ORENCIA 125 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

ORENCIA125mg solution for injection in pre-filled pen

abatacept

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 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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. Storage of ORENCIA
6. Contents of the pack and other information

1. What ORENCIA is and what it is used for

ORENCIA contains the active substance abatacept, a protein that is produced in cell cultures. ORENCIA reduces the attack of the immune system on normal tissues by interfering with immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T lymphocytes that participate in the inflammatory response of the immune system.

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

Rheumatoid Arthritis

Rheumatoid arthritis is a progressive disease of long duration that, if left untreated, can have serious consequences, such as destruction of joints, increased disability, and inability to perform daily activities. In people with rheumatoid arthritis, the body's own immune system attacks normal tissues, producing pain and swelling in the joints. This can damage the joints. Rheumatoid arthritis (RA) affects each person differently. In most people, joint symptoms develop gradually over several years. However, in some patients, RA can progress rapidly, and in others, it can occur for a limited period and then go into remission. RA is usually a chronic (long-term) disease, which means that, even with treatment, you may still have symptoms, and RA could continue to damage your joints. With the best treatment plan for you, you may be able to slow down this disease process, which could 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 have not responded sufficiently to treatment with other disease-modifying medicines or with another group of medicines called "tumor necrosis factor (TNF) inhibitors". It is used in combination with a medicine called methotrexate.

ORENCIA may also be used with methotrexate to treat rheumatoid arthritis that is progressive and has high activity without prior treatment with methotrexate.

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 sufficiently well to these medicines, you may be given ORENCIA to:

• reduce the signs and symptoms of your disease.
• reduce the damage to your bones and joints.
• improve your physical function and ability to perform normal daily activities.

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

2. What you need to know before you use ORENCIA

Do not use ORENCIA

• if you are allergicto 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 effects from ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse:

• if you experience allergic reactionssuch as chest tightness, asthma, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.
• if you, your partner, or your caregiver notice new onset or worsening of neurological symptoms, including general muscle weakness, vision changes, difficulty speaking, a change in the way you walkor problems with balance, changes in thinking, memory, and orientationthat lead to confusion and personality changes, contact your doctor immediatelybecause they may be symptoms of a rare, serious, and potentially life-threatening brain infection called progressive multifocal leukoencephalopathy (PML).
• if you have any type of infection, including prolonged or localized infection, or if you frequently get infections or if you have symptoms of an infection (such as fever, malaise, dental problems), it is important that you inform your doctor. ORENCIA may decrease your body's ability to fight an infection, and treatment may make you more prone to getting infections or worsening any infection you have.
• if you have had tuberculosis (TB)or have symptoms of tuberculosis (persistent cough, weight loss, apathy, low-grade fever) tell your doctor. Before using ORENCIA, your doctor will perform a tuberculosis test or a skin test.
• if you have viral hepatitisinform your doctor. Before using ORENCIA, your doctor may perform a test for hepatitis.
• if you have cancer, your doctor will decide if you can be given ORENCIA.
• if you have been recently vaccinatedor are thinking of getting vaccinated, tell your doctor. Some vaccines should not be given while you are being treated with ORENCIA. Consult with your doctor before you receive any vaccine.Certain vaccines may cause infections. If you receive ORENCIA during pregnancy, your baby may have a higher risk of getting such an infection during the approximately 14 weeks after the last dose you received during pregnancy. It is important that you inform your baby's doctors and other healthcare professionals about the use of ORENCIA during pregnancy so they can decide when to give your baby any vaccine.

Your doctor may also perform blood tests to check your blood values.

Children and adolescents

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

ORENCIA powder for concentrate for solution for infusion is available for pediatric patients from 6 years of age.

ORENCIA solution for injection in pre-filled syringe is available for pediatric patients from 2 years of age.

Using ORENCIA with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

ORENCIA must not be usedwith biologic medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is not enough evidence to recommend that it be given with anakinra and rituximab.

ORENCIA can be usedwith other medicines commonly used to treat rheumatoid arthritis, such as steroids or pain relievers, including non-steroidal anti-inflammatory drugs like ibuprofen or diclofenac.

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

Pregnancy and breastfeeding

The effects of ORENCIA in pregnancy are not known, therefore, you must not use ORENCIA if you are pregnant unless your doctor recommends it.

