ORENCIA 125 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN - patient leaflet, side effects, dosage

1. What ORENCIA is and what it is used for

3. How to use ORENCIA

5. How to store ORENCIA

6. Contents of the pack and other information

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

This medicine has been prescribed for you only. Do not pass it on to others.

1. What ORENCIA is and what it is used for

2. What you need to know before you use ORENCIA

3. How to use ORENCIA

4. Possible side effects

5. How to store ORENCIA

6. Contents of the pack and other information

Important instructions for use. Read carefully.

HOW TO USE

ORENCIA (abatacept)

ClickJect Pre-filled Pen

125 mg, solution for injection

subcutaneous use

Abdomen,

avoid 5 cm

around nave

Front of thighs

WAIT

until blue

indicator

moving

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 label and the

carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). Do not freeze

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your

will help to protect the environment.

What ORENCIA contains

Proceed to Step 2

2. PREPARE FOR INJECTION

Choose your injection site in either the abdomen or front of the thigh

site in that area.

DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard

Proceed to Step 3

3. INJECT YOUR DOSE

cleaned skin

ORENCIA can be used with other medicines commonly used to treat

Ask your doctor or pharmacist for advice before taking any other medicine while

using ORENCIA.

Pregnancy and breast-feeding

The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if

the last dose. Your doctor will advise you on suitable methods.

if you become pregnant while using ORENCIA, tell your doctor.

section on vaccination).

It is not known whether ORENCIA passes into human milk. You must stop

after the last dose.

Driving and using machines

ORENCIA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say

Always use this medicine exactly as your doctor or pharmacist has told you

ORENCIA solution for injection is injected under the skin (subcutaneous use)

Recommended dose

The recommended dose of ORENCIA for adults with rheumatoid arthritis or

psoriatic arthritis is 125 mg abatacept given every week regardless of weight.

Your doctor may start your ORENCIA treatment with or without a one-time dose of

subcutaneous injections

ORENCIA can be used by adults over 65 with no change in dose

Read these instructions before you use the ClickJect Pre-filled Pen.

Before you use the ClickJect Pen for the first time, make sure your healthcare

provider shows you the right way to use it

Keep the pen refrigerated until ready to use. DO NOT FREEZE.

If you have questions about this product, please read the Package Leaflet

BEFORE YOU BEGIN

Get to know the ClickJect Pre-filled Pen

from the skin.

DO NOT remove the orange needle cover until you are ready to inject.

Before Use

dry eye, reduced vision

eye inflammation

palpitation, rapid heart rate, low heart rate

low blood pressure, hot flush, blood vessels inflammation, flushing

throat tightness

rhinitis

increased tendency to bruise, dry skin, psoriasis, skin redness, excessive

sweating, acne

hair loss, itching, hives

painful joints

pain in the extremities

absence of menstruation, excessive menses

flu-like illness, increased weight

Rare (may affect up to 1 in 1,000 people):

tuberculosis

inflammation of uterus, fallopian tubes and/or ovaries

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes

(see below). By reporting side effects you can help provide more information on

Yellow Card Scheme

Push DOWN on skin to unlock the Pen.

a skin test

if you have cancer, your doctor will decide if you can still be given ORENCIA.

while you were pregnant, your baby may be at a higher risk for getting such

Your doctor may also do tests to examine your blood values

Children and adolescents

2 years of age and older.

Other medicines and ORENCIA

medicines

ORENCIA should not be used with biological medicines for rheumatoid arthritis,

abatacept

Transparent Tip

Gather supplies for your injection on a clean, flat surface

(only the ClickJect Pre-filled Pen is included in the package)

Alcohol swab

Adhesive plaster

You can discard the cap in your household waste after the injection.

DO NOT use the Pen if it is dropped after the cap is removed

Remove

Need e Cover

ORENCIA contains the active substance abatacept, a protein produced in cell

ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults

Rheumatoid Arthritis

Tell your doctor immediately if you notice any of the following

swollen face, hands or feet

trouble breathing or swallowing

The symptoms described above can be signs of the side effects listed below, all

of which have been observed with ORENCIA in adult clinical trials:

List of side effects:

sinuses)

Common (may affect up to 1 in 10 people):

headache, dizziness

high blood pressure

cough

rash

abnormal liver function tests.

