Renflexis

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Colorectal disorders
  • Psoriasis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Storage

    Store unopened Renflexis vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

    If needed, unopened Renflexis vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, Renflexis cannot be returned to the refrigerator.

     

    Manufacturer

    Organon & Co.

    Generic Availability

    NO

    Mechanism of Action

    Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Infliximab products inhibit the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. 

    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. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Pregnancy. Nursing mothers.

    Renflexis Pharmacokinetics

    Elimination

    Half-life: 7.7–9.5 days.

    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

    Storage

    Store unopened Renflexis vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

    If needed, unopened Renflexis vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, Renflexis cannot be returned to the refrigerator.

     

    Manufacturer

    Organon & Co.

    Generic Availability

    NO

    Mechanism of Action

    Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Infliximab products inhibit the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. 

    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. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Pregnancy. Nursing mothers.

    Renflexis Pharmacokinetics

    Elimination

    Half-life: 7.7–9.5 days.

    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

    Storage

    Store unopened Renflexis vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

    If needed, unopened Renflexis vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, Renflexis cannot be returned to the refrigerator.

     

    Manufacturer

    Organon & Co.

    Generic Availability

    NO

    Mechanism of Action

    Infliximab products neutralize the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Infliximab products inhibit the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which infliximab products exert their clinical effects is unknown. 

    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. Update vaccinations accordingly with current guidelines prior to initiation. Elderly. Pregnancy. Nursing mothers.

    Renflexis Pharmacokinetics

    Elimination

    Half-life: 7.7–9.5 days.

    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

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