IDACIO 40 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Idacio 40 mg solution for injection in pre-filled syringe

adalimumab

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.
• Your doctor will give you a patient information card, which contains important safety information that you need to know before and during treatment with Idacio.

Keep this patient information card during your treatment and for 4 months after your last injection (or your child's) of Idacio.

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

Contents of the pack

1. What is Idacio and what is it used for
2. What you need to know before you use Idacio
3. How to use Idacio
4. Possible side effects
5. Storing Idacio
6. Package contents and further information
7. Instructions for use

1. What is Idacio and what is it used for

Idacio contains the active substance adalimumab, a medicine that works on the immune system (defence system) of your body.

Idacio is used to treat the following inflammatory diseases:

• rheumatoid arthritis,
• juvenile idiopathic polyarticular arthritis,
• enthesitis-related arthritis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn's disease,
• ulcerative colitis and
• non-infectious uveitis.

The active substance in Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target in the body.

The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is found in high levels in the inflammatory diseases described above. By attacking TNFα, Idacio blocks its action and reduces the inflammation process in these diseases.

Rheumatoid Arthritis

Rheumatoid arthritis is an inflammatory disease of the joints.

Idacio is used to treat rheumatoid arthritis in adults. If you have moderate to severe active rheumatoid arthritis, you may have been given other medicines that modify the disease, such as methotrexate, before. If the effect of these medicines is not sufficient, you will be given Idacio to treat your rheumatoid arthritis.

Idacio can also be used to treat severe, active and progressive rheumatoid arthritis without prior treatment with methotrexate.

Idacio can reduce the damage to the cartilage and bones of the joints caused by the disease and improve physical function.

Idacio is usually used in combination with methotrexate. If your doctor considers that methotrexate is not appropriate, Idacio can be given alone.

Juvenile Idiopathic Polyarticular Arthritis and Enthesitis-Related Arthritis

Juvenile idiopathic polyarticular arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually appear for the first time in childhood.

Idacio is used to treat juvenile idiopathic polyarticular arthritis in children and adolescents from 2 to 17 years of age and enthesitis-related arthritis in children from 6 to 17 years of age. Patients may have received other disease-modifying medicines, such as methotrexate, first. If the effect of these medicines is not sufficient, patients will receive Idacio to treat their juvenile idiopathic polyarticular arthritis or enthesitis-related arthritis.

Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases that affect the spine.

Idacio is used in adults to treat these diseases. If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will be treated first with other medicines. If the effect of these medicines is not sufficient, you will receive Idacio to reduce the signs and symptoms of your disease.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.

Idacio is used to treat psoriatic arthritis in adults. Idacio can reduce the joint damage caused by the disease in the cartilage and bone and improve physical function.

Plaque Psoriasis in Adults and Children

Plaque psoriasis is an inflammatory disease of the skin that causes red, scaly, crusty, and silvery-skinned areas. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift off the nail bed, which can be painful. It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in the production of skin cells.

Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio is also used to treat severe plaque psoriasis in children and adolescents from 4 to 17 years of age who have not responded or are not suitable for topical medicines or ultraviolet light treatment.

Hidradenitis Suppurativa in Adults and Adolescents

Hidradenitis suppurativa (also known as inverse acne) is a long-term and often painful inflammatory disease of the skin. Symptoms can include painful nodules (lumps) and abscesses (boils) that can secrete pus. It usually affects specific areas of the skin, such as under the breast, armpits, inner thighs, groin, and buttocks. There may also be scarring in the affected areas.

Idacio is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. Idacio can reduce the number of nodules and abscesses and the pain that is usually associated with this disease. You may have received other medicines first. If the effect of these medicines is not sufficient, you will receive Idacio.

Crohn's Disease in Adults and Children

Crohn's disease is an inflammatory disease of the intestine.

Idacio is used to treat Crohn's disease in adults and children from 6 to 17 years of age. If you have Crohn's disease, you will be treated first with other medicines. If you do not respond sufficiently to these medicines, you will receive Idacio to reduce the signs and symptoms of Crohn's disease.

Ulcerative Colitis in Adults and Children

Ulcerative colitis is an inflammatory disease of the large intestine.

Idacio is used to treat moderate to severe ulcerative colitis in adults and children from 6 to 17 years of age. If you have ulcerative colitis, you may be given other medicines first. If the effect of these medicines is not sufficient, you will be given Idacio to reduce the signs and symptoms of your disease.

