Certolizumab Pegol

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Subcutaneous [preservative free]:

Cimzia: 200 mg

Cimzia Prefilled: 200 mg/mL

Cimzia Starter Kit: 6 X 200 mg/mL

Pharmacology

Mechanism of Action

Certolizumab is a pegylated humanized antibody Fab’ fragment of tumor necrosis factor alpha (TNF-alpha) monoclonal antibody. Certolizumab binds to and selectively neutralizes human TNF-alpha activity. (Elevated levels of TNF-alpha have a role in the inflammatory process associated with Crohn disease and in joint destruction associated with rheumatoid arthritis.) Since it is not a complete antibody (lacks Fc region), it does not induce complement activation, antibody-dependent cell-mediated cytotoxicity, or apoptosis. Pegylation of certolizumab allows for delayed elimination and therefore an extended half-life.

Pharmacokinetics/Pharmacodynamics

Distribution

V_ss: 4.7 to 8 L

Time to Peak

Plasma: 54 to 171 hours

Half-Life Elimination

~14 days

Use in Specific Populations

Special Populations Note

Body weight: Pharmacokinetic exposure is inversely related to body weight; however, no therapeutic benefit is expected from a weight-adjusted dose regimen.

Use: Labeled Indications

Ankylosing spondylitis: Treatment of adults with active ankylosing spondylitis (AS)

Axial spondyloarthritis, nonradiographic: Treatment of adults with nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Crohn disease: Treatment of moderately to severely active Crohn disease in patients who have inadequate response to conventional therapy

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Psoriatic arthritis: Treatment of adult patients with active psoriatic arthritis

Rheumatoid arthritis: Treatment of adults with moderately to severely active rheumatoid arthritis (RA) (as monotherapy or in combination with nonbiological disease-modifying antirheumatic drugs [DMARDS])

Use: Off Label

Crohn disease (perianal/fistulizing disease)cyes

Data from a post-hoc analysis of a randomized, double-blind, placebo-controlled trial evaluating the efficacy of certolizumab as maintenance therapy in adults with moderate to severe Crohn disease suggests that certolizumab may be beneficial for closure of perianal fistulas Schreiber 2011.

Based on the American College of Gastroenterology Guideline for the Management of Crohn's disease in Adults, certolizumab may be effective and should be considered in the management of perianal fistulas in patients with Crohn disease ACG [Lichtenstein 2018].

Contraindications

Hypersensitivity to certolizumab pegol or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Active tuberculosis or other severe infections (eg, sepsis, abscesses, opportunistic infections); moderate to severe heart failure (NYHA Class III/IV)

Dosage and Administration

Dosing: Adult

Note: Each 400 mg dose should be administered as 2 injections of 200 mg each.

Ankylosing spondylitis: SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks.

Axial spondyloarthritis, nonradiographic: SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks.

Crohn disease: SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 400 mg every 4 weeks.

Crohn disease (perianal/fistulizing disease) (off-label use): SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 400 mg every 4 weeks (Schreiber 2011).

Plaque psoriasis: SubQ: 400 mg every other week. Note: For patients ≤90 kg, an initial dose of 400 mg at weeks 0, 2, and 4 followed by 200 mg every other week thereafter may be considered.

Psoriatic arthritis: SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every other week. May consider maintenance dose of 400 mg every 4 weeks.

Rheumatoid arthritis: SubQ: Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every other week. May consider maintenance dose of 400 mg every 4 weeks. May be administered alone or in combination with methotrexate.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Hypersensitivity, lupus-like syndrome, serious infection, sepsis, or hepatitis B reactivation: Discontinue treatment.

Reconstitution

Vials: Allow vial to sit at room temperature for 30 minutes prior to reconstitution; do not warm in any other way. Reconstitute each vial with 1 mL sterile water for injection (provided) to a concentration of 200 mg/mL; the manufacturer recommends using a 20-gauge needle (provided). Direct sterile water for injection at the vial wall and gently swirl (avoid foaming) for about one minute to facilitate wetting of powder; do not shake. Continue swirling every 5 minutes until fully reconstituted (may take up to 30 minutes).

