Idacio: Uses, Side Effects and Dosage

What is the most important information I should know about IDACIO?

IDACIO is a medicine that affects your immune system. IDACIO can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

• Your healthcare provider should test you for TB before starting IDACIO.
• Your healthcare provider should check you closely for signs and symptoms of TB during treatment with IDACIO.

You should not start taking IDACIO if you have any kind of infection unless your healthcare provider says it is okay.

Before starting IDACIO, tell your healthcare provider if you:

• think you have an infection or have symptoms of an infection such as:

  fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body

  diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss

• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes
• have TB or have been in close contact with someone with TB.
• were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use IDACIO. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B
• use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
• are scheduled to have major surgery.

After starting IDACIO, call your healthcare provider right away if you have an infection, or any sign of an infection.

IDACIO can make you more likely to get infections or make any infection that you may have worse.

Cancer

• For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including IDACIO, the chances of getting cancer may increase.
• There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including IDACIO your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including IDACIO developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

What is IDACIO?

IDACIO is a medicine called a Tumor Necrosis Factor (TNF) blocker. IDACIO is used:

• To reduce the signs and symptoms of:

  • moderate to severe RA in adults. IDACIO can be used alone, with methotrexate, or with certain other medicines.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. IDACIO can be used alone, or with methotrexate.
  • psoriatic arthritis (PsA) in adults. IDACIO can be used alone or with certain other medicines.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe hidradenitis suppurativa (HS) in adults.
• To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• To treat non-infectious intermediate, posterior, and panuveitis in adults.

What should I tell my healthcare provider before taking IDACIO?

IDACIO may not be right for you. Before starting IDACIO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection. See “What is the most important information I should know about IDACIO?”
• have or have had cancer.
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using IDACIO. Children should be brought up to date with all vaccines before starting IDACIO.
• are allergic to IDACIO or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in IDACIO.

• are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take IDACIO while you are pregnant or breastfeeding.

• have a baby and you were using IDACIO during your pregnancy. Tell your baby's healthcare provider before your baby receives any vaccines.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use:

• ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use IDACIO while you are also using one of these medicines.
• RITUXAN (rituximab). Your healthcare provider may not want to give you IDACIO if you have received RITUXAN (rituximab) recently.
• IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take IDACIO?

• IDACIO is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of IDACIO. This is based on your condition to be treated. Do not inject IDACIO more often than you were prescribed.
• See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject IDACIO.
• Make sure you have been shown how to inject IDACIO before you do it yourself. If you have any questions about giving yourself an injection, you can call your healthcare provider or the patient support program at 1-833-522-4227. Someone you know can also help you with your injection after they have been shown how to prepare and inject IDACIO.
• Do not try to inject IDACIO yourself until you have been shown the right way to give the injections. If your healthcare provider decides that you or a caregiver may be able to give your injections of IDACIO at home, you should receive training on the right way to prepare and inject IDACIO.
• Do not miss any doses of IDACIO unless your healthcare provider says it is okay. If you forget to take IDACIO, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject IDACIO, call your healthcare provider or pharmacist.
• If you take more IDACIO than you were told to take, call your healthcare provider.

What are the possible side effects of IDACIO?

IDACIO can cause serious side effects, including:

See “What is the most important information I should know about IDACIO?”

• Serious Infections.

  Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with IDACIO and during treatment with IDACIO. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking IDACIO. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking IDACIO:

  cough that does not go away weight loss

  low grade fever loss of body fat and muscle (wasting)

• Hepatitis B infection in people who carry the virus in their blood.

  If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use IDACIO. Your healthcare provider should do blood tests before you start treatment, while you are using IDACIO, and for several months after you stop treatment with IDACIO. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:

  muscle aches feel very tired dark urine skin or eyes look yellow little or no appetite vomiting

  clay-colored bowel movements fever chills stomach discomfort skin rash

• Allergic reactions. Allergic reactions can happen in people who use IDACIO. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:

  Hives trouble breathing

  swelling of your face, eyes, lips or mouth

• Nervous system problems. Signs and symptoms of a nervous system problem include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

• New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking IDACIO, including:

  shortness of breath sudden weight gain

  swelling of your ankles or feet

• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop IDACIO.

• Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:

  feel very tired poor appetite or vomiting

  skin or eyes look yellow pain on the right side of your stomach (abdomen)

• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with IDACIO.

Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with IDACIO may be stopped.

The most common side effects of IDACIO include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
• upper respiratory infections (including sinus infections).
• headaches.
• rash.

These are not all the possible side effects with IDACIO. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IDACIO?

• Store IDACIO in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store IDACIO in the original carton until use to protect it from light.
• Do not freeze IDACIO. Do not use IDACIO if frozen, even if it has been thawed.
• Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton. Pen or prefilled syringe. Do not use IDACIO after the expiration date.
• If needed, for example when you are traveling, you may also store IDACIO at room temperature up to 77°F (25°C) for up to 28 days. Store IDACIO in the original carton until use, to protect it from light.
• Throw away IDACIO if it has been kept at room temperature and not been used within 28 days.
• Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton.
• Do not store IDACIO in extreme heat or cold.
• Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush IDACIO. The prefilled syringe is glass.

Keep IDACIO, injection supplies, and all other medicines out of the reach of children.

General information about the safe and effective use of IDACIO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use IDACIO for a condition for which it was not prescribed. Do not give IDACIO to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about IDACIO. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about IDACIO that is written for health professionals.

What are the ingredients in IDACIO?

Active ingredient: adalimumab-aacf

IDACIO 40 mg/0.8 mL Pen, IDACIO 40 mg/0.8 mL prefilled syringe and IDACIO 40 mg/0.8 mL institutional use vial kit.

Inactive ingredients: glacial acetic acid, trehalose, polysorbate 80, sodium chloride and Water for Injection. Sodium hydroxide is added as necessary to adjust pH.

Manufactured by: Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, U.S.A.

For more product information go to www. IDACIO .com. You can enroll in a patient support program by calling 1-833-522-4227 or visiting the patient support program website: https://kabicare.us/.

U.S. License number 2146

This Instruction for Use has been approved by the U.S. Food and Drug Administration Approved : 12/2022

Important information

Read the Medication Guide that comes with your IDACIO prefilled syringe for important information you need to know before using it.

Do not try to inject IDACIO yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injections of IDACIO at home, you should receive training on the right way to prepare and inject IDACIO. It is important that you read, understand, and follow these instructions so that you inject IDACIO the right way. It is also important to talk to your doctor to be sure you understand your IDACIO dosing instructions. To help you remember when to inject IDACIO, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject IDACIO.

How should I store IDACIO?

• Store IDACIO in the refrigerator between 36°F to 46°F (2°C to 8°C). Store IDACIO in the original carton until use to protect it from light.
• Do not freeze IDACIO. Do not use IDACIO if frozen, even if it has been thawed.
• Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton, or prefilled syringe. Do not use IDACIO after the expiration date.
• If needed, for example when traveling, you may also store IDACIO at room temperature up to 77°F (25°C) for up to 28 days. Store IDACIO in the original carton until use to protect it from light.
• Throw away IDACIO if it has been kept at room temperature and not been used within 28 days.
• Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton.
• Do not store IDACIO in extreme heat or cold.
• Do not use a prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush IDACIO. The prefilled syringe is glass.
• Keep IDACIO, injection supplies, and all other medicines out of the reach of children.

How should I use IDACIO?

• Only use IDACIO prefilled syringe if your healthcare provider has instructed you on how to use it.
• Do not try to reuse the IDACIO prefilled syringe.
• Before injecting, let IDACIO sit at room temperature for 15-30 minutes after removing it from the refrigerator.
• Do not use an IDACIO prefilled syringe to give IDACIO to a child who weighs less than 66 pounds (30 kg).

1.1 Gather the supplies for your injection.

• You will need the following supplies for each injection of IDACIO (Figure D). Find a clean, flat surface to place the supplies on.

  • 1 alcohol prep
  • 1 cotton ball or gauze pad (not included in your IDACIO carton)
  • 1 IDACIO prefilled syringe (See Figures A and B)
  • Puncture-resistant sharps disposal container for IDACIO prefilled syringe disposal (not included in your IDACIO carton). See Step 7 “Dispose of used prefilled syringes”.

