certolizumab

REMS

Moderately to severely active Crohn's disease when response to conventional therapy has been inadequate.
Moderately to severely active rheumatoid arthritis.
Active psoriatic arthritis.
Active ankylosing spondylitis.
Active polyarticular juvenile idiopathic arthritis.
Moderate to severe plaque psoriasis in patients who are not candidates for systemic therapy or phototherapy.
Active non-radiographic axial spondyloarthritis with objective signs of inflammation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active infection (including localized);
Concurrent use of anakinra.

Use Cautiously in:

History of chronic or recurrent infection or underlying illness/treatment predisposing to infection;
History of exposure to tuberculosis (TB);
History of opportunistic infection;
Patients residing, or who have resided, where TB, histoplasmosis, coccidioidomycoses, or blastomycosis is endemic;
History of demyelinating disorders (may exacerbate);
History of HF;
OB: Use during pregnancy only if potential maternal benefits justify potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefits justify potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: May ↑ risk of infection in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: psoriasis, skin reactions (rarely severe)

Hemat: hematologic reactions

MS: arthralgia

Misc: infection (including reactivation TB, hepatitis B virus [HBV] reactivation, and other opportunistic infections due to bacterial, invasive fungal, viral, mycobacterial, and parasitic pathogens), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, SERUM SICKNESS, AND URTICARIA), lupus-like syndrome, MALIGNANCY (INCLUDING LYMPHOMA, HEPATOSPLENIC T-CELL LYMPHOMA [HSTCL], LEUKEMIA, AND SKIN CANCER)

Interactions ⬆ ⬇

Drug-drug:

Anakinra↑ risk of serious infections; concurrent use contraindicated.
Concurrent use with azathioprine and/or methotrexate may ↑ risk of HSTCL.
May ↓ antibody response to or ↑ risk of adverse reactions to live vaccines; avoid concurrent use.

Availability ⬆ ⬇

Lyophilized powder for injection: 200 mg/vial
Solution for injection (prefilled syringes): 200 mg/mL

Route/Dosage ⬆ ⬇

Crohn's Disease

SC (Adults ): 400 mg (given as two 200-mg injections) initially; then repeat 2 and 4 wk later; may be followed by maintenance dose of 400 mg (given as two 200-mg injections) every 4 wk.

Rheumatoid Arthritis or Psoriatic Arthritis

SC (Adults ): 400 mg (given as two 200-mg injections) initially; then repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk (400 mg [given as two 200-mg injections] every 4 wk may be used alternatively).

Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

SC (Adults ): 400 mg (given as two 200-mg injections) initially; then repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk or 400 mg (given as two 200-mg injections) every 4 wk.

Polyarticular Juvenile Idiopathic Arthritis

SC (Children ≥2 yr and ≥40 kg): 400 mg (given as two 200-mg injections) initially; then repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk (starting at Wk 6).
SC (Children ≥2 yr and 20–<40 kg): 200 mg initially; then repeat 2 and 4 wk later; then maintenance dose of 100 mg every 2 wk (starting at Wk 6).
SC (Children ≥2 yr and 10–<20 kg): 100 mg initially; then repeat 2 and 4 wk later; then maintenance dose of 50 mg every 2 wk (starting at Wk 6).

Plaque Psoriasis

SC (Adults ): 400 mg (given as two 200-mg injections) every 2 wk; Patients ≤90 kg: may consider giving 400 mg (given as two 200-mg injections) initially; then repeat 2 and 4 wk later; then maintenance dose of 200 mg every 2 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Neutralizes tumor necrosis factor, a prime mediator of inflammation; pegylation provides a long duration of action.

Therapeutic effects:

Decreased signs/symptoms of Crohn's disease.
Decreased pain and swelling, decreased rate of joint destruction, and improved physical function in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis.
Decreased joint swelling and pain in psoriatic arthritis.
Decreased spinal pain and inflammation in ankylosing spondylitis.
Reduced severity of plaques.
Decreased pain and swelling, reduced C-reactive protein levels, and improved physical function in axial spondyloarthritis.

Classifications ⬆ ⬇

Therapeutic Classification: gastrointestinal anti-inflammatories, antirheumatics

Pharmacologic Classification: tumor necrosis factor blockers, dmards, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: 80% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 14 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	50–120 hr	2–4 wk

Patient/Family Teaching ⬆ ⬇

Advise patient of potential benefits and risks of certolizumab. Instruct patient in correct technique for injection, and care and disposal of equipment. Advise patient to read the Medication Guide prior to starting therapy.
Advise patient to avoid live vaccines during or immediately prior to initiating therapy.
Inform patient of risk of infection. Advise patient to notify health care professional if symptoms of infection (fever, cough, flu-like symptoms, open cuts or sores), including TB or reactivation of HBV infection, occur.
Counsel patient about possible risk of lymphoma and other malignancies while receiving certolizumab. Advise patient to obtain periodic skin examinations during therapy.
Advise patient to notify health care professional if signs of hypersensitivity reactions (rash, swollen face, difficulty breathing) or new or worsening medical conditions, such as heart or neurological disease or autoimmune disorders, occur and to report signs of bone marrow depression (bruising, bleeding, or persistent fever).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage pregnant patients to enroll in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). The OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/.

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Indications ⬇