Rilonacept Regeneron (previously Arcalyst)
rilonacept
rilonacept
Keep this leaflet. You may need to read it again.
If you have 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.
What Rilonacept Regeneron is and what it is used for
What you need to know before you use Rilonacept Regeneron
How to use Rilonacept Regeneron
Possible side effects
How to store Rilonacept Regeneron
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Contents of the pack and other information
Rilonacept Regeneron is used to treat adults and adolescents aged 12 years and older with severe symptoms of Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
Rilonacept Regeneron belongs to a group of medicines called interleukin inhibitors. Rilonacept Regeneron blocks the activity of substances including interleukin-1 beta (IL-1 beta). In patients with CAPS, the body produces excessive amounts of IL-1 beta. This may lead to symptoms such as fever, headache, fatigue, skin rash, or painful joints and muscles. By blocking the activity of IL-1 beta, Rilonacept Regeneron leads to an improvement in these symptoms.
If you have any questions about how Rilonacept Regeneron works or why this medicine has been prescribed for you, ask your doctor.
if you are allergic to rilonacept or any of the other ingredients of this medicine (listed in section 6).
if you have an active, severe infection.
Talk to your doctor before using Rilonacept Regeneron.
You should tell your doctor if you have:
an infection;
tuberculosis or you have been in close contact with someone who has had tuberculosis;
a history of infections that keep coming back;
been scheduled to receive any vaccines.
Rilonacept Regeneron is not recommended for children younger than 12 years of age.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
In particular, you should tell your doctor if you are using any of the below medicines:
Other medicines that block interleukin-1, such as anakinra or canakinumab.
Medicines called Tumour Necrosis Factor (TNF) inhibitors (such as etanercept, adalimumab, or infliximab) predominantly used in rheumatoid and autoimmune disease.
Any other medicines for chronic disorders, as Rilonacept Regeneron can affect how the liver processes some medicines, such as warfarin (a blood thinner). Your doctor may need to perform some tests and adjust the dose of such medicines.
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Rilonacept Regeneron has not been tested in pregnant women and should not be used during pregnancy unless clearly necessary. You should not become pregnant and must use birth control while using Rilonacept Regeneron and for at least six weeks after your last dose. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The safety of Rilonacept Regeneron in breast-feeding women is unknown. If you are breast-feeding you should ask your doctor for advice before using Rilonacept Regeneron.
Some symptoms associated with CAPS or with Rilonacept Regeneron treatment, such as a spinning sensation (known as vertigo), may affect your ability to drive or use machines. If you feel a spinning sensation, do not drive or operate any tools or machines until you are feeling normal again.
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Rilonacept Regeneron is intended for subcutaneous use. This means that it is injected through a short needle into the fatty tissue just under the skin.
The starting dose is 2 injections of 2 millilitres (ml) solution each, given on the same day at 2 different areas of the body.
After that, the recommended dose is 1 injection of 2 ml injected once weekly.
The dose will depend on the body weight of the patient and will be different for each patient. Your doctor will tell you how much medicine to inject.
The starting dose is 4.4 milligrams per kilogram of body weight, up to 320 milligrams (mg), given as one or two injections.
After that, the recommended dose is 2.2 milligrams per kilogram, up to 160 mg, once weekly on the same day of the week.
In both cases your doctor will calculate the corresponding volume to inject. The dose of Rilonacept Regeneron may need to be adjusted as the child grows. Talk with your doctor before making any dose adjustments.
Rilonacept Regeneron is injected under the skin (subcutaneously). The first injection of Rilonacept Regeneron should be given under the supervision of a trained healthcare professional. You or your caregiver will receive adequate training on how to mix the powder (dissolve to make a solution), prepare the dose, and administer the injection.
Please read the section “INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR
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SOLUTION FOR INJECTION” at the end of this leaflet. If you have questions, contact your doctor, nurse, or pharmacist.
If you accidentally inject more Rilonacept Regeneron than the recommended dose, you should contact your doctor right away.