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

1.2 Remove the carton of IDACIO prefilled syringes from the refrigerator (Figure E).

1.3 Check the expiration date (EXP:) on the side of the carton (Figure E).

• Do not use if the expiration date has passed.

1.4 Take one IDACIO prefilled syringe out of the original carton:

• Place two fingers on the middle of the clear needle guard
• Pull the syringe straight up and out of the packaging (Figure F)
• Put the syringe on a clean flat surface.
• Do not pick up the syringe by the plunger or the needle cap. Doing this could damage the syringe or activate the clear needle guard.

1.5 Return the remaining syringe in its original carton to the refrigerator (Figure G).

• See “How should I store IDACIO?” for information on how to store your unused syringe.

1.6 Take your IDACIO prefilled syringe out of the refrigerator 15-30 minutes before injecting to allow the liquid to reach room temperature (Figure H).

• Do not remove the needle cap while allowing it to reach room temperature.
• Do not warm the syringe in any other way (for example, do not warm it in a microwave or in hot water).

2.1 Make sure that:

• the name IDACIO appears on the prefilled syringe label (Figure I).
• the syringe, the clear needle guard, and the needle cap are not cracked or damaged (Figure K).
• the needle cap is securely attached (Figure L).
• the needle guard spring is not extended (Figure M).

2.2 Do not use and do call your doctor or pharmacist if:

• the IDACIO labeling has an expired date. Check the expiration date (EXP:) on the prefilled syringe label and do not use if the date has passed (Figure I).
• the prefilled syringe has been frozen or left in direct sunlight.
• IDACIO has been kept at room temperature for longer than 28 days or IDACIO has been stored above 77°F (25°C).
• the liquid in the prefilled syringe is cloudy, discolored or has flakes or particles in it. Make sure the liquid is clear and colorless to pale yellow. (Figure J).

See “How should I store IDACIO?” section at the beginning of this Instructions for Use.

3.1 Wash and dry your hands well (Figure N).

4.1 Choose an injection site on (Figure O):

• your lower abdomen (belly). If you choose your abdomen, do not use the area 2 inches around your belly button (navel) or
• the front of your thighs
• Choose a different site each time to reduce redness, irritation or other skin problems. Each new injection should be given at least 1 inch from a site you used before.

• Do not inject into skin that is:

  • sore (tender)
  • bruised
  • red
  • hard
  • scarred or where you have stretch marks.
• If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin.
• Do not inject through your clothes.

5.1 Wipe the injection site with an alcohol prep using a circular motion (Figure P).

• Do not touch this area again before giving the injection.

5.2 Allow the skin to dry before injecting.

• Do not fan or blow on the clean area.

6.1 Remove the needle cap:

• Hold the syringe in one hand. With the other hand gently remove the needle cap (Figure Q).
• Throw away the needle cap.
• Do not touch the needle with your fingers or let the needle touch anything.

6.2 Position the syringe

• Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil (Figure R).
• Do not pull back on the plunger at any time.
• With your other hand, gently squeeze the area of the cleaned skin and hold it firmly (Figure S).

6.3 Insert the needle

• Using a quick dart-like motion, insert the needle into the squeezed skin at a 45-degree angle (Figure T).

6.4 Inject IDACIO

• Slowly push the plunger all the way in until all the liquid is injected, and the syringe is empty (Figure T).
• The plunger must be pushed all the way down to be sure the full dose has been injected and the safety system is activated (Figure U).
• Do not remove the needle from the skin when the plunger is pushed all the way down.

6.5 Finish Injection

• Slowly remove your thumb upwards off of the plunger.

  This will allow the needle to move up into the clear needle guard and cover the entire needle (Figure V).

• Release the squeezed skin.

• Call your healthcare provider or pharmacist right away if:

  • you did not inject the full dose or
  • the clear needle guard does not activate after injecting.
• Do not reuse a syringe even if all of the medicine was not injected.
• Do not try to recap the needle as it could lead to a needle stick injury.
• Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds (Figure W). Do not rub the injection site. You may have slight bleeding. This is normal.