Non-Infectious Uveitis in Adults and Children

Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.

• Inflammation can lead to a decrease in vision and/or the presence of floaters in the eye (black dots or thin lines that move along the field of vision). Idacio works by reducing this inflammation.

Idacio is used to treat:

• adults with non-infectious uveitis with inflammation that affects the back of the eye.
• children from 2 years of age with chronic non-infectious uveitis with inflammation that affects the front of the eye.

2. What you need to know before you start using Idacio

Do not use Idacio

• if you are allergic to adalimumab or to any of the other components of this medicine (listed in section 6).

• if you have a severe infection, including tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a weakened immune system). If you have symptoms of any infection, such as fever, wounds, fatigue, dental problems, it is important that you inform your doctor (see "Warnings and precautions").

• if you have moderate or severe heart failure. It is important that you tell your doctor if you have had or have any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Idacio.

Allergic reaction

• If you experience an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Idacio and contact your doctor immediately, as in rare cases, these reactions can be life-threatening.

Infection

• If you have any infection, including chronic or localized infections (such as a leg ulcer), consult your doctor before starting treatment with Idacio. If you are unsure, contact your doctor.

• With Idacio treatment, you may be more likely to get infections. This risk may be greater if you have reduced lung function. These infections can be more serious and include tuberculosis, viral, fungal, parasitic, or bacterial infections, or other unusual infectious organisms, and sepsis (blood infection). In rare cases, these infections can be life-threatening. For this reason, it is essential that if you have symptoms such as fever, wounds, fatigue, or dental problems, you inform your doctor. Your doctor may recommend temporarily stopping treatment with Idacio.

Tuberculosis (TB)

• Since cases of tuberculosis have been reported in patients treated with Idacio, your doctor will examine you for signs or symptoms of tuberculosis before starting your treatment with Idacio. This will include a thorough medical evaluation, including your medical history and diagnostic tests (such as chest X-ray and tuberculin test). The performance and results of these tests should be recorded on your patient information card. It is crucial that you inform your doctor if you have had tuberculosis or have been in contact with a tuberculosis patient. Tuberculosis can develop during treatment, even if you have received preventive treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever) or any other infection appear during or after treatment, contact your doctor immediately.

Travel/recurrent infection

• Tell your doctor if you have lived or traveled to regions where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

• Tell your doctor if you have a history of recurrent infections or other conditions or factors that increase the risk of infections.

Hepatitis B virus

• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection, or if you think you may be at risk of contracting HBV. Your doctor should perform an HBV test. Adalimumab may reactivate HBV infection in people carrying this virus. In rare cases, especially if you are taking other medications that suppress the immune system, reactivation of HBV infection can be life-threatening.

Patient over 65 years old

• If you are over 65 years old, you may be more susceptible to infections while being treated with Idacio. Both you and your doctor should pay special attention to the appearance of signs of infection while being treated with Idacio. It is essential that you inform your doctor if you have symptoms of infections, such as fever, wounds, feeling tired, or dental problems.

Surgical or dental interventions

• If you are going to have surgery or dental work, inform your doctor that you are taking Idacio. Your doctor may recommend temporarily stopping treatment with Idacio.

Demyelinating disease

• If you have or develop a demyelinating disease (a disease that affects the insulating layer surrounding nerves, such as multiple sclerosis), your doctor will decide whether you should be treated or continue treatment with Idacio. Inform your doctor immediately if you experience symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling in any part of the body.

Vaccines

• Certain vaccines contain live, attenuated forms of bacteria or viruses that cause diseases and should not be administered during treatment with Idacio if these vaccines can cause infections. Consult your doctor before administering any vaccine. If possible, it is recommended that children receive all established vaccines for their age before starting treatment with Idacio. If you receive Idacio while pregnant, your child may have a higher risk of infection during the 5 months following the last dose of Idacio you received during pregnancy. It is essential that you inform your child's doctor and other healthcare professionals about your use of Idacio during pregnancy, so they can decide whether your child should receive any vaccine.

Heart failure

• It is essential that you inform your doctor if you have had or have serious heart problems. If you have mild heart failure and are being treated with Idacio, your doctor should continuously monitor your heart failure. If new symptoms of heart failure appear or existing ones worsen (such as difficulty breathing or swelling of the feet), you should contact your doctor immediately.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce a sufficient number of the type of blood cells that fight infections (white blood cells) or those that help stop bleeding (platelets). If you have persistent fever, or suffer from bruising or bleeding easily, or are very pale, consult your doctor immediately. Your doctor may decide to interrupt treatment.

