Patient Medication Information: uses, side effects, how to take - Idacio (Fresenius Kabi Canada, PM 00083255)

Serious Warnings and Precautions

Before starting, during and after treatment with Idacio, you/your child should be checked for active or inactive tuberculosis infection with a tuberculin skin test. Any medicine can have side effects. Like all medicines that affect your/your child’s immune system, Idacio can cause serious side effects. The possible serious side effects include:

Allergic reactions: If you/your child develop a severe rash, swollen face or difficulty breathing while taking Idacio, call your/your child’s doctor right away.
Hepatosplenic T-cell lymphoma: Very rare reports of hepatosplenic T-cell lymphoma (HSTCL), a rare serious lymphoma that is often fatal, have been identified in patients treated with adalimumab injection. Most patients had also been treated with other medications for Crohn’s disease and the majority were in adolescent and young adult males. The link between HSTCL and adalimumab injection is not clear.
Other cancers: There have been very rare cases of certain kinds of cancer in patients taking adalimumab injection or other TNF-blockers. Some patients receiving adalimumab injection have developed types of cancer called non-melanoma skin cancer. Tell your/your child’s doctor if you/your child have a bump or open sore that does not heal. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you/your child take Idacio or other TNF-blockers, your/your child’s risk may increase. There have been cases of lymphoma and other cancers, including unusual types, in children, adolescents and young adults taking TNF-blocking agents, including adalimumab injection, which sometimes resulted in death. For children and adults taking TNF-blocker medicines, the chances of developing lymphoma or other cancers may increase.
Lupus-like symptoms: Some patients have developed lupus-like symptoms that got better after their treatment was stopped. If you/your child have chest pains that do not go away, shortness of breath, joint pain or a rash on your/your child’s cheeks or arms that gets worse in the sun, call your/your child’s doctor right away. Your/your child’s doctor may decide to stop your/your child’s treatment.
Nervous system diseases: There have been rare cases of disorders that affect the nervous system of people taking adalimumab injection or other TNF-blockers. Signs that you/your child could be experiencing a problem affecting your/your child’s nervous system include: numbness or tingling, problems with your/your child’s vision, weakness in your/your child’s legs, and dizziness.
Serious infections: There have been rare cases where patients taking adalimumab injection or other TNF-blocking agents have developed serious infections. Some of these cases have been life-threatening. Such infections include tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis). Infection causes include tuberculosis, legionellosis (a serious form of bacterial pneumonia), listeriosis (an infection that usually develops after eating food contaminated by bacteria called listeria), and very rare cases of hepatitis B infection relapse.
Blood problems: In some instances, patients treated with TNF-blocking agents may develop low blood counts, such as anemia (low red blood cells) or low platelets. If you/your child develop symptoms such as persistent fever, bleeding, or bruising, you should contact your/your child’s doctor right away.

What is Idacio used for?

Idacio is a medicine that is used in:

adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
adults with ankylosing spondylitis, which is a form of arthritis.
adults with Crohn’s disease, which is an inflammatory disease of the digestive tract.
patients 2 years of age and older, weighing ≥ 30 kg, who have polyarticular juvenile idiopathic arthritis, which is an inflammatory disease affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years.
adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
adults or adolescents (12 to 17 years of age, weighing ≥30 kg) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
adults with psoriasis, which is an inflammatory disease of the skin. The doctor prescribed Idacio to reduce the signs and symptoms of your plaque psoriasis.
adults with uveitis, which is an inflammatory disease of the eye.
children with chronic non-infectious uveitis from 2 years of age weighing ≥ 30 kg, with inflammation affecting the front of the eye.

Patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, psoriasis, or uveitis may be given other medicines for their disease before they are given Idacio. If you have ulcerative colitis or you have Crohn’s disease, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Idacio to reduce the signs and symptoms of your/your child’s disease.

How does Idacio work?

