This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use IDACIO 40 MG/0.8 ML INJECTABLE SOLUTION FOR PAEDIATRIC USE

Introduction

Package Leaflet: Information for the Patient

Idacio 40 mg/0.8 ml solution for injection for pediatric use

adalimumab

Read all of this leaflet carefully before your child starts 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 your child's treatment with Idacio.
Keep this patient information card for you or your child during treatment and for 4 months after the 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 your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
If your child experiences side effects, consult your doctor or pharmacist. This includes possible side effects not listed in this leaflet (see section 4).

Contents of the pack

What is Idacio and what is it used for
What you need to know before your child starts using Idacio
How to use Idacio
Possible side effects
Storage of Idacio
Contents of the pack and further information
Instructions for use

1. What is Idacio and what is it used for

Idacio contains the active substance adalimumab, a medicine that acts on the immune system (defense) of the body.

Idacio is indicated for the treatment of the following inflammatory diseases:

juvenile idiopathic polyarticular arthritis
arthritis associated with enthesitis
pediatric plaque psoriasis
hidradenitis suppurativa in adolescents
pediatric Crohn's disease
pediatric ulcerative colitis
pediatric 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 tumor necrosis factor (TNFα), which is found in high levels in the inflammatory diseases described above. By attacking TNFα, Idacio blocks its action and reduces inflammation in these diseases.

Juvenile idiopathic polyarticular arthritis and arthritis associated with enthesitis

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

Idacio is used to treat juvenile idiopathic polyarticular arthritis and arthritis associated with enthesitis. Your child may have first received other disease-modifying drugs, such as methotrexate. If the effect of these medications is not sufficient, your child will receive Idacio to treat their juvenile idiopathic polyarticular arthritis or arthritis associated with enthesitis.

Pediatric plaque psoriasis

Psoriasis is a skin disease that causes red, scaly, crusty, and silvery-scaled areas. 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 skin cell production.

Idacio is used to treat severe plaque psoriasis in children and adolescents between 4 and 17 years of age who have not responded, or are not good candidates for, topical medications or ultraviolet light therapy.

Hidradenitis suppurativa in adolescents

Hidradenitis suppurativa (also known as inverse acne) is a long-term and often painful inflammatory skin disease. 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 adolescents from 12 years of age. Idacio may reduce the number of nodules and abscesses your child has, and the pain normally associated with this disease. Your child may have received other medications previously. If the effect of these medications is not sufficient, your child will receive Idacio.

Pediatric Crohn's disease

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

Idacio is indicated for the treatment of Crohn's disease in children between 6 and 17 years of age. Your child may have first received other medications. If these medications do not respond well enough, your child will receive Idacio to reduce the signs and symptoms of their disease.

Pediatric ulcerative colitis

Ulcerative colitis is an inflammatory disease of the large intestine. Idacio is used to treat moderate to severe ulcerative colitis in children from 6 to 17 years of age. Your child may have first received other medications. If these medications do not respond well enough, your child will receive Idacio to reduce the signs and symptoms of their disease.

Pediatric uveitis

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

The 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 children from 2 years of age with chronic non-infectious uveitis with inflammation that affects the front part of the eye.

2. What you need to know before your child starts using Idacio

Do not use Idacio

if your child is allergic to adalimumab or any of the other components of this medicine (listed in section 6).

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

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

Warnings and precautions

Consult your child's doctor or pharmacist before starting to use Idacio.

Allergic reaction

If your child notices an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, discontinue the administration of Idacio and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infection

If your child has any infection, including chronic or localized infections (e.g., a leg ulcer), consult your doctor before starting treatment with Idacio. If you are unsure, contact your doctor.

With Idacio treatment, your child may be more likely to get infections. This risk may be higher if your child has 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. Therefore, it is essential that if your child has symptoms such as fever, wounds, fatigue, or dental problems, you tell your doctor. Your doctor may recommend temporarily discontinuing Idacio treatment.

Tuberculosis (TB)

Since cases of tuberculosis have been reported in patients treated with adalimumab, your child's doctor will examine your child for signs or symptoms of tuberculosis before starting treatment with Idacio. This includes a thorough medical evaluation, including your child's medical history and diagnostic tests (e.g., chest X-ray and tuberculin test). The performance and results of these tests should be recorded on your child's patient information card. It is crucial that you inform your doctor if your child has had tuberculosis or has been in contact with a tuberculosis patient. Tuberculosis can develop during treatment, even if your child has 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 your child has lived or traveled to areas where fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are common.