Cancer

• In very rare cases, certain types of cancer have been reported in children and adults treated with adalimumab or other TNFα blockers. People with more severe rheumatoid arthritis and who have had the disease for a long time may have a higher-than-average risk of developing lymphoma and leukemia (cancers that affect blood cells and bone marrow). If you are being treated with Idacio, the risk of lymphoma, leukemia, and other types of cancer may increase. A specific and severe type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also receiving treatment with azathioprine or mercaptopurine. Inform your doctor if you are taking azathioprine or mercaptopurine with adalimumab.

• Additionally, cases of non-melanoma skin cancer have been observed in patients using adalimumab. Inform your doctor if new damaged areas appear on your skin or if existing marks or damaged areas change in appearance during or after treatment.

• Cancers other than lymphoma have been reported in patients with a specific lung disease, called chronic obstructive pulmonary disease (COPD), treated with another TNFα blocker. If you have COPD or are a heavy smoker, you should consult your doctor to determine if treatment with a TNFα blocker is suitable for you.

Lupus-like syndrome

• Rarely, treatment with Idacio may cause a lupus-like syndrome. Contact your doctor if you experience symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

Children and adolescents

• Vaccination: if possible, your child should be up-to-date with all vaccines before using Idacio.
• Do not administer Idacio to children under 2 years old with juvenile idiopathic polyarticular arthritis.
• Do not use the 40 mg prefilled syringe or the 40 mg prefilled pen if doses other than 40 mg are recommended.

Other medicines and Idacio

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

Idacio can be taken with methotrexate or with certain disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold preparations), corticosteroids, or pain medications, including non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use Idacio with medicines whose active substances are anakinra or abatacept due to an increased risk of serious infections. The combination of adalimumab and other TNFα blockers and anakinra or abatacept is not recommended due to the possible increased risk of infections, including serious infections, and other potential pharmacological interactions. If you have any doubts, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You are advised to avoid becoming pregnant and should use adequate contraceptive methods during treatment with Idacio and continue their use for at least 5 months after the last administration of Idacio. If you become pregnant, you should contact your doctor.

Idacio should be used during pregnancy only if necessary.

According to a pregnancy study, there was no increased risk of congenital defects when the mother had received adalimumab treatment during pregnancy compared to mothers with the same disease who did not receive adalimumab treatment.

Idacio can be used during breastfeeding.

If you use Idacio while pregnant, your child may have a higher risk of infection.

It is essential that you inform your child's doctor and other healthcare professionals about your use of Idacio during pregnancy before your baby receives any vaccine (for more information, see the "Vaccination" section).

Driving and using machines

The influence of Idacio on the ability to drive, ride a bicycle, or use machines is small. You may experience dizziness and vision disturbances after using Idacio.

Idacio contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 0.8 ml dose, which is essentially "sodium-free".

3. How to use Idacio

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Idacio is injected under the skin (subcutaneously). Patients who need a dose less than 40 mg must use the 40 mg Idacio vial presentation.

The recommended dose of Idacio for each of the approved uses is shown in the following table.

Form and route of administration

Idacio is administered by subcutaneous injection.

For instructions for use, see section 7 "Instructions for use".

If you use more Idacio than you should

If you accidentally inject Idacio more frequently than you need, you should inform your doctor or pharmacist. Always carry the medicine box with you, even if it is empty.

If you forget to use Idacio

If you forget to administer an injection, you should inject the next dose of Idacio as soon as you remember. Then, the next dose will be administered as usual, as if you had not forgotten a dose.

If you stop treatment with Idacio

The decision to stop using Idacio should be discussed with your doctor. Your symptoms may return after stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Most adverse effects are mild to moderate. However, some can be serious and require treatment. Adverse effects may appear up to 4 months or more after the last injection of Idacio.

Seek medical attention urgentlyif you notice any of the following signs of allergic reaction or heart failure:

• severe rash, hives;
• swelling of the face, hands, feet;
• difficulty breathing, swallowing;
• shortness of breath when exercising or lying down, swelling of feet.

