Kineret 100 mg solution for injection in a pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Kineret is and what it is used for
2. What you need to know before you use Kineret
3. How to use Kineret
4. Possible side effects
5. How to store Kineret
6. Contents of the pack and other information

• if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6;
• if you are allergic to other products that are produced by DNA technology using the micro-organism E. coli;
• if you have neutropenia (low white blood cell count) determined after a blood test.

• if you get a rash all over your body, shortness of breath, wheezing, fast pulse or sweating after your Kineret injection. These may be signs that you are allergic to Kineret.
• if you have ever developed an atypical, widespread rash or skin peeling after taking Kineret.

Talk to your doctor before using Kineret:

• if you have a history of recurring infections, or if you suffer from asthma. Kineret may worsen these conditions;
• if you have cancer. Your doctor will have to decide if you can still be given Kineret;
• if you have a history of increased levels of liver enzymes;
• if you require vaccinations. You must not be given live vaccines while being treated with Kineret.

Still’s disease

• In rare cases patients with Still’s disease, mainly children, may develop lung disease, also during Kineret treatment. The risk may be increased in patients with Down’s syndrome (trisomy 21). Symptoms of lung disease can be e.g. shortness of breath during light exercise, morning cough, and difficulties breathing. If you develop signs of lung disease you should contact your health care provider as soon as possible.
• The serious skin reaction, DRESS (drug reaction with eosinophilia and systemic symptoms), has rarely been reported in association with Kineret treatment, predominantly in patients with systemic juvenile idiopathic arthritis (SJIA). Seek medical attention immediately if you notice an atypical, widespread rash, which may occur in conjunction with high body temperature and enlarged lymph nodes.

CAPS

• Few cases of systemic amyloidosis (a condition where abnormal proteins build up in tissues and organs) have been reported in patients with NOMID/CINCA, who first developed lumps under the skin at the injection sites (amyloid deposits). These patients had been using anakinra in high doses for several years. Symptoms of systemic amyloidosis can include swelling (particularly in the legs and ankles), foamy urine, increased or decreased urination, muscle cramps, unexplained weight loss, diarrhoea or constipation, and fatigue. Tell your doctor if you notice any of these symptoms.

• RA: Use of Kineret in children and adolescents with Rheumatoid Arthritis has not been fully investigated and therefore cannot be recommended.
• CAPS, FMF, Still’s disease: Kineret is not recommended for children younger than 8 months of age because there is no data in this age group.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.

When you start taking Kineret the chronic inflammation in your body will decrease. This could mean that the doses of some other medicines, e.g. warfarin or phenytoin, have to be adjusted.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Kineret has not been tested in pregnant women. Use of Kineret is not recommended during pregnancy and in women of childbearing potential not using contraception. It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby. Your doctor will discuss with you the potential risks of taking Kineret during pregnancy.

It is not known whether anakinra is excreted in human milk. You must not breast-feed if you use Kineret.

This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free’.

Your doctor may decide that it would be more convenient for you to inject Kineret yourself. Your doctor or nurse will show you how to inject yourself. Do not try to inject yourself if you have not been trained.

For instructions on how to inject yourself or your child with Kineret, please read the “Instructions for preparing and giving an injection of Kineret” section at the end of this leaflet.

You should have no serious problems if you accidentally take more Kineret than you need. However, you should contact your doctor, nurse or pharmacist if this does happen. If you feel unwell in any way you should contact your doctor or nurse immediately.

If you have forgotten to take a dose of Kineret, you should contact your doctor to discuss when you should take the next dose.

• The active substance is anakinra. Each graduated pre-filled syringe contains 100 mg of anakinra.
• The other ingredients are anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80 and sodium hydroxide and water for injections.

Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe. It may contain some translucent-to-white particles of protein. The presence of these particles does not affect the quality of the product.

Pack sizes of 1, 7 or 28 (multipack containing 4 packs of 7 pre-filled syringes) pre-filled syringes.