Tell your doctor if your child has a history of recurrent infections or other conditions or factors that increase the risk of infections.

Hepatitis B virus

Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), has active HBV infection, or thinks they may be at risk of getting HBV. Your child's doctor should perform an HBV test on your child. Adalimumab may reactivate HBV infection in people who carry this virus. In rare cases, especially if your child is taking other medications that suppress the immune system, reactivation of HBV infection can be life-threatening.

Symptoms of infections

It is essential that you tell your doctor if your child has symptoms of infections, such as fever, wounds, fatigue, or dental problems.

Surgical or dental interventions

If your child is going to have surgery or dental work, tell your doctor that they are taking Idacio. Your doctor may recommend temporarily discontinuing Idacio treatment.

Demyelinating disease

If your child has or develops a demyelinating disease (a disease that affects the protective covering of the nerves, such as multiple sclerosis), your doctor will decide whether your child should be treated or continue treatment with Idacio. Tell your doctor immediately if your child experiences 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, as they may cause infections. Consult your doctor before your child receives any vaccine. If possible, it is recommended that children receive all scheduled vaccinations for their age before starting treatment with Idacio. If your child receives Idacio while you are pregnant, your child may have a higher risk of getting infections during the 5 months following the last dose of Idacio they received during your pregnancy. It is essential that you tell 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 tell your doctor if your child has had or has serious heart problems. If your child has mild heart failure and is being treated with Idacio, your doctor should closely monitor their heart failure. If your child experiences new symptoms of heart failure or worsening of existing symptoms (e.g., difficulty breathing, swelling of their feet), they should contact their 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 help the body fight infections (white blood cells) or those that help stop bleeding (platelets). If your child has persistent fever, bruising, or bleeding easily, or is very pale, consult your doctor immediately. Your doctor may decide to discontinue 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 those 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 your child is being treated with Idacio, the risk of developing lymphoma, leukemia, and other types of cancer may increase. A specific and severe type of lymphoma has been observed in rare cases in patients treated with adalimumab. Some of these patients were also receiving treatment with azathioprine or mercaptopurine. Tell your doctor if your child is taking azathioprine or mercaptopurine with Idacio.

Additionally, cases of non-melanoma skin cancer have been observed in patients using adalimumab. Tell your doctor if new areas of damaged skin appear 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 certain lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker. If your child has COPD or is a heavy smoker, they should consult their doctor about whether treatment with a TNFα blocker is suitable for them.

Lupus-like syndrome

In rare cases, treatment with Idacio may lead to a lupus-like syndrome. Contact your doctor if you experience symptoms such as unexplained persistent rash, fever, joint pain, or fatigue.

Other medicines and Idacio

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

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

Your child should 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, 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 your daughter thinks she might be pregnant or plans to become pregnant, ask her doctor or pharmacist for advice before using this medicine.

Your daughter is advised to avoid becoming pregnant and to use adequate contraceptive methods during treatment with Idacio and to continue their use for at least 5 months after the last administration of Idacio. If your daughter becomes pregnant, she should contact her doctor.

Idacio should be used during pregnancy only if necessary.

According to a pregnancy study, there was no increased risk of congenital malformations 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 your daughter used Idacio during pregnancy, her child may have a higher risk of getting infections. It is essential that you tell your child's pediatrician or other healthcare professionals about your daughter's use of Idacio during pregnancy before the baby receives any vaccine (for more information on vaccines, 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. Dizziness and vision disturbances may occur 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 the administration instructions for this medication exactly as indicated by your child's doctor or pharmacist. In case of doubt, consult your child's doctor or pharmacist again. Your doctor may prescribe a different dose of Idacio if your child needs a different dose.

Idacio is injected under the skin (subcutaneously). A 40 mg pre-filled syringe and a 40 mg pre-filled pen are also available for use.