Contact your doctor as soon as possibleif you notice any of the following effects:

• signs and symptoms of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating;
• feeling of weakness or fatigue, cough;
• symptoms of nervous system problems such as tingling, numbness, double vision or weakness in arms or legs;
• signs of skin cancer such as a lump or an open sore that does not heal;
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness.

The following adverse effects have been observed with adalimumab:

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

• reactions at the injection site (including pain, swelling, redness, or itching);
• lower respiratory tract infections (including colds, runny nose, sinusitis, pneumonia);
• headache;
• abdominal pain (stomach);
• nausea and vomiting;
• rash;
• muscle pain.

Common(may affect up to 1 in 10 people)

• severe infections (including sepsis and flu);
• intestinal infections (including gastroenteritis);
• skin infections (including cellulitis and herpes);
• ear infection;
• mouth infections (including dental infection and cold sore);
• infections of the reproductive system;
• urinary tract infection;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• difficulty sleeping;
• sensory disturbances such as tingling, itching, or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• vertigo (feeling of spinning);
• feeling of rapid heartbeat;
• high blood pressure;
• flushing;
• bruises (a palpable swelling with clotted blood);
• cough;
• asthma;
• difficulty breathing;
• gastrointestinal bleeding;
• indigestion (heartburn, bloating, and discomfort);
• acid reflux;
• Sjögren's syndrome (including dry eyes and dry mouth);
• itching;
• itchy rash;
• bruises;
• skin inflammation (such as eczema);
• breaking of fingernails and toenails;
• increased sweating;
• hair loss;
• new or worsening psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (fluid accumulation in the body that causes swelling of the affected tissue);
• fever;
• low platelet count in blood, which increases the risk of bleeding or bruising;
• wound healing problems.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections) that occur when disease resistance decreases;
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• cancer, including cancer that affects the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin, and lymph nodes (most commonly as a disease called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• double vision;
• hearing loss, tinnitus;
• feeling of irregular heartbeat like skips;
• heart problems that can cause difficulty breathing or swelling of ankles;
• heart attack;
• aneurysm (a bulge in the wall of a major artery), inflammation, and blood clot in a vein, blockage of a blood vessel;
• lung diseases that can cause difficulty breathing (including inflammation);
• pulmonary embolism (blockage of a lung artery);
• pleural effusion (abnormal fluid accumulation in the pleural space);
• pancreatitis (inflammation of the pancreas that causes severe abdominal and back pain);
• difficulty swallowing;
• facial edema (swelling);
• gallbladder inflammation, gallstones;
• fatty liver (fat accumulation in liver cells);
• night sweats;
• scars;
• abnormal muscle crisis;
• systemic lupus erythematosus (an immune system disorder that includes skin, heart, lung, joint, and other organ inflammation);
• sleep disturbances;
• impotence;
• inflammations.

Rare(may affect up to 1 in 1000 people)

• leukemia (cancer that affects the blood and bone marrow);
• severe allergic reaction with shock;
• multiple sclerosis;
• nervous system disorders (such as optic neuritis and Guillain-Barré syndrome, a disease that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring in the lungs);
• intestinal perforation (hole in the intestinal wall);
• hepatitis (liver inflammation);
• reactivation of hepatitis B virus;
• autoimmune hepatitis (liver inflammation caused by the body's own immune system);
• cutaneous vasculitis (inflammation of blood vessels in the skin);
• Stevens-Johnson syndrome (a potentially life-threatening disease with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory rash on the skin);
• lupus-like syndrome;
• angioedema (localized skin inflammation);
• lichenoid skin reaction (purple-red itchy rash)

Frequency not known(cannot be estimated from the available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer);
• Merkel cell carcinoma (a type of skin cancer);
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple-colored skin lesions.
• liver failure;
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness).
• Weight gain (for most patients, weight gain was reduced)

Some adverse effects observed in clinical trials with adalimumab do not have symptoms and can only be identified through a blood test. These include:

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

• low white blood cell count;
• low red blood cell count;
• increased lipids in blood;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

• high white blood cell count;
• low platelet count;
• increased uric acid in blood;
• abnormal sodium levels in blood;
• low calcium level in blood;
• low phosphate level in blood;
• high blood sugar;
• high lactate dehydrogenase levels in blood;
• presence of autoantibodies in blood;
• low potassium level in blood.

Uncommon(may affect up to 1 in 100 people)

• elevated bilirubin levels (liver function test).

Rare(may affect up to 1 in 1000 people)

• low counts in blood for white blood cells, red blood cells, and platelets.

