Idacio (Fresenius Kabi Canada, PM 00076425): Uses, Side Effects and Dosage

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

• 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.

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Step 1: Prepare for your injection

Each box of Idacio prefilled pens comes with two pens.

1. a) Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
2. 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.
3. c) Remove the box from the refrigerator.
4. d) Check the expiration date on the side of the box. Do not use if expiration date has passed.

1. e)

   Take a prefilled pen out of the original box:

   1. • place two fingers on the label area
   2. • pull the prefilled pen straight up and out of the packaging (Fig. A).

Put it on a clean flat surface.

1. f)

   Place the remaining prefilled pen in its original box back in the refrigerator.

   Refer to Storage Information for how to store your unused prefilled pen.

1. g) Leave the prefilled 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 prefilled 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 prefilled pen

1. 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 prefilled 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.

1. b)

   Check the label to make sure that:

   1. • The name on the prefilled pen says Idacio (Fig. C).
   2. • The expiration date on the prefilled pen has not passed (Fig. C).

Do not use the prefilled 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 prefilled pen in a sharps disposal container and contact your healthcare professional or pharmacist.

Step 4: Choose and clean the injection site

1. 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).

1. 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.

1. 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.

1. a)

   Remove the needle cap

   1. • Hold the prefilled 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 prefilled pen.

1. b)

   Position the prefilled pen

   1. • Hold the prefilled 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 prefilled pen against your skin at a 90° angle (Fig. G).
• Push and hold the prefilled pen firmly against your skin until the safety guard is fully depressed. This will unlock the injection button.

1. 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 prefilled 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 prefilled 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 prefilled 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.

1. 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 prefilled Pen

Throw away your used prefilled 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).

Get Familiar with your Idacio Prefilled Syringe

Step 1: Prepare for your injection

Each box of Idacio prefilled syringe comes with two syringes

1. a) Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
2. b) You will also need an alcohol pad (not included in the box), a cotton ball or gauze, and a sharps disposal container.

Open your sharps disposal container so it is ready to use.

1. c) Remove the box from the refrigerator.
2. d) Check the expiration date on the side of the box. Do not use if expiration date has passed.
3. e) Do not pick up the syringe by the plunger or the needle cap. Doing so could damage the syringe or activate the clear needle guard.

Take a syringe out of the original box:

• place two fingers on middle of the clear needle guard
• pull the syringe straight up and out of the packaging (Fig. A).

Put it on a clean flat surface.

1. f) Place the remaining syringe in its original box back in the refrigerator. Refer to Storage information for how to store your unused syringe.

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

Do not warm the syringe 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 Syringe

1. a)

   Check the syringe to make sure that:

   1. • The syringe, the clear needle guard, and the needle cap are not cracked or damaged (Fig. C).
   2. • The needle cap is securely attached (Fig. D).
   3. • The needle guard spring is not extended (Fig. E).

Do not use the syringe if it shows any sign of damage. If so, throw away the syringe in a sharps disposal container and contact your healthcare professional or pharmacist.

1. b) Check the liquid to make sure that the liquid is clear, colorless, and free of particles. Do not use the syringe if liquid contains particles, or is cloudy or if it is colored or has flakes in it.

1. c)

   Check the label to make sure that:

   1. • The name on the syringe says Idacio (Fig. F).
   2. • The expiration date on syringe has not passed (Fig. F).

Do not use the syringe if:

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

If so, throw away the syringe in a sharps disposal container and contact your healthcare professional or pharmacist.

Step 4: Choose, clean the injection site

1. a)

   Choose an injection site (Fig. G) on:

   1. • Top of the thighs.
   2. • Abdomen (inject at least 5 centimeters away from the belly button).

1. 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.
2. 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

1. a)

   Remove the needle cap

   1. • Always hold the syringe by the clear needle guard.
   2. • Hold the syringe upward and pull the needle cap straight off (Fig. H).

You may see drops of liquid at the needle tip.

Throw away the needle cap. Do not touch the needle.

1. b)

   Pinch the skin

   1. • Hold the syringe like a pencil.
   2. • With your other hand gently pinch skin (without squeezing) to avoid injecting into a muscle (Fig. I).

1. c)

   Insert the needle

   1. • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Fig. J).
   2. • After the needle is inserted, release the pinched skin.

1. d) Inject: Use your thumb to gently push plunger all the way down (Fig. K).

• Give plunger a final push to ensure the full dose has been injected (Fig. L).
• Hold the syringe firmly without moving it, at the same angle (Fig. L).

Do not remove the needle from the skin when the plunger reaches the end.

Slowly release your thumb up. This will allow the needle to move up into the clear needle guard and cover the entire needle (Fig. M).

Call your healthcare professional or pharmacist if you did not inject the full dose or the clear needle guard does not activate after injecting. Do not reuse a syringe in case of partial injection. Do not try to recap needle as it could lead to needle stick injury.

1. e) 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 Syringe

Throw away your used syringe 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.

Step 1: Gather supplies and check for damages

1. a) Remove the Idacio Vial Kit from the refrigerator.