• if you are a woman who could become pregnant, you must use reliable contraceptive methods (birth control) while you are using ORENCIA and for 14 weeks after the last dose. Your doctor will advise you on suitable methods.
• if you become pregnant during treatment with ORENCIA, inform your doctor.

If you receive ORENCIA during pregnancy, your baby may have a higher risk of getting an infection. It is essential that you inform your baby's doctors and other healthcare professionals about the use of ORENCIA during pregnancy before any vaccine is given to your baby (for more information, see the section on vaccination).

It is not known whether ORENCIA passes into breast milk. You must not breastfeedif you are being treated with ORENCIA until 14 weeks after the last dose.

Driving and using machines

It is unlikely that the use of ORENCIA will affect your ability to drive or use machines. However, if you feel tired or unwell after receiving ORENCIA, do not drive or operate any machinery.

ORENCIA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to use ORENCIA

Follow the instructions for administration of this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.

ORENCIA solution for injection is injected under the skin (subcutaneously).

Recommended dose

The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg of abatacept every week, regardless of weight.

Your doctor may start your treatment with ORENCIA with or without a single dose of powder for concentrate for solution for infusion (which is given into a vein, usually in the arm, over a period of 30 minutes). If you are given a single intravenous dose to start treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by weekly subcutaneous injections of 125 mg.

ORENCIA can be used in adults over 65 years of age without the need to change the dose.

If you are already receiving treatment with intravenous ORENCIA and want to switch to subcutaneous ORENCIA, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.

Your doctor will inform you about the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you can continue to take while being treated with ORENCIA.

Initially, your doctor or nurse may inject ORENCIA for you. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will be instructed on how to inject ORENCIA yourself.

Ask your doctor if you have any questions about the administration of the injection. You will find detailed instructions for 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 your doctor immediately, who will monitor you for any signs or symptoms of adverse effects and treat them if necessary.

If you forget to use ORENCIA

Keep track of your next dose. It is very important to use ORENCIA exactly as your doctor has told you. If you forget a dose within 3 days of when it was due, give the dose as soon as you remember and then follow your original schedule on the designated day. If you forget your dose for more than 3 days, ask your doctor when you should give your next dose.

If you stop treatment with ORENCIA

The decision to stop treatment with 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 upper respiratory tract infections (including infections of the nose and throat), headache, and nausea. ORENCIA can cause serious side effects that may require treatment.

Serious side effectsinclude severe infections, malignant neoplasms (cancer), and allergic reactions, as listed below.

Tell your doctor immediatelyif you notice any of the following symptoms:

• severe rash, hives, or other symptoms of an allergic reaction
• face, hands, or feet swollen
• difficulty breathing or swallowing
• fever, persistent cough, weight loss, fatigue

Tell your doctor immediatelyif you notice any of the following:

• general malaise, dental problems, burning sensation when urinating, painful skin rash, painful blisters on the skin, cough

The symptoms described above may be signs of the side effects listed below, which have been seen with ORENCIA in clinical trials in adults:

List of side effects:

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

• upper respiratory tract infections (including infections of the nose, throat, and sinuses).

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

• lung infections, urinary tract infections, painful blisters on the skin (herpes), flu
• headache, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhea, nausea, stomach upset, mouth ulcers, vomiting
• skin rash
• fatigue, weakness, reactions at the injection site
• abnormal liver function tests.

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

• dental infection, fungal infection of the nails, muscle infection, infection of the bloodstream, accumulation of pus under the skin, kidney infection, ear infection
• low white blood cell count in the blood
• skin cancer, warts
• low platelet count in the blood
• allergic reactions
• depression, anxiety, sleep disturbance
• migraine
• numbness
• dry eye, decreased vision
• eye inflammation
• palpitations, rapid heartbeat, slow heartbeat
• low blood pressure, flushing, inflammation of the blood vessels, redness
• difficulty breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat tightness
• rhinitis
• increased tendency to bruise, dry skin, psoriasis, redness of the skin, excessive sweating, acne
• hair loss, itching, hives
• joint pain
• limb pain
• absence of menstruation, heavy menstrual bleeding
• pseudoflu syndrome, weight gain

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

• tuberculosis
• inflammation of the uterus, fallopian tubes, and/or ovaries
• gastrointestinal infection
• leukemia, lung cancer

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ORENCIA

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 after EXP and on the carton after CAD. The expiry date is the last day of the month stated.