7.1 Put your used prefilled syringes in a FDA-cleared sharps disposal container right away after use (Figure X). Do not throw away (dispose of) prefilled syringes in your household trash.

• If you do not have a FDA-cleared 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, without sharps being able to come 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 community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
• For the safety and health of you and others, used syringes must never be re-used.
• The used alcohol prep, cotton balls, dose trays and packaging may be placed in your household trash.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• Always keep the sharps container out of the reach of children.

8.1 To help you remember when and where on your body to give your next injection, keep a record of the dates and injection sites used for your injections (Figure Y).

Manufactured by:

Fresenius Kabi USA, LLC

Lake Zurich, Illinois 60047

U.S. License No. 2146

Read this Instructions for Use before using your IDACIO prefilled pen.

Do not try to inject IDACIO yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of IDACIO at home, you should receive training on the right way to prepare and inject IDACIO. It is important that you read, understand, and follow these instructions so that you inject IDACIO the right way. It is also important to talk to your healthcare provider to be sure you understand your IDACIO dosing instructions. To help you remember when to inject IDACIO, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject IDACIO.

Important information

• Read the Medication Guide that comes with your IDACIO prefilled pen for important information you need to know before using it.
• Call your healthcare provider if you have any questions about IDACIO or how to give your injection.
• IDACIO prefilled pen is for single-dose (one-time) use only.

• Do not share your IDACIO prefilled pen with another person.

  You may give another person an infection or get an infection from them.

Storing IDACIO prefilled pens

• Store IDACIO prefilled pen in the original carton to protect it from light.
• Store IDACIO prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze IDACIO. Do not use IDACIO if frozen, even if it has been thawed.
• Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton, dose tray or pen. Do not use IDACIO after the expiration date.
• If needed, for example when traveling, IDACIO prefilled pen can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days.
• Throw away IDACIO if it has been kept at room temperature and not been used within 28 days.
• Record the date you first remove IDACIO from the refrigerator in the spaces provided on the carton.
• Throw away (dispose of) the IDACIO prefilled pen in a sharps disposal container if it has been stored above 77°F (25°C). (See Step 7 “Dispose of your prefilled pens”).
• Do not store IDACIO in extreme heat or cold.
• Do not use IDACIO if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush IDACIO.
• Keep the IDACIO prefilled pen, injection supplies, and all other medicines out of the reach and sight of children.

Using the IDACIO prefilled pen

• Only use IDACIO prefilled pen if your healthcare provider has instructed you on how to use it.
• Do not try to reuse the IDACIO prefilled pen.
• Before injecting, let IDACIO sit at room temperature for 15-30 minutes after removing it from the refrigerator.
• Always inject IDACIO using the technique your healthcare provider taught you.
• Do not use an IDACIO prefilled pen to give IDACIO to a child who weighs less than 66 pounds (30 kg).
• Do not insert your fingers into the opening of the safety guard.
• Do not use the prefilled pen if the new carton is open or damaged.
• Do not use an IDACIO prefilled pen that has been frozen or left in direct sunlight.

• Do not use and do call your healthcare provider or pharmacist if: you drop or crush your IDACIO prefilled pen.

  

  

1.1 Gather the supplies for your injection.

• You will need the following supplies for each injection of IDACIO (figure C). Find a clean flat surface, such as a table or countertop, in a well-lit area.

  • 1 Alcohol prep
  • 1 cotton ball or gauze (not included in your IDACIO carton)
  • 1 IDACIO prefilled pen (see figure A)

  • Pucture-resistant sharps disposal container for IDACIO prefilled pen disposal (not included in your IDACIO carton. (See Step 7 “Dispose of used prefilled pens”).

    

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

1.2 Remove the carton of IDACIO prefilled pens from the refrigerator (Figure D).

1.3 Check the expiration date (EXP:) on the side of the carton (Figure E).

Do not use if the expiration date has passed.

1.4 Take one IDACIO prefilled pen out of the original carton:

• Place two fingers on the label
• Pull the pen straight up and out of the packaging (Figure F)

• Place the capped pen on a clean flat surface

  

1.5 Return the remaining pen in its original carton to the refrigerator

(Figure G).

