Certolizumab Injection
Certolizumab pegol injection (Cimzia) is a TNF blocker used to treat Crohn's disease, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Cimzia carries a serious FDA boxed warning about life-threatening infections and cancer. People taking Cimzia have a higher risk of developing severe infections — including tuberculosis (TB), serious bacterial infections, invasive fungal infections (like histoplasmosis), and infections from other unusual germs — that can lead to hospitalization or death. Most people who developed these infections were also taking other immune-suppressing medicines like methotrexate or steroids. Cimzia must be stopped immediately if a serious infection or blood poisoning (sepsis) develops. All patients must be tested for latent (hidden) TB before starting, and TB treatment must begin before Cimzia is used. Even if your TB test is negative, your doctor should monitor you for TB throughout treatment. Additionally, cases of lymphoma and other cancers — some fatal — have been reported in children and adolescents treated with TNF blockers, including Cimzia. Watch for signs of infection (fever, chills, cough, fatigue) or unusual lumps or swollen lymph nodes, and contact your doctor right away.
📖 Certolizumab Injection: Patient Information Guide
A plain-language walkthrough of Certolizumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Cimzia (certolizumab pegol) subcutaneous injection is approved for multiple inflammatory conditions across adult and some pediatric patients.
- Moderately to severely active Crohn's disease in adults who have not responded adequately to conventional therapy
- Moderately to severely active rheumatoid arthritis in adults
- Active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older — Cimzia is approved for this pediatric use; effectiveness in pediatric Crohn's disease was not demonstrated
- Active psoriatic arthritis in adults
- Active ankylosing spondylitis in adults
- Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults
- Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
⚙️How it works▾
Certolizumab pegol works by targeting and neutralizing a protein called TNFα (tumor necrosis factor-alpha) — a key chemical messenger that drives inflammation throughout the body. In conditions like Crohn's disease and rheumatoid arthritis, TNFα levels are abnormally high, fueling tissue damage and symptoms. By blocking TNFα, Cimzia reduces inflammation, eases symptoms, and helps prevent further damage to joints and other tissues.
Cimzia has a unique structure compared to other TNF blockers: it is a PEGylated Fab' antibody fragment, meaning it lacks the Fc region found in complete antibodies. This means it does not trigger certain immune reactions (like complement activation or cell-killing effects) that full antibodies can cause. Studies also show it has very low placental transfer, which is relevant for pregnant patients.
💊How it's taken▾
Cimzia is always given as a subcutaneous (under-the-skin) injection. The starting schedule typically involves loading doses given at the beginning of treatment, followed by ongoing maintenance doses every two weeks or every four weeks depending on the condition being treated — your prescriber will tailor this to you. For children with pJIA, the dose is based on body weight and must be given by a healthcare professional if the dose required is below 200 mg. Always follow your prescriber's exact schedule and instructions.
- Inject into the thigh or abdomen; rotate sites with each injection
- Remove from the refrigerator and allow to reach room temperature before injecting
- Inspect the solution before use — do not use if it is cloudy or contains particles
- No food or drink restrictions are associated with this injection
🤒Side effects — in detail▾
The most common side effects with Cimzia include:
- Upper respiratory tract infections (colds, sore throat, nasopharyngitis)
- Rash
- Urinary tract infections
- Headache
- High blood pressure (hypertension)
- Injection site reactions (redness, bruising, swelling, or pain at the injection site)
- Back pain
- Fatigue
More serious reactions — including severe infections, signs of TB, allergic reactions (like hives, swelling, or trouble breathing), liver enzyme elevations, or blood count problems — require prompt medical attention. Contact your doctor or seek emergency care if any of these occur.
⚠️Warnings & precautions▾
Serious infections are the biggest risk with Cimzia. Because it suppresses part of the immune system, Cimzia raises the risk of life-threatening infections including tuberculosis (TB), invasive fungal infections, and bacterial or viral infections from unusual germs. TB testing is mandatory before starting, and any active infection must be treated first. Cimzia must be stopped immediately if a serious infection develops. Older patients, those on other immune-suppressing medicines, and those with chronic health conditions face even higher infection risk.
- Cancer risk: Lymphoma and other malignancies — some fatal — have been reported, especially in children and adolescents treated with TNF blockers. Periodic skin exams are recommended for all patients.
- Heart failure: Cimzia may worsen existing heart failure or trigger new-onset heart failure — monitor for swelling, shortness of breath, or sudden weight gain.
- Hepatitis B reactivation: Patients who carry hepatitis B virus can have a dangerous flare-up; testing before starting is required.
- Nervous system effects: Rare cases of new or worsening demyelinating disorders (such as MS-like symptoms) have been reported.
- Blood count problems: Low white blood cells, platelets, or other blood abnormalities have occurred — seek care for unusual bruising or persistent infections.
- Autoimmune reactions: A lupus-like syndrome can develop; stop Cimzia if this occurs.
🔀What it interacts with▾
Cimzia can interact with several other medicines — always give your full medication list to your prescriber and pharmacist.
