Rheumatology Information Service Europe
Frequently Asked Questions for Patients who use Kineret®
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What are cytokines?
While the cause of rheumatoid arthritis (RA) remains unknown, the destructive processes of this disease are becoming increasingly well understood. Researchers believe that the immune system of people with RA produce an excess of certain proteins called cytokines. Normally, cytokines can help fight infection and heal injury. A healthy body also produces substances called antagonists to counteract these cytokines. Antagonists keep cytokines in check, ensuring that they attack only damaged cells and not healthy ones. In RA, however, the body's balance between cytokines and their antagonists is disrupted. An excess of cytokines leads to joint tissue damage. The resulting inflammation causes joints to become swollen, hot, and painful. Cytokines can cause long-term damage that can progress even when the painful signs and symptoms of RA are under control. While several different cytokines appear to be involved in the RA disease process, research indicates that one particular cytokine, called interleukin-1 (IL-1), plays a pivotal role in the long-term signs and symptoms of RA.
For a cytokine to carry out its task, it must bind to a receptor site on the surface of a cell. This can be prevented by a cytokine antagonist, which occupies the cytokine's receptor site before the cytokine can bind (see figure).

What are cytokines?

Why has my doctor prescribed Kineret®?
Kineret® is used with methotrexate to treat the symptoms of rheumatoid arthritis in patients who do not respond to methotrexate alone.

What is Kineret® and how does it work?
People with RA produce too much of a protein called interleukin-1 (IL-1). High levels of IL-1 lead to pain and swelling. Normally, the body blocks high levels of IL-1 with a substance that it produces known as IL-1 receptor antagonist (IL-1Ra). People with RA do not have enough IL-1Ra to block the high levels of IL-1. Kineret® is the first treatment to be made available that acts in exactly the same way as IL-1Ra. By topping up levels of IL-1Ra that the body produces naturally, Kineret® helps block the harmful effects of too much IL-1.

How is Kineret® supplied?
Kineret® comes in packs of 28 filled syringes (one month's supply), made up of four separate packs of seven syringes (one week's supply). Each syringe is ready to use and contains one daily dose of 100 milligrams of Kineret®.

What dose of Kineret® should I take?
The recommended dose is 100 milligrams of Kineret® injected under the skin every day.

Can I inject myself?
Most people who use Kineret® inject themselves, or ask their partner or carer to give them the injection. Your doctor or nurse can explain how to inject Kineret®.

Where should I inject myself?
You should inject Kineret® into your thigh or stomach. If someone else is giving you the injection, they can also use the back of your arm. You should inject yourself in different places to prevent soreness. For example, use your left thigh one day, your right thigh the next day, the left side of your stomach the next day, the right side of your stomach the day after that and so on. You should not inject into tender, bruised, red or hard skin (see figure).

You should inject Kineret® into your thigh or stomach

What should I do before I give myself a subcutaneous injection of Kineret®?
Take your Kineret® pre-filled syringe out of the refrigerator.
Do not shake the pre-filled syringe.
Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
Check the appearance of Kineret®. It must be a clear, colourless-to-white solution. If there are particles in it, you must not use it.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Kineret® in any other way (for example, do not warm it in a microwave or in hot water).
Wash your hands thoroughly.
Find a comfortable, well-lit place and put everything you need where you can reach it (the Kineret® pre-filled syringe, alcohol wipes and the puncture-proof container).
How do I prepare my Kineret® injection?
Before you inject Kineret® you must do the following:
Gently take the cover from the needle without twisting. Do not touch the needle or push the plunger.
Hold the syringe with the needle pointing up to see if it has any air bubbles inside. If there are, gently press the plunger until all the air (but none of the liquid) has been removed.
You can now use the pre-filled syringe.
How do I give my Kineret® injection?
To administer your Kineret® injection, you should do the following:
Disinfect your skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Put the needle fully into the skin at an angle of about 45 degrees (see figure).
Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
Inject the liquid slowly and evenly, always keeping your skin pinched.
After injecting the liquid, remove the needle and let go of your skin.
Only use each syringe for one injection.
ow do I give my Kineret® injection?

How long will Kineret® take to work?
Most people notice an effect fairly quickly, often within the first few weeks and nearly always within the first 3 months.

Is it safe to take other medicines at the same time as Kineret®?
You should tell your doctor about any other medication you are taking, including medicines that you have bought from a pharmacy. The way that Kineret® reacts with other medicines has not been investigated in formal clinical studies. However, people taking part in clinical studies of Kineret® have taken other medicines as well as Kineret® (including non-steroidal anti-inflammatory drugs, hormones and anti-rheumatic drugs) without any negative reactions being observed.

What are the possible side effects of Kineret® therapy?
The safety of Kineret® has been studied in over 2,600 people with rheumatoid arthritis and most have not experienced any serious problems.

Reactions in the injection area
The most common side effect associated with Kineret® is a reaction in the area where it has been injected. This ranges from itching or redness to soreness, swelling or pain. This type of reaction is common with medicine that is injected under the skin. Injection-site reactions to Kineret® are generally mild or moderate, although sometimes they can be more severe. Reactions in the injection area usually happen within the first month of treatment. Injection-site reactions usually disappear in about 2 to 4 weeks with continued treatment.

The most common side effect associated with Kineret® is a reaction in the area where it has been injected

Reactions in the injection area in people taking Kineret® are uncommon after the first month of therapy. For a more comfortable injection, let the filled syringe stand for 30 minutes to reach room temperature, or hold the syringe in your hand for a few minutes. Do not warm Kineret® in any other way. Pressing an ice pack on the area where you will inject, before and after the injection, may also reduce any discomfort.
If you are using alcohol wipes to clean your skin, make sure that the alcohol is dry before you inject Kineret® as injecting it through skin that is still wet may cause stinging. If you are concerned about a reaction in the injection area please speak to your doctor or nurse.

Headaches
Headaches are the next most common side effect of taking Kineret®.

Infections
If you have a history of infections or another condition that may make you more likely to get infections, such as diabetes, you should speak to your doctor. If you develop an infection after you have started taking Kineret®, you should speak to your doctor.

Are there any other special precautions I should take when receiving Kineret® therapy?

Pregnancy
The use of Kineret® in pregnant women, and women who are breast-feeding, has not been studied so we do not recommend it. If you may become pregnant, you should use effective contraception during treatment.

Cancer
There is no information on the long-term use of Kineret® in people with cancer, so we do not recommend that people with cancer use Kineret®.

Do I need any special tests or checks while I am taking Kineret®?
We recommend that your white blood cell (neutrophil) count is assessed before you start taking Kineret®. You should be assessed every month during the first 6 months of your treatment, and then every 3 months after that.

Can I have vaccine injections while I am taking Kineret®?
There is no information available on how vaccinations affect people taking Kineret®. Your vaccinations should be up to date before you start taking Kineret®.

How should I store Kineret®?
Do not use Kineret® after the date shown on the box of syringes. You should store the box of syringes in a refrigerator at between 2°C and 8°C. Always store the syringes in the box to protect them from light. Do not freeze.
Once a syringe has been removed from the refrigerator and has reached room temperature (not more than 25°C), you must use it within 12 hours or get rid of it safely.

Where can I get more information about Kineret®?
If you need any more information, or you have any concerns about Kineret®, please speak to your doctor, nurse or pharmacist.


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Facts about ISRs.ppt
Facts about ISRs.ppt
Learn about injection-site reactions and how can they be managed.
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Kineret® Summary of Product Characteristics
Kineret® Summary of Product Characteristics
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