Administration

SubQ: Bring to room temperature prior to administration. After reconstitution (of vials), draw each vial into separate syringes (using 20-gauge needles).

Administer subcutaneously (using provided 23-gauge needle) into the thigh or abdomen (avoiding areas within 2 inches of navel). For a 400 mg (2 syringes) dose, administer each 200 mg syringe at a separate site; rotate injection sites (at least 1 inch from the previous site). Do not administer to areas where skin is tender, bruised, red, hard, or has scars or stretch marks.

Prefilled syringes may be self-administered after proper training.

Storage

Store intact vials and syringes at 2°C to 8°C (36°F to 46°F); do not freeze. Do not separate contents of carton prior to use. Protect from light. Bring to room temperature prior to administration. Prefilled syringes may be stored at ≤25°C (≤77°F) for ≤7 days; write date removed from refrigerator and discard if not used within 7 days. Store in original carton (to protect from light) and do not return to refrigerator.

Store reconstituted solution for up to 24 hours at 2°C to 8°C (36°F to 46°F) (do not freeze); however, do not leave at room temperature for more than 2 hours prior to administration. Discard unused portion of vial or syringe.

Drug Interactions

Abatacept: Anti-TNF Agents may enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Avoid combination

Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Avoid combination

Anti-TNF Agents: May enhance the immunosuppressive effect of Certolizumab Pegol. Avoid combination

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: May enhance the immunosuppressive effect of Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination

Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): May enhance the immunosuppressive effect of other Biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Avoid combination

Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Avoid combination

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Pegloticase: May diminish the therapeutic effect of PEGylated Drug Products. Monitor therapy

Pegvaliase: PEGylated Drug Products may enhance the adverse/toxic effect of Pegvaliase. Specifically, the risk of anaphylaxis or hypersensitivity reactions may be increased. Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Thiopurine Analogs: Anti-TNF Agents may enhance the adverse/toxic effect of Thiopurine Analogs. Specifically, the risk for T-cell non-Hodgkin's lymphoma (including hepatosplenic T-cell lymphoma) may be increased. Monitor therapy

Tocilizumab: May enhance the immunosuppressive effect of Anti-TNF Agents. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Avoid combination

Test Interactions

Tests for latent tuberculosis may be falsely negative while on certolizumab treatment. Falsely elevated aPTT assays have been reported with PTT-Lupus Anticoagulant (LA) and Standard Target Activated Partial Thromboplastin time (STA-PTT) tests from Diagnostica Stago, and with HemosiL APTT-SP liquid and HemosiL lyophilized silica tests from Instrumentation Laboratories.

Adverse Reactions

>10%:

Gastrointestinal: Nausea (≤11% [Schreiber 2005])

Immunologic: Antibody development (7% to 23%; neutralizing: 3% to 8%)

Infection: Infection (38%)

Respiratory: Upper respiratory tract infection (18% to 22%)

1% to 10%:

Central nervous system: Headache (4%)

Dermatologic: Skin rash (9%)

Genitourinary: Urinary tract infection (7% to 8%)

Hematologic & oncologic: Positive ANA titer (4%)

Hepatic: Increased serum transaminases (≤4%)

Infection: Herpes virus infections (2%)

Local: Injection site reaction (2% to 3%)

Neuromuscular & skeletal: Arthralgia (6%)

Respiratory: Cough (3%)

Frequency not defined:

Dermatologic: Cellulitis

Gastrointestinal: Diarrhea, intestinal obstruction

Hematologic & oncologic: Hematoma, leukopenia, pancytopenia

Infection: Abscess (abdominal), aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, fungal infection, histoplasmosis, listeriosis, opportunistic infection, sepsis, serious infection, tuberculosis

Renal: Pyelonephritis

Respiratory: Infection due to an organism in genus Pneumocystis, lower respiratory tract infection, pneumonia

