.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using RENFLEXIS against the benefits this medicine is expected to have for you.

RENFLEXIS contains the active ingredient, infliximab.

RENFLEXIS is a biosimilar medicine. Comparability in safety, efficacy and quality between RENFLEXIS and the reference product has been established.

Infliximab is a monoclonal antibody that is produced from human and mouse proteins by recombinant technology. Monoclonal antibodies are proteins that recognise and bind to certain special proteins in the body.

Infliximab acts by binding to a special protein in the body called tumour necrosis factor alpha (TNFα). In people with diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the body produces too much TNFα, which can cause the body's immune system to attack normal healthy parts of the body. RENFLEXIS can block the damage caused by too much TNFα.

 

Rheumatoid arthritis is an inflammatory disease of the joints. RENFLEXIS is used to reduce the signs and symptoms of rheumatoid arthritis and to prevent damage to the joints. You will also be given a disease-modifying medicine called methotrexate.

 

Ankylosing spondylitis is an inflammatory disease of the spine. RENFLEXIS can reduce the signs and symptoms of ankylosing spondylitis, thereby improving physical function.

 

Psoriatic arthritis is an inflammatory disease of the joints in which psoriasis usually occurs in association with arthritis. Often the fingers and toes are affected, although it may occur in other parts of the body. RENFLEXIS is used to reduce the signs and symptoms of psoriatic arthritis and improve the physical function in adults who have not responded well enough to previous treatments with other disease-modifying anti-rheumatic drugs (DMARDS). RENFLEXIS may be given alone or in combination with methotrexate.

 

Psoriasis is an inflammatory disease of the skin. RENFLEXIS is used to treat patients with moderate to severe psoriasis who have not responded well enough to treatments such as phototherapy or conventional systemic treatments, or when these treatments are not appropriate.

 

Crohn's disease is a chronic inflammatory disease of the bowel. It may also affect any part of the gut. RENFLEXIS is used to treat moderate to severe Crohn's disease in adult patients and in children and adolescent patients (6 to 17 years old) who have not responded well enough to other treatments.

RENFLEXIS can also reduce the number of abnormal openings from the bowel through the skin (called draining enterocutaneous fistula), a common complication of Crohn's disease.

 

Ulcerative colitis is an inflammatory disease of the bowel. RENFLEXIS is used to treat the signs and symptoms of ulcerative colitis in adult patients and in children and adolescent patients (6 to 17 years old) who have not responded well enough to other treatments.

Your doctor, however, may prescribe RENFLEXIS for another purpose.

Some of the symptoms of an allergic reaction to RENFLEXIS may include skin rash, hives, fatigue, wheezing, difficulty in breathing, and/or low blood pressure.

If you have never been given RENFLEXIS and have congestive heart failure, you should not use it.

Some medicines may affect the way other medicines work.

Tell your doctor if you are already taking another medicine for arthritis, which contains the substance called abatacept.

Tell your doctor if you are receiving other treatments

Tell your doctor you are taking RENFLEXIS before receiving any vaccinations. Some vaccinations should not be given while you are being treated with RENFLEXIS.

Your doctor or pharmacist will be able to tell you what to do when being given RENFLEXIS with other medicines.

RENFLEXIS is only available on prescription. RENFLEXIS is given in a drip into a vein (called an infusion) over at least 2 hours.

If you were able to tolerate the first 3 two-hour infusions, your doctor may decide to give your next RENFLEXIS infusions over a period of not less than 1 hour.

For children and adolescents (6-17 years) the infusion is given over at least 2 hours.

You will be observed for at least 1 to 2 hours after your infusion is finished.

 

The recommended starting dose is an infusion of 3 mg/kg. You will get additional doses of 3 mg/kg at 2 and 6 weeks after your first infusion and then every 8 weeks after that.

If, after 12 weeks of treatment, your arthritis does not respond well enough to the 3 mg/kg dose, your doctor may decide to gradually increase your dose to a maximum of 7.5 mg/kg every 8 weeks.

You will also be taking methotrexate as part of your treatment.

 

The recommended starting dose is an infusion of 5 mg/kg. You will get additional doses of 5 mg/kg at 2 and 6 weeks after your first infusion and then every 6 weeks after that.

 

The recommended starting dose is an infusion of 5 mg/kg. You will receive additional doses of 5 mg/kg at 2 and 6 weeks after your first infusion, then every 8 weeks after that. RENFLEXIS may be given alone or in combination with methotrexate.

 

The recommended starting dose is an infusion of 5 mg/kg. You will get additional doses of 5 mg/kg at 2 and 6 weeks after your first infusion, and then every 8 weeks after that.

 

The recommended starting dose for Crohn's disease in adults and in children and adolescents (6 to 17 years); and for closure of fistula in adult patients is an initial infusion of 5 mg/kg followed by additional doses of 5 mg/kg at 2 and 6 weeks after your first infusion, and then every 8 weeks after that. In some cases, your doctor may decide to increase your dose up to 10 mg/kg.

 

The recommended starting dose for ulcerative colitis in adults and in children and adolescents (6 to 17 years) is an infusion of 5 mg/kg. You will get additional doses of 5 mg/kg at 2 and 6 weeks after your first infusion, and then every 8 weeks after that.

As RENFLEXIS is being given to you under the supervision of your doctor it is very unlikely you will receive too much.

If you think you or anybody else has been given too much RENFLEXIS, contact your doctor, pharmacist or the Poisons Information Centre who will advise you what to do, or go to Accident and Emergency at your nearest hospital.

Some vaccinations should not be given while you are being treated with RENFLEXIS.

Your doctor will also advise you not to breastfeed.

RENFLEXIS 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.

Your doctor may discontinue RENFLEXIS until the symptoms go away and then begin giving the medicine again. Symptoms will resolve with appropriate treatment.

RENFLEXIS is unlikely to make you drowsy. If you are tired, do not drive a car or work with machinery.

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.

Generally, patients with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or psoriasis already take several medicines to treat their disease. These medicines may themselves cause side effects.

Do not be alarmed by the following list of possible side effects. You may not experience any of them.

During the infusion of RENFLEXIS the following reactions may occur:

These reactions are more likely to occur during the first and second infusion but may also appear up to six months after the last infusion.

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

Most of the side effects are mild to moderate in severity. Other side effects not listed above may also occur in some patients. Some side effects may appear up to six months after the last infusion.

 

In clinical studies, more cancers were seen in patients who received TNF-blockers, including infliximab, 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 infliximab. All of these patients were also receiving drugs known as azathioprine or 6-mercaptopurine. No cases of HSTCL have been reported in patients receiving infliximab only. HSTCL often results in death. The role of TNF blockers in the development of cancers in children and adolescents remains unclear.

Skin cancers (melanoma and Merkel cell carcinoma) have been reported rarely in patients treated with TNF-blockers, including infliximab.

Cervical cancer may occur more frequently in women treated with RENFLEXIS. Periodic screening of women treated with RENFLEXIS should continue.

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 RENFLEXIS.

These symptoms may appear several months after your last RENFLEXIS treatment.

Your doctor will advise you not to breastfeed for at least 6 months after your last infusion of RENFLEXIS.

RENFLEXIS should be stored at 2°C to 8°C (Refrigerate.) Do not freeze. Do not use beyond the expiry date.

RENFLEXIS vials are for single use only. Any unused portion should be discarded.

RENFLEXIS comes as a white powder in a glass vial.

Infliximab 100 mg per vial