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Related to infliximab: methotrexate
Pharmacologic class: Monoclonal antibody
Therapeutic class: Antirheumatic, GI anti-inflammatory
Pregnancy risk category B
FDA Box Warning
• Patients treated with infliximab are at increased risk for developing serious infections, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis), and infections due to other opportunistic pathogens (including Legionella and Listeria species), that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants (such as methotrexate or corticosteroids).
• Carefully consider risks and benefits of treatment with infliximab before starting therapy in patients with chronic or recurrent infection.
• TB includes active TB and reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before starting infliximab and during therapy. Treatment for latent infection should be started before initiating infliximab.
• Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
• Closely monitor patients for signs and symptoms of infection during and after treatment with infliximab, including possible development of TB in patients who tested negative for latent TB before starting infliximab.
• Discontinue drug if patient develops a serious infection or sepsis.
• Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab. All cases occurred in patients with Crohn's disease and ulcerative colitis, the majority of whom were adolescent or young adult males. This rare, aggressive T-cell lymphoma is fatal. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with infliximab at or before diagnosis.
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.
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 and children age 6 and older: 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 some adults patients who respond initially but then stop responding, dosage of 10 mg/kg may be warranted.
➣ Ulcerative colitis
Adults and children age 6 and older: 5 mg/kg I.V. infusion given as induction therapy at 0, 2, and 6 weeks, followed by maintenance regimen of 5 mg/kg I.V. q 8 weeks thereafter
➣ Ankylosing spondylitis
Adults: 5 mg/kg I.V. infusion at 0, 2, and 6 weeks, followed by maintenance regimen of 5 mg/kg q 6 weeks thereafter
➣ Psoriatic arthritis
Adults: 5 mg/kg I.V. infusion (with or without methotrexate) given as induction therapy at 0, 2, and 6 weeks, followed by maintenance regimen of 5 mg/kg q 8 weeks thereafter
➣ Plaque psoriasis
Adults: 5 mg/kg I.V. infusion given as induction therapy at 0, 2, and 6 weeks, followed by maintenance regimen of 5 mg/kg q 8 weeks thereafter
• Hypersensitivity to drug, murine proteins, or other drug components
• Dosages above 5 mg/kg for patients with moderate to severe heart failure
Use cautiously in:
• history of tuberculosis (TB), active infection, or exposure to TB; patients who have resided or traveled in areas of endemic TB or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis
• chronic or recurrent infection or underlying conditions that may predispose to infection; history of opportunistic infection; hepatitis B virus (HBV) carriers
• jaundice or marked liver enzyme elevations, cytopenias
• neurologic disorders (including CNS manifestation of systemic vasculitis, seizures), new-onset or exacerbation of demyelinating disorders (including multiple sclerosis and optic neuritis) and peripheral demyelinating disorders (including Guillain-Barré syndrome)
• male patients with Crohn's disease or ulcerative colitis who are receiving azathioprine or 6-mercaptopurine treatment
• concurrent use of live vaccines, tocilizumab (avoid use)
• concurrent use of anakinra or abatacept (use not recommended)
• when switching between biological disease-modifying antirheumatics (overlapping biological activity may further increase risk of infection)
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 6 (safety not established).
• 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.
• Premedicate with antihistamines, acetaminophen, and corticosteroids, as prescribed.
☞ Watch for infusion reactions, especially after first infusion. Be aware that mild to moderate infusion reactions may improve after slowing or suspension of infusion. Upon resolution of reaction, restart infusion at lower infusion rate or administer antihistamines, acetaminophen, or corticosteroids. Discontinue drug in patients who don't tolerate infusion following these interventions; permanently discontinue drug in patients who have severe infusion-related hypersensitivity reactions.
• 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.
CNS: fatigue, headache, anxiety, depression, dizziness, insomnia, CNS manifestation of systemic vasculitis, seizures, new-onset or exacerbation of demyelinating disorders (including multiple sclerosis, optic neuritis, Guillain-Barré syndrome)
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, anemia, hemolytic anemia, pancytopenia
Hepatic: HBV reactivation, hepatotoxicity
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, autoimmunity, lupuslike syndrome, serious infections, malignancies, infusion reactions, hypersensitivity reaction including anaphylaxis or serum sickness-like reactions
Drug-drug.Abatacept, anakinra: increased risk of infections
Tocilizumab: increased immunosuppression and increased risk of infection
Vaccines: decreased antibody response to vaccine
Drug-diagnostic tests.Antinuclear antibodies: positive titer
Hepatic enzymes: increased values
Hemoglobin: decreased value
☞ Stay alert for signs and symptoms of hypersensitivity and infusion reactions, 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.
☞ Be aware that CNS disorders (such as seizures, new-onset or exacerbation of demyelinating disorders), malignancies including lymphoma, HBV reactivation, hepatotoxicity, and cytopenias may occur.
☞ 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.
• Advise patient not to receive live vaccines while receiving infliximab.
☞ Instruct patient how to recognize and immediately report signs and symptoms of blood dyscrasias, hepatotoxicity, or other new or worsening symptoms.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.