Certolizumab Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Crohn's Disease - Maintenance

Initial dose: 400 mg subcutaneously initially and at weeks 2 and 4
Maintenance dose: 400 mg subcutaneously every 4 weeks in patients who obtain a clinical response

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 400 mg subcutaneously initially and at weeks 2 and 4 followed by 200 mg every other week
Maintenance dose: 400 mg subcutaneously every 4 weeks can be considered

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Patients treated with certolizumab are at increased risk for developing serious infections involving multiple organ systems and sites that may progress to hospitalization or death. Such infections have included tuberculosis, invasive fungal infections, and bacterial, viral, and other opportunistic infections. Certolizumab should not be started in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with comorbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. The risks and benefits of therapy should be considered before starting treatment in patients with chronic or recurrent infection, who have been exposed to tuberculosis, with a history of an opportunistic infection, who have resided or traveled in areas of endemic tuberculosis or mycosis, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for signs and symptoms of infection during and after treatment with certolizumab, including the possible development of tuberculosis in patients testing negative for latent tuberculosis prior to starting treatment. Patients developing new infections should be closely monitored, have prompt and complete diagnostic workups appropriate for immunocompromised patients, and have appropriate antimicrobial therapy started. Certolizumab should be discontinued in patients developing a serious infection or sepsis.

Tuberculosis has been observed in patients receiving certolizumab. Patients should be evaluated for active tuberculosis and tuberculosis risk factors and tested for latent tuberculosis infection prior to initiating certolizumab and during therapy. Treatment of latent tuberculosis should be initiated prior to therapy with certolizumab. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving certolizumab. Some patients who tested negative for latent tuberculosis prior to receiving certolizumab have developed active tuberculosis. Physicians should monitor patients receiving certolizumab for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Tests for latent tuberculosis may be falsely negative during treatment with certolizumab.

Use of TNF blockers, including certolizumab, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker treatment has been fatal. The majority of reports have been in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating certolizumab therapy. Caution should be exercised in prescribing certolizumab for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with antiviral treatment in conjunction with TNF blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require therapy with certolizumab should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, certolizumab should be discontinued and effective antiviral therapy with appropriate supportive treatment initiated. The safety of resuming TNF blocker treatment after HBV reactivation is controlled is not known. Therefore, caution should be exercised when considering resumption of certolizumab therapy in this situation and monitor patients closely.

In the controlled portions of clinical studies of some TNF blockers, more cases of malignancies have been observed among patients receiving TNF blockers compared to control subjects. The size of the control group and limited duration of the controlled portions of the trials precludes the ability to draw firm conclusions. In the controlled portions of clinical trials of all the TNF blockers, more cases of lymphoma have been noted among patients receiving TNF blockers compared to control subjects. Patients with Crohn's disease or other diseases that require chronic exposure to immunosuppressant therapies may be at higher risk than the general population for the development of lymphoma, even in the absence of TNF blocker treatment. The potential role of TNF blocker treatment in the development of malignancies is not known.

Lymphoma and other malignancies, some fatal, have been reported in children and young adults treated with TNF blockers, of which certolizumab is a member. Reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immunosuppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine in most patients), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease, or other diseases. About half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphomas, while the other cases were a variety of malignancies (including rare malignancies usually associated with immunosuppression and malignancies not usually reported in children and adolescents). These cases were reported during postmarketing experience. Certolizumab is not indicated for use in pediatric patients.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, of which certolizumab is a member. These cases have had a very aggressive disease course and have usually been fatal. The majority of cases have occurred in patients with Crohn's disease or ulcerative colitis, but also included a psoriasis patient and two patients treated for rheumatoid arthritis, and primarily in adolescent and young adult males. Most cases have occurred in patients receiving combination therapy known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine; therefore, the risks and benefits of these agents should be taken into account when treating adolescents and young adults, especially for inflammatory bowel disease. Patients should be monitored for the development of sign and symptoms of malignancies including splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.

The following symptoms that could be compatible with hypersensitivity reactions have been observed rarely following certolizumab administration to patients: angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria. If such reactions occur, further administration of certolizumab should be discontinued and appropriate therapy instituted. There are no data on the risks of using certolizumab in patients who have experienced a severe hypersensitivity reaction towards another TNF blocker; in these patients caution is advised.

Use of TNF blockers has been associated with rare reports of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome. Caution should be exercised when considering the use of certolizumab in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy, have been observed in patients treated with certolizumab.

Rare reports of pancytopenia, including aplastic anemia, have been observed with TNF blockers. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) have been infrequently observed with certolizumab. The causal relationship of these events to certolizumab therapy remains unclear. Although no high risk group has been identified, caution should be exercised in patients being treated with certolizumab who have ongoing, or a history of, significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on certolizumab therapy. Discontinuation of certolizumab therapy should be considered in patients with confirmed significant hematologic abnormalities.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been observed with TNF blockers. Certolizumab has not been formally studied in patients with CHF; however, in clinical studies in CHF of another TNF blocker, a higher rate of serious CHF-related adverse reactions was noted. Caution should be exercised when using certolizumab in patients who have heart failure and monitor them carefully.

Therapy with certolizumab may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with certolizumab, treatment should be discontinued.

Patients treated with certolizumab may receive vaccinations, except for live or live attenuated vaccines. No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving certolizumab.

Since TNF mediates inflammation and modulates cellular immune responses, the possibility exists for TNF blockers, including certolizumab therapy, to affect host defenses against infections and malignancies. The impact of therapy with certolizumab on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood. The safety and efficacy of certolizumab in patients with immunosuppression has not been formally studied.

Interference with certain coagulation assays has been noted in patients treated with certolizumab. Certolizumab may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities. This effect has been noted with the PTT-LA test from Diagnostica Stago, and the HemosIL APTT-SP liquid and HemosIL lyophilized silica tests from Instrumentation Laboratories. Other aPTT assays may be affected also. Interference with thrombin time (TT) and prothrombin time (PT) assays has not been noted. There is no evidence that certolizumab therapy has an effect on in vivo coagulation.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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