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Remicade Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use vials—1
Manufacturer
Remicade Indications
Indications
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.
Remicade Dosage and Administration
Adult
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
Not established.
Remicade Contraindications
Contraindications
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Remicade Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Remicade Warnings/Precautions
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 Pharmacokinetics
See Literature
Remicade Interactions
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.
Remicade Adverse Reactions
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.
Remicade Clinical Trials
See Literature
Remicade Note
Not Applicable
Remicade Patient Counseling
See Literature
Remicade Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use vials—1
Manufacturer
Remicade Indications
Indications
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.
Remicade Dosage and Administration
Adult
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
<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
Contraindications
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Remicade Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Remicade Warnings/Precautions
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 Pharmacokinetics
See Literature
Remicade Interactions
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.
Remicade Adverse Reactions
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.
Remicade Clinical Trials
See Literature
Remicade Note
Not Applicable
Remicade Patient Counseling
See Literature
Remicade Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use vials—1
Manufacturer
Remicade Indications
Indications
Severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Remicade Dosage and Administration
Adult
Give by IV infusion over at least 2hrs. 5mg/kg at weeks 0, 2, 6, then once every 8 weeks.
Children
Not established.
Remicade Contraindications
Contraindications
Moderate or severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Remicade Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Remicade Warnings/Precautions
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 Pharmacokinetics
See Literature
Remicade Interactions
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.
Remicade Adverse Reactions
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.
Remicade Clinical Trials
See Literature
Remicade Note
Not Applicable
Remicade Patient Counseling
See Literature