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

Juvenile idiopathic polyarticular arthritis
Age or body weight	Dose and frequency of administration	Notes
Children, adolescents, and adults from 2 years old who weigh 30 kg or more	40 mg every other week	Not applicable
Children and adolescents from 2 years old who weigh between 10 kg and less than 30 kg	20 mg every other week	Not applicable

Arthritis related to enthesitis
Age or body weight	Dose and frequency of administration	Notes
Children, adolescents, and adults from 6 years old who weigh 30 kg or more	40 mg every other week	Not applicable
Children and adolescents from 6 years old who weigh 15 kg and less than 30 kg	20 mg every other week	Not applicable

Pediatric plaque psoriasis
Age or body weight	Dose and frequency of administration	Notes
Children and adolescents from 4 to 17 years old who weigh 30 kg or more	Initial dose of 40 mg, followed by 40 mg one week later. After that, the usual dose is 40 mg every other week.	Not applicable
Children and adolescents from 4 to 17 years old who weigh between 15 kg and less than 30 kg	Initial dose of 20 mg, followed by 20 mg one week later. After that, the usual dose is 20 mg every other week.	Not applicable

Hidradenitis suppurativa

Age or body weight

Dose and frequency of administration

Notes

Adolescents from 12 years old to 17 years old who weigh 30 kg or more

Initial dose of 80 mg (as two 40 mg injections on one day), followed by 40 mg every other week starting one week later.

Depending on the response, your child's doctor may increase the dose to 40 mg weekly or 80 mg every other week.

It is recommended to use an antiseptic liquid daily on the affected areas.

Pediatric Crohn's disease
Age or body weight	Dose and frequency of administration	Notes
Children and adolescents from 6 to 17 years old who weigh 40 kg or more	Initial dose of 80 mg (as two 40 mg injections on one day), followed by 40 mg two weeks later. If a faster response is needed, your child's doctor may prescribe an initial dose of 160 mg (as four 40 mg injections on one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections on one day) two weeks later. After that, the usual dose is 40 mg every other week.	Depending on the response, your child's doctor may increase the dose to 40 mg weekly or 80 mg every other week.
Children and adolescents from 6 to 17 years old who weigh less than 40 kg	Initial dose of 40 mg, followed by 20 mg two weeks later. If a faster response is needed, your child's doctor may prescribe an initial dose of 80 mg (two 40 mg injections on one day), followed by 40 mg two weeks later. After that, the usual dose is 20 mg every other week.	Depending on the response, your child's doctor may increase the frequency of the dose to 20 mg weekly.

Pediatric ulcerative colitis
Age or body weight	How much and how often to take	Notes
Children and adolescents from 6 to 17 years old who weigh 40 kg or more	Initial dose of 160 mg (four 40 mg injections on one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections on one day) two weeks later. After that, the usual dose is 80 mg every other week.	Patient who turn 18 years old while receiving treatment with 80 mg every other week should continue with their prescribed dose.
Children and adolescents from 6 to 17 years old who weigh less than 40 kg	Initial dose of 80 mg (two 40 mg injections per day), followed by 40 mg (one 40 mg injection) two weeks later. After that, the usual dose is 40 mg every other week.	Patient who turn 18 years old while receiving treatment with 40 mg every other week should continue with their prescribed dose.

Pediatric uveitis
Age or body weight	Dose and frequency of administration	Notes
Children and adolescents from 2 years old who weigh less than 30 kg	20 mg every other week	Your child's doctor may prescribe an initial dose of 40 mg that can be administered one week before the start of the usual dose. It is recommended to use Idacio in combination with methotrexate.
Children and adolescents from 2 years old who weigh 30 kg or more	40 mg every other week	Your child's doctor may prescribe an initial dose of 80 mg that can be administered one week before the start of the usual dose. It is recommended to use Idacio in combination with methotrexate.

Form and route of administration

Idacio is injected 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 a larger amount of Idacio or if you inject Idacio more frequently than prescribed by your doctor, inform your child's doctor that your child has taken more medication. Always carry the medicine box with you, even if it is empty.

If you use less Idacio than you should

If you accidentally inject a smaller amount of Idacio, or if you inject Idacio less frequently than prescribed by your doctor, you should inform your child's doctor that your child has taken less medication. Always carry the medicine box with you, even if it is empty.

