Rilonacept Regeneron (previously Arcalyst)

Основна информация

  • Търговско наименование:
  • Rilonacept Regeneron (previously Arcalyst)
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Rilonacept Regeneron (previously Arcalyst)
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunosuppressants,
  • Терапевтична област:
  • Cryopyrin-Associated Periodic Syndromes
  • Терапевтични показания:
  • Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.
  • Каталог на резюме:
  • Revision: 5

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Withdrawn
  • Номер на разрешението:
  • EMEA/H/C/001047
  • Дата Оторизация:
  • 22-10-2009
  • EMEA код:
  • EMEA/H/C/001047
  • Последна актуализация:
  • 31-03-2019

Доклад обществена оценка

Medicinal product no longer authorised

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

EMA/548888/2010

EMEA/H/C/001047

EPAR summary for the public

Rilonacept Regeneron

rilonacept

This document is a summary of the European public assessment report (EPAR) for Rilonacept

Regeneron. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the

medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations

on the conditions of use for Rilonacept Regeneron.

What is Rilonacept Regeneron?

Rilonacept Regeneron is a powder and solvent that are made up into a solution for injection. It

contains the active substance rilonacept (80 mg/ml).

What is Rilonacept Regeneron used for?

Rilonacept Regeneron is used to treat cryopyrin-associated periodic syndromes (CAPS). CAPS are a

group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.

This leads to inflammation in many parts of the body, with symptoms such as fever, rash, joint pain,

and tiredness. Severe disabilities such as deafness and loss of vision may also occur.

Rilonacept Regeneron is used to treat CAPS that are causing severe symptoms in adults and children

aged 12 years and older, including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells

syndrome (MWS).

Because the number of patients with CAPS is low, the diseases are considered ‘rare’, and Rilonacept

Regeneron was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 July 2007.

The medicine can only be obtained with a prescription.

Previously known as Arcalyst.

Medicinal product no longer authorised

How is Rilonacept Regeneron used?

Treatment with Rilonacept Regeneron should be started and supervised by a specialist doctor

experienced in diagnosing and treating CAPS.

Rilonacept Regeneron is given as injections under the skin. Adults should be given a starting dose of

two injections of 160 mg each in two different parts of the body on the same day. A week later, the

patient should start receiving once weekly injections of 160 mg. For children aged from 12 to 17 years,

the dose will depend on the patient’s weight. The starting dose is 4.4 mg per kilogram body weight (up

to a maximum of 320 mg), which is followed a week later by once weekly injections of 2.2 mg/kg (up

to a maximum of 160 mg).

Patients may inject themselves once they have been trained if their doctor believes it is appropriate.

Patients treated with Rilonacept Regeneron must be given an alert card that summarises the key

safety information about the medicine.

How does Rilonacept Regeneron work?

The active substance in Rilonacept Regeneron, rilonacept, is an interleukin inhibitor. It works by

attaching to chemical messengers in the body called interleukin-1beta and interleukin-1 alpha. One of

these messengers, interleukin-1 beta, is produced at high levels in patients with CAPS, causing

inflammation. By attaching to interleukin-1 beta, it blocks its activity, helping to relieve the symptoms

of the disease.

How has Rilonacept Regeneron been studied?

In the first part of one main study involving 47 patients with CAPS, patients were given either

Rilonacept Regeneron or placebo (a dummy treatment) for six weeks. In the second part of the study,

all patients were given Rilonacept Regeneron treatment before receiving either Rilonacept Regeneron

or placebo for another nine weeks.

The main measure of effectiveness was how much their symptoms reduced after the six-week

treatment and how much the improvements were maintained after the nine-week treatment. Five

symptoms (rash, fever or chills, joint pain, tiredness and eye redness or pain) were assessed by

patients themselves on a scale from 0 to 10 points.

What benefit has Rilonacept Regeneron shown during the studies?