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 that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Idacio

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the label/box after "EXP". The expiration date is the last day of the month indicated.

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

Keep the pre-filled syringe in the outer packaging to protect it from light.

Alternative storage:

When necessary (e.g., when traveling), a single pre-filled syringe of Idacio can be stored at room temperature (up to 25°C) for a maximum period of 28 days (make sure to protect it from light). Once the pre-filled syringe is removed from the refrigerator to store at room temperature, it must be used within the next 28 days or discarded, even if it is then returned to the refrigerator.

You should record the date you removed the syringe from the refrigerator and the date after which it should be discarded.

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

6. Container Contents and Additional Information

Idacio Composition

• The active ingredient is adalimumab. Each prefilled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
• The other components are: Sodium dihydrogen phosphate dihydrate, Disodium phosphate dihydrate, Mannitol, Sodium chloride, Citric acid monohydrate, Sodium citrate, Polysorbate 80, Sodium hydroxide, and Water for injectable preparations.

Product Appearance and Container Contents

Idacio 40 mg injectable solution (injectable) in a prefilled syringe is presented as 0.8 ml of a sterile, colorless, and clear solution of 40 mg of adalimumab.

The Idacio prefilled syringe is presented in a glass syringe with a needle shield and finger grips. Each package contains 2 or 6 prefilled syringes and 2 or 6 alcohol swabs.

Idacio may be available in a vial, prefilled syringe, and prefilled pen.

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1

61352 Bad Homburg v.d.Höhe

Germany

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstraße 36,

8055 Graz

Austria

Date of Last Revision of this Leaflet

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

1. Instructions for Use

Make sure to read, understand, and follow these instructions for use before injecting Idacio. Your doctor should show you how to prepare and inject Idacio properly using the prefilled syringe before you use the medicine for the first time. Consult your doctor if you have any questions.

Read these instructions carefully before using your Idacio prefilled syringe.

Important Information

• Only use the Idacio prefilled syringe if your healthcare professional has taught you how to use the prefilled syringe correctly.

• Idacio is a single-use prefilled syringe.

• The Idacio prefilled syringe has a transparent needle shield that covers the needle after the injection is complete.

• Children under 12 years of age cannot inject themselves, and the injection must be performed by a trained adult.

• Keep the Idacio prefilled syringe and the sharps container out of the reach and sight of children.

• Do notshake. Shaking can damage the prefilled syringe and the medicine.

• Do notuse the Idacio prefilled syringe if the liquid looks cloudy or has changed color, or if it has particles or flakes. The liquid should be clear and colorless.

• Do nottry to activate the transparent needle shield before injecting.

• Do notput your fingers into the opening of the transparent needle shield.

• Do notuse an Idacio prefilled syringe that has been frozen or exposed to direct sunlight.

• Do notuse the Idacio prefilled syringe if it has been dropped or crushed, as the prefilled syringe may be broken even if you cannot see the break.

Use a new prefilled syringe instead.

Storage Information

• Keep the prefilled syringe in its original carton to protect it from light.

• Store the prefilled syringe in the refrigerator, between 2°C and 8°C.

• If necessary, for example, when traveling, a single prefilled syringe can be stored at room temperature for up to 28 days.

Familiarize yourself with your Idacio prefilled syringe

Before use

After use

Step 1: Prepare your injection

Each Idacio prefilled syringe carton comes with two or six syringes.

1. Prepare a flat and clean surface, such as a table or countertop, in a well-lit area.
2. You will also need (Figure A):

• an alcohol swab (included in the carton)
• a cotton ball or gauze, and
• a sharps container.

Open your sharps container so it is ready for use.

Figure A

1. Take the carton out of the refrigerator (Figure B).

1. Check the expiration date (EXP) (Figure B).

Warning: Do notuse if the expiration date has passed.

Figure B

1. Caution: Do notgrasp the syringe by the plunger or the needle shield. If you do, you might damage the syringe or activate the transparent needle shield.

Take a syringe out of the original carton:

• place two fingers on the center of the transparent needle shield
• pull the syringe up and out of the packaging (Figure C).

Put it on a flat and clean surface.

Figure C

1. Put the remaining syringes back in their original carton in the refrigerator (Figure D).

Refer to the storage information to know how to store your unused syringe(s).

Figure D

1. Let the syringe come to room temperature for 30 minutes before injection to allow it to warm up.

Injecting cold medicine can be painful (Figure E).

