Cimzia (Certolizumab pegol): Uses, Side Effects and Dosage

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

CIMZIA may cause serious side effects, including:

• CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blockerthat can lower the ability of your immune system to fight infections. Some people who received CIMZIA have developed serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some of these serious infections have caused hospitalization and death.

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

  Before starting CIMZIA, tell your healthcare provider if you:

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

• fever, sweat, or chills
• cough
• blood in phlegm
• warm, red, or painful skin or sores on your body
• burning when you urinate or urinate more often than normal

• muscle aches
• shortness of breath
• weight loss
• diarrhea or stomach pain
• feeling very tired

• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes, HIV-1 or a weak immune system. People with these conditions have a higher chance for infections.
• have tuberculosis (TB), or have been in close contact with someone with TB.
• were born in, live, have lived, or traveled to certain countries where there is more risk for getting TB. Ask your healthcare provider if you are not sure.
• live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis). These infections may develop or become more severe if you receive CIMZIA. 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 Kineret (anakinra), Orencia ^®(abatacept), Rituxan ^®(rituximab), or Tysabri ^®(natalizumab).

Stop using CIMZIA, and tell your healthcare provider right awayif you have any of the symptoms of an infection listed above.

• Cancer.

  • For people who receive TNF blockers, including CIMZIA, the chances of getting certain types of cancers may increase.
  • Some children, teenagers, and young adults who received TNF blockers, including CIMZIA, have developed lymphoma and other certain types of rare cancers, some of which have caused death. These cancers are not usually seen in this age group.
  • People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.
  • Some people who receive TNF blockers, including CIMZIA, have developed a rare type of cancer which may cause death, called hepatosplenic T-cell lymphoma. Most of these people were male teenagers and young adult males with Crohn's disease or ulcerative colitis. Also, most of these people had been treated with both a TNF blocker and another medicine called IMURAN ^®(azathioprine) or PURINETHOL ^®(6-mercaptopurine, 6-MP).
  • Some people who receive CIMZIA, have developed certain types of skin cancer. Tell your healthcare provider if you develop any changes in the appearance of your skin, including growths on your skin, during or after treatment with CIMZIA. You should see your healthcare provider periodically during treatment for skin examinations, especially if you have a history of skin cancer.

What is CIMZIA?

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used to:

• Lessen the signs and symptoms of moderately to severely active Crohn's disease (CD) in adults who have not been helped enough by usual treatments
• Treat moderately to severely active rheumatoid arthritis (RA) in adults
• Treat active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
• Treat active psoriatic arthritis (PsA) in adults
• Treat active ankylosing spondylitis (AS) in adults
• Treat active non-radiographic axial spondyloarthritis (nr-axSpA) with measures of inflammation in adults
• Treat moderate to severe plaque psoriasis (PsO) in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)

Before receiving CIMZIA, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection.
• have or have had lymphoma or any other type of cancer.
• have or had congestive heart failure.
• are allergic to rubber or latex. The plastic needle shield inside the removable cap of the prefilled syringe contains natural rubber.
• have or have had seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or Guillain-Barre syndrome.
• have or had serious blood conditions.
• are scheduled to receive a vaccine. Do not receive a live vaccine immediately before starting treatment with CIMZIA or while receiving CIMZIA.
• are allergic to certolizumab pegol or any of the ingredients in CIMZIA. See the end of this Medication Guide for a complete list of the ingredients in CIMZIA.

• are pregnant or plan to become pregnant. You and your doctor should decide if you should continue to take CIMZIA while you are pregnant. It is not known if CIMZIA will harm your unborn baby.

• are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with CIMZIA.

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

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I receive CIMZIA?

• CIMZIA comes as lyophilized powder or as a solution in a prefilled syringe for injection.

