Orencia 125 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ORENCIA 125 mg 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What ORENCIA is and what it is used for
2. What you need to know before using ORENCIA
3. How to use ORENCIA
4. Possible side effects
5. How to store 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 produced in cell cultures. ORENCIA reduces the immune system's attack on normal tissues by interfering with immune cells (so-called T-lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T-lymphocytes involved in the immune system's inflammatory response.

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

Rheumatoid arthritis

Rheumatoid arthritis is a progressive, long-term systemic disease which, if left untreated, can have serious consequences such as joint destruction, increasing disability, and inability to perform daily activities. In people with rheumatoid arthritis, the body's own immune system attacks normal tissues, causing 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, while others 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 that, even if you receive treatment and whether or not you have symptoms, RA may 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 do not respond adequately to treatment with other disease-modifying drugs or with another group of medicines called "tumour necrosis factor (TNF) inhibitors". It is used in combination with a medicine called methotrexate.

ORENCIA may also be used with methotrexate to treat progressive rheumatoid arthritis with high disease activity and no prior treatment with methotrexate.

ORENCIA is used to:

• slow down joint damage
• improve your physical function

Psoriatic arthritis

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

• reduce the signs and symptoms of your disease
• reduce damage to your bones and joints
• improve your physical function and your 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 using ORENCIA

Do not use ORENCIA

• if you are allergic to abatacept or to any of the other components of this medicine (listed in section 6).
• if you have a severe or uncontrolled infection, do not start treatment with ORENCIA. Having an infection may put you at risk of experiencing serious side effects from ORENCIA.

Warnings and precautions

Consult your doctor, pharmacist, or nurse:

• if you experience allergic reactions such as chest tightness, asthma, severe dizziness or lightheadedness, swelling or rash of the skin—inform your doctor immediately.
• if you, your partner, or caregiver notice a new onset or worsening of neurological symptoms, including general muscle weakness, vision disturbances, difficulty speaking, a change in the way you walk, or problems with balance, changes in thinking, memory, and orientation leading to confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare, serious, and potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML).
• if you have any type of infection, including a prolonged or localized infection, or if you frequently suffer from infections, or if you have symptoms of an infection (e.g., fever, feeling unwell, dental problems), it is important to inform your doctor. ORENCIA may reduce your body's ability to fight infections, and treatment may make you more susceptible to infections or worsen any existing infection.
• if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, fatigue, low-grade fever), inform your doctor. Before using ORENCIA, your doctor will perform a tuberculosis test or a skin test.
• if you have viral hepatitis, inform your doctor. Before using ORENCIA, your doctor may test you for hepatitis.
• if you have cancer, your doctor will decide whether ORENCIA can be administered to you.
• if you have recently been vaccinated or are planning to be vaccinated, inform your doctor. Some vaccines should not be given while you are being treated with ORENCIA. Consult your doctor before receiving any vaccine. Certain vaccines may cause infections. If you receive ORENCIA during pregnancy, your baby may have an increased risk of developing such an infection for approximately 14 weeks after your last dose. It is important that you inform your baby's doctors and other healthcare professionals about your use of ORENCIA during pregnancy so they can determine when your baby should receive any vaccine.

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

Children and adolescents

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

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

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

Use of ORENCIA with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

ORENCIA must not be used with biologic medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend concomitant use with anakinra and rituximab.

ORENCIA may be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or analgesics, including non-steroidal anti-inflammatory drugs like ibuprofen or diclofenac.

Seek advice from your doctor or pharmacist before taking any other medicine while using ORENCIA.

Pregnancy and breastfeeding

The effects of ORENCIA in pregnancy are unknown; therefore, you should not use ORENCIA if you are pregnant unless specifically advised by your doctor.

• If you are a woman of childbearing potential, you should use reliable contraceptive methods (birth control) while 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 an increased risk of infection. It is important that you inform your baby's doctors and other healthcare professionals about your use of ORENCIA during pregnancy before any vaccine is administered (for more information, see the vaccination section).

It is unknown whether ORENCIA passes into breast milk. You must stop breastfeeding if you are being treated with ORENCIA, up to 14 weeks after the last dose.

Driving and use of machines

ORENCIA is not expected to affect your ability to drive or operate machinery. However, if you feel tired or unwell after receiving ORENCIA, you should not drive or operate machinery.

ORENCIA contains sodium

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

3. How to use ORENCIA

Follow exactly the administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

ORENCIA injectable solution 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 weekly, regardless of body weight.

Your doctor may start your treatment with ORENCIA with or without a single dose of powder for concentrate for solution for infusion (administered intravenously, usually into the arm, over a 30-minute period). If you are given a single intravenous dose to initiate treatment, the first subcutaneous injection of ORENCIA should be administered within one day following the IV infusion, followed by weekly subcutaneous injections of 125 mg.

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

If you are already receiving treatment with intravenous ORENCIA and wish 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 which other medications, including other disease-modifying agents, if any, you may continue taking while on ORENCIA treatment.

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

Consult your doctor if you have any questions about administering the injection. Detailed instructions for the preparation and administration of ORENCIA can be found at the end of this leaflet (see “Important instructions for use”).

If you use more ORENCIA than you should

If this occurs, contact your doctor immediately. Your doctor will monitor you for any signs or symptoms of adverse reactions and treat them as necessary.