If you miss a dose of Rilonacept Regeneron and remember within a few days, inject it as soon as you remember. The next dose should be injected at the next regularly scheduled time. Do not inject a double dose to make up for the forgotten dose. Do not inject Rilonacept Regeneron more frequently than once weekly.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must tell your doctor right away if any of the following serious side effects occur while you are using Rilonacept Regeneron:
- fever lasting longer than 3 days, or any other symptoms possibly related to an infection, such as
prolonged cough, prolonged headache or localised redness, warmth or swelling of your skin. You must stop treatment with Rilonacept Regeneron if you develop a severe infection.
Very common side effects (affects 1 or more users in 10)
Reactions at injection site (such as redness, swelling, itching, and bruising at the injection site)
Upper respiratory infection
Sinus infection
Headache
Common side effects (affects 1 to up to 10 users in 100)
Viral infection
Bronchitis
Skin, eye, or ear infection
Tiredness (fatigue)
Increased blood pressure
Pneumonia
Stomach/Intestinal infection
Dizziness
Flushing
Allergic reaction
Anxiety
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Being unable to sleep (insomnia)
Uncommon side effects (affects 1 to up to 10 users in 1,000)
Meningitis
Inflammation of the eye (iritis)
Changes in your blood cholesterol levels or in your blood counts may also occur. These will be monitored by your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator. Do not freeze.
Keep the vials in the outer carton in order to protect from light.
After preparing the Rilonacept Regeneron solution, it is best if used right away because it does not contain a preservative. If necessary, the product may be kept at room temperature, but should be used within 3 hours of mixing.
The solution is viscous, clear and colourless to pale yellow. Prior to injection, the solution should be carefully inspected for any discolouration or particulate matter. If there is discolouration or particulate matter in the solution, the product must not be used.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is rilonacept. Each vial of powder contains 220 mg rilonacept. After reconstitution, each ml of solution contains 80 mg rilonacept.
The other ingredients in the powder are glycine, arginine hydrochloride, histidine, histidine hydrochloride monohydrate, polyethylene glycol 3350 and sucrose. The solvent is water for injections.
Rilonacept Regeneron is provided as a powder for solution for injection in a glass vial. The powder is white to off-white.
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Solvent is provided in a 5 ml transparent plastic vial containing 5 ml water for injections. The solvent is a colourless liquid.
Each pack contains:
4 vials of powder for solution for injection 4 vials of solvent
8 disposable 3-ml syringes
8 disposable 27-gauge, ½-inch needles
Regeneron UK Limited 40 Bank Street
E14 5DS London
United Kingdom
Brecon Pharmaceuticals Ltd Wye Valley Business Park Hay-on-Wye
HR3 5PG Hereford United Kingdom
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
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This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
See also section 3, “How to inject Rilonacept Regeneron.” Read these instructions all the way through before beginning. Supplies needed:
The following items are included in each Rilonacept Regeneron dose pack:
8 sterile, 3-ml disposable syringes
8 sterile, disposable needles (27-gauge, ½-inch)
4 vials of Rilonacept Regeneron powder
4 vials of sterile water (solvent)
You will also need to obtain these items from your pharmacist, which are not included in the Rilonacept Regeneron dose pack:
Alcohol wipes
Gauze pads
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A puncture-resistant container for disposal of used needles, syringes, and vials Ask your pharmacist for these supplies.
Check the expiration date (month and year) on the Rilonacept Regeneron carton and vial. It is stated on the vial label and carton after “EXP”. Do not use Rilonacept Regeneron after the expiry date. The expiry date refers to the last date of the month.
Do not touch the needles or the rubber stopper on the Rilonacept Regeneron vial with your hands. If you do touch the rubber stopper, clean it with a fresh alcohol wipe.
If you touch a needle or the needle touches any surface, throw away the entire syringe into your puncture-resistant container and start over with a new syringe.
Do not reuse needles or syringes.
To protect yourself and others from possible needle sticks, it is very important to throw away every syringe, with the needle attached, in the puncture-resistant container right after use. Do not try to recap the needle.
