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Basics of Biologics and BiosimilarsAbout INFLECTRA
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Full Prescribing Information, including BOXED WARNINGMedication Guide Indication Patient Site

Efficacy

Rheumatoid Arthritis

Ankylosing Spondylitis

Crohn’s Disease & Real-world Evidence

All Indications

Efficacy in RA
Similar efficacy to Remicade in RA1,2RA Study Design1,2

*Study was conducted using EU-approved Remicade. An analytical bridge between EU-approved Remicade, US-licensed Remicade, and INFLECTRA was established to justify the relevance of the comparative data generated using EU-approved Remicade in order to support a demonstration of the biosimilarity of INFLECTRA and US-licensed Remicade.3

54-week study4†

The primary endpoint was to demonstrate equivalent efficacy of CT-P13 to innovator infliximab at week 30, as determined by ACR20 response criteria.
The intent-to-treat (ITT) population is the set of all randomized patients enrolled in the clinical trial.5

  • 606 biologic-naive adult patients (age 18 to 75 years) with active RA diagnosed according to 1987 ACR classification ≥1 year prior to screening and who have completed 3 months of treatment with methotrexate2
  • Secondary endpoints, including Disease Activity Score (DAS28), were also similar2,4
ACR response rates measured in the extension of study
Proportion of patients achieving clinical response according to ACR20, ACR50, and ACR70 criteria was observed to be similar between INFLECTRA and Remicade treatment groups.1

The brand names included throughout are the properties of their respective owners.
References:
1. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76(2):355-363. doi:10.1136/annrheumdis-2015-208786
2. Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82. doi:10.1186/s13075-016-0981-6
3. Celltrion. CT-P1 3 (infliximab biosimilar). Briefing document for the US FDA Arthritis Advisory Committee. Published February 9, 2016.
4. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-1620. doi:10.1136/annrheumdis-2012-203090
5. Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109-112. doi:10.4103/2229-3485.83221

Efficacy in AS

Pharmacokinetic (PK) study: patients with moderate to severe ankylosing spondylitis (AS)1,2

Study was conducted using EU-approved Remicade. An analytical bridge between EU-approved Remicade, US-licensed Remicade, and INFLECTRA was established to justify the relevance of the comparative data generated using EU-approved Remicade in order to support a demonstration of the biosimilarity of INFLECTRA and US-licensed Remicade.3
Patients received either INFLECTRA or Remicade (5 mg/kg) by a 2-hour IV infusion during the induction, maintenance, and extension phases per the European product labeling.1
In the US, the recommended maintenance dosage is 5 mg/kg every 6 weeks for patients with AS.

CI=confidence interval; GMR=geometric mean ratio; LSM=least squares mean; the units of Cmax and AUC are μg/mL and μg*hr/mL, respectively.

References: 
1. Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25. doi:10.1186/s13075-016-0930-4
2. Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76(2):346-354. doi:10.1136/annrheumdis-2015-208783
3. Celltrion. CT-P1 3 (infliximab biosimilar). Briefing document for the US FDA Arthritis Advisory Committee. Published February 9, 2016. 

Efficacy in CD
Study 3.4:

Efficacy and safety of INFLECTRA compared to Remicade in a clinical study in patients with active CD1

Similar clinical response in patients with Crohn’s Disease1

Efficacy evaluated by assessment of CD activity index 70 (CDAI-70)* response to week 61Clinical response at Week 6 was similar between INFLECTRA and Remicade in patients with CD, thereby meeting the criterion for noninferiority1Efficacy was maintained after switching1

INFLECTRA 54-week results compared to Remicade in patients with CD1,3 (secondary endpoints)

Complementing the evidence for INFLECTRA

Select characteristics of randomized controlled trials and real-world evidence

Important considerations for real-world evidence (RWE)4-6

Strengths4-6

  • Safety and effectiveness, treatment patterns, and economic outcomes can be studied in real-world settings
  • Factors beyond clinical trial parameters and protocols can be studied for association with treatment
  • Potential for findings with broad generalizability based on larger and more diverse patient population than RCTs

Limitations4,5

  • May not be randomized and may lack a control or comparator group
  • Potential for reduced data quality (eg, lack of standardization; missing or misclassified data)
  • May require statistical adjustments to address bias or confounding factors (eg, propensity-score matching)
Findings from real-world analyses should not be directly compared with those from RCTs.4,5
Real-world analyses use designs, measures, and analysis approaches that may differ from those typically prespecified in RCTs.5,6

Real-world evidence: An integrated US healthcare system switch study in adult patients with CD and UC7||