If you forget to use ORENCIA

Keep track of your next dose. It is very important to use ORENCIA exactly as directed by your doctor. If you miss your dose within three days of the scheduled date, administer the dose as soon as you remember, then continue with your original dosing schedule. If you miss your dose for more than three days, ask your doctor when you should take your next dose.

If you stop using ORENCIA

The decision to discontinue treatment with ORENCIA should be discussed with your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The most common adverse effects with ORENCIA are upper respiratory tract infections (including infections of the nose and throat), headache, and nausea. ORENCIA may cause serious adverse effects that may require treatment.

Possible serious adverse effects include serious infections, malignant neoplasms (cancer), and allergic reactions, as listed below.

Tell your doctor immediately if you notice any of the following symptoms:

• severe rash, hives, or other symptoms of allergic reaction
• swelling of the face, hands, or feet
• difficulty breathing or swallowing
• fever, persistent cough, weight loss, tiredness

Tell your doctor immediately if 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 adverse effects listed below, which have been observed with ORENCIA in clinical trials in adults:

List of adverse effects:

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

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

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

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

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

• dental infection, fungal nail infection, muscle infection, bloodstream infection, pus accumulation under the skin, kidney infection, ear infection
• low white blood cell count
• skin cancer, warts
• low platelet count in blood
• allergic reactions
• depression, anxiety, sleep disturbances
• migraines
• numbness
• dry eye, vision decrease
• eye inflammation
• palpitations, fast heartbeat, slow heartbeat
• low blood pressure, hot flushes, blood vessel inflammation, flushing
• 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, skin redness, excessive sweating, acne
• alopecia, pruritus, urticaria
• painful joints
• limb pain
• absence of menstruation, heavy periods
• flu-like syndrome, weight gain

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 packaging after CAD. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Do not use this medicine if the solution is cloudy or discolored, or if it contains large particles. The solution should be colorless to pale yellow.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused packaging and medicines. This helps protect the environment.

6. Package contents and other information

Composition of ORENCIA

• The active substance is abatacept.
• Each pre-filled pen contains 125 mg of abatacept in one ml.
• The other components are sucrose, poloxamer 188, monosodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, and water for injections (see section 2 "ORENCIA contains sodium").

Appearance of the product and contents of the pack

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

ORENCIA is available in the following pack sizes:

• • pack of 4 pre-filled pens and multiple pack of 12 pre-filled pens (3 packs of 4).

Only certain 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

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 the most recent revision of this leaflet:

Other sources of information

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

Important instructions for use. Read carefully.

HOW TO USE

ORENCIA (abatacept)
Pre-filled pen ClickJect
125 mg, injectable solution
for subcutaneous use

Read these instructions before using the pre-filled pen ClickJect.

Before using the ClickJect pen for the first time, ensure that your healthcare provider 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 Package Leaflet.

BEFORE YOU START

Get to know the pre-filled pen ClickJect

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

Before use

After use

Gather your injection supplies on a clean, flat surface
(only the pre-filled ClickJect pen is included in the pack):

• Alcohol swab
• Adhesive bandage
• Cotton ball or gauze
• Pre-filled ClickJect pen
• Sharps container

Proceed to Step 1

1. PREPARE YOUR CLICKJECT PEN

Allow your ClickJect pen to reach room temperature.

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

DO NOT remove the needle cap while allowing the pen to warm up.

Wash your hands thoroughly with soap and water before preparing for injection.

Inspect the pre-filled ClickJect pen:

• Check the expiry date printed on the label.

DO NOT use if the expiry date has passed.

• Check for pen damage.

DO NOT use if the pen is cracked or broken.

• Check the liquid through the viewing window. It should be clear to slightly yellow. An air bubble may be visible. There is no need to remove it.

DO NOT inject if the liquid is cloudy, has changed colour, or contains visible particles.

Proceed to Step 2

2. PREPARE FOR INJECTION

Choose an injection site, such as the abdomen or the front of the thigh.

You may use the same body area each week, but select a different injection site within that area.

DO NOT inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.

Gently clean the injection site with an alcohol swab and allow the skin to dry.

Remove the orange needle cap STRAIGHT OFF

• DO NOT twist the needle cap off.
• DO NOT replace the pen cap.

The cap may be disposed of in household waste after the injection.

• DO NOT use the pen if it is dropped after removing the cap.

It is normal to see a small drop of liquid at the needle tip.

Proceed to Step 3

3. INJECT YOUR DOSE

Place the ClickJect pen so that you can see the viewing window and hold it at a 90-degree angle to the injection site. With your other hand, gently pinch the cleaned area of skin.

COMPLETE ALL STEPS to deliver the full dose:

PUSH DOWN on the skin to unlock the pen.

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

• You will hear a click when the injection starts.
• To ensure complete dose delivery, keep the pre-filled pen in place for 15 seconds AND wait until the blue indicator in the viewing window stops moving.

Remove the pre-filled ClickJect pen by lifting it straight up from the injection site. Once removed from the skin, the clear shield will automatically close over the needle. Release the pinched skin.

Proceed to Step 4

4. AFTER THE INJECTION

Care for the injection site:

• Mild bleeding at the injection site may occur. You may apply gentle pressure with a cotton ball or gauze.
• DO NOT rub the injection site.
• If needed, you may cover the injection site with a small plaster.

Dispose of the used pre-filled ClickJect pen immediately into a sharps container. If in doubt, consult your pharmacist.

• DO NOT recap the used pen.

For further information on disposal, see the Package Leaflet.

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

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

Record the date, time, and injection site.