Adult Dosing
Moderate-to-severe Crohn's disease
- Initial dose: 400 mg SC x 1 on wk 0, 2 and 4
- Maintenance dose: 400 mg SC q4 wks
Rheumatoid arthritis
- Initial doses: 400 mg SC x 1 on wk 0, 2 and 4 followed by 200 mg every other week
- Maintenance doses: 400 mg SC q4 wks
Active psoriatic arthritis (PsA)
- 400 mg SC x 1 (given as 2 subcutaneous injections of 200 mg each) on wk 0, 2 and 4
- Maintenance dose: 400 mg SC q4 wks
Ankylosing Spondylitis
- Initial doses: 400 mg SC x 1 on wk 0, 2 and 4 followed by 200 mg every other week
- Maintenance doses: 400 mg SC q4 wks
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- It may cause serious infections including tuberculosis (TB), bacterial sepsis, invasive fungal infections and other opportunistic infections. Therefore carefully weigh risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infection [US Black Box Warning]
- Suspend therapy if a patient develops a serious infection or sepsis [US Black Box Warning]
- Prior to initiating therapy perform test for TB; if positive start treatment for TB first. Closely monitor patients for the development of signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy [US Black Box Warning]
- Since histoplasmosis may be present in patients with negative antigen and antibody tests, consider empiric anti-fungal therapy in patients with severe systemic illness if at risk for invasive fungal infection [US Black Box Warning]
- Do not start treatment if active infection is present
- Cases of lymphoma and other malignancies have been observed in patients receiving TNF blockers
- Acute and chronic leukemia cases have been reported in association with post-marketing TNF-blocker use in RA as well as other indications. In absence of TNF-blocker treatment, patients with RA may be at a greater risk than the common population for the development of leukemia
- Regular skin examinations are recommended for all patients, especially individuals with risk factors for skin cancer
- Worsening of CHF and/or new onset CHF has been reported with TNF blockers
- It can also cause hematological reactions including pancytopenia and aplastic anemia; advise patients to seek immediate medical attention if symptoms develop and consider stopping the drug
- Monitor patients for the development of opportunistic infections
- Monitor HBV carriers during and several months after therapy due to risk of hepatitis B reactivation; if reactivation occurs, stop treatment and start antiviral therapy
- Lupus-like syndrome may develop; discontinue treatment if symptoms occur following treatment with the drug
- Do not administer live vaccines or attenuated vaccines concurrently with the drug
- Demyelinating disease (exacerbation or new onset) may occur. Exercise caution in the use of the drug in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disease
- Use of the drug in combination with other biological DMARDs is not recommended
Cautions: Use cautiously in
- Latent and active tuberculosis
- Hx of oppurtunistic infections
- Hx of chronic/recurrent infections
- Tuberculosis risk factors
- Immunosuppressant use
- Myelosuppression
- Hx of seizure disorder
- CNS demyelinating disease
- Hepatitis B carrier
- Hx of CHF
- Lactation
Pregnancy Category:B
Breastfeeding: Preliminary data indicates that certolizumab is minimally excreted into breastmilk; however it is unlikely to affect the breastfed infant > 1 month of age. Long term follow up data for use during nursing are not available, hence an alternate drug might be preferred, especially while nursing a newborn or preterm infant. This information is based upon data from LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2010).