  • If your healthcare provider prescribes the CIMZIA powder, it should be injected by a healthcare provider. Each dose of CIMZIA will be given as 1 or 2 separate injections under the skin (subcutaneous injection) in your stomach area (abdomen) or upper thighs.
  • If your healthcare provider prescribes the CIMZIA prefilled syringe, you will be trained on how to inject CIMZIA.
• You will receive a CIMZIA Prefilled Syringe Kitincluding a complete Instructions for Usebooklet for instructions on how to inject CIMZIA the right way.
• Read the detailed Instructions for Use for instructions about how to prepare and inject your dose of CIMZIA, and how to properly throw away used syringes containing the needle.
• Do not give yourself an injection of CIMZIA unless you have been shown by your healthcare provider. A family member or friend can also be trained to help you give your injection. Talk to your healthcare provider if you have questions.
• CIMZIA prefilled syringe is given as an injection under the skin (subcutaneous injection) in your stomach area (abdomen) or upper thighs. Your healthcare provider will tell you how much and how often to inject CIMZIA. Do not use more CIMZIA or inject more often than prescribed.
• You may need more than 1 injection at a time depending on your prescribed dose of CIMZIA. If you are prescribed more than 1 injection, each injection should be given at a different site in your stomach or upper thighs and at least 1 inch from your last injection.
• Make sure the solution in the CIMZIA prefilled syringe is clear to opalescent, and colorless to yellow and free from particles. Do not use the CIMZIA prefilled syringe if the medicine is cloudy, discolored, or contains particles.

What are the possible side effects of CIMZIA?

CIMZIA can cause serious side effects, including:

• See " What is the most important information I should know about CIMZIA?"
• Heart failure including new heart failure or worsening of heart failure you already have.Symptoms include shortness of breath, swelling of your ankles or feet, or sudden weight gain.

• Allergic reactions.Get medical help right away if you have any signs of an allergic reaction which include a skin rash, swelling or itching of the face, tongue, lips, or throat, or trouble breathing.

  The plastic needle shield inside the removable cap of the prefilled syringe contains natural rubber and may cause an allergic reaction if you are sensitive to latex.

• Hepatitis B virus reactivation in people who carry the virus in their blood.In some cases, people who received CIMZIA have died because of the hepatitis B virus being reactivated. Your healthcare provider should monitor you carefully before and during treatment with CIMZIA to see if you carry the hepatitis B virus in your blood. Tell your healthcare provider if you have any of the following symptoms:

• feel unwell
• tiredness (fatigue)
• pain on the right side of your stomach (abdomen)

• skin or eyes look yellow
• poor appetite or vomiting

• New or worsening nervous system problems, such as multiple sclerosis (MS), Guillain-Barre syndrome, seizures, or inflammation of the nerves of the eyes.Symptoms may include:

• dizziness
• problems with your vision

• numbness or tingling
• weakness in your arms or legs

• Blood problems.Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Tell your healthcare provider right away if you have any bruising, bleeding or a fever that does not go away.
• Immune reactions including a lupus-like syndrome.Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.

Call your healthcare provider right away if you have any serious side effects listed above.

The most common side effects of CIMZIA includeupper respiratory infections (flu, cold), rash, urinary tract infections (bladder infections).

These are not all of the possible side effects of CIMZIA.

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 CIMZIA?

• Keep CIMZIA in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze CIMZIA. Do not shake.
• Protect CIMZIA from light .Store CIMZIA in the carton it came in.
• Do not use CIMZIA if the medicine is expired. Check the expiration date on the prefilled syringe or carton.
• If needed, CIMZIA syringes may be stored at room temperature up to 77ºF (25ºC) in the original carton to protect from light for a single period of up to 7 days. After your CIMZIA syringe has been stored at room temperature, do not place back in refrigerator.
• Write the date removed from the refrigerator in the space provided on the carton and throw away (discard) if not used within the 7-day period.
• The CIMZIA prefilled syringe is made of glass. Do not drop or crush the syringe.

Keep CIMZIA and all medicines out of the reach of children.

General information about the safe and effective use of CIMZIA.

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

What are the ingredients in CIMZIA?

CIMZIA lyophilized powder:

Active ingredient: certolizumab pegol

Inactive ingredients:lactic acid, polysorbate, sucrose

CIMZIA lyophilized powder is mixed with sterile Water for Injection.

CIMZIA prefilled syringe:

Active ingredient: certolizumab pegol

Inactive ingredients:sodium acetate, sodium chloride, Water for Injection

CIMZIA has no preservatives.