Wash your hands thoroughly.
Put the following items on a clean flat surface (see Figure 1):
2 sterile, 3-ml disposable syringes
one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder
one used for injection
2 sterile, disposable needles (27-gauge, ½-inch)
one used for adding the sterile water (solvent) to the Rilonacept Regeneron powder
one used for injection
1 vial of Rilonacept Regeneron powder
1 vial of sterile water (solvent)
3 alcohol wipes
1 gauze pad
1 puncture-resistant container for disposal of used needles, syringes and vials
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Remove the plastic cap from the Rilonacept Regeneron vial.
Clean the top of the Rilonacept Regeneron vial with a fresh, never-used alcohol wipe, wiping in one direction around the top.
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Set the vial aside.
Snap off the plastic tab on the top of the vial containing sterile water for injection (solvent).
Open the wrapper that contains a 27-gauge needle by pulling apart the tabs. Place the capped needle on a clean surface. Open the wrapper that contains a syringe by pulling apart the tabs.
Attach the exposed top of the sterile water vial to the top of a syringe by twisting the syringe onto the vial of sterile water (solvent) (see Figure 2).
Hold the vial with the sterile water (solvent) in one hand and the syringe in the other hand.
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Carefully turn the vial upside down. While holding the syringe at eye level, slowly pull the syringe plunger back to the 2.5-ml line so that the sterile water (solvent) moves from the vial into the syringe (see Figure 3).
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Remove the vial from the syringe. Hold the barrel of the syringe with one hand and twist the
27-gauge needle onto the tip of the syringe with the other hand until it fits snugly (see Figure 4).
Turn the syringe so that the needle is facing straight up. Pull the needle cap straight off. Do not twist the needle or the cap as you pull it off. Gently tap the syringe until air bubbles rise to the top of the syringe (see Figure 5).
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Point the syringe and needle straight upward. The sterile water should be at the 2.3-ml line (see Figure 6). If there is more sterile water in syringe, then push the syringe plunger to force out sterile water until the water reaches the 2.3-ml line.
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With one hand, hold the Rilonacept Regeneron powder vial on a firm surface.
With the other hand, take the syringe with the sterile water (solvent) and slowly insert the needle straight down through the centre of the rubber stopper of the Rilonacept Regeneron powder vial. Push the syringe plunger down all the way so that the sterile water (solvent) in the syringe flows into the vial (see Figure 7).
Remove the syringe and needle from the stopper and throw away the syringe attached to the needle and sterile water (solvent) vial in the puncture-resistant container. Do not try to put the needle cover back on the needle.
Hold the vial containing the mixture of powder and sterile water (solvent) sideways (not upright) with your thumb and a finger at the top and bottom of the vial, and quickly shake the vial back and forth (side-to-side) for about 1 minute.
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Put the vial back on the table and let the vial sit for about 1 minute.
Check if the vial contains any particles or clumps of powder that have not dissolved.
If the powder has not completely dissolved, shake the vial quickly back and forth for 30 seconds more. Let the vial sit for about 1 minute.
Repeat step 7 until the powder is completely dissolved and the solution is clear.
The dissolved Rilonacept Regeneron solution should be a thick, clear liquid, colourless to pale yellow. Do not use the solution if it is discoloured or cloudy, or if it contains small particles (see Figure 8).
NOTE: Contact your pharmacy to report any dissolved Rilonacept Regeneron that is discoloured or contains particles.
It is best to move to the next step and inject the medicine immediately after dissolving the Rilonacept Regeneron powder in the sterile water (solvent). If necessary, the product may be kept at room temperature (20 to 25°C) for no more than 3 hours. Keep Rilonacept Regeneron away from light.
Hold the vial with the solution on a firm surface and wipe the top of the vial with a new alcohol wipe.
Open a wrapper containing a new, sterile, disposable needle. Open a wrapper containing a new, disposable syringe. Attach the needle securely to the syringe without removing the needle cover.