If you forget to use Idacio

If you forget to give your child an injection, you should inject the dose of Idacio as soon as you remember. Then, your child's next dose will be administered as usual, as if no dose had been missed.

If your child stops treatment with Idacio

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some can be serious and require treatment. Side 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 when 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 side 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 pain);
nausea and vomiting;
rash;
muscle pain.

Common(may affect up to 1 in 10 people)

serious 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 infections;
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, prickling, 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 that the room is spinning);
feeling of rapid heartbeat;
high blood pressure;
flushing;
bruising (a palpable swelling with clotted blood);
cough;
asthma;
difficulty breathing;
gastrointestinal bleeding;
indigestion (indigestion, bloating, and heartburn);
acid reflux;
Sjögren's syndrome (including dry eyes and dry mouth);
itching;
pruritic rash;
bruising;
skin inflammation (such as eczema);
breaking of fingernails and toenails;
increased sweating;
hair loss;
new onset or worsening of psoriasis;
muscle spasms;
blood in urine;
kidney problems;
chest pain;
edema (fluid accumulation in the body that causes swelling of the affected tissue);
fever;
decrease in 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 frequently as a disease called sarcoidosis);
vasculitis (inflammation of blood vessels);
tremors;
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 (balloon in the wall of a major artery), inflammation, and clotting in a vein, blockage of a blood vessel;
lung diseases that can cause difficulty breathing (including inflammation);
pulmonary embolism (blockage of a pulmonary 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;
fat in the liver (accumulation of fat in liver cells);
night sweats;
scars;
abnormal muscle crisis;
systemic lupus erythematosus (an immune system disorder that includes inflammation of the skin, heart, lungs, joints, and other organs);
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 wall of the intestine);
hepatitis (inflammation of the liver);
reactivation of hepatitis B virus;
autoimmune hepatitis (inflammation of the liver 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 rash with itching)

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 occurs more frequently as purple-colored skin lesions
liver failure;
worsening of a disease called dermatomyositis (seen as a skin rash accompanied by muscle weakness)
Weight gain (for most patients, weight gain was reduced)

Some side 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 side effects

If your child experiences any side effects, consult with your child's doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Idacio

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/carton after "EXP". The expiry date is the last day of the month shown.

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

Keep the vial in the outer packaging to protect it from light.

When necessary (e.g., when traveling), you can store Idacio at room temperature (up to 25°C) for a maximum period of 28 days (make sure to protect it from light). Once the vial has been removed from the refrigerator to store at room temperature, it must be used within the next 28 days or discarded, even if it is put back in the refrigerator later.

You should note the date when you removed the vial 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 medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Idacio Composition

The active ingredient is adalimumab. Each vial 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 (injection) for pediatric use is supplied as 0.8 ml of a sterile, colorless, and clear solution of 40 mg of adalimumab.

Idacio 40 mg/0.8 ml injectable solution for pediatric use is supplied in a glass vial. Each container contains 1 vial (0.8 ml of sterile solution), 1 sterile syringe, 1 sterile needle, 1 vial adapter, and 2 alcohol swabs.

Idacio may be available in a vial, pre-filled syringe, and pre-filled 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.

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 using the vial kit before you use the medicine for the first time. Consult your doctor if you have any questions.

Idacio Vial Kit with medicinal vial of adalimumab and pre-filled syringe for 40mg/0.8ml subcutaneous injection

Note: Images are for illustrative purposes only.

Read these instructions carefully before using your Idacio Vial Kit.

Important Information

Only use the Idacio Vial Kit if your healthcare professional has taught you how to use it correctly.
The Idacio Vial Kit is for single use.
Children cannot inject themselves, and the injection must be performed by a trained adult.
Keep all components of the Idacio Vial Kit and the sharps container out of the reach and sight of children.
Do notshake the syringe or vial. Shaking can cause damage.
Contact your doctor or pharmacist if you have any questions or need help.

Storage Information

Keep the Idacio Vial Kit in its original box to protect it from light.
Store the Idacio Vial Kit in the refrigerator, between 2°C and 8°C.
If necessary, for example, when traveling, the Idacio Vial Kit can be stored at room temperature for up to 28 days.

Step 1: Gather Materials and Check for Damage

1.1Remove the Idacio Vial Kit from the refrigerator.