See “Storing IDACIO prefilled pens” for information on how to store your unused pen.

1.6 Let the IDACIO prefilled pen sit at room temperature for 15-30 minutes before use to allow the medicine to reach room temperature (Figure H).

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

• Do not remove the needle cap until you are ready to inject.

  

2.1 Wash your hands well with soap and water and dry them with a clean towel (Figure I).

3.1 Check the transparent syringe housing to make sure that:

• the liquid is clear and colorless to pale yellow, and

  free of particles and flakes (Figure J).

• the syringe is not cracked or damaged.

  (Figure J).

Do not use the prefilled pen if the liquid is cloudy or colored, if the liquid has particles or flakes in it, or if the prefilled pen looks damaged. Dispose of the pen in your sharps disposal container (see Step 7 “Dispose of your prefilled pens”) and call your healthcare provider or pharmacist.

3.2 Check the prefilled pen label to make sure that:

• the name on the pen says IDACIO

  (Figure K).

• the expiration date (EXP:) on the pen

  has not passed (Figure K).

Do not use the prefilled pen if the label does not have IDACIO on it or the expiration date has passed. Dispose of the pen in your sharps disposal container (see Step 7 “Dispose of used prefilled pens”) and call your healthcare provider or pharmacist.

4.1 Choose an injection site on

• your stomach (abdomen). If you choose your stomach, do not use the area 2 inches around your belly button (navel) or

• the front of your thighs (Figure L)

  

Only inject into injection sites shown (Figure L).

4.2 Choose a different site (at least one inch away from your last injection site) for each injection to reduce redness, irritation or other skin problems. Each new injection should be given at least 1 inch from a site you used before.

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

• Do not inject through your clothes.

  

5.1 Wipe the skin of your injection site with an alcohol swab using a circular motion to clean it (Figure M).

Let the skin dry before injecting.

Do not blow on or touch the injection site again after cleaning.

6.1 Remove the needle cap

• Hold the pen upwards.

• Remove the needle cap with your other hand by pulling the cap straight off (Figure N).

  

Do not twist the cap.

Do not insert your fingers into the opening of the safety guard

You may see a few drops of liquid at the needle tip. This is normal

• Dispose of the needle cap in your sharps disposal container.

6.2 Position the pen

• Hold the pen so that you can see the transparent syringe housing.

• Place your thumb above (not touching) the yellow injection button (Figure O)

  

• Place the pen straight and flat against your skin at a 90° angle (Figure P).

  

6.3 Administer the Injection

• Push and hold the pen firmly against your skin until the safety guard is fully pushed down. This will unlock the injection button (Figure Q).

  

• Push the injection button with your thumb (Figure R). You will hear a loud ‘click', which means the injection has started.
• Continue to hold the pen firmly.

• Watch the syringe plunger to make sure it moves all the way down to the bottom of the transparent syringe housing (Figure R).

  

• Continue holding the pen for 5 seconds

  after the syringe plunger has reached the bottom of the transparent syringe housing. (Figure S)

  

Do not lift the pen from the skin until the syringe plunger has moved all the way down and you have waited 5 seconds.

• Lift the pen from your skin (Figure T).

  The safety guard will slide down and lock into place to cover the needle (Figure T).

  

Do not recap the pen.

Call your healthcare provider or pharmacist if you have any problem with your injection.

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

Do not rub the injection site

You may use an adhesive bandage if needed.

7.1 Put your used prefilled pens in a FDA-cleared sharps disposal container right away after use (Figure V).

Do not throw away (dispose of) prefilled pens in your household trash.

• If you do not have a FDA-cleared 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, without sharps being able to come 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 community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and pens.
• For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Always keep the sharps container out of the reach of children.

8.1 To help you remember when and where on your body to give your next injection, keep a record of the dates and injection sites used for your injections (Figure W).

Manufactured by:

Fresenius Kabi USA, LLXC

Lake Zurich, Illinois 60047

U.S. License No. 2146

This Instructions for Use has been approved by the U. S. Food and Drug Administration Approved: 12/2022

Read this Instructions for Use before using your IDACIO prefilled pen.