Product manufactured by:

UCB, Inc. 1950 Lake Park Drive Smyrna, GA 30080

US License No. 1736

For more information, go to www.CIMZIA.com or call 1-866-424-6942.

Instructions for Use

CIMZIA ^®(CIM-zee-uh)

(certolizumab pegol)

injection for subcutaneous use

Prefilled Syringes

Read this Instructions for Use booklet that comes with CIMZIA before you start receiving it, and before each injection of CIMZIA. This Instructions for Use booklet does not take the place of talking with your healthcare provider about your medical condition or treatment. These instructions are for 1 injection only. You may need more than 1 injection at a time depending on your prescribed dose of CIMZIA.

Do not share your CIMZIA Prefilled Syringe with needle attached with another person. You may give another person an infection or get an infection from them. Important: The plastic needle shield inside the removable cap contains natural rubber. Tell your healthcare provider if you are allergic to latex. Supplies you will need to give your CIMZIA injection: See Figure Aand Figure B. 1 CIMZIA prefilled syringe with needle attached. You may need 2 CIMZIA prefilled syringes with needles attached to give higher doses. 1 or 2 alcohol swabs 1 or 2 clean cotton balls or gauze pads 1 puncture-resistant sharps disposal container. See " Disposal of your syringes with needles attached" at the end of this Instructions for Use booklet. CIMZIA comes in a tray containing either 1 or 2 prefilled glass syringes. Use a new CIMZIA syringe for each injection.

Storage information: Keep CIMZIA in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Protect CIMZIA from light. Store CIMZIA in the carton it came in. Do not use CIMZIA if the medicine is expired. Check the expiration date on the prefilled syringe or carton. If needed, CIMZIA syringes may be stored at room temperature up to 77°F (25°C) in the original carton to protect from light for a single period of up to 7 days. After your CIMZIA syringe has been stored at room temperature, do not place back in refrigerator. Write the date removed from the refrigerator in the space provided on the carton and throw away (discard) if not used within the 7-day period.

Setting up for your CIMZIA injection: Step 1. If refrigerated, take the carton containing the number of prefilled syringes needed for your dosage of CIMZIA out of the refrigerator. Check the expiration date on the syringe carton and label. See Figure C.

If the expiration date has passed, do notuse the syringe. Call your pharmacist for questions about the expiration date. Do not use CIMZIA if the carton has been opened or tampered with.

Step 2. Remove the prefilled syringe from the carton and let it warm to room temperature, this will take about 30 minutes. Do not warm the syringe in any other way. If you have a second syringe and are not using the syringe, put the carton containing the remaining prefilled syringe back in the refrigerator.

Step 3. Find a clean, flat work surface, such as a table.

Step 4. Make sure the liquid medicine in the prefilled syringe is clear to opalescent, and colorless to yellow and free from particles. Do notinject the medicine if it is cloudy, discolored, or contains particles. Call your healthcare provider or pharmacist if you have any questions about your CIMZIA prefilled syringe.

Step 5. Gather all the supplies you will need for your injection.

Step 6. Wash your hands with soap and warm water and dry with a clean towel.

Selecting and preparing your injection site:

Step 7. Choose your injection sites on your stomach or upper thighs. See Figure D. Choose a new injection site each time you use CIMZIA. Each new injection should be given at least 1 inch from the site you used before. If you choose your stomach, avoid the 2 inches around your belly button (navel). Do not inject into areas where your skin is tender, bruised, red or hard, or where you have scars or stretch marks. Change injection sites between your stomach and upper thighs to reduce the chance of having a skin reaction. You may want to write down the site you use for your injection to help you remember to use a different site each time you inject.

Step 8. Clean your injection site with an alcohol swab. Let the area dry completely.

Giving your CIMZIA injection: Step 9. Pick up the prefilled syringe with 1 hand and hold it with the needle pointing up. You may see air bubbles. This is normal. There is no need to remove air bubbles before giving your injection. Injecting the solution with air bubbles will not harm you. With your other hand, remove the plastic ring needle cap by pulling straight up on the plastic ring. See Figure E.

