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RENFLEXIS
Arthritis/rheumatic disorders
Colorectal disorders
Psoriasis
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Drug Name:

RENFLEXIS Rx

Generic Name and Formulations:
Infliximab-abda 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for RENFLEXIS:

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:

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 premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Children:

Not established.

Contraindications:

Moderate-to-severe heart failure (doses >5mg/kg). Allergy to murine proteins.

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. Hematological 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 hematological 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. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma; perform periodic skin exams). Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Generic Availability:

NO

How Supplied:

Single-use vials—1

Indications for RENFLEXIS:

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.

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. Crohn’s disease: 5mg/kg at weeks 0, 2, 6, then every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Contraindications:

Moderate-to-severe heart failure (doses >5mg/kg). Allergy to murine proteins.

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. Hematological 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 hematological 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. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma; perform periodic skin exams). Children: complete vaccinations before starting therapy (see full labeling). Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Generic Availability:

NO

How Supplied:

Single-use vials—1

Indications for RENFLEXIS:

Severe chronic plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Adult:

Give by IV infusion over at least 2hrs. 5mg/kg at weeks 0, 2, 6, then every 8 weeks. May premedicate with antihistamines, acetaminophen, and/or corticosteroids.

Children:

Not established.

Contraindications:

Moderate-to-severe heart failure (doses >5mg/kg). Allergy to murine proteins.

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. Hematological 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 hematological 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. CNS demyelinating or seizure disorders; discontinue if significant CNS effects occur. Malignancies (eg, lymphomas, melanoma; perform periodic skin exams). Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

Adverse Reactions:

Infections (eg, upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache, abdominal pain, rash, pruritus, cough, fatigue, pain, dizziness; malignancies, autoantibody formation, optic neuritis, seizures, lupus-like syndrome, blood dyscrasias, hepatotoxicity.

Generic Availability:

NO

How Supplied:

Single-use vials—1

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