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Renflexis Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab-abda 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-dose vials—1
Manufacturer
Generic Availability
NO
Renflexis 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.
Renflexis Dosage and Administration
Adult
Give by IV infusion over at least 2hrs. RA: 3m/kg at weeks 0, 2, 6, then every 8 weeks; if incomplete response 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; may be used alone or with methotrexate. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.
Children
Not established.
Renflexis Contraindications
Contraindications
Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Renflexis Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Renflexis Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial, mycobacterial, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. 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. Hematologic abnormalities. 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. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, jaundice and/or marked liver enzyme elevations ≥5xULN occurs. Moderate to severe COPD. Pre-existing heart failure; closely monitor and discontinue if new or worsening symptoms occur. Cardiovascular/cerebrovascular reactions: monitor; discontinue if serious. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma, cervical cancer); perform periodic screening. Elderly. Pregnancy. Nursing mothers.
Renflexis Pharmacokinetics
See Literature
Renflexis 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-mercaptopruine; 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.
Renflexis Adverse Reactions
Adverse Reactions
Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.
Renflexis Clinical Trials
See Literature
Renflexis Note
Not Applicable
Renflexis Patient Counseling
See Literature
Renflexis Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab-abda 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-dose vials—1
Manufacturer
Generic Availability
NO
Renflexis 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.
Renflexis Dosage and Administration
Adult
Give by IV infusion over at least 2hrs. Crohn's disease: 5mg/kg at weeks 0, 2, 6, then 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 every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.
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 every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.
Renflexis Contraindications
Contraindications
Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Renflexis Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Renflexis Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial, mycobacterial, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. 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. Hematologic abnormalities. 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. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, jaundice and/or marked liver enzyme elevations ≥5xULN occurs. Moderate to severe COPD. Pre-existing heart failure; closely monitor and discontinue if new or worsening symptoms occur. Cardiovascular/cerebrovascular reactions: monitor; discontinue if serious. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma, cervical cancer); perform periodic screening. Children: complete vaccinations before starting therapy (see full labeling). Elderly. Pregnancy. Nursing mothers.
Renflexis Pharmacokinetics
See Literature
Renflexis 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-mercaptopruine; 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.
Renflexis Adverse Reactions
Adverse Reactions
Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.
Renflexis Clinical Trials
See Literature
Renflexis Note
Not Applicable
Renflexis Patient Counseling
See Literature
Renflexis Generic Name & Formulations
Legal Class
Rx
General Description
Infliximab-abda 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-dose vials—1
Manufacturer
Generic Availability
NO
Renflexis Indications
Indications
Severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Renflexis Dosage and Administration
Adult
Give by IV infusion over at least 2hrs. 5mg/kg at weeks 0, 2, 6, then every 8 weeks; may be used alone or with methotrexate. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.
Children
Not established.
Renflexis Contraindications
Contraindications
Moderate to severe heart failure (doses >5mg/kg). Allergy to murine proteins.
Renflexis Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Renflexis Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial, mycobacterial, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. 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. Hematologic abnormalities. 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. Discontinue if lupus-like syndrome with autoantibody formation, severe hypersensitivity reactions, jaundice and/or marked liver enzyme elevations ≥5xULN occurs. Moderate to severe COPD. Pre-existing heart failure; closely monitor and discontinue if new or worsening symptoms occur. Cardiovascular/cerebrovascular reactions: monitor; discontinue if serious. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma, cervical cancer); perform periodic screening. Elderly. Pregnancy. Nursing mothers.
Renflexis Pharmacokinetics
See Literature
Renflexis 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-mercaptopruine; 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.
Renflexis Adverse Reactions
Adverse Reactions
Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, GI upset, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.
Renflexis Clinical Trials
See Literature
Renflexis Note
Not Applicable
Renflexis Patient Counseling
See Literature