Check the expiration date on the side of the box. Do not use if the expiration date has passed.

1. b) Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up. Injecting cold medicine may be painful (Fig. A).

Do not warm the kit any other way, such as in a microwave, hot water, or direct sunlight.

1. c) Open the kit and take out all components and put them on a clean, dry, flat surface. Check components to make sure that the packaging and the content are not damaged (Fig. B).

Do not use if damaged.

1. d)

   You will also need following supplies that are not included in the kit:

   1. • A clean cotton ball or gauze, and
   2. • A sharps container

• Alcohol pads

Open your sharps container so it is ready.

1. e) Check your records for injection dates and injection sites to figure out the injection site for this session.

Step 2: Wash your hands

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

Gloves do not replace the need for washing hands.

Step 3: Prepare your vial

1. a) Check the label on the vial for Idacio and expiration date

Do not use the vial if:

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

1. b) Check the liquid to make sure that:

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

Do not use the vial if the liquid is cloudy, colored or has particles or flakes in it.

1. c) Gently remove the yellow cap from the vial (Fig. C).

1. d) Wipe the entire vial top with an alcohol pad and throw the pad away. Do not touch the top of the vial after cleaning.

1. e) Peel off the paper from the vial adapter packaging without taking the vial adaptor out of its packaging (Fig. D).

Do not touch the vial adapter

1. f) With the vial adapter still in its packaging, push the vial adapter onto the vial top until it snaps in place (Fig. E).

1. g) Hold the vial and lift the packaging off. To ensure the adapter remains on top of the vial, hold the packaging by the outer rim (Fig. F).

Step 4: Prepare Syringe

1. a)

   Peel open the syringe packaging and grab the syringe by the barrel (Fig. H).

   Do not touch the syringe tip.

1. b) Hold the vial adapter, insert the syringe tip into it and screw to connect (Fig. I).

1. c) Turn the vial upside down so it is vertical with the syringe still attached.
2. d) Keep the vial and syringe vertical and slowly pull the prescribed dose.

If the plunger rod is pulled completely out, throw away the syringe.

Do not try to reinsert it and use a new kit.

1. e)

   Slowly push the plunger rod all the way in to push the medicine back into the vial. This is to remove any air gaps or bubbles.

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

If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone (Fig. K).

Do not shake the syringe.

Do not use the syringe if there is a large amount of air in the syringe.

1. f) Turn over the vial and syringe, firmly hold the vial adapter and unscrew the syringe from the vial adapter (Fig. L).
2. g) Place the syringe on a clean, flat surface.

Do not touch the syringe tip.

Do not throw the vial away.

Step 5: Prepare Needle

1. a) Peel open the needle packaging to uncover the yellow syringe connector (Fig. N).

Do not take the needle out of its packaging.

Do not touch the yellow connector.

1. b) Insert the syringe tip into the yellow syringe connector and screw to connect.
2. c) Pull the needle packaging off. Do not remove the clear needle cap (Fig. O).

1. d)

   Pull back the pink needle safety cover toward the syringe (Fig. P).

   Do not detach the pink needle safety cover from the yellow connector.

2. e) Place the syringe on a clean, flat surface

1. a)

   Choose an injection site on (Fig. Q):

   1. • Top of the thighs or
   2. • Lower stomach area (inject at least 5 centimeters away from the belly button).

Choose a different injection 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 there are stretch marks.

1. b) Clean the injection site with an alcohol pad and throw the pad away. Do not blow on or touch the injection site after cleaning.

1. c)

   Remove the clear needle cap by pulling it straight off and throw it away (Fig. R).

   Do not try to put the needle cap back on the needle.

1. d) Hold the syringe like a pencil with the pink needle safety cover pointing up (Fig S)

Step 7: Give Injection

1. a) With the other hand, gently pinch a fold of cleaned skin and maintain it (Fig. T).

Do not touch where you aim to inject.

1. b) With a quick, short motion, push the needle into the skin at an angle of 45° (Fig. U).

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

1. c) Gently push the white plunger rod all the way down until the syringe is empty (Fig. V).

1. d) Remove the needle from the skin, being careful to pull it out at the same angle that it was inserted. Then release the pinched skin.

1. e) Center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it locks (Fig W).

1. f) The needle is now covered and is safe. It can now be thrown away in the sharps container (Fig. X).

Call your healthcare professional if you did not inject the full dose.

1. g) If there is blood or liquid on the injection site, gently press a clean cotton ball or gauze on the skin for 10 seconds.

Step 8: Record injection and dispose components

1. a)

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

   1. • the injection site
   2. • the date
   3. • any issue you had
   4. • the lot number (on vial label).
2. b) Throw away the used syringe with the protected needle and the vial with attached vial adapter into a sharps container.

Keep your sharps disposal container out of the reach of children.

Do not keep any unused medicine.

Do not throw away the syringe or the vial in your household trash.

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

• Made of a heavy-duty plastic;
• Can be closed with a tight-fitting, puncture-resistant lid; that will keep sharps from coming out,
• Upright and stable during use,
• Leak-resistant and
• Properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.

Do not recycle your used sharps disposal container.