Study objective7
  • To compare outcomes in adult patients with CD and UC who switched to INFLECTRA with those who remained on reference product (Remicade) in a retrospective, propensity score-matched, noninferiority, US cohort study

Primary and secondary outcome measures7

  • Primary outcome: Composite measure of disease worsening requiring acute care
    • Acute care was defined as IBD-related hospitalization, emergency room visit, or surgery
  • Secondary outcome: Composite measure of disease worsening requiring acute care or treatment failure
    • Treatment failure was defined as a switch to another IBD treatment for CD or UC, including a switch back to Remicade (study group only)
These event-driven outcomes differ from the endpoints in Study 3.4, which focus on Crohn’s Disease Activity Index (CDAI) scores to assess clinical response and clinical remission. The CDAI combines weighted scores of clinical and laboratory variables to estimate disease severity requiring prospective physician assessment of signs, symptoms, and laboratory parameters.1,8
Study design and methodology7
  • Eligible patients identified using electronic databases within an integrated delivery network between January 1, 2013 to March 31, 2018
  • Inclusion criteria: ≥18 years of age, diagnosis of CD or UC within 6 months prior to the index date, received Remicade for ≥3 months
  • Patients without continuous enrollment of benefits for ≥6 months before index date were excluded
Statistical analysis7
  • The non-inferiority margin was set at +10% of the upper limit due to the retrospective nature of the study
||A national integrated healthcare system that serves over 12 million members in the US; among them, 9 million members in California.7
IBD is defined as CD and UC.7

 

Real-world evidence: An integrated US healthcare system switch study7

Propensity score matching (PSM)7
  • PSM is a statistical matching technique designed to minimize the difference of each confounding variable
    • Each patient who switched from Remicade to INFLECTRA was matched to a unique patient who remained on Remicade using propensity score at a 1:1 ratio
Baseline characteristics after PSM: Matched and unmatched7
SD=Standard deviation; CCI=Charlson Comorbidity Index; IQR=Interquartile range.
#CCI quantifies an individual’s burden of disease and corresponding 1-year mortality risk.7
**Surgery for UC or CD within 2 years of index date.7
††Use of steroids=a cumulative of >1800 mg prednisone dose equivalents of systemic steroid within 6 months prior to index date.7

Real-world evidence: Study limitations in an integrated US healthcare system switch study7

This study, a retrospective database analysis, assessed an association between variables but cannot determine casuality7,9

  • Outcomes are specific to the setting and population in the cohort study and the results may not be transferred to other settings and populations9
  • Baseline characteristics that could not be matched included history of CD or UC, years on infliximab, smoking history, and steroid/aminosalicylate use7‡‡
  • Potential for selection bias7
    • After propensity score matching (PSM)§§ some confounding factors remained unbalanced
    • Patients switched to INFLECTRA had a significantly longer history of CD or UC and prior use of reference product infliximab
    • Patients switched to INFLECTRA were generally believed to be more stable and had less risk of relapse
    • Patients switched to INFLECTRA might have been followed up more closely than patients who remained on Remicade, which could have impacted treatment outcomes
  • Electronic rather than patient-reported outcomes were utilized: Disease-worsening rates may have been underestimated in situations where symptoms were not severe enough to require acute care7
  • The primary and secondary outcomes (disease worsening requiring acute care, disease worsening requiring acute care or treatment failure, respectively) were not validated endpoints and chart reviews were not performed7
  • Follow-up period was 9 months, which may not have been long enough to evaluate disease worsening or full effects of therapies7
‡‡Use of steroids=a cumulative of >1800 mg prednisone dose equivalents of systemic steroid within 6 months prior to index date.7
§§PSM is a statistical matching technique designed to minimize the difference of each confounding variable.7

Real-world evidence: Results from an integrated US healthcare system switch study7

For the primary composite endpoint, 10.2% (n=144) patients in the INFLECTRA group experienced disease worsening requiring acute care vs 17.4% (n=245) in the Remicade group7
  • Noninferiority was met, as the difference in the proportion of patients with the primary composite endpoint was –7.2%, which fell within the prespecified noninferiority margin of +10%
Primary and secondary outcomes7||||
IBD=inflammatory bowel disease
||||Patients were followed until a switch in RP infliximab or INFLECTRA therapy, end of membership in the healthcare system, death, or up to 9 months, whichever occurred first.7
¶¶Defined as IBD-related hospitalization, emergency room visit, or surgery.7
##Treatment failure was defined as switching to another IBD treatment for CD or UC.7
  • Treatment failure was defined as switching to another IBD treatment for CD or UC because chart review was not done to confirm whether patients were not responding to or failing the therapy7
  • Among patients who switched therapy7:
    • INFLECTRA group (15.7%, n= 221/1409)
      • 77% in the INFLECTRA group switched back to Remicade
    • Remicade group (11.6%, n= 163/1409)
      • 100% in Remicade group switched to a non-infliximab biologic
  • Due to the nature of the study design and methodology, study limitations should be taken into account when interpreting these data7