Not all pack sizes may be marketed.

You will need to give yourself or your child an injection at the same time every day. Kineret is injected just under the skin. This is called a subcutaneous injection.

To give yourself or your child a subcutaneous injection you will need:

• a pre-filled syringe of Kineret
• alcohol wipes or similar; and
• a sterile gauze or tissue

1. Take your Kineret pre-filled syringe out of the refrigerator.
2. Do not shake the pre-filled syringe.
3. 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.
4. Check the appearance of Kineret. It must be a clear, colourless-to-white solution. There may be some translucent-to-white particles of protein in the solution. The presence of these particles does not affect the quality of the product. The solution should not be used if it is discoloured or cloudy, or if any particles other than translucent-to-white particles are present.
5. For a more comfortable injection, leave at room temperature for approximately 30 minutes 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).
6. Do not remove the cover from the syringe until you are ready to inject.
7. Wash your hands thoroughly.
8. Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
9. Make sure you know what Kineret dose your doctor has prescribed; 20 to 90 mg, 100 mg or higher.

• If your doctor has prescribed a 100 mg dose you should continue to the “How to prepare a 100 mg dose” section.
• If your doctor has prescribed a lower dose you should continue to the “How to prepare a 20 to 90 mg dose” section.

Before you inject Kineret you must do the following:

1. Hold the syringe barrel and gently remove the cover from the needle without twisting. Pull straight as shown in Figure A. Do not touch the needle or push the plunger. Immediately discard the needle cover.
2. You may notice a small air bubble in the pre-filled syringe. You do not have to remove the air bubble before injecting. Injecting the solution with the air bubble is harmless.
3. You can now use the pre-filled syringe as described in the “Where should you give your injection?” section and “How do you give your injection?” section.

Before you inject Kineret you must do the following:

1. Hold the syringe barrel and gently remove the cover from the needle without twisting. Pull straight as shown in Figure A. Do not touch the needle or push the plunger. Immediately discard the needle cover.
2. You should position the syringe in one hand with the needle pointing straight upwards as shown in Figure B. Put your thumb on the plunger rod and push slowly until you see a tiny liquid drop at the tip of the needle.
3. Turn the syringe so that the needle is now pointing downwards. Place a sterile gauze or tissue on a flat surface and hold the syringe above it with the needle pointing towards the gauze or tissue, as shown in Figure C. Make sure the needle does not touch the gauze or tissue.
4. Put your thumb on the plunger rod and push slowly until the plunger front has reached the scale mark of your Kineret dose. (Your doctor will have told you what dose you need to use.) The ejected liquid will be absorbed by the gauze or tissue as shown in Figure C.
5. If you are not able to set the correct dose, dispose of the syringe and use a new one.
6. You can now use the pre-filled syringe as described in the “Where should you give your injection?” section and the “How do you give your injection?” section.

The most suitable places to inject yourself or your child are (See Figure D):

• the abdomen (except for the area around the navel)
• the top of the thighs
• the upper outer areas of the buttocks; and
• the outer area of the upper arms.

Change the place that you inject each time so you don’t become sore in one area. If someone else is injecting for you, they can also use the back of your arms.

1. Disinfect the skin by using the alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
2. Put the needle fully into the skin as shown by your nurse or doctor.
3. Inject the liquid slowly and evenly, always keeping the skin pinched as in Figure E.

4. After injecting the liquid, remove the needle and let go of the skin.
5. Any unused medicine must be discarded. Only use each syringe for one injection. Do not reuse a syringe as this can cause infection.

If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.

• Do not put the cover back on used needles.
• Keep used syringes out of reach and sight of children.
• Never put the pre-filled syringes that you have used into your normal household rubbish bin.
• If you had a dose lower than 100 mg you will have been told to eject liquid from the syringe onto a gauze or tissue. After your injection discard the wet gauze or tissue with your syringe and clean the surface with a fresh tissue.
• The used pre-filled syringe and any gauze or tissue with Kineret solution should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.