Hand opening a white box with an arrow pointing to an open medical refrigerator with shelves and compartments

1.2Let the kit stand at room temperature for at least 30 minutes to allow the medicine to reach room temperature.

Injecting cold medicine can be painful.

Circular clock showing the number 30 with the word

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

1.3Open the kit and remove all components, placing them on a clean, dry, and flat surface. Check the components to ensure that the packaging and contents are not damaged.

Transparent medicine vial with label and transparent plastic vial adapter with white base

Alcohol swabs inside a sealed and rectangular transparent plastic wrapper

Medical needle with removable transparent protector showing the metal tip and white plastic body

Pre-filled transparent syringe with clear liquid and visible numerical graduations inside the cylinder

Warning: Do notuse if damaged.

1.4In addition to the components included in the kit, you will also need:

A cotton ball or clean gauze, and
A sharps container (see section 7.2).

Open the sharps container so it is ready for use.

Gray pharmaceutical waste container with white cotton balls and wet wipes next to it

1.5Review your injection records to determine the injection site for this session.

Hand holding a black pen over a sheet of paper with horizontal white lines

Step 2: Prepare the Vial

2.1Wash your hands with water and soap and dry them well.

Hands washing under a curved metal faucet in a stainless steel sink

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

2.2Check the vial label to ensure it contains Idacio and the expiration date.

Idacio medicine vial with label showing expiration date and batch number inside explanatory circles

Warning: Do notuse the vial if:

The vial name is not Idacio.
The vial expiration date has passed.

2.3Check the liquid to ensure that:

The liquid is clear, colorless, and free of particles.

Idacio medicine vial with batch information and expiration date next to a representation of a human eye

Warning: Do notuse the vial if the liquid is cloudy, colored, or has particles or flakes.

2.4Gently remove the yellow cap from the vial.

Hands holding a transparent vial and a gray vial adapter preparing for use

2.5Clean the top of the vial with an alcohol swab and discard it.

Hands holding a vial and preparing to remove the protective cover of a connected needle

Warning: Do nottouch the top of the vial after cleaning.

2.6Remove the paper packaging from the vial adapter without removing the adapter from its packaging.

Hands applying a transparent and circular transdermal patch over a white plastic protective pad

Warning: Do nottouch the vial adapter.

2.7With the vial adapter still in its packaging, push the adapter onto the vial until it clicks into place.

Hands holding an injection device with a visible needle and a vial of medicine below with an arrow indicating direction

2.8Hold the vial and lift the packaging. To ensure the adapter remains on top of the vial, hold the packaging by the outer edge.

Hands holding an insulin applicator and a pen needle with an arrow indicating the direction of insertion

Step 3: Prepare the Syringe

Transparent syringe with visible plunger and numerical graduations, showing the tip and body labeled with arrows

3.1Open the syringe packaging and grasp the syringe by the body.

Hand holding a transparent auto-injector with a white button pressed for medication administration

Warning: Do nottouch the syringe tip.

3.2Hold the vial adapter firmly, insert the syringe tip into the vial adapter, and twist to connect.

Hands holding a syringe and a transparent vial with liquid, curved arrow indicates vial rotation

3.3Turn the vial upside down so that it is vertical with the syringe still connected.

3.4Hold the vial and syringe in a vertical position and slowly pull the plunger to the prescribed dose.

Hand holding a syringe with a needle inserted into the skin, black arrow indicates direction of injection, subcutaneous administration technique

Warning:If the plunger is pulled out completely, discard the syringe.

Do notattempt to reinsert it and use a new kit.

3.5Slowly push the plunger to the bottom to reintroduce the medicine into the vial.

This is done to eliminate air pockets or bubbles.

Transparent syringe with liquid and milliliter scale, focus on 01, 02, 03, and 04 marks, held by a hand

Again, slowly pull the plunger to the prescribed dose and stop.

If there are still air pockets or bubbles in the syringe tip, repeat this step until the air pockets or bubbles have disappeared. Do not shake the syringe.

Warning: Do notuse the syringe if there is a large amount of air in it.

3.6Turn the vial and syringe, hold the vial adapter firmly, and unscrew the syringe from the vial adapter.