The brand names included throughout are the properties of their respective owners.
References:
1. Ye BD, Pesegova M, Alexeeva O, et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019;393(10182):1699-1707. doi:10.1016/S0140-6736(18)32196-2
2. Celltrion. CT-P13 (infliximab biosimilar). Briefing document for the US FDA Arthritis Advisory Committee. Published February 9, 2016.
3. Data on file. Pfizer Inc., New York, NY.
4. Katkade VB, Sanders KN, Zou KH. Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J Multidiscip Healthc. 2018;11:295-304. doi:10.2147/JMDH.S160029
5. Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763-1774. doi:10.1007/s12325-018-0805-y
6. Garrison LP, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value in Health. 2007;10(5):326-335. doi:10.1111/j.1524-4733.2007.00186.x
7. Ho SL, Niu F, Pola S, Velayos FS, Ning X, Hui RL. Effectiveness of switching from reference product infliximab to infliximab-dyyb in patients with inflammatory bowel disease in an integrated healthcare system in the United States: a retrospective, propensity score-matched, non-inferiority cohort study. BioDrugs. 2020;34(3):395-404. doi:10.1007/s40259-020-00409-y
8. Freeman H-J. Use of the Crohn's disease activity index in clinical trials of biological agents. World J Gastroenterol. 2008;14(26):4127-4130.
9. Kovesdy CP, Kalantar-Zadeh K. Observational studies versus randomized controlled trials: avenues to causal inference in nephrology. Adv Chronic Kidney Dis. 2012;19(1):11-18. doi:10.1053/j.ackd.2011.09.004

All Indications

Evidence from a 52-week switch study supports switching patients from Remicade to INFLECTRA1

This was a randomized, double-blind switch trial. INFLECTRA* demonstrated noninferiority to Remicade. Adult patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, chronic plaque psoriasis, Crohn’s disease, or ulcerative colitis, on stable treatment with Remicade for at least 6 months, were eligible. NOR-SWITCH, funded by the Norwegian government, was the first government-funded randomized study of patients switching from originator to biosimilar infliximab. The NOR-SWITCH trial showed that switching from infliximab originator to CT-P13 was not inferior to continued treatment with infliximab originator, according to a prespecified noninferiority margin of 15%1

This study was not powered to show noninferiority in individual diseases1

PRIMARY ENDPOINT: The primary endpoint was disease worsening during follow-up, according to disease-specific composite measures or a consensus about worsening between investigator and patient leading to change in treatment1

NOR-SWITCH study limitations1:
  • This study was not powered for noninferiority in individual diseases
  • Some indications have few patients
  • The endpoint of disease worsening is defined by different criteria in each indication
  • The study met a prespecified noninferiority margin of 15%. The study showed noninferiority by the European Medicines Agency (EMA) [95% CI and 15% margin] and FDA (90% CI and 12% margin) preferences; however, it would not have shown noninferiority at a more stringent 95% CI and 12% margin standard
  • Patient inclusion in the study was based on clinical diagnosis vs clear disease criteria
  • The study protocol lacks clear definition(s) of “stable” patients

*Also known as CT-P13. INFLECTRA is marketed under other brand names in some countries.

INFLECTRA demonstrated noninferiority to Remicade when measured across all indications in a 52-week switch study1

According to a pre-specified margin of 15%. The study was not powered to show noninferiority in individual diseases.1

†Only single one-way switching from Remicade to INFLECTRA was examined in this study. The NOR-SWITCH trial included only patients on Remicade and INFLECTRA; its findings do not support that any other biosimilars of infliximab can achieve the same result.

Overall, across disease states, 26.2% of Remicade patients and 29.6% of INFLECTRA patients experienced disease worsening (primary endpoint) for a risk difference of -4.4% (95% 
CI: -12.7 to 13.2)1

  • The primary endpoint was disease worsening during follow-up, according to disease-specific composite measures or a consensus about worsening between investigator and patient leading to change in treatment1
Similar immunogenicity and adverse event profile1
  • Patients switched from Remicade to INFLECTRA experienced no substantial change in anti-drug antibody levels compared with those remaining on Remicade (8% [n=19/240] INFLECTRA vs 7% [n=17/241] Remicade)
  • Frequency of adverse events (68% [n=164/240] INFLECTRA vs 70% [n=168/241] Remicade) or serious adverse events (9% [n=21/240] INFLECTRA vs 10% [n=24/241] Remicade) was similar between the two groups

The brand names included throughout are the properties of their respective owners.

Reference: 
1.
Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304-2316. doi:10.1016/S0140-6736(17)30068-5

Efficacy and SafetyKeep Up With INFLECTRA

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PP-IFA-USA-1314
INDICATIONS INFLECTRA® is indicated for:Crohn’s Disease
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
Pediatric Crohn’s Disease
  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy
Ulcerative Colitis
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
Pediatric Ulcerative Colitis
  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy
Rheumatoid Arthritis
  • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
Ankylosing Spondylitis
  • Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)
Psoriatic Arthritis
  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA)
Plaque Psoriasis
  • The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
  • INFLECTRA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician
Please see full Prescribing Information, including BOXED WARNING and Medication Guide, for INFLECTRA®. The brand names included throughout are the properties of their respective owners.
Important Safety Information

SERIOUS INFECTIONS

Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue INFLECTRA® (infliximab-dyyb) if a patient develops a serious infection or sepsis.
Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with INFLECTRA®. Treatment for latent infection should be initiated prior to treatment with INFLECTRA®.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  •  
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with INFLECTRA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with INFLECTRA®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included pneumonia, cellulitis, abscess, and skin ulceration.
 

MALIGNANCIES
 

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.


Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with INFLECTRA®, especially in these patient types.


In clinical trials of all TNF blockers, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among infliximab-treated patients was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF blocker use. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).


Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.


A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between infliximab products and cervical cancer cannot be excluded. Periodic screening should continue in women treated with INFLECTRA®.


CONTRAINDICATIONS


The use of INFLECTRA® at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. INFLECTRA® is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of INFLECTRA® or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).


HEPATITIS B REACTIVATION


TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating INFLECTRA®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing INFLECTRA® for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with INFLECTRA®. Discontinue INFLECTRA® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of INFLECTRA®, and monitor patients closely.


HEPATOTOXICITY


Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, INFLECTRA® should be discontinued, and a thorough investigation of the abnormality should be undertaken.


HEART FAILURE


In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg, and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking INFLECTRA® (≤5 mg/kg) or patients with mild heart failure should be closely monitored, and treatment should be discontinued if new or worsening symptoms appear.


HEMATOLOGIC EVENTS


Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of INFLECTRA® in patients who develop significant hematologic abnormalities.


HYPERSENSITIVITY 


Infliximab products have been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of infliximab products. Medications for the treatment of hypersensitivity reactions should be available. 


CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION


Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of infliximab product infusion. Cases of transient visual loss have been reported during or within 2 hours of infliximab product infusion. Monitor patients during infusion, and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.


NEUROLOGIC EVENTS 


Agents that inhibit TNF have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering INFLECTRA® in patients with these disorders and consider discontinuation if these disorders develop.


CONCURRENT ADMINISTRATION WITH OTHER BIOLOGICS


Concurrent use of infliximab products with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as INFLECTRA® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.


AUTOIMMUNITY 


Treatment with infliximab products may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue INFLECTRA® treatment if symptoms of a lupus-like syndrome develop.


VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS


Prior to initiating INFLECTRA®, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with INFLECTRA® due to the possibility of clinical infections, including disseminated infections.

At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to INFLECTRA®.


ADVERSE REACTIONS


In clinical trials with infliximab products, the most common adverse reactions occurring in >10% of infliximab treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. 


For more information, please see full Prescribing Information, including BOXED WARNING and Medication Guide.

IndicationS

INFLECTRA® is indicated for:

Crohn's Disease

  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
Pediatric Crohn's Disease
  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy
Ulcerative Colitis 
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy​​​​​​​​​​​​​​
Pediatric Ulcerative Colitis
  • Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy​​​​​​​
Rheumatoid Arthritis
  • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)​​​​​​​​​​​​​​
Ankylosing Spondylitis
  • Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)​​​​​​​
​​​​​​​Psoriatic Arthritis
  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA)​​​​​​​
Plaque Psoriasis
  • The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
  • INFLECTRA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician​​​​​​
​​​Please see full Prescribing Information, including BOXED WARNING and Medication Guidefor INFLECTRA®.
​​​​​​​The brand names included throughout are the properties of their respective owners.