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

Store in the original package to protect from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

ORENCIA Composition

• The active ingredient is abatacept.
• Each preloaded pen contains 125 mg of abatacept in 1 mL.
• The other components are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, and water for injectable preparations (see section 2 "ORENCIA contains sodium").

Product Appearance and Container Contents

ORENCIA injectable solution (injection) is a clear, colorless to pale yellow solution presented in a preloaded pen called ClickJect.

ORENCIA is available in the following presentations:

• - 4-preloaded pen pack and 12-preloaded pen multipack (3 packs of 4).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Manufacturer

CATALENT ANAGNI S.R.L.

Loc. Fontana del Ceraso snc

Strada Provinciale 12 Casilina, 41

03012 Anagni (FR)

Italy

Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.

Important Instructions for Use. Read Carefully.

HOW TO USE

ORENCIA (abatacept)

Preloaded ClickJect Pen

125 mg, injectable solution

for subcutaneous use

Read these instructions before using the preloaded ClickJect pen.

Before using the ClickJect pen for the first time, make sure the healthcare professional administering it shows you the correct way to use it.

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

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

BEFORE YOU START

Get to Know the Preloaded ClickJect Pen

• The pen automatically releases the medication. The transparent protector closes over the needle once the injection is complete and the pen is removed from the skin.
• DO NOT remove the orange needle protector until you are ready to inject.

Before Use

After Use

Gather Supplies for Your Injection on a Clean and Flat Surface

(only the preloaded ClickJect pen is included in the pack):

• Alcohol swab
• Adhesive bandage
• Cotton ball or swab
• Preloaded ClickJect pen
• Sharps container

Proceed to Step 1

1. PREPARE YOUR CLICKJECT PEN

Let your ClickJect pen come to room temperature.

Remove a pen from the refrigerator and let it sit at room temperature (above 25°C) for 30minutes.

DO NOTremove the needle protector from the pen while it is coming to room temperature.

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

Examine the preloaded ClickJect pen:

• Check the expiration dateprinted on the label.

DO NOTuse if the expiration date has passed.

• Check if the pen is defective.

DO NOTuse if it is cracked or broken.

• Check the liquidthrough the inspection window. It should be clear to pale yellow. You may see an air bubble. There is no reason to remove it.

DO NOT injectif the liquid is cloudy, has changed color, or has visible particles.

Proceed to Step 2

1. PREPARE FOR INJECTION

Choose an injection sitesuch as the abdomenor the front of the thigh.

You can use the same area of the body each week, but choose a different injection site within that area.

DO NOTinject into areas where the skin is painful, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

Gently clean the injection sitewith a cotton swab and let the skin dry.

Pull the orange needle protector straight off

• DO NOTtwist the needle protector.
• DO NOTreplace the pen cap.

You can discard the cap in the household trash after injection.

• DO NOTuse the pen if it falls after removing the cap.

It is normal to see a drop of liquid coming out of the needle.

Proceed to Step 3

1. ADMINISTER YOUR DOSE

Place the ClickJect penso you can see the inspection windowand it is at a 90-degree angle to the injection site. With your other hand, gently pinch the skin area you cleaned.

Complete ALL the steps to administer the full dose:

PRESS DOWNon the skin to unlock the pen.

Press the button, HOLD for 15seconds AND watch the inspection window.

• You will hear a click when the injection starts.
• To release the full dose, hold the preloaded pen in place for 15 seconds AND wait until the blue indicator stops moving in the inspection window.

Remove the preloaded ClickJect penfrom the injection site by lifting it straight up. Once you have removed it from your skin, the transparent protector will close over the needle. Stop pinching the skin.

Proceed to Step 4

1. AFTER INJECTION

Take care of the injection site:

• You may see a small amount of bleeding at the injection site. You can press on the injection site with a cotton ball or swab.
• DO NOTrub the injection site.
• If necessary, you can cover the injection site with a small adhesive bandage.

Dispose of the used preloaded ClickJect penin the sharps container immediately after use. If you have any questions, ask your pharmacist.

• DO NOTput the cap back on the used pen

For more information on disposal, see the Leaflet.

If the injection is administered by a caregiver, this person should also handle the pen with care to avoid accidental needlestick injuries and possible infection transmission.

Keep the pen and sharps container out of the reach of children.

Record the date,time, and injection site.