<1%, postmarketing, and/or case reports: Abdominal pain, allergic dermatitis, anaphylaxis, angioedema, aplastic anemia, autoimmune hepatitis (Shelton 2015), cardiac failure, cytopenia, dyspnea, erythema at injection site, erythema nodosum, hepatosplenic T-cell lymphomas, hepatotoxicity (idiosyncratic) (Chalasani 2014), Hodgkin lymphoma, hot flash, hypersensitivity reaction, hypotension, lichenoid eruption, limb pain, lupus-like syndrome, malaise, malignant lymphoma, malignant melanoma, malignant neoplasm, Merkel cell carcinoma, non-Hodgkin lymphoma, optic neuritis, orthostatic dizziness, pain at injection site, peripheral edema, peripheral neuropathy, psoriasis (including new onset, palmoplantar, pustular, or exacerbation), reactivation of HBV, sarcoidosis, seizure, serum sickness, syncope, thrombocytopenia, urticaria, viral infection

Warnings/Precautions

Concerns related to adverse effects:

• Autoimmune disorder: Autoantibody formation may develop; rarely resulting in autoimmune disorder, including lupus-like syndrome; monitor and discontinue if symptoms develop.
• Demyelinating CNS disease: Rare cases of optic neuritis, seizure, peripheral neuropathy, and demyelinating disease (eg, multiple sclerosis, Guillain-Barré syndrome; new onset or exacerbation) have been reported. Use with caution in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
• Hematologic effects: Rare cases of pancytopenia and other significant cytopenias, including aplastic anemia, have been reported with TNF-blocking agents. Leukopenia and thrombocytopenia have occurred with certolizumab. Consider discontinuing therapy with significant hematologic abnormalities. Use with caution in patients with underlying hematologic disorders.
• Hepatitis B: Rare reactivation of hepatitis B virus (HBV) has occurred in chronic carriers of the virus, usually in patients receiving concomitant immunosuppressants; evaluate for HBV prior to initiation in all patients. Patients who test positive for HBV surface antigen should be referred for hepatitis B evaluation/treatment prior to certolizumab initiation. Monitor for clinical and laboratory signs of active infection during and for several months following discontinuation of treatment in HBV carriers; interrupt therapy if reactivation occurs and treat appropriately with antiviral therapy; if resumption of therapy is deemed necessary, exercise caution and monitor patient closely.
• Hypersensitivity: Hypersensitivity reactions, including angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness and urticaria have been reported (rarely) with treatment. Some of these reactions have occurred after the first dose. Discontinue and do not resume therapy if hypersensitivity occurs. Use with caution in patients who have experienced hypersensitivity with other TNF blockers.
• Immunogenicity: Development of antibodies to certolizumab during therapy may occur. Antibody-positive patients may have an increased incidence of adverse events (including injection site pain/erythema, abdominal pain, and erythema nodosum) and may have lower certolizumab concentrations with reduced efficacy.
• Infections: [US Boxed Warning]: Patients treated with certolizumab are at increased risk for developing serious infections, which may result in hospitalization or death; infections usually developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate, corticosteroids) and may present as disseminated (rather than local) disease. Active tuberculosis (including reactivation of latent tuberculosis), invasive fungal (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and pneumocystosis) and bacterial, viral, or other opportunistic infections (including legionellosis and listeriosis) have been reported in patients receiving certolizumab. Monitor closely for signs/symptoms of infection. Discontinue for serious infection or sepsis. Consider risks vs benefits prior to use in patients with a history of chronic or recurrent infection. Consider empiric antifungal therapy in patients who are at risk for invasive fungal infection and develop severe systemic illness. The elderly, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at a greater risk of infection. Consider risks vs benefits prior to initiating therapy in patients with a history of opportunistic infection; patients who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; and patients with underlying conditions, which may predispose them to infection. Do not initiate certolizumab therapy with active infection, including clinically important localized infection. Patients who develop a new infection while undergoing treatment should be monitored closely.
• Malignancy: [US Boxed Warning]: Lymphoma and other malignancies (some fatal) have been reported in children and adolescent patients receiving TNF-blocking agents. Certolizumab is not indicated for use in pediatric patients. Approximately half of the malignancies reported in children were lymphomas (Hodgkin and non-Hodgkin) while other cases varied and included malignancies not typically observed in this population. The onset of malignancy was after a median of 30 months (range: 1 to 84 months) after the initiation of the TNF-blocking agent. Use of TNF blockers may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. Chronic immunosuppressant therapy use may be a predisposing factor for malignancy development; rheumatoid arthritis alone has been previously associated with an increased rate of lymphoma. Hepatosplenic T-cell lymphoma (HSTCL), a rare T-cell lymphoma, has also been associated with TNF-blocking agents, including certolizumab, primarily reported in adolescent and young adult males with Crohn disease or ulcerative colitis, most of whom had received concurrent treatment with azathioprine and/or 6-mercaptopurine. Melanoma and Merkel cell carcinoma have been reported with TNF-blocking agents including certolizumab. Perform periodic skin examinations in all patients during therapy, particularly those at increased risk for skin cancer.
• Tuberculosis: [US Boxed Warning]: Tuberculosis (disseminated or extrapulmonary disease) has been reported; both reactivation of latent infection and new infections have been reported. Patients should be tested for latent tuberculosis infection before and during therapy; consider treatment of latent tuberculosis prior to certolizumab treatment. Monitor for development of tuberculosis during and after treatment, including patients with initial negative skin tests. Use with caution in patients who have resided in regions where tuberculosis is endemic. Consider antituberculosis treatment prior to initiation of certolizumab in patients with a history of latent or active tuberculosis if adequate treatment course cannot be confirmed, and for patients with risk factors for tuberculosis despite a negative test. Strongly consider tuberculosis in patients who develop a new infection during treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Disease-related concerns:

