Remicade

Remicade®

A chimeric monoclonal antibody which is used to manage psoriasis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis ankylosing spondylitis

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infliximab

Remicade

Pharmacologic class: Monoclonal antibody

Therapeutic class: Antirheumatic, GI anti-inflammatory

Pregnancy risk category C

FDA Boxed Warning

• Drug increases risk of infection, including progression to serious infections leading to hospitalization or death. Infections have included bacterial sepsis, tuberculosis (TB), and invasive fungal and other opportunistic infections. Teach patients signs and symptoms of infection; monitor closely for these during and after treatment, and ensure that patient has access to appropriate medical care. If infection occurs, evaluate for appropriate antimicrobial therapy; for serious infection, discontinue drug.
• Evaluate patient for TB risk factors and test for latent TB infection before and during therapy. Start treatment of latent TB before therapy.
• Rare postmarketing cases of hepatosplenic T-cell lymphoma have occurred in adolescents and young adults with Crohn's disease. This lymphoma is highly aggressive and usually fatal. All cases have occurred in patients receiving concomitant azathioprine or 6-mercaptopurine.

Action

Neutralizes and prevents activity of tumor necrosis factor-alpha (TNF-alpha) by binding to soluble and transmembrane forms of TNF and inhibiting its receptors, resulting in anti-inflammatory and antiproliferative activity. Reduces rate of joint destruction in rheumatoid arthritis and eases symptoms of Crohn's disease.

Availability

Powder for injection: 100 mg/vial

⊘Indications and dosages

➣ Rheumatoid arthritis (given with methotrexate)

Adults: Initially, 3 mg/kg I.V., followed by 3 mg/kg 2 and 6 weeks after initial dose, then q 8 weeks. In partial responders, dosage may be adjusted up to 10 mg/kg or treatment may be repeated as often as q 4 weeks.

➣ Crohn's disease

Adults: 5 mg/kg I.V. as a single infusion, starting as induction regimen at 0, 2, and 6 weeks, then a maintenance regimen of 5 mg/kg q 8 weeks. For patients who respond initially but then stop responding, dosage of 10 mg/kg may be warranted.

➣ Ulcerative colitis

Adults: 5 mg/kg I.V. given as induction therapy at 0, 2, and 6 weeks, followed by 5 mg/kg I.V. every 8 weeks thereafter

Off-label uses

• Complicated ankylosing spondylitis
• Sarcoidosis

Contraindications

• Hypersensitivity to drug, murine proteins, or other drug components
• Heart failure (NYHA class III or IV)

Precautions

Use cautiously in:
• history of tuberculosis (TB), active infection, or exposure to TB
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Know that latent TB should be treated before infliximab therapy begins.
• To reconstitute, use 21G or smaller needle to add 10 ml of sterile water to each vial. To mix, swirl (don't shake). Solution may foam and appear clear or light yellow.
• Withdraw volume equal to amount of reconstituted drug from 250-ml polypropylene or polyolefin infusion bag or glass bottle of normal saline solution. Slowly add reconstituted drug to infusion bag or bottle, and gently mix. Use within 3 hours.
• Know that concentration of infusion should be 0.4 mg/ml to 4 mg/ml.
• Give I.V. infusion over at least 2 hours. Use polyethylene-lined infusion set equipped with in-line filter, with pore size of 1.2 microns or less.
• Discard unused portions of infusion solution.
• Don't give to patient with active infection.
• Be aware that patient who doesn't respond by week 14 isn't likely to respond, and therapy should cease.

Route	Onset	Peak	Duration
I.V.	1-2 wk	Unknown	12-48 wk

Adverse reactions

CNS: fatigue, headache, anxiety, depression, dizziness, insomnia

CV: chest pain, hypertension, hypotension, tachycardia, peripheral edema, worsening of heart failure

EENT: conjunctivitis, rhinitis, sinusitis, laryngitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, ulcerative stomatitis, intestinal obstruction

GU: dysuria, urinary frequency, urinary tract infection

Hematologic: hematoma, pancytopenia

Musculoskeletal: arthritis, joint pain, back pain, myalgia, involuntary muscle contractions

Respiratory: upper respiratory tract infection, bronchitis, cough, dyspnea

Skin: acne, diaphoresis, dry skin, bruising, eczema, erythema, flushing, pruritus, urticaria, rash, alopecia

Other: oral pain, tooth pain, moniliasis, chills, hot flashes, flulike symptoms, herpes simplex, herpes zoster, lupuslike syndrome, infections, hypersensitivity reaction, anaphylaxis

Interactions

Drug-drug. Vaccines: decreased antibody response to vaccine

Drug-diagnostic tests. Antinuclear antibodies: positive titer

Hepatic enzymes: increased values

Hemoglobin: decreased value

Patient monitoring

☞ Stay alert for signs and symptoms of hypersensitivity reaction, including fever, chills, itching, rash, chest pain, dyspnea, facial flushing, and headache.
☞ Watch for evidence of infection, especially in patients who have chronic infections or are receiving immunosuppressants. Drug increases risk of life-threatening opportunistic infections and TB.
• Monitor platelets and CBC with white cell differential.
☞ Assess for heart failure in patients with history of cardiac disease.

Patient teaching

☞ Instruct patient to report signs or symptoms of hypersensitivity reaction, such as fever, chills, itching, rash, chest pain, dyspnea, and facial flushing (may occur up to 12 days after therapy).
☞ Tell patient to report infection symptoms, such as fever, burning on urination, cough, or sore throat.
• Advise patient to avoid potential infection sources, such as crowds and people with known infections.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

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Remicade®

Avakine^™, cA2^™, CenTNF^™, infliximab Immunology An agent used to manage severe or mutilating rheumatoid arthritis, or severe or active–eg, fistulizing–Crohn's disease. See Rheumatoid arthritis.