Rilonacept Regeneron was more effective than placebo at treating symptoms of CAPS. After the six-

week treatment, patients who received Rilonacept Regeneron had a reduction in symptoms of 2.5

points on the scale compared with 0.3 points in patients who received placebo. In the second part of

the study, symptoms increased more in patients switched to placebo (0.9 points) compared with

patients who remained on Rilonacept Regeneron (0.1 points).

What is the risk associated with Rilonacept Regeneron?

The most common side effects with Rilonacept Regeneron (seen in more than 1 patient in 10) are

reactions at the injection site, upper respiratory tract infections (colds), sinusitis (inflammation of the

sinuses) and headache. For the full list of all side effects reported with Rilonacept Regeneron, see the

package leaflet.

Rilonacept Regeneron should not be used in people who may be hypersensitive (allergic) to rilonacept

or any of the other ingredients. It must not be used in patients with an active, severe infection.

Rilonacept Regeneron

EMA/548888/2010

Page 2/3

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Rilonacept Regeneron

EMA/548888/2010

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Blocking interleukin-1 may interfere with the body’s immune response to infection and there have been

reports of serious infections in patients taking Rilonacept Regeneron.

Why has Rilonacept Regeneron been approved?

The CHMP decided that Rilonacept Regeneron’s benefits are greater than its risks and recommended

that it be given marketing authorisation.

Rilonacept Regeneron has been authorised under ‘exceptional circumstances’. This means that because

the diseases are rare, it has not been possible to obtain complete information about Rilonacept

Regeneron. Every year, the European Medicines Agency will review any new information that may

become available and this summary will be updated as necessary.

What information is still awaited for Rilonacept Regeneron?

The company that makes Rilonacept Regeneron will provide regular information on the safety and

effectiveness of Rilonacept Regeneron in adults and children from a registry and will perform a study in

children to further investigate what happens to the medicine in the body.

What measures are being taken to ensure the safe use of Rilonacept

Regeneron?

The company that makes Rilonacept Regeneron will provide doctors in all Member States who will use

Rilonacept Regeneron with a pack containing the prescribing information, a patient alert card and

information for doctors explaining the risk of side effects and how to use the medicine properly.

Other information about Rilonacept Regeneron:

The European Commission granted a marketing authorisation valid throughout the European Union for

Arcalyst to Regeneron UK Limited on 23 October 2009. The name of the medicine was changed to

Rilonacept Regeneron on 23 July 2010. The marketing authorisation is valid for five years, after which

it can be renewed.

The summary of opinion of the Committee for Orphan Medicinal Products for Rilonacept Regeneron is

available here

The full EPAR for Rilonacept Regeneron can be found on the Agency’s website under EMA website/Find

medicine/Human medicines/European Public Assessment Reports

For more information about

treatment with Rilonacept Regeneron, read the package leaflet (also part of the EPAR) or contact your

doctor or pharmacist.

This summary was last updated in 08-2010.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

Medicinal product no longer authorised

B. PACKAGE LEAFLET

Medicinal product no longer authorised

Package leaflet: Information for the user

Rilonacept Regeneron 80 mg/ml powder and solvent for solution for injection

rilonacept

Read all of this leaflet carefully before you start using this medicine because it contains important

information for you.

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 is 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

Contents of the pack and other information

1.

What Rilonacept Regeneron is and what it is used for

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.

2.

What you need to know before you use Rilonacept Regeneron

Do not use Rilonacept Regeneron:

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.

Warnings and precautions

Talk to your doctor before using Rilonacept Regeneron.

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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.

Children and adolescents

Rilonacept Regeneron is not recommended for children younger than 12 years of age.

Other medicines and Rilonacept Regeneron

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

3.

How to use Rilonacept Regeneron

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.

How much Rilonacept Regeneron to use

Medicinal product no longer authorised

Adults (including the elderly)

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.

Adolescents (aged 12 to 17 years old)

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.

How to inject Rilonacept Regeneron

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

SOLUTION FOR INJECTION” at the end of this leaflet. If you have questions, contact your doctor,

nurse, or pharmacist.

