Etanercept

What is etanercept and how is it used?

In rheumatoid arthritis and some other conditions, too much of a protein called TNF is produced causing inflammation, pain and damage to the bones and joints. Anti-TNF drugs such as etanercept block the action of TNF and so reduce this inflammation.

Etanercept isn’t a painkiller, but can modify the disease and should start to improve your symptoms over a period of 2–12 weeks.

Etanercept can be prescribed for:

• rheumatoid arthritis
• psoriatic arthritis
• ankylosing spondylitis
• juvenile idiopathic arthritis (JIA).

National and local guidelines determine when it can be prescribed, according to which condition you have. It’s usually given along with other diseasemodifying drugs – for example, methotrexate or sulfasalazine.

Etanercept won’t be started if:

• your arthritis isn’t active
• you have an infection
• you haven’t tried other treatments appropriate for your condition first.

Your doctor may decide not to prescribe etanercept if you’ve ever had:

• repeated or serious infections
• multiple sclerosis (MS)
• cancer
• a serious heart condition
• lung fibrosis (scarring of the lung tissue).

Before starting etanercept you’ll have a chest x-ray and tests to check if you’ve ever been exposed to tuberculosis (TB). You may need treatment for latent (asymptomatic) TB before starting etanercept. You’ll also be checked for previous hepatitis infection, as etanercept may increase the risk of hepatitis being reactivated.

You may have further blood tests while you’re on etanercept to monitor its effects.

When and how do I take etanercept?

Etanercept can be taken either once or twice a week, depending on which brand you are using and your dosage.
It is administered as an injection under the skin (subcutaneous injection) using a pre-filled pen-like syringe – these should be stored in the fridge. You, your partner, or another member of your family can learn to give these injections at home.

Because it’s a long-term treatment, it’s important to keep taking etanercept (unless you have severe side-effects):

• even if it doesn’t seem to be working at first
• even when your symptoms start to improve (to help keep the disease under control).

Etanercept was originally available only under the brand name Enbrel. More recently, a new version of etanercept with the brand name Benepali has become available. This new drug is referred to as a ‘bio-similar’ because it’s meant to act in the same way as the original drug. Because this drug is newer, we don’t yet know as much about it in terms of safety and effectiveness in all the situations described in this leaflet. Benepali is only licensed for adults aged 18 and over, whereas Enbrel can be prescribed to children from the age of 2 years old as well as to adults. Some known risks associated with Enbrel are thought to apply to Benepali, for example, people taking Benepali are warned that they are more at risk of infectious diseases such as tuberculosis. If you are currently being treated with Enbrel and it is proposed that you change to Benepali, we strongly advise you discuss this with your rheumatology team before any change is made.

Possible risks and side-effects

The most common side-effects are:

• a blocked or runny nose
• nausea (feeling sick)
• a mild fever
• headaches
• dizziness
• a rash
• stomach pain or indigestion.

Some people may have reactions at the injection site such as redness, swelling or pain. Regularly changing the injection site will help reduce the chances of this irritation.

Because etanercept affects the immune system, it can make you more likely to pick up infections. It can also make them harder to spot. Tell your doctor or rheumatology nurse straight away if you develop any signs of infection such as a sore throat or fever, or have unexplained bruising, bleeding or paleness, or any other new symptoms that concern you. If any of these symptoms are severe, you should stop taking etanercept and see your doctor straight away.

You should also see your doctor if you develop chickenpox or shingles or come into contact with someone who has chickenpox or shingles. These illnesses can be more severe if you’re on etanercept. You may need antiviral treatment, and your etanercept may be stopped until you’re better.

Rarely, people may have an allergic reaction. Contact your healthcare team if you think this may be happening. If the reaction is severe the drug will have to be stopped.

Anti-TNF drugs have been associated with some types of skin cancer – these can be readily treated when diagnosed early. Research so far hasn’t confirmed an increased risk of other cancers.

Very rarely, etanercept may cause a condition called drug-induced lupus, which can be diagnosed by a blood test. Symptoms include a rash, fever and increased joint pain. If you develop these symptoms you should contact your rheumatology team. This condition is generally mild and usually clears up if etanercept is stopped.

Reducing the risk of infection

• Try to avoid close contact with people with severe active infections.
• For advice on avoiding infection from food, visit: http://www.nhs.uk/Conditions/Food-poisoning/Pages/Prevention.aspx

Taking other medicines

Etanercept may be prescribed along with other drugs, including methotrexate. Check with your doctor before starting any new medications, and remember to mention you’re on etanercept if you’re treated by anyone other than your usual rheumatology team.

• You can carry on taking nonsteroidal anti-inflammatory drugs (NSAIDs) or painkillers if needed, unless your doctor advises otherwise.
• Don’t take over-the-counter or herbal remedies without discussing this first with your healthcare team.

It’s recommended that you carry a biological therapy alert card so anyone treating you will know that you’re on etanercept – you can get a card from your rheumatology department.

Vaccinations

It’s best to discuss vaccinations with your healthcare team before starting etanercept.

It’s usually recommended that people on etanercept avoid live vaccines such as yellow fever. However, sometimes a live vaccine may be necessary – for example, rubella immunisation in women of childbearing age.

If you’re offered shingles vaccination (Zostavax) it’s best if you can have this before starting etanercept. Shingles vaccination isn’t recommended for people who are already on etanercept.

Pneumococcal vaccine (which protects against the most common cause of pneumonia) and yearly flu vaccines are safe and recommended.

If possible, children should have the standard immunisations before starting etanercept. Measles, mumps and rubella (MMR) immunisation may need to be delayed in children being treated with etanercept.

Having an operation

Talk this over with your specialists. It’s likely you’ll be advised to stop etanercept for a time before and after surgery.

Alcohol

There’s no known interaction between etanercept and alcohol.

However, if you’re also taking methotrexate, you should keep well within the recommended limits of no more than 14 units of alcohol per week for adults because methotrexate and alcohol can interact and affect your liver. In some circumstances your doctor may advise lower limits.

Fertility, pregnancy and breastfeeding

If you’re planning to try for a baby, if you become pregnant, or if you’re thinking of breastfeeding we suggest you discuss your medications with your rheumatologist.

Current guidelines state that etanercept can be used during pregnancy and in men trying to father a child. If it’s used during pregnancy it will usually be stopped after about six months. If it’s used after this, then it’s possible (though not proven) that it may increase the risk of infection in the newborn baby.

However, if there’s concern that your arthritis may flare up if etanercept is stopped then you can continue with it throughout your pregnancy – in this case, your baby should not have any live vaccines (such as BCG) until they’re seven months old.

Women who are also on methotrexate should stop taking it and use contraception for at least three months before trying for a baby.

The guidelines state that there’s no need for men to stop methotrexate when trying to father a baby.

There’s only limited information about the use of etanercept while breastfeeding, but we have no evidence that it’s harmful. If you were also taking methotrexate before your pregnancy this should not be restarted until you stop breastfeeding.