Do nottouch the needle and do not let the needle touch any surface. Do not bend the needle. Place the plastic ring needle cap to the side.

Step 10. With your other hand, gently pinch a fold of skin at the cleaned injection site. See Figure F.

Step 11. With a quick, dart-like motion, insert the needle into your skin at about a 45-degree angle. Release the pinched skin, keeping the syringe in position. Slowly push on the plunger all the way down until the syringe is empty. See Figure G.

Step 12. When the syringe is empty, pull the needle out of your skin while carefully keeping the needle at the same angle as inserted. See Figure H.

Step 13. Place a dry cotton ball or gauze pad over the injection site for several seconds. See Figure I.

Do not rub the injection site. Do not use an alcohol swab as it may cause stinging. If there is a little bleeding, cover the injection site with a small bandage. To avoid a needle-stick injury, do not try to recap the needle. Do not reuse any of your injection supplies.

Disposal of your syringes with needles attached: Put your used syringes with needle attached in a FDA-cleared sharps disposal container right away after use. See Figure J.

Do not throw away (dispose of) loose syringes and needles 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

  • 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.

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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Product manufactured by:

UCB, Inc.

1950 Lake Park Drive

Smyrna, GA 30080

Revised: 9/2024

CIMZIA®

(certolizumab pegol)

Preparation and Administration of Lyophilized

Powder for Injection

(200 mg/vial)

CIMZIA Lyophilized powder should be prepared and administered by a health care professional.

Contents:

2 inner kits, each containing 1 vial of CIMZIA 200 mg, 1 vial of sterile water for injection (USP 1 mL), 1 single-dose plastic syringe, 4 alcohol swabs, two reconstitution needles, and one dosing needle.

Refrigerate carton at 2 to 8°C (36 to 46°F). DO NOT FREEZE. Do not separate contents of carton prior to use. Do not use beyond expiration date on container.

Unopened CIMZIA vials may also be stored at room temperature up to a maximum of 25°C (77°F) for 6 months, but not exceeding the original expiration date. If stored at room temperature, do not place back in refrigerator and write the new expiration date on the carton in the space provided.

If refrigerated, remove CIMZIA from the refrigerator and allow the vial(s) to sit at room temperature for 30 minutes before reconstituting. Do not warm the vial in any other way. Using appropriate aseptic technique, reconstitute each lyophilized vial of CIMZIA with 1 mL of sterile water for injection using a syringe with a fresh 20-gauge needle. The sterile water for injection should be directed at the vial wall rather than directly on CIMZIA. (See Figure 1.)

The resultant solution will contain 200 mg/mL.

Gently swirl each vial of CIMZIA for about one minute without shaking, ensuring that all of the powder comes into contact with the Sterile Water for Injection. The swirling should be as gentle as possible in order to avoid creating a foaming effect. (See Figure 2.)

Continue swirling every 5 minutes as long as non-dissolved particles are observed. Full reconstitution may take as long as 30 minutes. The final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to yellow liquid and essentially free from particulates.

Once reconstituted, CIMZIA can be stored in the vials for up to 24 hours between 2° to 8° C (36° to 46° F) prior to injection. Do not freeze.

When ready to inject, reconstituted CIMZIA should be at room temperature. Do not leave reconstituted CIMZIA at room temperature for more than 2 hours prior to administration.

Withdraw the reconstituted solution into a separate syringe for each vial using a new 20-gauge needle for each vial so that each syringe contains the required volume of CIMZIA. (See Figure 3.)

Replace the 20-gauge needle(s) on the syringes with a 23-gauge needle(s) for administration. (See Figure 4.)

Inject the full contents of the syringe(s) subcutaneously by pinching the skin of the abdomen (See Figure 5) or thigh (See Figure 6). Where a 400 mg dose is required, two injections are required. Therefore, separate sites should be used for each 200 mg injection.

OR

You can also visit the CIMZIA Web site at www.cimziahcp.com

9/2024

U.S. License No. 1736

Manufactured by UCB Inc. Smyrna GA 30080

UCB Pharma S.A.