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Hold the syringe upright at eye level. With the needle cover on, pull back the plunger on the syringe to the mark that is equal to the volume of the solution that your doctor has prescribed for you to inject, filling the syringe with air (see Figure 9).
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Remove the needle cover and be careful not to touch the needle. Keep the vial on a flat surface and slowly insert the needle straight down through the stopper. Push the plunger down and inject all the air into the vial (see Figure 10).
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Hold the vial in one hand and the syringe in the other hand and carefully turn the vial upside down so that the needle is pointing straight up. Hold the vial at eye level.
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Keep the tip of the needle in the liquid and slowly pull back on the plunger to the mark on the syringe that matches the amount of medicine prescribed by your doctor (see Figure 11).
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Tap the syringe until the air bubbles rise to the top of the syringe. Then slowly and gently, push in the plunger so that all of the air is pushed through the needle.
Check to make sure that you have the amount of medicine prescribed by your doctor in the syringe.
Throw away the vial in the puncture-resistant container even if there is some medicine left in the vial. Do not use any vial of Rilonacept Regeneron more than one time.
Hold the syringe and needle in your hand ready for injecting. Do not touch the needle with your hands or allow it to come into contact with any surfaces. Proceed with the injection as described in Step 6 below.
Rilonacept Regeneron is injected into the tissue directly below the layers of skin. It is not meant to go into any muscle, vein, or artery.
Inject in a different place each time in order to keep your skin healthy.
Changing injection sites helps to prevent irritation and allows the medicine to be better absorbed. Ask your doctor any questions that you have about rotating injection sites.
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Do not inject into skin that is tender, red, or hard. If an area is tender or feels hardened, choose another site for injection until the tenderness or “hardening” goes away.
Tell your doctor about any skin reactions including redness, swelling, or hardening of the skin.
Areas where you may inject Rilonacept Regeneron include the left and right sides of the abdomen, and left and right thighs. If someone else is giving you the injection, the upper arms may also be used for injection (see Figure 12):
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(Do not inject within a 5-cm area around the navel.)
Choose the area for the injection. Clean the area in a circular motion with a new alcohol wipe.
Begin at the centre of the site and move outward. Let the alcohol air dry completely. Do not touch this area again before injecting.
Hold the syringe in one hand like you would hold a pencil.
With the other hand gently pinch a fold of skin around the site that you cleaned for injection.
Use a quick “dart like” motion to insert the needle straight into the skin (90° angle) (see Figure 13a). Do not push down on the plunger while inserting the needle into the skin. For small children or persons with little fat under the skin, you may need to hold the syringe and needle at a 45° angle (see Figure 13b).
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After the needle is completely in the skin, let go of the skin that you are pinching.
With your free hand hold the syringe near its base. Gently pull back the plunger. If blood comes into the syringe, the needle has entered a blood vessel. Remove the needle, discard the syringe and needle. Start over with ‘STEP 1: Setting up for an injection’ using new supplies.
If no blood appears, inject all the medicine in the syringe at a slow, steady rate, pushing the plunger all the way down. It may take up to 30 seconds to inject the entire dose.
Pull the needle out of the skin, and hold a piece of sterile gauze over the injection site for several seconds.
Do not replace the needle cover. Throw away the vials, used syringes and needles in the puncture- resistant container. Do not recycle the container. Do not throw away vials, needles, or syringes in the household rubbish.
Keep the puncture-resistant container out of reach of children. When the container is about two- thirds full, dispose of it as instructed by your doctor or pharmacist.
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Used alcohol wipes can be thrown away in the household rubbish.
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The following information is intended for medical or healthcare professionals only and is provided as a tear-off leaflet:
Rilonacept Regeneron is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older.
Adults
Treatment in adults should be initiated with a loading dose of 320 mg. Dosing should be continued with a once-weekly injection of 160 mg. Rilonacept Regeneron should not be given more often than once weekly.
Paediatric population (12 to 17 years old)
Treatment should be initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg. Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg (see Table 1). Dosing in children must be adjusted as the child grows. The patient or care giver should be advised to speak to the treating physician before adjusting the dose. The experience in children is limited. In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months.