Idacio is a fully human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognize and bind to other unique proteins. Idacio binds to a specific protein called TNF-alpha (also known as tumor necrosis factor). People with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa or psoriasis have too much of TNF-alpha in their bodies. The extra TNF-alpha in your/your child’s body can attack normal healthy body tissues and cause inflammation, especially in the tissues of your /your child’s bones, cartilage, joints, digestive tract and skin. By binding to TNF-alpha, Idacio decreases the inflammation process of these diseases.

Idacio helps reduce the signs and symptoms of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis (such as pain and swollen joints), may help improve your/your child’s ability to perform daily activities (such as getting dressed, walking and climbing stairs), and may help prevent further damage to your/your child’s bones and joints. In addition, Idacio helps reduce the signs and symptoms of ankylosing spondylitis (back pain and morning stiffness) and Crohn’s disease or ulcerative colitis (abdominal pain and diarrhea).

Idacio is also used to treat inflammatory lesions (nodules and abscesses) in adults and adolescents (12 to 17 years of age, weighing ≥30 kg) with hidradenitis suppurativa.

Idacio also helps reduce the signs and symptoms of psoriasis (such as pain, itching and scaly patches on skin).

Idacio helps control uveitis by reducing the risk of inflammation and loss of vision in adult and pediatric patients.

Idacio, however, can also lower your/your child’s body’s ability to fight infections. Taking Idacio can make you/your child more prone to getting infections or make any infection you/your child have worse.

What are the ingredients in Idacio?

Medicinal ingredients: adalimumab injection

Non-medicinal ingredients: glacial acetic acid, trehalose, polysorbate 80, sodium chloride, Sodium hydroxide and Water for Injection.

Idacio comes in the following dosage forms:

Single-use, 1 mL auto-injector containing 40 mg adalimumab injection in 0.8 mL sterile solution (50 mg/mL).
Single-use, 1 mL prefilled glass syringe containing 40 mg adalimumab injection in 0.8 mL sterile solution (50 mg/mL).

All packaging components do not contain natural rubber latex.

Do not use Idacio if:

You/your child should not take Idacio if you/your child have:

an allergy to any of the ingredients in Idacio (see What are the ingredients in Idacio? section).
a serious infection such as tuberculosis, infections caused by bacteria or fungi, and bacterial infections that have spread throughout the body (sepsis).
moderate to severe heart failure (NYHA class III/IV).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Idacio. Talk about any health conditions or problems you may have, including if you/your child:

have or have had any kind of infection including an infection that is in only one place in your/your child’s body (such as an open cut or sore), or an infection that is in your/your child’s whole body (such as the flu). Having an infection could put you/your child at risk for serious side effects from Idacio. If you are unsure, ask your/your child’s doctor.
have a history of infections that keep coming back or other conditions that might increase your/your child’s risk of infections, including fungal infections.
have ever had tuberculosis, or if you/your child have been in close contact with someone who has had tuberculosis. If you/your child develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your/your child’s doctor right away. Your/your child’s doctor will need to examine you/your child for tuberculosis and perform a skin test.
resided or travelled to areas where there is a greater risk for certain kinds of infections such as tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, or parasitic infections. These infections are caused by a bacteria or a fungus that can affect the lungs or other parts of your/your child’s body. If you/your child Idacio these may become active or more severe. If you don’t know if you/your child have lived in or travelled to an area where these infections are common, ask your/your child’s doctor.
have ever had liver injury or hepatitis B virus infection or are at risk of developing this infection. Signs and symptoms include the following: yellowing of the skin or eyes (jaundice), feeling of sickness, tiredness, loss of appetite, joint pain, fever, dark brown-colored urine, vomiting, and abdominal pain. If you/your child experience any of these signs and symptoms, contact your/your child’s doctor immediately. These symptoms may occur several months after starting therapy with Idacio.
experience any numbness or tingling or have ever had a disease that affects your/your child’s nervous system like multiple sclerosis or Guillain-Barré syndrome.
have or have had heart failure.
are scheduled to have major surgery or dental procedures.
are scheduled to be vaccinated for anything. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations according to current guidelines before starting Idacio.
are taking other medicines for your/your child’s rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, or other conditions. You/your child can take other medicines provided your/your child’s doctor has prescribed them or has told you/your child it is acceptable that you/your child take them while you/your child are taking Idacio. It is important that you tell your/your child’s doctor about any other medicines you/your child are taking for other conditions (for example, high blood pressure medicine) before you/your child start taking Idacio.
are taking any over-the-counter drugs, herbal medicines and vitamin and mineral supplements.
are pregnant or could become pregnant
are breast-feeding or plan to breast-feed.

