Remsima

Indications

Infliximab is a biological medicine used to treat long-term inflammatory diseases when other treatments have not worked well enough. These include rheumatoid arthritis (usually together with Methotrexate), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and severe plaque psoriasis. It is used in adults, and for Crohn's disease and ulcerative colitis also in children from 6 years.

How It Works

Infliximab is a monoclonal antibody, a laboratory-made protein that attaches to a specific target. It binds to and blocks tumour necrosis factor alpha (TNF-alpha), a messenger protein of the immune system that drives inflammation in these diseases. Blocking it reduces inflammation, pain, swelling and tissue damage.

Dosage and Administration

Infliximab is given by a doctor or nurse as a drip into a vein, usually over about 2 hours, in a hospital or infusion clinic. The dose is calculated from body weight and is usually repeated at weeks 2 and 6 and then every 8 weeks, as prescribed by the specialist. Some products are also available as an injection under the skin for maintenance treatment, used as prescribed. Patients are observed during and after the infusion for reactions.

Interactions

Live vaccines (such as BCG, measles-mumps-rubella, oral polio, yellow fever or varicella) should not be given during treatment. Combining Infliximab with other biological medicines such as Anakinra, Abatacept or Tocilizumab increases the risk of serious infection and is avoided. Other immunosuppressants such as Methotrexate, Azathioprine or corticosteroids add to the risk of infection and are used only as the specialist directs.

Contraindications

Infliximab must not be used in people with:

• Active tuberculosis or other severe infections such as sepsis or abscesses
• Moderate or severe heart failure
• Allergy to Infliximab, to mouse proteins or to any ingredient

Side Effects

Common side effects include:

• Infusion reactions such as flushing, itching, headache, chills or fever
• Respiratory, sinus or urinary infections
• Abdominal pain, nausea or diarrhoea
• Tiredness, rash or raised liver enzymes

Rare but serious effects include tuberculosis or hepatitis B reactivation, serious infections, lupus-like illness, nerve problems and some cancers such as lymphoma. Get urgent medical help for fever, persistent cough, night sweats or weight loss, breathlessness or chest pain during or after an infusion, yellowing of the skin or eyes, numbness or weakness, or swelling of the face or throat.

Pregnancy and Lactation

Infliximab crosses the placenta, mainly in late pregnancy. It may be continued in pregnancy only if the specialist decides the benefit is greater than the risk. Babies exposed in the womb should not receive live vaccines for several months after birth, so tell the baby's doctor. Small amounts may pass into breast milk; discuss breastfeeding with your specialist.

Precautions and Warnings

Before starting, you will be tested for tuberculosis and hepatitis B. Tell your doctor about any infection, heart problems, nerve disease such as multiple sclerosis, cancer history or planned surgery. Avoid live vaccines and keep routine vaccines up to date before starting. Report any infection promptly during treatment.

Overdose

Single doses well above the usual amount have been given without obvious toxic effects. If an overdose occurs, the patient is monitored for side effects and treated as needed.

Therapeutic Class

TNF-alpha inhibitor (monoclonal antibody, immunosuppressant).

Storage

Stored by the hospital or pharmacy in a refrigerator at 2 to 8°C, as directed on the pack. Do not freeze. Keep out of the reach of children.