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Pharmacologic classification: tumor necrosis factor blocker
Therapeutic classification: immunomodulator
Pregnancy risk category: B
AVAILABLE FORMS
Injection: 200-mg single-use vials
INDICATIONS AND DOSAGES
Moderately to severely active Crohn's disease and maintenance of clinical response in patients who have had an inadequate response to conventional therapy--
Adults: Initially, 400 mg subcutaneously (give as two subcutaneous injections of 200 mg each), repeated at weeks 2 and 4; if clinical response occurs, give maintenance dose of 400 mg subcutaneously every 4 weeks.
CONTRAINDICATIONS AND CAUTIONS
There are no known contraindications.
Use cautiously in patients with active and recurrent infections, tuberculosis, hepatitis B, pre-existing CNS demyelinating disease, significant hematologic abnormalities, heart failure, and in elderly patients and patients who are pregnant or breast-feeding.
INTERACTIONS
Drug-drug.
Anakinra: May increase risk of serious infections and neutropenia. Avoid using together.
Live or attenuated vaccines: May increase risk of viral transmission or inadequate response. Avoid using together.
ADVERSE REACTIONS
CNS: optic neuritis, retinal hemorrhage, uveitis, anxiety, demyelinating disease.
CV: angina, arrhythmias, heart failure, hypertensive heart disease, myocardial infarction, myocardial ischemia, pericardial effusion, pericarditis.
GU: UTI, nephritic syndrome.
Hematologic: anemia, leukopenia, lymphadenopathy, pancytopenia, thrombophilia.
Respiratory: respiratory tract infections.
Skin: dermatitis, erythema nodosum, urticaria, Stevens-Johnson syndrome.
Other: serious infections, malignancies, hypersensitivity reactions, arthralgia.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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certolizumab pegol