If you/your child are not sure or have any questions about any of this information, ask your/your child’s doctor.

Other warnings you should know about:

If you/your child received Idacio while pregnant, your/her baby may be at higher risk for getting an infection for up to approximately five months after the last dose of Idacio received during pregnancy. It is important that you/she tell your/her baby's doctors and other healthcare professionals about your/her Idacio use during pregnancy so they can decide when your/her baby should receive any vaccine.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Idacio:

You/your child should not take Idacio with:

other TNF-blockers such as Enbrel®, Remicade®, Cimzia®, or Simponi®
abatacept (Orencia®)
anakinra (Kineret®)

If you/your child have questions, ask your/your child’s doctor.

How to take Idacio:

Idacio is administered by injection under the skin (by subcutaneous injection).

Usual dose:

Adults with Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis:

The recommended dose is 40 mg administered every other week as a subcutaneous injection.

Patients, aged 2 years and older, with polyarticular juvenile idiopathic arthritis:

weighing 30 kg or more: the recommended dose of Idacio is 40 mg every other week.

There is no dosage form of Idacio that allows weight-based dosing for pediatric patients who require less than a full 40 mg dose.

Adults with Crohn’s Disease or Ulcerative Colitis:

The recommended dose is 160 mg at Week 0, followed by 80 mg at Week 2 administered by subcutaneous injection. The first dose of 160 mg can be given in one day (four 40mg injections) or split over two consecutive days (two 40 mg injections each day). The second dose of 80 mg at Week 2 is given as two 40 mg injections in one day.
The recommended maintenance dose regimen is 40 mg every other week beginning at Week 4.

Adults with Hidradenitis Suppurativa:

The recommended initial dose is 160 mg, followed by 80 mg two weeks later administered by subcutaneous injection. The first dose of 160 mg at Week 0 can be given in one day (four 40 mg
- injections) or split over two consecutive days (two 40 mg injections). The second dose of 80 mg at Week 2 is given as two 40 mg injections in one day.
The recommended maintenance dose regimen is 40 mg every week beginning four weeks after the initial dose.

Adults with Psoriasis or Uveitis:

The recommended dose is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose administered by subcutaneous injection. The first dose of 80 mg can be given as two 40 mg injections.

Adolescents, 12 to 17 years of age weighing ≥30 kg, with Hidradenitis Suppurativa:

The recommended initial dose is 80 mg administered by subcutaneous injection, followed by 40 mg every other week starting one week later. Depending on your/your child’s response, the doctor may increase the dose to 40 mg every week.

Children, from 2 years of age with Uveitis:

weighing 30 kg or more: the usual dose of Idacio is 40 mg every other week with methotrexate. Your child’s doctor may also prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose.

There is no dosage form of Idacio that allows weight-based dosing for pediatric patients who require less than a full 40 mg dose.

Overdose:

If you think you, or a person you are caring for, have taken too much Idacio, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you/your child forget to give yourself/your child an injection, you/your child should inject the missed dose of Idacio as soon as you/your child remember. Then administer the next dose as you/your child would have on the originally scheduled date.

What are possible side effects from using Idacio?