• Heart failure: Use with caution in heart failure patients; worsening heart failure and new-onset heart failure have been reported with TNF blockers, including certolizumab; monitor closely. In a scientific statement from the American Heart Association, TNF blockers have been determined to be agents that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]).
• Renal impairment: Use has not been studied in patients with renal impairment; however, the pharmacokinetics of the pegylated (polyethylene glycol) component may be dependent on renal function.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in elderly patients, may be at higher risk for infections.
• Pediatric: Malignancies have been reported among children and adolescents receiving TNF-blocking agents.

Dosage form specific:

• Latex: The packaging (needle shield inside the removable cap of prefilled syringe) may contain a plastic derived from natural rubber latex.

Other warnings/precautions:

• Immunizations: Patients should be up to date with all immunizations before initiating therapy; patients may receive vaccines other than live or live attenuated vaccines during therapy. There is no data available concerning the effects of therapy on vaccination or secondary transmission of live vaccines in patients receiving therapy.

Monitoring Parameters

Monitor improvement of symptoms and physical function assessments. Latent TB screening prior to initiating and during therapy; signs/symptoms of infection (prior to, during, and following therapy); CBC with differential; signs/symptoms/worsening of heart failure; HBV screening prior to initiating (all patients), HBV carriers (during and for several months following therapy); signs and symptoms of hypersensitivity reaction; symptoms of lupus-like syndrome; signs/symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) including periodic skin examinations.

The American Gastroenterological Association suggests reactive therapeutic drug monitoring to guide treatment changes in adult patients treated with certolizumab for active inflammatory bowel disease (Feuerstein 2017).

Pregnancy

Pregnancy Considerations

Placental transfer of certolizumab pegol is minimal (Förger 2016; Mariette 2018).

Certolizumab pegol is a humanized Fab-fragment conjugated to polyethylene glycol (PEG). Placental transfer of Fab-fragments is expected to be low to absent (Pentsuk 2009).

Serum concentrations of certolizumab pegol in 12 infants of 10 mothers were ≥75% lower than the maternal serum at delivery (last maternal dose of 400 mg given 5 to 42 days prior to birth; median: 19 days). PEG was not present in infant plasma or cord blood. Although placental transfer of certolizumab pegol was low, based on the rate certolizumab pegol decline in one case, infants may have a slower rate of elimination than adults (Mahadevan 2013). In a study with information from 11 infants, certolizumab pegol cord concentrations were below the limit of detection (n=8) to 1 mcg/mL (n=3). In comparison, median maternal serum levels were 32.97 mcg/mL following administration of certolizumab 200 mg every 2 weeks (Förger 2016). Information is also available from a multicenter study which included 16 mothers on various certolizumab doses during pregnancy. All mothers in the study had therapeutic drug concentrations. The median time between the last maternal dose and delivery was 11 days (range: 1 to 27 days). Certolizumab pegol was measurable in the cord blood in one of 14 infants; concentrations were 0.09% of the maternal plasma levels. Certolizumab pegol was not present in infant serum 4 and 8 weeks after birth. In addition, 14 of 15 umbilical cord samples did not have detectable concentrations of PEG (Mariette 2018).

