Certolizumab pegol

What is Certolizumab pegol?

• Certolizumab pegol (Cimzia) is a tumor necrosis factor (TNF) blocker used for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis and non-radiographic axial spondyloarthritis.

CertolizumaB 5WUV

Certolizumab binding TNF-alpha homotrimer 5WUX

Syringe with Certolizumab pegol-1800

What are the uses of this medicine?

Certolizumab pegol (Cimzia) is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker used in adults 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)
• Treat active psoriatic arthritis (PsA)
• Treat active ankylosing spondylitis (AS)
• Treat active non-radiographic axial spondyloarthritis (nr-axSpA) with measures of inflammation
• 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)

How does this medicine work?

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• A Fab fragment of a recombinant, humanized monoclonal antibody directed against the proinflammatory cytokine tumor necrosis factor-alpha (TNF-alpha) and conjugated to polyethylene glycol (PEG), with anti-inflammatory activity.
• Upon administration, certolizumab binds to TNF-alpha and prevents the interaction of this cytokine with endogenous cell surface receptors, thereby rendering TNF-alpha inactive and inhibiting TNF-mediated inflammatory responses.
• TNF-alpha is a protein involved in inflammation, cell survival, and apoptosis.
• Pegylation of certolizumab allows for an improved pharmacokinetic profile.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Serious hypersensitivity reaction to certolizumab pegol or to any of the excipients.

What drug interactions can this medicine cause?

• The use of Cimzia in combination with anakinra, abatacept, rituximab, or natalizumab is not recommended.
• Avoid use of live (including attenuated) vaccines concurrently with Cimzia.
• Interference with certain coagulation assays has been detected in patients treated with Cimzia.

Is this medicine FDA approved?

• Certolizumab was approved in the United States in 2008 for use in Crohn disease and its indications were subsequently extended to rheumatoid arthritis and psoriatic arthritis and ankylosing spondylitis.

How should this medicine be used?

Recommended dosage:

• The recommended initial dose of Cimzia is 400 mg (given as two subcutaneous injections of 200 mg).

Crohn's Disease:

• 400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks

Rheumatoid Arthritis:

• 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

Psoriatic Arthritis:

• 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:

• 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:

• 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:

• 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.
• For some patients (with body weight ≤ 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.

Administration:

• 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 Kit including a complete "Instructions for Use" booklet 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 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 200 mg lyophilized powder in a single-dose vial (certolizumab pegol kit)
• Injection: 200 mg/mL solution in a single-dose prefilled syringe (certolizumab pegol injection, solution)

This medicine is available in fallowing brand namesː

• Cimzia

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory infections (flu, cold)
• rash
• urinary tract infections (bladder infections)

Cimzia can cause serious side effects, including:

• Cancer
• Heart failure
• Allergic reactions
• Hepatitis B virus reactivation in people who carry the virus in their blood
• Blood problems
• Immune reactions including a lupus-like syndrome

What special precautions should I follow?

• Cimzia should not be initiated in patients with an active infection. Monitor for infection during and after treatment; discontinue if a serious infection develops. If invasive fungal infection develops in patients who reside or travel to regions where mycoses are endemic, consider empiric antifungal therapy.
• Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including Cimzia.
• Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including Cimzia. Exercise caution in patients with heart failure and monitor them carefully.
• The following symptoms that could be compatible with hypersensitivity reactions have been reported rarely following Cimzia administration to patients: angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria. Discontinue Cimzia and institute appropriate therapy if anaphylaxis or other serious hypersensitivity reactions occur.
• Use of TNF blockers, including Cimzia, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Test for HBV infection before starting Cimzia. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Cimzia and begin anti-viral therapy.
• Exacerbation or new onset demyelinating disease including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome may occur; use caution in patients with pre-existing or recent-onset demyelinating disorders.
• Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Use with caution in patients who have ongoing, or a history of, significant hematologic abnormalities. Advise patients to seek immediate medical attention if symptoms develop; consider discontinuing Cimzia in patients with confirmed abnormalities.
• A higher risk of serious infections was also observed in combination use of TNF blockers with abatacept and rituximab. Therefore, the use of Cimzia in combination with other biological DMARDs is not recommended.
• Since TNF mediates inflammation and modulates cellular immune responses, the possibility exists for TNF blockers, including Cimzia Discontinue Cimzia if lupus-like syndrome develops.
• Patients treated with Cimzia may receive vaccinations, except for live or live attenuated vaccines. Avoid use with Cimzia.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no evidence of dose-limiting toxicities.

Management of overdosage:

• In cases of overdosage, it is recommended that patients be monitored closely for any adverse reactions or effects, and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• It is not known if Cimzia will harm your unborn baby.
• If you become pregnant during treatment with Cimzia, talk to your healthcare provider about registering in the pregnancy exposure registry for Cimzia. You can enroll in this registry by calling 1-877-311-8972. The purpose of this registry is to collect information about the safety of Cimzia during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

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.

Who manufactures and distributes this medicine?

Manufactured by: UCB, Inc. 1950 Lake Park Drive Smyrna, GA

What should I know about storage and disposal of this medication?

• Keep Cimzia in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze Cimzia.
• 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.
• The Cimzia prefilled syringe is made of glass.
• Do not drop or crush the syringe.

• Dailymed label info on Certolizumab pegol
• FDA Certolizumab pegol