If you use more Rilonacept Regeneron than you should

If you accidentally inject more Rilonacept Regeneron than the recommended dose, you should contact

your doctor right away.

If you forget to use Rilonacept Regeneron

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.

4.

Possible side effects

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:

Serious infections. Tell your doctor right away if you develop symptoms of an infection while being

treated with Rilonacept Regeneron, such as:

- 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.

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Allergic reactions. If you develop signs of an allergic (hypersensitivity) reaction during treatment with

Rilonacept Regeneron (such as chest tightness, wheezing, trouble breathing, severe dizziness or light-

headedness, swelling of lips, or rash during or after the injection) then stop taking Rilonacept Regeneron

and tell your doctor right away.

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

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.

5.

How to store Rilonacept Regeneron

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.

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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.

6.

Contents of the pack and other information

What Rilonacept Regeneron contains

- The

active

substance

rilonacept.

Each

vial

powder

contains

220 mg

rilonacept.

After

reconstitution, each ml of solution contains 80 mg rilonacept.

- The

other

ingredients

powder

glycine,

arginine

hydrochloride,

histidine,

histidine

hydrochloride monohydrate, polyethylene glycol 3350 and sucrose. The solvent is water for

injections.

What Rilonacept Regeneron looks like and contents of the pack

Rilonacept Regeneron is provided as a powder for solution for injection in a glass vial. The powder

is white to off-white.

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

Marketing Authorisation Holder

Regeneron UK Limited

40 Bank Street

E14 5DS London

United Kingdom

Manufacturer

Brecon Pharmaceuticals Ltd

Wye Valley Business Park

Hay-on-Wye

HR3 5PG Hereford

United Kingdom

This leaflet was last revised in

Medicinal product no longer authorised

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.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Medicinal product no longer authorised

INSTRUCTIONS FOR USE OF RILONACEPT REGENERON POWDER FOR SOLUTION FOR

INJECTION

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

A puncture-resistant container for disposal of used needles, syringes, and vials

Ask your pharmacist for these supplies.

General guidelines when giving a Rilonacept Regeneron injection:

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.

STEP 1: Setting up for an injection

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

Medicinal product no longer authorised

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

Figure 1

STEP 2: Preparing the vial of Rilonacept Regeneron powder

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.

Set the vial aside.

STEP 3: Filling a syringe with sterile water for injection (solvent)

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).

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Figure 2

Hold the vial with the sterile water (solvent) in one hand and the syringe in the other hand.

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).

Figure 3

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).

Figure 4

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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).

Figure 5

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.

Figure 6

STEP 4: Dissolving Rilonacept Regeneron powder with the sterile water for injection (solvent)

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).

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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.

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.

Medicinal product no longer authorised

Figure 8

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.

STEP 5: Preparing the injection

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.

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).

Figure 9

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).

Medicinal product no longer authorised

Figure 10

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.

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).

Figure 11

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.

Medicinal product no longer authorised

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.

STEP 6: Giving the injection

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.

Where to inject

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.

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):

(Do not inject within a 5-cm area around the navel.)

Figure 12

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.

Medicinal product no longer authorised

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).

Figure 13a (Adults)

Figure 13b (Small Children, Thin Patients)

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.

Medicinal product no longer authorised

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.

Used alcohol wipes can be thrown away in the household rubbish.

Medicinal product no longer authorised

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The following information is intended for medical or healthcare professionals only and is provided as a

tear-off leaflet:

Indication

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.

Posology

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.

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.

Medicinal product no longer authorised

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

27.3 to 30.8

30.9 to 34.4

34.5 to 38.1

38.2 to 41.7

41.8 to 45.4

45.5 to 49.0

49.1 to 52.6

52.7 to 56.3

56.4 to 59.9

60.0 to 63.5

63.6 to 67.2

67.3 to 70.8

70.9 or greater

Special precautions for storage

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.

Reconstitution and administration instructions

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.

Medicinal product no longer authorised

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.

Patients or their caregivers should be instructed on the appropriate procedure for disposal of the vials,

needles, and syringes.