Uncommon (may affect up to 1 in 100 people):

low white blood cells count

skin cancer, skin warts

low blood platelet count

allergic reactions

depression, anxiety, sleep disturbance

migraine

numbness

ORENCIA 125 mg solution for injection in pre-filled pen

If you have any further questions, ask your doctor, pharmacist or nurse

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, pharmacist or nurse. This

includes any possible side effects not listed in this leaflet. See section 4 cultures. ORENCIA lessens the immune system’s attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T cells involved in the immune system’s inflam­matory response.

Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body’s own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. Rheumatoid arthritis (RA) affects everyone differently. In most people, joint symptoms develop gradually over several years. However, in some, RA may progress rapidly and yet other people may have RA for a limited period of time and then enter a period of remission. RA is usually a chronic (long-term), progressive disease. This means even if you’re on treatment, whether or not you’re still having symptoms, RA could be continuing to damage your joints. By finding the right treatment plan for you, you may be able to slow down this disease process, which may help reduce long-term joint damage, as well as pain and fatigue and improve your overall quality of life.

ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you do not respond well enough to treatment with other disease-modifying medicines or with another group of medicines called ‘tumour necrosis factor (TNF) blockers’. It is used in combination with a medicine called methotrexate.

ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.

ORENCIA is used to:

• – slow down the damage to your joints

• – improve your physical function

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given ORENCIA to:

Reduce the signs and symptoms of your disease.

Slow down the damage to your bones and joints.

Improve your physical function and your ability to do normal daily activities.

ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.

2. what you need to know before you use orencia

Do not use ORENCIA

if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).

if you have a severe or uncontrolled infection , do not start treatment with ORENCIA. Having an infection could put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse:

if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.

if you have any kind of infection , including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor. ORENCIA can

lower your body’s ability to fight infection and the treatment can make you

more likely to get infections or make any infection you have worse

if you have had tuberculosis (TB) or have symptoms of tuberculosis

(persistent cough, weight loss, listlessness, mild fever) tell your doctor.

Before you use ORENCIA, your doctor will examine you for tuberculosis or do

if you have viral hepatitis tell your doctor. Before you use ORENCIA, your

doctor may examine you for hepatitis.

if you recently had a vaccination or are planning to have one, tell your

doctor. Some vaccines should not be given while you are receiving ORENCIA.

Check with your doctor before you are given any vaccines. Certain

vaccinations may cause infections from the vaccine. If you received ORENCIA

an infection for up to approximately 14 weeks after the last dose you received

during pregnancy. It is important that you tell your baby’s doctors and other

health care professionals about your ORENCIA use during your pregnancy so

they can decide when your baby should receive any vaccine.

ORENCIA solution for injection in pre-filled pen has not been studied in children and adolescents under the age of 18 years. Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.

ORENCIA powder for concentrate for solution for infusion is available for paediatric patients 6 years of age and older.

ORENCIA solution for injection pre-filled syringe is available for paediatric patients

Tell your doctor if you are taking, have recently taken or might take any other including TNF-blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab. rheumatoid arthritis, such as steroids or painkillers, including non-steroida anti-inflammatories such as ibuprofen or diclofenac.

you are pregnant unless your doctor specifically recommends it.

if you are a woman who could become pregnant, you must use reliable

contraception (birth control) while using ORENCIA and up to 14 weeks after

If you received ORENCIA during your pregnancy, your baby may have a higher

risk for getting an infection. It is important that you tell your baby’s doctors

and other health care professionals about your ORENCIA use during your

pregnancy before the baby receives any vaccine (for more information see

breast-feeding if you are being treated with ORENCIA and for up to 14 weeks

The use of ORENCIA is not expected to affect the ability to drive or use machines.

However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery.

essentially ‘sodium-free’.

Check with your doctor or pharmacist if you are not sure powder for concentrate for solution for infusion (given to you into a vein, usually n your arm, over a period of 30 minutes). If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly 125 mg

If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.

Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.

At the start, your doctor or nurse may inject ORENCIA. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will get training on how to inject ORENCIA yourself.

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed instructions for the preparation and administration of ORENCIA at the end of this leaflet (see

“Important instructions for use”)

.

If you use more ORENCIA than you should

If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.

If you forget to use ORENCIA

Keep track of your next dose. It is very important to use ORENCIA exactly as prescribed by your doctor. If you miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day. If you miss your dose by more than three days, ask your doctor when to take your next dose.

If you stop using ORENCIA

The decision to stop using ORENCIA should be discussed with your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects with ORENCIA are infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA can cause serious side effects, which may need treatment.

Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.

severe rash, hives or other signs of allergic reaction

fever, persistent cough, weight loss, listlessness

Tell your doctor as soon as possible if you notice any of the following:

feeling generally unwell, dental problems, burning sensation during urination

painful skin rash, painful skin blisters, coughing

Very common (may affect more than 1 in 10 people)

infections of the upper airway (including infections of the nose, throat and

infections of lungs, urinary infections, painful skin blisters (herpes), flu

abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting

fatigue, weakness, injection site reactions

tooth infection, nail fungal infection, infection in the muscles, blood stream

infection, collection of pus under the skin, kidney infection, ear infection

difficulty in breathing, wheezing, shortness of breath, acute worsening of a

lung disease called chronic obstructive pulmonary disease (COPD)

gastrointestinal infection

cancer of white blood cells, lung cancer any possible side effects not listed in this leaflet. You can also report side effects the safety of this medicine.

Website: at: or search for MHRA Yellow Card in the

Google Play or Apple App Store

Do not use this medicine if the liquid is cloudy or discoloured, or has large particles. The liquid should be clear to pale yellow.

pharmacist how to throw away medicines you no longer use. These measures

The active substance is abatacept.

Each pre-filled pen contains 125 mg of abatacept in one mL.

The other ingredients are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections (see section 2 “ORENCIA contains sodium”).

What ORENCIA looks like and contents of the pack

ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution provided in a pre-filled pen called ClickJect.

ORENCIA is available in the following presentations:

• – pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

This leaflet was last revised in February 2022

The Pen automatically delivers the medicine. The transparent tip locks

over the needle once the injection is complete and the Pen is removed

Needle Cover (ORANGE Cap)

Cotton ball or gauze ClickJect Pre-filled Pen Sharps disposal container

Proceed to Step 1

• 1. PREPARE YOUR CLICKJECT PEN Let your ClickJect Pen warm up.

Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes.

DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.

Wash your hands well with soap and water to prepare for injection.

Examine the ClickJect Pre-filled Pen:

• Check the expiry date printed on the label.

DO NOT use if past the expiry date.

• Check the Pen for damage.

DO NOT use if it is cracked or broken.

• Check the liquid through the viewing window. It should be clear to pale yellow. You may see a small air bubble. You do not need to remove it. DO NOT inject if the liquid is cloudy, discoloured or has visible particles.

Expiry Date

Each week you can use the same area of your body, but use a different injection

Avoid any areas with scars or stretch marks.

Pull orange needle cover STRAIGHT off.

DO NOT replace the cap on the Pen.

It’s normal to see a drop of fluid leaving the needle.

Position the ClickJect Pen so you can see the viewing window and it’s at a 90° angle to the injection site. With your other hand, gently pinch the

Press button, HOLD for 15 seconds AND watch window.

• You will hear a click as the injection begins.
• For full-dose delivery, hold the Pre-filled Pen in place for 15 seconds AND wait until blue indicator stops moving in window.

Remove the ClickJect Pre-filled Pen from the injection site by lifting it straight up. Once you remove it from your skin, the transparent tip will lock over the needle. Release skin pinch.

Proceed to Step 4

• 4. AFTER THE INJECTION

Care of injection site:

• There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
• DO NOT rub the injection site.
• If needed, you may cover the injection site with a small adhesive plaster.

Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use. Should you have any questions, ask your pharmacist.

• DO NOT replace the cap on the used Pen.

Approved