Cimzia certolizumab pegol Kit — NDC 50474-700-61 (Billing 50474-0700-61)

1 INDICATIONS AND USAGE CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis.

( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ( 1.7 )

1.1Crohn's Disease CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

1.2Rheumatoid Arthritis CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

1.3Polyarticular Juvenile Idiopathic Arthritis CIMZIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

1.4Psoriatic Arthritis CIMZIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

1.5Ankylosing Spondylitis CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis (AS). [see Clinical Studies (14.5) ]

1.6Non-radiographic Axial Spondyloarthritis CIMZIA is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation [see Clinical Studies (14.6) ].

1.7Plaque Psoriasis CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy [see Clinical Studies (14.7) ]

2 DOSAGE AND ADMINISTRATION CIMZIA is administered by subcutaneous injection . Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. When a 400 mg dose is needed (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.

The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear to opalescent, colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded.

CIMZIA is administered by subcutaneous injection ( 2 ). Crohn's Disease ( 2.1 ) 400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks Rheumatoid Arthritis ( 2.2 ) 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered Polyarticular Juvenile Idiopathic Arthritis ( 2.3 ) 10 kg (22 lbs) to less than 20 kg (44 lbs): 100 mg initially and at Weeks 2 and 4, followed by 50 mg every other week 20 kg (44 lbs) to less than 40 kg (88 lbs): 200 mg initially and at Weeks 2 and 4, followed by 100 mg every other week Greater than or equal to 40 kg (88 lbs): 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week Psoriatic Arthritis ( 2.4 ) 400 mg initially and at week 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered.

Ankylosing Spondylitis ( 2.5 ) 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks. Non-radiographic Axial Spondyloarthritis ( 2.6 ) 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks. Plaque Psoriasis ( 2.7 , 14.7 ) 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.

For some patients (with body weight less than or equal to 90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered.

2.1Crohn's Disease The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

2.2Rheumatoid Arthritis The recommended dose of CIMZIA for adult patients with rheumatoid arthritis is 400 mg (given as two subcutaneous injections of 200 mg) initially and at Weeks 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg every 4 weeks can be considered [see Clinical Studies (14.2) ] .

2.3Polyarticular Juvenile Idiopathic Arthritis The recommended dose of CIMZIA for patients 2 years of age and older with pJIA is based on weight as shown below. Weight range (2 years of age and older) Loading dose Maintenance dose (beginning at Week 6) 10 kg (22 lbs) to less than 20 kg (44 lbs) 100 mg at Week 0, 2 and 4 50 mg every 2 weeks 20 kg (44 lbs) to less than 40 kg (88 lbs) 200 mg at Week 0, 2 and 4 100 mg every 2 weeks Greater than or equal to 40 kg (88 lbs) 400 mg at Week 0, 2 and 4 200 mg every 2 weeks There is no dosage form for Cimzia that allows for patient self-administration for doses below 200 mg.

Doses less than 200 mg require administration by a health care professional using the vial kit.

2.4Psoriatic Arthritis The recommended dose of CIMZIA for adult patients with psoriatic arthritis is 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, CIMZIA 400 mg e… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS For injection: 200 mg lyophilized powder in a single-dose vial ( 3 ) Injection: 200 mg/mL solution in a single-dose prefilled syringe ( 3 ) For Injection: 200 mg of white to off-white lyophilized powder in a single-dose vial for reconstitution Injection: 200 mg/mL clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) Risk of Serious Infections Inform patients that CIMZIA may lower the ability of the immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis and reactivation of hepatitis B virus infections. Because caution should be exercised in prescribing CIMZIA to patients with clinically important active infections, advise patients of the importance of informing their health care providers about all aspects of their health [see Warnings and Precautions (5.1 , 5.5) ] .

Malignancies Counsel patients about the possible risk of lymphoma and other malignancies while receiving CIMZIA [see Warnings and Precautions (5.2) ] . Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as heart disease, neurological disease, or autoimmune disorders [see Warnings and Precautions (5.3 , 5.6 , 5.9) . Advise patients to report promptly any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions (5.7) ] .

Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. Advise latex-sensitive patients that the needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex [see Warnings and Precautions (5.4) ] . Preparation and Administration of CIMZIA Using the Prefilled Syringe Instruct patients and caregivers on how to inject the Prefilled Syringe.

Complete instructions are provided in the Instructions for Use packaged in each CIMZIA Prefilled Syringe kit. If refrigerated, remove the prefilled syringe from the carton and let it warm to room temperature. Inspect the liquid in the prefilled syringe.

It should be clear to opalescent, and colorless to yellow and free from particulates. Discard the syringe if cloudy, discolored or contains particulates. Suitable sites for injection include the thigh or abdomen.

Inject at least 1 inch from the previous site. Do not inject into areas where the skin is tender, bruised, red or hard, or where there are scars or stretch marks. Instruct patients and caregivers in proper syringe and needle disposal technique.

To avoid needle-stick injury, do not to place the needle cap back on the syringe or otherwise recap the needle. Properly dispose of needles and syringes in a puncture-proof container. Do not reuse the injection materials.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 09/2025 MEDICATION GUIDE CIMZIA ® (CIM-zee-uh) (certolizumab pegol) injection for subcutaneous use 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) blocker that 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 away if 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… [Excerpted — this section continues on DailyMed.]

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.

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