Certolizumab Pegol

Dosage Forms & Strengths

lyophilized powder for reconstitution

• 200mg/vial

Moderate-to-Severe Crohn Disease

Initial: 400 mg SC as 2 injections of 200 mg each, repeat at 2 and 4 weeks

Maintenance: 400 mg SC q4Weeks

Moderate-to-Severe Rheumatoid Arthritis

Initial: 400 mg SC as 2 injections of 200 mg, repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Active Psoriatic Arthritis

Initial: 400 mg SC as 2 injections of 200 mg, repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Active Ankylosing Spondylitis

Initial: 400 mg SC as 2 injections of 200 mg; repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4weeks

Safety and efficacy not established

Crohn’s Disease

Used to reduce the signs and symptoms of moderately to severely active Crohn’s disease and to maintain clinical response in adults who have had an inadequate response to conventional therapies.1 2 3

Rheumatoid Arthritis

Management of moderately to severely active rheumatoid arthritis in adults.1 May be used alone or in combination with methotrexate or other nonbiologic DMARDs.1

Ankylosing Spondylitis

Management of active ankylosing spondylitis in adults.1 31

Psoriatic Arthritis

Management of active psoriatic arthritis in adults.1 32 33

• Recombinant humanized Fab′ fragment of an anti-TNF monoclonal antibody conjugated to an approximately 40-kilodalton polyethylene glycol (PEG2MAL40K) in order to prolong the half-life.1 2 3 7 8

• Binds with high affinity to TNF-α, a cytokine involved in the regulation of immune response.1 2 3 7 8

• Does not contain a fragment crystallizable (Fc) region or induce complement activation, antibody-dependent cellular cytotoxicity, apoptosis, or neutrophil degranulation in vitro.1 2 3 7 8

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

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

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

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])

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); pharmacokinetics of the pegylated (polyethylene glycol) component of certolizumab is expected to be dependent on renal function.

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.

>10%:

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

Immunologic: Antibody development (7% to 23%)

Infection: Infection (38%; serious: 3%)

Respiratory: Upper respiratory tract infection (6% to 20%)

1% to 10%:

Cardiovascular: Hypertension (≤5%), angina pectoris (<5%), atrial fibrillation (<5%), cardiac arrhythmia (<5%), cardiac failure (<5%; new or worsening), cerebrovascular accident (<5%), hypertensive heart disease (<5%), ischemic heart disease (<5%), myocardial infarction (<5%), pericardial effusion (<5%), pericarditis (<5%), transient ischemic attacks (<5%), vasculitis (<5%)

Central nervous system: Headache (5%), anxiety (<5%), bipolar mood disorder (<5%), suicidal tendencies (<5%), fatigue (≤3%)

Dermatologic: Skin rash (≤9%), alopecia (<5%), dermatitis (<5%), erythema nodosum (<5%), urticaria (<5%)

Endocrine & metabolic: Menstrual disease (<5%)

Genitourinary: Urinary tract infection (≤8%), nephrotic syndrome (<5%)

Hematologic & oncologic: Anemia (<5%), hemorrhage (<5%), hypercoagulability state (<5%), leukopenia (<5%), lymphadenopathy (<5%), pancytopenia (<5%), thrombophlebitis (<5%), positive ANA titer (≤4%)

Hepatic: Hepatitis (<5%), increased serum transaminases (<5%)

Neuromuscular & skeletal: Arthralgia (6% to 7%), back pain (≤4%)

Ophthalmic: Optic neuritis (<5%), retinal hemorrhage (<5%), uveitis (<5%)

Renal: Renal failure (<5%)

Respiratory: Cough (≤6%), nasopharyngitis (5%), tuberculosis (<5%; peritoneal, pulmonary, and disseminated), bronchitis (≤3%), pharyngitis (≤3%)

Miscellaneous: Fever (3%)

<1% (Limited to important or life-threatening): Aplastic anemia, autoimmune hepatitis (Shelton 2015), cytopenia, demyelinating disease (exacerbation), fistula, hepatosplenic T-cell lymphoma, hepatotoxicity (idiosyncratic) (Chalasani 2014), herpes virus infection, hypersensitivity reaction (eg, dyspnea, hot flush, hypotension, malaise, serum sickness, syncope), intestinal obstruction, leukemia, lupus erythematosus, lupus-like syndrome, lymphoma, malignant melanoma, malignant neoplasm, Merkel cell carcinoma, neoplasm (benign, malignant, and unspecified; including cysts and polyps), opportunistic infection (rare), peripheral edema, peripheral neuropathy, pneumonia, psoriasis (including new onset, palmoplantar, pustular, or exacerbation), pyelonephritis, reactivation of HBV, sarcoidosis, seizure, thrombocytopenia, viral infection

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience signs of common cold. Have patient report immediately to prescriber signs of infection, signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, severe dizziness, passing out, severe headache, skin growth, skin lump, mole changes, vision changes, bruising, bleeding, excessive weight loss, extremity weakness, night sweats, severe injection site irritation, burning or numbness feeling, signs of heart problems (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, enlarged lymph nodes, severe loss of strength and energy, pale skin, urinary retention, or change in amount of urine passed (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.