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Paediatric population (up to 12 years old)
No data are available on the use of Rilonacept Regeneron in children with CAPS under 12 years of age, therefore it is not recommended in this paediatric age group.
Elderly (65 years old or older)
Available data indicate that dose modification is not required based on advanced age. However, clinical experience in patients above 65 years is limited, therefore caution is recommended.
Renal impairment
No dose adjustment is required in patients with mild, moderate or severe renal impairment, or end stage renal disease. However, clinical experience in such patients is limited.
Hepatic impairment
Rilonacept Regeneron has not been studied in patients with hepatic impairment.
Method of administration
Rilonacept Regeneron is for subcutaneous use only. It is not intended for intravenous or intramuscular use.
The adult loading dose should be administered as two 2 ml subcutaneous injections (320 mg of rilonacept in total) given on the same day at different sites. The subsequent doses are administered as a 2 ml (160 mg of rilonacept) subcutaneous injection once a week.
For paediatric patients, the dose is delivered as one or two (for loading dose) subcutaneous injections with a maximum single-injection volume of 2 ml.
For convenience, the corresponding dose volume for weekly injection in paediatric patients is presented in Table 1 below.
Table 1: Rilonacept Regeneron dose volume (after reconstitution) by body weight for paediatric patients, aged 12-17 years
Weight range (kg) | Dose volume (ml) |
23.6 to 27.2 | 0.7 |
27.3 to 30.8 | 0.8 |
30.9 to 34.4 | 0.9 |
34.5 to 38.1 | 1 |
38.2 to 41.7 | 1.1 |
41.8 to 45.4 | 1.2 |
45.5 to 49.0 | 1.3 |
49.1 to 52.6 | 1.4 |
52.7 to 56.3 | 1.5 |
56.4 to 59.9 | 1.6 |
60.0 to 63.5 | 1.7 |
63.6 to 67.2 | 1.8 |
67.3 to 70.8 | 1.9 |
70.9 or greater | 2 |
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Store in a refrigerator. Do not freeze.
Keep the vials in the outer carton in order to protect from light.
After reconstitution, if necessary the product may be kept at room temperature, but should be used within three hours of reconstitution because it does not contain a preservative.
Instructions for reconstitution
Using aseptic technique, Rilonacept Regeneron powder should be reconstituted with 2.3 ml solvent (water for injections) prior to administration.
The 2.3 ml of solvent should be withdrawn from the solvent vial attached directly to a 3-ml syringe and then injected into the powder vial for reconstitution with 27-gauge, ½-inch needle (to obtain a final reconstitution volume of 2.75 ml). The needle and syringe used for reconstitution with solvent should then be discarded and should not be used for subcutaneous injections. After the addition of solvent, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute. The resulting 80 mg/ml solution is sufficient to allow a withdrawable volume of up to 2 ml for subcutaneous administration.
The reconstituted solution is viscous, clear and colourless to pale yellow. Prior to injection, the reconstituted solution should be carefully inspected for any discolouration or particulate matter. If there is discolouration or particulate matter in the solution, the product must not be used.
Instructions for administration
Using aseptic technique, the recommended dose volume, up to 2 ml (160 mg) of the solution should be withdrawn with a new 27-gauge, ½-inch injection needle attached to a new 3-ml syringe for subcutaneous injection.
Sites for subcutaneous injection, such as the abdomen, thigh, or upper arm, should be rotated. Injections should never be made at sites that are bruised, red, tender, or hard.
The initial administration of Rilonacept Regeneron by a patient or caregiver should be under the guidance of a trained healthcare professional. For subsequent self-administration by patients, appropriate instruction in proper injection technique should be provided and ability to apply that technique ascertained.
Disposal
Each vial should be used for a single dose only. The vial should be discarded after withdrawal of the solution.
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Patients or their caregivers should be instructed on the appropriate procedure for disposal of the vials, needles, and syringes.