Arthritis/rheumatic disorders:
Indications for: REMICADE
To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in psoriatic arthritis and with methotrexate in moderately to severely active rheumatoid arthritis (RA). To reduce signs/symptoms of active ankylosing spondylitis.
Adult Dosage:
Give by IV infusion over at least 2hrs. RA: 3mg/kg at weeks 0, 2, 6, then every 8 weeks. May increase to 10mg/kg or give every 4 weeks. Ankylosing spondylitis: 5mg/kg at weeks 0, 2, 6, then every 6 weeks. Psoriatic arthritis: 5mg/kg at weeks 0, 2, 6, then every 8 weeks. All: max 5mg/kg in heart failure.
Children Dosage:
Not established.
REMICADE Contraindications:
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Boxed Warning:
Serious infections. Malignancy.
REMICADE Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Neonatal/infants. Pregnancy. Nursing mothers.
REMICADE Classification:
Tumor necrosis factor (TNF) blocker.
REMICADE Interactions:
Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.
Adverse Reactions:
Infections, infusion reactions (esp. after a period of no treatment), headache, abdominal pain, GI upset, fatigue, cough, fever, pain, dizziness, rash, pruritus, CHF, autoantibody formation; malignancies (eg, skin, lymphomas, cervical, others), lupus-like syndrome, blood dyscrasias, hepatotoxicity.
How Supplied:
Single-use vials—1
Colorectal disorders:
Indications for: REMICADE
In moderately to severely active Crohn's disease: to reduce signs/symptoms and to induce and maintain clinical remission in adult and pediatric patients with inadequate response to conventional therapy. In fistulizing Crohn's disease: to reduce number of draining enterocutaneous and rectovaginal fistula(s); and maintain fistula closure in adults. In moderately to severely active ulcerative colitis (UC): to reduce signs/symptoms, to induce and maintain clinical remission and mucosal healing, and to eliminate corticosteroid use in adults with inadequate response to conventional therapy. In moderately to severely active UC: to reduce signs/symptoms and to induce and maintain clinical remission in pediatric patients with inadequate response to conventional therapy.
Adult Dosage:
Give by IV infusion over at least 2hrs. Crohn's disease: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks; if relapse, may increase to 10mg/kg; discontinue if no response by week 14. UC: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks. Both: max 5mg/kg in heart failure.
Children Dosage:
<6yrs: not established. ≥6yrs: Give by IV infusion over at least 2hrs. Active Crohn's disease or UC: 5mg/kg at weeks 0, 2, 6, then once every 8 weeks.
REMICADE Contraindications:
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Boxed Warning:
Serious infections. Malignancy.
REMICADE Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Neonatal/infants. Pregnancy. Nursing mothers.
REMICADE Classification:
Tumor necrosis factor (TNF) blocker.
REMICADE Interactions:
Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.
Adverse Reactions:
Infections, infusion reactions (esp. after a period of no treatment), headache, abdominal pain, GI upset, fatigue, cough, fever, pain, dizziness, rash, pruritus, CHF, autoantibody formation; malignancies (eg, skin, lymphomas, cervical, others), lupus-like syndrome, blood dyscrasias, hepatotoxicity.
How Supplied:
Single-use vials—1
Psoriasis:
Indications for: REMICADE
Severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Adult Dosage:
Give by IV infusion over at least 2hrs. 5mg/kg at weeks 0, 2, 6, then once every 8 weeks.
Children Dosage:
Not established.
REMICADE Contraindications:
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Boxed Warning:
Serious infections. Malignancy.
REMICADE Warnings/Precautions:
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections or hematologic abnormalities. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematologic abnormality develops. History of malignancies; perform periodic screening. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, or jaundice with marked liver enzyme elevations ≥5×ULN occurs. Preexisting heart failure; closely monitor and discontinue if new or worsening symptoms occur. Monitor for cardiovascular and cerebrovascular reactions during and after infusion; discontinue if serious. Neurologic disorders (eg, CNS demyelinating, seizures, multiple sclerosis, optic neuritis, others); discontinue if occurs. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Neonatal/infants. Pregnancy. Nursing mothers.
REMICADE Classification:
Tumor necrosis factor (TNF) blocker.
REMICADE Interactions:
Concurrent anakinra, abatacept, tocilizumab, live vaccines, therapeutic infectious agents (eg, live attenuated bacteria), other TNF blockers or biological therapeutics: not recommended. Concomitant azathioprine or 6-mercaptopurine; possible higher risk of HSTCL. Concomitant immunosuppressants (eg, corticosteroids, methotrexate) may increase risk of infection. May be potentiated by methotrexate. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline): monitor and may need to adjust dose of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.
Adverse Reactions:
Infections, infusion reactions (esp. after a period of no treatment), headache, abdominal pain, GI upset, fatigue, cough, fever, pain, dizziness, rash, pruritus, CHF, autoantibody formation; malignancies (eg, skin, lymphomas, cervical, others), lupus-like syndrome, blood dyscrasias, hepatotoxicity.
How Supplied:
Single-use vials—1