Pre-filled needle connecting to an applicator with a circular arrow indicating the direction of fixation

3.7Place the syringe on a clean and flat surface.

Warning: Do nottouch the syringe tip.

Warning: Do notdiscard the vial in the trash.

Step 4: Prepare the Needle

Safety Cover

Needle with transparent cap and yellow connector, textured needle protector for finger pointing to specific parts

4.1Open the needle packaging to expose the yellow connector of the syringe.

Hands holding and opening a blister pack with two visible capsules inside

Warning: Do notremove the needle from its packaging.

Warning: Do nottouch the yellow connector.

4.2Insert the syringe tip into the yellow connector and twist the syringe as indicated by the arrow in the drawing until it is secure.

Hand holding a pre-filled syringe twisting to mix the transparent medicine with the lyophilized component

4.3Remove the needle packaging

Warning: Do notremove the transparent needle protector.

4.4Pull the pink safety cap backward toward the syringe.

Hand holding an auto-injector with an exposed needle and a curved arrow indicating the direction of insertion

Warning: Do notseparate the pink safety cap from the yellow connector.

4.5Place the syringe on a clean and flat surface.

Step 5: Prepare the Injection

5.1Choose an injection site:

On the front of the thighs

Lower abdomen (inject at a minimum distance of 5 centimeters from the navel).

Human torso showing areas for applying medicinal patches on the abdomen, left hip, and thighs

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

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

5.2Clean the injection site with an alcohol swab and discard it.

Hand applying a white medicinal patch over smooth and clear skin possibly on the arm or abdomen

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

5.3Remove the transparent needle protector by pulling it outward and discard it.

Hand holding a syringe with a connected needle and another hand holding a white safety device on the plunger

Warning: Do notattempt to replace the transparent needle protector.

5.4Hold the syringe like a pencil with the pink safety cap pointing upward.

Hand holding a syringe with a needle inserted into a transparent and white needle safety device

Step 6: Administer the Injection

6.1With your other hand, gently pinch a clean skin fold and hold it.

Hand holding and pressing a white oval device over clear human skin

Warning: Do nottouch the area where you want to inject.

6.2With a quick and short motion, push the needle into the skin at a 45° angle.

Hand holding a syringe with a needle inserted into the skin at 45 degrees, arrow indicates angle of injection and raised skin

Note:With experience, you will find the angle (between 45° and 90°) that is most comfortable for you and the child.

6.3Slowly push the plunger downward until the syringe is empty.

Hand holding a syringe with a needle inserted into the skin, another hand pinching the injection area showing administration angle

6.4Remove the needle from the skin, taking care to pull it out at the same angle it was inserted. Then release the pinched skin.

6.5Place your thumb or index finger on the textured needle protector for the finger and push the safety cap forward over the needle until you hear or feel it click into place.

Auto-injector device with two views showing the pressed button and the extended needle for subcutaneous injection

6.6The needle is now covered and is safe. It can now be discarded in the sharps container.

Warning:Contact your doctor or pharmacist if the full dose was not injected.

6.7If there is blood or liquid at the injection site, gently press a cotton ball or clean gauze over the skin for 10 seconds.

Hand pressing a white cotton ball over the skin after an injection or puncture in the arm

Warning: Do notrub the injection site.

Step 7: Record the Injection and Dispose of Components

7.1Now that you have completed your injection, update your record with:

the injection site
the date
any problems you had
the batch number (on the vial label).

Hand holding a black pen over a sheet of paper with white lines ready to write

7.2Discard the used syringe with the protected needle and the vial with the attached vial adapter in a sharps container.

Syringe with needle descending into a white circular filter inside a gray square container

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

Warning: Do notstore any unused medicine.

Warning: Do notthrow the syringe or vial in the household trash.

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

Made of sturdy plastic;
Can be closed with a tight and puncture-resistant lid; that will prevent the sharps from coming out,
Vertical and stable during use,
Leak-resistant and
Properly labeled to warn of the hazardous waste inside the container.

7.3When your sharps container is almost full, you will need to follow local recommendations for the proper disposal of the container.

Warning: Do notrecycle your used sharps container.

IDACIO 40 MG/0.8 ML INJECTABLE SOLUTION FOR PAEDIATRIC USE