Figure E

Warning: Do notheat the syringe in any other way, such as in a microwave, hot water, or direct sunlight.

Warning: Do notremove the needle shield while the syringe is warming up to room temperature.

Step 2: Wash your hands

1. Wash your hands with soap and water and dry them well. (Figure F)

Warning:Gloves will not replace the need to wash your hands.

Figure F

Step 3: Check the prefilled syringe

1. Check the syringe to make sure:

• The syringe, transparent needle shield, and needle cap are not cracked or damaged (Figure G).

Figure G

• The needle shield is securely attached (Figure H).

Figure H

• The cap spring is not extended (Figure I).

Figure I

Warning: Do notuse the syringe if it shows any signs of damage.

If it does, discard the syringe in a sharps container and contact your doctor or pharmacist.

3.2Check the liquid to make sure that:

• The liquid is transparent, colorless, and free of particles (Figure J).

Warning:Do not use the syringe if the liquid contains particles, is cloudy, is colored, or has flakes.

Figure J

1. Check the label to make sure that:

• The name on the syringe says Idacio (Figure K).
• The expiration date on the syringe has not passed (Figure K).

Figure K

Warning: Do notuse the syringe if:

• The name on the syringe is not Idacio.
• The expiration date on the syringe has passed.

If it does, discard the syringe in a sharps container and contact your doctor or pharmacist.

Step 4: Choose the injection site

1. Choose an injection site (Figure L):

• On the front of the thighs.
• Abdomen (inject at least 5 centimeters away from the navel).

Figure L

4.2Choose a different site (at least 2.5 centimeters away from the last injection site) each time to reduce redness, irritation, or other skin problems.

Warning: Do notinject into an area that is painful (sensitive), bruised, red, hard, scarred, or has stretch marks.

Warning:If you have psoriasis, do notinject into any lesions or areas that are red, thickened, raised, or scaly.

Step 5: Clean the injection site

5.1Clean the skin at the injection site with an alcohol swab (Figure M)

Warning: Do notblow or touch the injection site after cleaning.

Figure M

Step 6: Apply your injection

6.1Remove the needle shield

• Always hold the syringe by the transparent needle shield.
• Hold the syringe upright and pull the needle shield straight off (Figure N).

Figure N

You may see drops of liquid on the tip of the needle.

• Discard the needle shield.

Warning: Do nottouch the needle.

6.2Pinch the skin

• Hold the syringe like you would hold a pen.
• With your other hand, gently pinch the skin (without squeezing) to avoid injecting into a muscle (Figure O).

Figure O

1. Insert the needle

• With a quick and straight motion, push the needle into the skin at an angle between 45° and 90° (Figure P).

Figure P

• After inserting the needle, release the pinched skin.

1. Inject

• Use your thumb to gently push the plunger down (Figure Q).

Figure Q

• Push the plunger again to make sure the full dose has been injected (Figure R).
• Hold the syringe firmly in place without moving it, at the same angle (Figure R).

Figure R

Do notremove the needle from the skin when the plunger reaches the end.

Slowly release your thumb upward.

This will allow the needle to move up into the transparent needle shield and cover the entire needle. (Figure S).

Figure S

Warning:Call your doctor or pharmacist if:

• The full dose was not injected or
• The transparent needle shield did not activate after the injection.

Warning: Do notreuse a syringe in case of partial injection.

Do notattempt to recap the needle, as you may stick yourself

1. If there is blood or liquid at the injection site, press a cotton ball or gauze gently onto the skin (Figure T).

Figure T

Step 7: Dispose of your syringe

7.1. Dispose of the used syringe in a sharps container immediately after use (Figure U).

Figure U

Warning:Keep the sharps container out of the reach of children.

Warning: Do notthrow the syringe away in household trash.

If you do not have a sharps container, you can use a household container that is:

• Made of heavy-duty plastic;
• Can be closed with a tight-fitting, puncture-resistant lid; this will prevent sharps from coming out,
• Upright and stable during use,

• Leak-resistant and
• Properly labeled to warn of hazardous waste inside the container.

7.2When your sharps container is almost full, you will need to follow local guidelines for the proper disposal of the container.

Do notrecycle your used sharps container.

Step 8: Record your injection

1. To help you remember when and where you should have your next injection, you should keep a record of the dates and injection sites used for your injections (Figure V).

Figure V