Pregnancy outcome data from the UCB Pharma safety database collected through March 6, 2017 has been published. Among 528 prospective pregnancies with 538 known outcomes (10 twin pregnancies), 85.3% resulted in live births; among these, 81.2% had at least first trimester exposure. Other outcomes reported were miscarriage (8.7%), elective abortions (5%), major congenital malformations (1.7%), and stillbirths (0.9%). There were no patterns of birth defects among the eight infants with congenital malformations and the rate of birth defects was not greater than that observed in the general population. Pregnancy outcomes were not known for 411 cases reported to the database; 198 additional pregnancies were ongoing at the time of the report (Clowse 2018). Information related to this class of medications is emerging, but based on available data, tumor necrosis factor alpha (TNFα) blocking agents are considered to have low to moderate risk when used in pregnancy (ACOG 776 2019).

Inflammatory bowel disease is associated with adverse pregnancy outcomes including an increased risk of miscarriage, premature delivery, delivery of a low birth weight infant, and poor maternal weight gain. Management of maternal disease should be optimized prior to pregnancy. Treatment decreases disease flares, disease activity, and the incidence of adverse pregnancy outcomes (Mahadevan 2019).

Use of immune modulating therapies in pregnancy should be individualized to optimize maternal disease and pregnancy outcomes (ACOG 776 2019). The American Academy of Dermatology considers TNFα blocking agents for the treatment of psoriasis to be compatible with pregnancy (AAD-NPF [Menter 2019]). When treatment for inflammatory bowel disease is needed in pregnant women, certolizumab pegol can be continued without interruption. Serum levels should be evaluated prior to conception and optimized to avoid subtherapeutic concentrations or high levels which may increase placental transfer (Mahadevan 2019).

The American Academy of Dermatology considers TNFα blocking agents for the treatment of psoriasis to be compatible for use in male patients planning to father a child (AAD-NPF [Menter 2019]). Women with psoriasis planning a pregnancy may continue treatment with certolizumab pegol. Women with well-controlled psoriasis who wish to avoid fetal exposure can consider discontinuing certolizumab pegol 10 weeks prior to attempting pregnancy (Rademaker 2018). Treatment algorithms are available for use of biologics in female patients with Crohn disease who are planning a pregnancy (Weizman 2019).

Data collection to monitor pregnancy and infant outcomes following exposure to certolizumab pegol is ongoing. Health care providers are encouraged to enroll women exposed to certolizumab pegol during pregnancy in the MotherToBaby Pregnancy Studies by contacting the Organization of Teratology Information Specialists (OTIS) (877-311-8972) or http://mothertobaby.org/pregnancy-studies/.

Patient Education

What is this drug used for?

• It is used to treat Crohn disease.
• It is used to treat rheumatoid arthritis.
• It is used to treat psoriatic arthritis.
• It is used to treat ankylosing spondylitis.
• It is used to treat plaque psoriasis.
• It is used to treat spondyloarthritis.
• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Common cold

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection
• Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain.
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.
• Lupus like rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Aplastic anemia like fever, sore throat, mouth sores, infections, bruising, or purple skin splotches.
• Chills
• Shortness of breath
• Nerve problems like sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet.
• Severe dizziness
• Passing out
• Skin growth
• Skin lump
• Mole changes
• Vision changes
• Excessive weight loss
• Extremity weakness
• Night sweats
• Severe injection site irritation, burning or numbness feeling
• Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out.
• Seizures
• Pale skin
• Mood changes
• Thoughts of suicide
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.