- Anakinra, abatacept, rituximab, natalizumab: Combining these with Cimzia significantly increases the risk of serious infections — these combinations are not recommended
- Live vaccines: Do not receive live or live-attenuated vaccines while on Cimzia or just before starting — the weakened virus in live vaccines could cause infection in someone on immune-suppressing therapy
- Other TNF blockers: Using Cimzia alongside another TNF blocker is not recommended
- Blood clotting tests (aPTT): Cimzia can cause falsely high results on certain aPTT blood clotting tests — always tell your lab and any treating doctor that you take this medication, so results are interpreted correctly
- Methotrexate and corticosteroids: Commonly used alongside Cimzia for RA, but they add to immune suppression and infection risk
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active infections: Cimzia should not be started if you have any active infection, including localized ones
- Tuberculosis history or risk: TB testing is required before starting; those with a history of TB or travel to high-TB regions need special evaluation
- Hepatitis B carriers: Must be identified and monitored — HBV reactivation can be fatal
- Heart failure: Use with caution; Cimzia has not been formally studied in heart failure patients
- Neurological conditions: Tell your doctor if you have or have had any demyelinating disorder (e.g., multiple sclerosis)
- Blood disorders: Those with significant blood count abnormalities should be monitored carefully
- Pregnancy: Data show very low placental transfer of Cimzia; discuss risks and benefits with your doctor — a pregnancy registry is available for those exposed during pregnancy
- Breastfeeding: Very low levels of Cimzia appear in breast milk; discuss the benefits and any potential risks with your doctor
- Children: Cimzia is approved for pJIA in children 2 and older; it is not approved for Crohn's disease in children, and its safety/effectiveness for other pediatric indications has not been established
- Latex sensitivity: The needle shield in the Cimzia prefilled syringe cap contains a natural rubber latex derivative — alert your healthcare provider if you have a latex allergy
📡Pharmacodynamics — effects in the body▾
By blocking TNFα, Cimzia reduces the downstream chain reaction of inflammation — including the production of inflammatory chemicals like interleukin-1, prostaglandins, and nitric oxide. In Crohn's disease, TNFα is highly expressed in the bowel wall, and treatment with Cimzia has been shown to reduce levels of C-reactive protein (CRP), a marker of inflammation. In rheumatoid arthritis, elevated TNFα in joint fluid plays a major role in the joint destruction that characterizes the disease — blocking it helps slow that process.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, Cimzia reaches peak blood levels roughly 54 to 171 hours (about 2 to 7 days) after the injection, with a bioavailability of about 80% compared to intravenous administration. The drug has a terminal half-life of approximately 14 days, meaning it stays active in the body for a prolonged period — which supports every-two-week or every-four-week dosing schedules. The PEG (polyethylene glycol) component attached to the antibody fragment extends its time in circulation by slowing its clearance from the body. The main route of elimination is through the urine, primarily as the PEG portion; the metabolism of certolizumab pegol has not been formally studied in humans.
📦How to store it▾
Refrigerate CIMZIA vials and prefilled syringes between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. stored at room temperature up to a maximum of 25°C (77°F) for 6 months, but not exceeding the original expiration date.
📄 Written from Certolizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Certolizumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Cimzia used for? ▾
How do I give myself this injection, and does it hurt? ▾
What are the most important warning signs I should watch for? ▾
Do I need any tests before I start Cimzia? ▾
Can I get vaccines while on Cimzia? ▾
Is it safe to use Cimzia during pregnancy or while breastfeeding? ▾
Is Certolizumab Injection available over the counter? ▾
When was Certolizumab Injection first available? ▾
Who makes Certolizumab Injection? ▾
💬 Answers drafted from Certolizumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Certolizumab Injection comes
Certolizumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Cimzia subcutaneous injection is used to treat moderately to severely active Crohn's disease in adults who haven't responded to standard therapies
- Cimzia subcutaneous injection is used to treat moderately to severely active rheumatoid arthritis in adults
- Cimzia subcutaneous injection is used to treat active polyarticular juvenile idiopathic arthritis in patients 2 years and older
- Cimzia subcutaneous injection is used to treat active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, and moderate-to-severe plaque psoriasis in adults
- Cimzia is injected under the skin (subcutaneously) into the thigh or abdomen; rotate injection sites and avoid tender, bruised, red, or hard skin
- Cimzia prefilled syringes can be self-injected at home after proper training from a healthcare professional; pediatric doses below 200 mg require administration by a healthcare professional using the vial kit
- Cimzia lyophilized (powder) vials must be reconstituted and administered by a healthcare professional — allow the vial to reach room temperature before preparing, and inspect the solution for cloudiness or particles before use
- Cimzia prefilled syringe caps contain a natural rubber latex derivative — individuals with latex sensitivity should handle with caution and inform their healthcare provider
📊 Certolizumab Injection across the U.S. market
How Certolizumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Certolizumab Injection is used
A general measure of how commonly Certolizumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Certolizumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Certolizumab Injection prescribed? Of the 1,596 medications we measure, Certolizumab Injection ranks #722 by Medicaid prescriptions — more than 55% of them.
Utilization by Certolizumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
certolizumab pegol 200 MG Injection
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 795081
Other Certolizumab Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 7 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Certolizumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 9 listed Certolizumab Injection NDCs with Medicaid activity.
🔍 Compare Certolizumab Injection products
A representative set of FDA-listed product records for Certolizumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 200 mg/mL | — | Patheon Italia S.p.A | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg/mL | Subcutaneous | UCB, Inc. × 4 listings | BLA | View NDC → |
| 1 g/g | — | UCB Farchim SA × 2 listings | BULK INGREDIENT | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Certolizumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Certolizumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Certolizumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Certolizumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 709271 2 dose forms · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1653728In current FDA listingsClinical drug / strength (SCD) 200 MGRxCUI 795081 -
Dose form (SCDF) Prefilled Syringe RxCUI 849596No current FDA listingClinical drug / strength (SCD) 1 ML certolizumab pegol 200 MG/MLRxCUI 849597
Look up RxCUI 709271 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Certolizumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Certolizumab Injection belongs to the Tumor Necrosis Factor Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. UCB, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.