These are not all the possible side effects you/your child may feel when taking Idacio. If you/your child experience any side effects not listed here, contact your/your child’s healthcare professional. Please also see Warnings and Precautions.

Like all medicines, Idacio can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment. Tell your/your child’s doctor immediately if you/your child experience any of the following:

severe rash, hives or other signs of allergic reaction
swollen face, hands, feet
trouble breathing, swallowing
sudden weight gain (this is possibly indicative of new or worsening heart failure)
bruising or bleeding very easily, looking very pale; this could mean a blood problem such as low red blood cells (anemia) or low platelets.

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

signs of infection such as fever, malaise, wounds, dental problems, burning on urination
feeling weak or tired
coughing
tingling
numbness
double vision
arm or leg weakness
arm or leg pain, swelling or redness
bump or open sore that does not heal
red scaly patches or raised bumps that are filled with pus (this could be new or worsening hidradenitis suppurativa, new or worsening psoriasis or a skin infection)
alopecia (loss of hair)
changes in the colour of the skin
changes in the colour of your/your child’s urine (dark or red)
worsening of the appearance of a scar
night sweats
weight loss
pain in the abdomen or chest

Serious side effects and what to do about them
Serious side effects and what to do about them
Symptom/effect	Talk with your healthcare professional	Stop taking drug and get immediate medical help
Symptom/effect	Talk with your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
VERY COMMON
Injection site reaction		√
COMMON
Cough and cold symptoms, including sore throat		√
Headache	√
Rash		√
Nausea		√
Pneumonia		√	√
Fever		√
Abdominal pain	√
UNCOMMON
Tuberculosis		√	√
Other serious infections		√	√
Nerve disorder		√	√
Appendicitis		√	√
Blood clots: abdominal pain, chest pain, leg or arm pain with redness and swelling		√	√
Bladder infection (painful urination)		√	√
Hepatitis [jaundice (yellow skin, dark urine), abdominal pain, tiredness]		√	√

If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, talk to your/your child’s healthcare professional.

General Advice About Prescription Medicines

Talk to your/your child’s doctor or other healthcare provider if you/your child have any questions about this medicine or your/your child’s condition. Medicines are sometimes prescribed for purposes other than those listed in a PATIENT MEDICATION INFORMATION leaflet. If you/your child have any concerns about this medicine, ask the doctor. The doctor or pharmacist can give you/your child information about this medicine that was written for health care professionals. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people. A toll-free information service is also available at 1-877-821-7724.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store between 2^oC and 8^oC (in a refrigerator) in the original carton until ready to use. DO NOT FREEZE. Protect from light. Refrigerated Idacio remains stable until the expiration date printed on the auto-injector or prefilled syringe. Do not use beyond the expiration date.

When needed, for example when you/your child are travelling, an Idacio auto-injector (pen) or prefilled syringe can be stored at room temperature (up to 25^oC/77^oF) for a single maximum period of 28 days – be sure to protect it from light.

Once taken out of the refrigerator for room temperature storage, an Idacio auto-injector (pen) or prefilled syringe must be used within 28 days, even if it is put back in the refrigerator. If not used within 28 days, the Idacio auto-injector (pen) or prefilled syringe must be discarded. You should record the date when the Idacio auto-injector (pen) or prefilled syringe is first removed from the refrigerator. Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.

Keep out of reach and sight of children.

If you want more information about Idacio:

Talk to your/your child’s healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database) the manufacturer’s website (https://www.fresenius-kabi.com/en-ca), or by calling 1-877-821-7724.

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100,

Toronto, ON M9W 0C8

Last Revised: 2026-01-21

Idacio is a trademark of Fresenius Kabi AG. Fresenius Kabi AG is a trademark of Fresenius SE.

Instructions for use:

^PrIdacio^®

adalimumab injection

40 mg/0.8 mL (50 mg/mL)

Sterile solution for Subcutaneous (SC) use

Single use Auto-injector (pen)

For your/your child’s protection, it is important that you follow these instructions.