Do not try to inject IDACIO yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of IDACIO at home, you should receive training on the right way to prepare and inject IDACIO. It is important that you read, understand, and follow these instructions so that you inject IDACIO the right way. It is also important to talk to your healthcare provider to be sure you understand your IDACIO dosing instructions. To help you remember when to inject IDACIO, you can mark your calendar ahead of time. Call your healthcare provider if you or your caregiver have any questions about the right way to inject IDACIO.

Important information

• Read the Medication Guide that comes with your IDACIO prefilled pen for important information you need to know before using it.
• Call your healthcare provider if you have any questions about IDACIO or how to give your injection.
• Each IDACIO prefilled pen is for single-dose (one-time) use only.

• Do not share your IDACIO prefilled pen with another person.

  You may give another person an infection or get an infection from them.

Storing IDACIO prefilled pens

• Store IDACIO prefilled pen in the original carton to protect it from light.
• Store IDACIO prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze IDACIO. Do not use IDACIO if frozen, even if it has been thawed.
• Refrigerated IDACIO may be used until the expiration date printed on the IDACIO carton, dose tray or pen. Do not use IDACIO after the expiration date.
• If needed, for example when traveling, IDACIO prefilled pen can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days.
• Throw away the IDACIO prefilled pens if it has been kept at room temperature and not been used within 28 days.
• Record the date you first removed the IDACIO prefilled pens from the refrigerator in spaces provided on the carton.
• Throw away (dispose of) the IDACIO prefilled pen in a sharps disposal container if it has been stored above 77°F (25°C). (See Step 7 “Dispose of your prefilled pens”).
• Do not store IDACIO in extreme heat or cold.
• Do not use IDACIO if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush IDACIO.
• Keep the IDACIO prefilled pen, injection supplies, and all other medicines out of the reach and sight of children.

Using the IDACIO prefilled pen

• Only use IDACIO prefilled pen if your healthcare provider has instructed you on how to use it.
• Do not try to reuse the IDACIO prefilled pen.
• Before injecting, let IDACIO sit at room temperature for 15-30 minutes after removing it from the refrigerator.
• Always inject IDACIO using the technique your healthcare provider taught you.
• Do not insert your fingers into the opening of the safety guard.
• Do not use the prefilled pen if the new carton is open or damaged.
• Do not use an IDACIO prefilled pen that has been frozen or left in direct sunlight.

• Do not use and do call your healthcare provider or pharmacist if you drop or crush your IDACIO prefilled pen.

  

  

1.1 Your Starter Package includes multiple alcohol preps and prefilled pens for your starter treatment period.

Always make sure to use a new alcohol prep whenever you use a new pen.

Gather the supplies for your injection.

• You will need the following supplies for each injection of IDACIO (figure C). Find a clean flat surface, such as a table or countertop, in a well-lit area.

  

  • 1 Alcohol swab
  • 1 cotton ball or gauze (not included in your IDACIO carton)
  • 1 IDACIO prefilled pen (see figure A)
  • Puncture-resistant sharps disposal container for IDACIO prefilled pen disposal (not included in your IDACIO carton. (See Step 7 “Dispose of used prefilled pens”).

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

1.2 Remove the pack of IDACIO prefilled pens from the refrigerator (Figure D).

1.3 Check the expiration date (EXP:) on the side of the pack (Figure E).

Do not use if the expiration date has passed.

1.4 Take the IDACIO prefilled pens you need for the day out of the original pack (refer to the schedule on the inner flap of your Starter Package for the number of prefilled pens to inject):

• Place two fingers on the label
• Pull the pen straight up and out of the packaging (Figure F)

• Place the capped pen on a clean flat surface

  

1.5 Return the remaining pen(s) in the original pack to the refrigerator (Figure G).

See “Storing IDACIO prefilled pens” for information on how to store your unused prefilled pen(s).

1.6 Let the IDACIO prefilled pen(s) sit at room temperature for 15-30 minutes before use to allow the medicine to reach room temperature (Figure H).

Do not warm the pen(s) in any other way, such as in a microwave, hot water, or direct sunlight.

Do not remove the needle cap until you are ready to inject.

2.1 Wash your hands well with soap and water and dry them with a clean towel (Figure I).

3.1 Check the transparent syringe housing to make sure that:

• the liquid is clear and colorless to pale yellow, and free of particles and flakes (Figure J).

• the syringe is not cracked or damaged. (Figure J).

  

Do not use the prefilled pen if the liquid is cloudy or colored, if the liquid has particles or flakes in it, or if the prefilled pen looks damaged. Dispose of the pen in your sharps disposal container (see Step 7 “Dispose of your prefilled pens”) and call your healthcare provider or pharmacist.

3.2 Check the prefilled pen label to make sure that:

• the name on the pen says IDACIO (Figure K).

• the expiration date (EXP:) on the pen has not passed (Figure K).

  

Do not use the prefilled pen if the label does not have IDACIO on it or the expiration date has passed. Dispose of the pen in your sharps disposal container (see Step 7 “Dispose of used prefilled pens”) and call your healthcare provider or pharmacist.

4.1 Choose an injection site on:

• your stomach (abdomen). If you choose your stomach, do not use the area 2 inches around your belly button (navel) or

• the front of your thighs (Figure L)

  

Only inject into injection sites shown (Figure L)

4.2 Choose a different site (at least one inch away from your last injection site) for each injection to reduce redness, irritation or other skin problems. Each new injection should be given at least 1 inch from a site you used before.

• Do not inject IDACIO into skin that is sore (tender), bruised, red, hard, scarred or where you have stretch marks or tattoos.
• If you have psoriasis, do not inject into any lesions or red, thick, raised or scaly patches.
• Do not inject through your clothes.

5.1 Using a new alcohol prep, clean the skin of your injection site using a circular motion (Figure M). Always make sure to use a new alcohol prep whenever you use a new pen.

Let the skin dry before injecting.

Do not blow on or touch the injection site again after cleaning.

6.1 Remove the needle cap

• Hold the pen upwards.

• Remove the needle cap with your other hand by pulling the cap straight off (Figure N).

  

Do not twist the cap.

Do not insert your fingers into the opening of the safety guard

You may see a few drops of liquid at the needle tip. This is normal

• Dispose of the needle cap in your sharps disposal container.

6.2 Position the pen

• Hold the pen so that you can see the transparent syringe housing.

• Place your thumb above (not touching) the yellow injection button (Figure O).

  

• Place the pen straight and flat against your skin at a 90° angle (Figure P).

  

6.3 Administer the Injection

• Push and hold the pen firmly against your skin until the safety guard is fully pushed down. This will unlock the injection button (Figure Q).

  

• Push the injection button (Figure R). You will hear a loud ‘click', which means the injection has started.
• Continue to hold the pen firmly.

• Watch the syringe plunger to make sure it moves all the way down to the bottom of the transparent syringe housing (Figure R).

  

• Continue holding the pen for 5 seconds

  after the syringe plunger has reached the bottom of the transparent syringe housing (Figure S).

  

Do not lift the pen from the skin until the syringe plunger has moved all the way down and you have waited 5 seconds.

• Lift the pen from your skin (Figure T). The safety guard will slide down and lock into place to cover the needle (Figure T).

  

Do not recap the pen.

Call your healthcare provider or pharmacist if you have any problem with your injection.

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

Do not rub the injection site

You may use an adhesive bandage if needed.

6.5 Check the schedule on your Starter Package to know the number of prefilled pens needed for the day, and repeat the previous steps (step 3, step 4, step 5 and step 6) as needed.

7.1 Put your used prefilled pens in a FDA-cleared sharps disposal container right away after use (Figure V).

Do not throw away (dispose of) prefilled pens in your household trash.

• If you do not have a FDA-cleared 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,

    without sharps being able to come 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 community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should Dispose of used needles and pens.
• For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container.

Always keep the sharps container out of the reach of children.

8.1 To help you remember when and where on your body to give your next injection(s), keep a record of the dates and injection sites used for your injections (Figure W).

Manufactured by:

Fresenius Kabi USA, LLC

Lake Zurich, Illinois 60047

U.S. License No. 2146

This Instructions for Use has been approved by the U. S. Food and Drug Administration Approved: 12/2022