Get Familiar with your Idacio Auto-injector (pen)

Step 1: Prepare for your injection

Each box of Idacio auto-injectors comes with two pens.

a) Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
b)
You will also need:
1. •
  an alcohol pad (not included in the box)
2. • a cotton ball or gauze, and
3. • a sharps disposal container.
c) Remove the box from the refrigerator.
d) Check the expiration date on the side of the box. Do not use if expiration date has passed.

e)
Take an auto-injector (pen) out of the original box:
1. • place two fingers on the label area
2. • pull the auto-injector (pen) straight up and out of the packaging (Fig. A).

Put it on a clean flat surface.

f)
Place the remaining auto-injector (pen) in its original box back in the refrigerator.
Refer to Storage Information for how to store your unused auto-injector (pen).

g) Leave the auto-injector (pen) at room temperature for 30 minutes to allow the medicine to warm up (Fig. B). Injecting cold medicine can be painful.

Do not warm the auto-injector (pen) any other way, such as in a microwave, hot water, or direct sunlight. Do not remove the needle cap while allowing syringe to reach room temperature.

Step 2: Wash your hands

Wash your hands well with soap and water and dry them. Gloves will not replace the need for washing hands.

Step 3: Check the auto-injector (pen)

a)
Check the transparent syringe housing to make sure that:
1. • The liquid is clear, colorless, and free of particles
2. • The glass syringe is not cracked or broken

Do not use the auto-injector (pen) if the liquid contains particles, or is cloudy or if it is colored, or has flakes in it or shows any sign of damage. If so, throw it away in a sharps disposal container and contact your healthcare Professional or pharmacist.

b)
Check the label to make sure that:
1. • The name on the auto-injector (pen) says Idacio (Fig. C).
2. • The expiration date on the auto-injector (pen) has not passed (Fig. C).

Do not use the auto-injector (pen) if the name on the label is not Idacio and/or the expiration date on the label has passed. If so, throw away the auto-injector (pen) in a sharps disposal container and contact your healthcare professional or pharmacist.

Step 4: Choose and clean the injection site

a)
Choose an injection site (Fig. D) on:
1. • Top of the thighs.
2. • Abdomen (inject at least 5 centimeters away from the belly button).
b) Choose a different site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.

Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have stretch marks. If you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches.

c) Wipe the skin of your injection site with an alcohol pad to clean it. Do not blow on or touch the injection site after cleaning.

Step 5: Give your Injection

a)
Remove the needle cap
1. • Hold the auto-injector (pen) upwards and pull the needle cap straight off (Fig. E).

You may see drops of liquid at the needle tip.

Throw away the needle cap.

Do not twist the cap. Do not recap the auto-injector (pen).

b)
Position the auto-injector (pen)
1. • Hold the auto-injector (pen) so that you can see the transparent syringe housing.
2. • Place your thumb above (not touching) the yellow injection button (Fig. F).

Place the auto-injector (pen) against your skin at a 90° angle (Fig. G).
Push and hold the auto-injector (pen) firmly against your skin until the safety guard is fully depressed. This will unlock the injection button.

c)
Administer the Injection
1. • Push the injection button (Fig. H). You will hear a loud click, which means the injection has started.
2. • Continue to HOLD the auto-injector (pen) firmly.
3. • WATCH the syringe plunger to make sure it moves all the way down to the bottom (Fig. H).

Do not lift the auto-injector (pen) from the skin until the plunger has moved all the way down and all the liquid has been injected.

When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Lift the auto-injector (pen) from your skin (Fig. I).
The safety guard will slide down and lock into place to protect you from the needle (Fig. I).

Call your healthcare professional or pharmacist if you have any problem.

d) If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin.

Step 6: Throw away your auto-injector (pen)

Throw away your used auto-injector (pen) in a sharps disposal container right away after use.

Step 7: Record your Injection

To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Fig. J).

Instructions for use: