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Does Inflectra (infliximab-dyyb) cause side effects?
It is a biosimilar version of the biologic drug, infliximab (Remicade). Biologic drugs are drugs that are produced by natural, biologic processes, for example, within cells. A biosimilar version is a medication that works like the original biologic drug but is manufactured by a different company by a different process.
Inflectra works by blocking the effects of tumor necrosis factor alpha (TNF alpha), a substance made by cells of the body which has an important role in promoting inflammation. Inflectra reduces the signs and symptoms of inflammation by blocking the action of TNF-alpha.
Common side effects of Inflectra include
- upper respiratory tract infections,
- urinary tract infections (UTIs),
- back pain,
- abdominal pain,
- low or high blood pressure,
- chest pain,
- difficulty breathing,
- fever, and
Serious side effects of Inflectra include
- hepatosplenic T-cell lymphoma,
- serious bacterial infections (sepsis),
- serious fungal infections,
- liver toxicity,
- heart failure,
- optic neuritis,
- severe allergic reactions (anaphylaxis),
- sun sensitivity,
- pulmonary edema,
- severe infusion reactions,
- lupus erythematosus,
- interstitial lung disease,
- hepatitis B virus (HBV) reactivation,
- cytopenias, and
- demyelinating disease.
Inflectra may indirectly alter blood levels of warfarin, cyclosporine, and other medications metabolized by liver enzymes called CYP450 because the formation of these liver enzymes is affected by the level of cytokines.
Use of Inflectra during pregnancy has not been adequately evaluated.
What are the important side effects of Inflectra (infliximab-dyyb)?
WARNING: Infliximab-dyyb is associated with increased risk of serious infections leading to hospitalization or death. These infections include:
- Tuberculosis (TB)
- Bacterial sepsis
- Invasive fungal infections (such as histoplasmosis)
- Infections due to other opportunistic pathogens. Infliximab-dyyb should be stopped if a serious infection develops.
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients received treatment with tumor necrosis factor (TNF) blockers, including infliximab products.
- Post marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products.
Common side effects of infliximab-dyyb include:
- Upper respiratory tract infections
- Urinary tract infections (UTIs)
- Back pain
- Abdominal pain
- Low or high blood pressure
- Chest pain
- Difficulty breathing
Serious side effects of infliximab-dyyb include:
- Hepatosplenic T-cell lymphoma
- Serious bacterial infections (sepsis)
- Serious fungal infections
- Liver toxicity
- Heart failure
- Optic neuritis
- Severe allergic reactions (anaphylaxis)
- Sun sensitivity
- Pulmonary edema
- Severe infusion reactions
- Lupus erythematosus
- Interstitial lung disease
- Hepatitis B virus (HBV) reactivation
- Demyelinating disease
Inflectra (infliximab-dyyb) side effects list for healthcare professionals
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not predict the rates observed in broader patient populations in clinical practice.
Adverse Reactions In Adults
- The data described herein reflect exposure to infliximab in 4779 adult patients (1304 patients with rheumatoid arthritis, 1106 patients with Crohn's disease, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 484 with ulcerative colitis, 1373 with plaque psoriasis, and 17 patients with other conditions), including 2625 patients exposed beyond 30 weeks and 374 exposed beyond 1 year.
- One of the most common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache and rash).
- An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 hour after an infusion.
- In phase 3 clinical studies, 18% of patients treated with infliximab experienced an infusion reaction compared to 5% of placebo-treated patients.
- Of these infliximab-treated patients who had an infusion reaction during the induction period, 27% experienced an infusion reaction during the maintenance period.
- Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
- Among all infusions with infliximab, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions.
- Serious infusion reactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension.
- Approximately 3% of patients discontinued treatment with infliximab because of infusion reactions, and all patients recovered with treatment and/or discontinuation of the infusion.
- Infliximab infusions beyond the initial infusion were not associated with a higher incidence of reactions.
- The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis Study I.
- In psoriasis Study II, the rates were variable over time and somewhat higher following the final infusion than after the initial infusion.
- Across the 3 psoriasis studies, the percent of total infusions resulting in infusion reactions (i.e., an adverse event occurring within 1 hour) was 7% in the 3 mg/kg group, 4% in the 5 mg/kg group, and 1% in the placebo group.
- Patients who became positive for antibodies to infliximab were more likely (approximately two to three-fold) to have an infusion reaction than were those who were negative.
- Use of concomitant immunosuppressant agents appeared to reduce the frequency of both antibodies to infliximab and infusion reactions.
Infusion Reactions Following Re-administration
- In a clinical trial of patients with moderate to severe psoriasis designed to assess the efficacy of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab following disease flare, 4% (8/219) of patients in the re-treatment therapy arm experienced serious infusion reactions versus <1% (1/222) in the maintenance therapy arm.
- Patients enrolled in this trial did not receive any concomitant immunosuppressant therapy.
- In this study, the majority of serious infusion reactions occurred during the second infusion at Week 2. Symptoms included, but were not limited to, dyspnea, urticaria, facial edema, and hypotension.
- In all cases, treatment with infliximab was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Delayed Reactions/Reactions Following Readministration
- In psoriasis studies, approximately 1% of patients treated with infliximab experienced a possible delayed hypersensitivity reaction, generally reported as serum sickness or a combination of arthralgia and/or myalgia with fever and/or rash.
- These reactions generally occurred within 2 weeks after repeat infusion.
- In infliximab clinical studies, treated infections were reported in 36% of patients treated with infliximab (average of 51 weeks of follow-up) and in 25% of placebo-treated patients (average of 37 weeks of follow-up).
- The infections most frequently reported were respiratory tract infections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections. Among patients treated with infliximab, serious infections included
- In clinical trials, 7 opportunistic infections were reported; 2 cases each of coccidioidomycosis (1 case was fatal) and histoplasmosis (1 case was fatal), and 1 case each of pneumocystosis, nocardiosis and cytomegalovirus.
- Tuberculosis was reported in 14 patients, 4 of whom died due to miliary tuberculosis.
- Other cases of tuberculosis, including disseminated tuberculosis, also have been reported postmarketing.
- Most of these cases of tuberculosis occurred within the first 2 months after initiation of therapy with infliximab and may reflect recrudescence of latent disease.
- In the 1-year placebo-controlled studies RA I and RA II, 5.3% of patients receiving infliximab every 8 weeks with methotrexate (MTX) developed serious infections as compared to 3.4% of placebo patients receiving MTX.
- Of 924 patients receiving infliximab, 1.7% developed pneumonia and 0.4% developed tuberculosis, when compared to 0.3% and 0.0% in the placebo arm respectively.
- In a shorter (22-week) placebo-controlled study of 1082 RA patients randomized to receive placebo, 3 mg/kg or 10 mg/kg infusions with infliximab at 0, 2, and 6 weeks, followed by every 8 weeks with MTX, serious infections were more frequent in the 10 mg/kg infliximab group (5.3%) than the 3 mg/kg or placebo groups (1.7% in both).
- During the 54-week Crohn's II Study, 15% of patients with fistulizing Crohn's disease developed a new fistula-related abscess.
- In clinical studies with infliximab in patients with ulcerative colitis, infections treated with antimicrobials were reported in 27% of patients treated with infliximab (average of 41 weeks of follow-up) and in 18% of placebo-treated patients (average 32 weeks of follow-up).
- The types of infections, including serious infections, reported in patients with ulcerative colitis were similar to those reported in other clinical studies.
- The onset of serious infections may be preceded by constitutional symptoms such as
- The majority of serious infections, however, may also be preceded by signs or symptoms localized to the site of the infection.
Approximately half of patients treated with infliximab in clinical trials who were antinuclear antibody (ANA) negative at baseline developed a positive ANA during the trial compared with approximately one-fifth of placebo-treated patients.
Anti-dsDNA antibodies were newly detected in approximately one-fifth of patients treated with infliximab compared with 0% of placebotreated patients.
- In controlled trials, more patients treated with infliximab developed malignancies than placebo-treated patients.
- In a randomized controlled clinical trial exploring the use of infliximab in patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
- Of these patients treated with infliximab, 9 developed a malignancy, including 1 lymphoma, for a rate of 7.67 cases per 100 patient-years of follow-up (median duration of follow-up 0.8 years; 95% confidence interval [CI] 3.51 – 14.56).
- There was 1 reported malignancy among 77 control patients for a rate of 1.63 cases per 100 patient-years of followup (median duration of follow-up 0.8 years; 95% CI 0.04 – 9.10).
- The majority of the malignancies developed in the lung or head and neck.
Patients with Heart Failure
- In a randomized study evaluating infliximab in moderate to severe heart failure (NYHA Class III/IV; left ventricular ejection fraction ≤35%), 150 patients were randomized to receive treatment with 3 infusions of infliximab at 10 mg/kg, 5 mg/kg, or placebo, at 0, 2, and 6 weeks.
- Higher incidences of mortality and hospitalization due to worsening heart failure were observed in patients receiving the 10 mg/kg infliximab dose. At 1 year, 8 patients in the 10 mg/kg infliximab group had died compared with 4 deaths each in the 5 mg/kg infliximab and the placebo groups.
- There were trends toward increased dyspnea, hypotension, angina, and dizziness in both the 10 mg/kg and 5 mg/kg infliximab treatment groups, versus placebo. Infliximab has not been studied in patients with mild heart failure (NYHA Class I/II).
- Treatment with infliximab products can be associated with the development of antibodies to infliximab.
- An enzyme immunoassay (EIA) method was originally used to measure anti-infliximab antibodies in clinical studies of infliximab.
- The EIA method is subject to interference by serum infliximab, possibly resulting in an underestimation of the rate of patient antibody formation.
- A separate, drug-tolerant electrochemiluminescence immunoassay (ECLIA) method for detecting antibodies to infliximab was subsequently developed and validated.
- This method is 60-fold more sensitive than the original EIA. With the ECLIA method, all clinical samples can be classified as either positive or negative for antibodies to infliximab without the need for the inconclusive category.
- The incidence of antibodies to infliximab in patients given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through 1 to 2 years of treatment with infliximab.
- A higher incidence of antibodies to infliximab was observed in Crohn's disease patients receiving infliximab after drug-free intervals >16 weeks.
- In a study of psoriatic arthritis in which 191 patients received 5 mg/kg with or without MTX, antibodies to infliximab occurred in 15% of patients.
- The majority of antibody-positive patients had low titers. Patients who were antibody-positive were more likely to have higher rates of clearance, reduced efficacy and to experience an infusion reaction than were patients who were antibody negative.
- Antibody development was lower among rheumatoid arthritis and Crohn's disease patients receiving immunosuppressant therapies such as 6-mercaptopurine /azathioprine (6-MP/AZA) or MTX.
- In the psoriasis Study II, which included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 36% of patients treated with 5 mg/kg every 8 weeks for 1 year, and in 51% of patients treated with 3 mg/kg every 8 weeks for 1 year.
- In the psoriasis Study III, which also included both the 5 mg/kg and 3 mg/kg doses, antibodies were observed in 20% of patients treated with 5 mg/kg induction (weeks 0, 2 and 6), and in 27% of patients treated with 3 mg/kg induction.
- Despite the increase in antibody formation, the infusion reaction rates in Studies I and II in patients treated with 5 mg/kg induction followed by every 8 week maintenance for 1 year and in Study III in patients treated with 5 mg/kg induction (14.1% – 23.0%) and serious infusion reaction rates (<1%) were similar to those observed in other study populations.
- The clinical significance of apparent increased immunogenicity on efficacy and infusion reactions in psoriasis patients as compared to patients with other diseases treated with infliximab products over the long term is not known.
- The data reflect the percentage of patients whose test results were positive for antibodies to infliximab in an ELISA assay, and they are highly dependent on the sensitivity and specificity of the assay.
- Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medication, and underlying disease.
- For these reasons, comparison of the incidence of antibodies to infliximab products with the incidence of antibodies to other products may be misleading.
- Severe liver injury, including acute liver failure and autoimmune hepatitis, has been reported rarely in patients receiving infliximab products.
- Reactivation of HBV has occurred in patients receiving TNF blocking agents, including infliximab products, who are chronic carriers of this virus.
- In clinical trials in rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls (Table 1), both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
- In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant medications.
Table 1 Proportion of patients with elevated ALT in clinical trials
|Proportion of patients with elevated ALT|
|>1 to 3 × ULN||≥3 × ULN||≥5 × ULN|
* Placebo patients received methotrexate while patients treated with infliximab received both infliximab and methotrexate. Median
follow-up was 58 weeks.
†Placebo patients in the 2 Phase 3 trials in Crohn's disease received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase. Patients who were randomized to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in ALT analysis. Median follow-up was 54 weeks.
‡ Median follow-up was 30 weeks. Specifically, the median duration of follow-up was 30 weeks for placebo and 31 weeks for infliximab.
§ Median follow-up was 24 weeks for the placebo group and 102 weeks for infliximab group.
¶ Median follow-up was 39 weeks for infliximab group and 18 weeks for the placebo group.
# ALT values are obtained in 2 Phase 3 psoriasis studies with median follow-up of 50 weeks for infliximab and 16 weeks for placebo.
Adverse Reactions in Psoriasis Studies
- During the placebo-controlled portion across the 3 clinical trials up to week 16, the proportion of patients who experienced at least 1 serious adverse reaction (SAE; defined as resulting in death, life threatening, requires hospitalization, or persistent or significant disability/incapacity) was 0.5% in the 3 mg/kg infliximab group, 1.9% in the placebo group, and 1.6% in the 5 mg/kg infliximab group.
- Among patients in the 2 Phase 3 studies, 12.4% of patients receiving infliximab 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 SAE in Study I. In Study II, 4.1% and 4.7% of patients receiving infliximab 3 mg/kg and 5 mg/kg every 8 weeks, respectively, through 1 year of maintenance treatment experienced at least 1 SAE.
- One death due to bacterial sepsis occurred 25 days after the second infusion of 5 mg/kg of infliximab.
- Serious infections included sepsis, and abscesses. In Study I, 2.7% of patients receiving infliximab 5 mg/kg every 8 weeks through 1 year of maintenance treatment experienced at least 1 serious infection.
- In Study II, 1.0% and 1.3% of patients receiving infliximab 3 mg/kg and 5 mg/kg, respectively, through 1 year of treatment experienced at least 1 serious infection.
- The most common serious infection (requiring hospitalization) was abscess (skin, throat, and peri-rectal) reported by 5 (0.7%) patients in the 5 mg/kg infliximab group. Two active cases of tuberculosis were reported: 6 weeks and 34 weeks after starting infliximab.
- In the placebo-controlled portion of the psoriasis studies, 7 of 1123 patients who received infliximab at any dose were diagnosed with at least one NMSC compared to 0 of 334 patients who received placebo.
- In the psoriasis studies, 1% (15/1373) of patients experienced serum sickness or a combination of arthralgia and/or myalgia with fever, and/or rash, usually early in the treatment course.
- Of these patients, 6 required hospitalization due to fever, severe myalgia, arthralgia, swollen joints, and immobility.
Other Adverse Reactions
- Safety data are available from 4779 adult patients treated with infliximab, including 1304 with rheumatoid arthritis, 1106 with Crohn's disease, 484 with ulcerative colitis, 202 with ankylosing spondylitis, 293 with psoriatic arthritis, 1373 with plaque psoriasis and 17 with other conditions.
- Adverse reactions reported in ≥5% of all patients with rheumatoid arthritis receiving 4 or more infusions are in Table 2.
- The types and frequencies of adverse reactions observed were similar in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and Crohn's disease patients treated with infliximab except for abdominal pain, which occurred in 26% of patients with Crohn's disease.
- In the Crohn's disease studies, there were insufficient numbers and duration of follow-up for patients who never received infliximab to provide meaningful comparisons.
Table 2: Adverse reactions occurring in 5% or more of patients receiving 4 or more infusions for
|Average weeks of follow-up||59||66|
|Upper respiratory tract infection||25%||32%|
|Skin and appendages disorders|
|Body as a whole-general disorder|
|Resistance mechanism disorders|
|Central and peripheral nervous system disorders|
|Musculoskeletal system disorders|
|Urinary system disorders|
|Urinary tract infection||6%||8%|
|Cardiovascular disorders, general|
The most common serious adverse reactions observed in clinical trials of infliximab were infections. Other serious, medically relevant adverse reactions ≥0.2% or clinically significant adverse reactions by body system were as follows:
- Body as a whole: allergic reaction, edema
- Blood: pancytopenia
- Cardiovascular: hypotension
- Gastrointestinal: constipation, intestinal obstruction
- Central and Peripheral Nervous: dizziness
- Heart Rate and Rhythm: bradycardia
- Liver and Biliary: hepatitis
- Metabolic and Nutritional: dehydration
- Platelet, Bleeding and Clotting: thrombocytopenia
- Neoplasms: lymphoma
- Red Blood Cell: anemia, hemolytic anemia
- Resistance Mechanism: cellulitis, sepsis, serum sickness, sarcoidosis
- Respiratory: lower respiratory tract infection (including pneumonia), pleurisy, pulmonary edema
- Skin and Appendages: increased sweating
- Vascular (Extracardiac): thrombophlebitis
- White Cell and Reticuloendothelial: leukopenia, lymphadenopathy
Adverse Reactions In Pediatric Patients
Pediatric Crohn's Disease
There were some differences in the adverse reactions observed in the pediatric patients receiving infliximab compared to those observed in adults with Crohn's disease. These differences are discussed in the following paragraphs.
The following adverse reactions were reported more commonly in 103 randomized pediatric Crohn's disease patients administered 5 mg/kg infliximab through 54 weeks than in 385 adult Crohn's disease patients receiving a similar treatment regimen:
- anemia (11%),
- leukopenia (9%),
- flushing (9%),
- viral infection (8%),
- neutropenia (7%),
- bone fracture (7%),
- bacterial infection (6%), and
- respiratory tract allergic reaction (6%).
Infections were reported in 56% of randomized pediatric patients in Study Peds Crohn's and in 50% of adult patients in Study Crohn's I.
- In Study Peds Crohn's, infections were reported more frequently for patients who received every 8-week as opposed to every 12-week infusions (74% and 38%, respectively), while serious infections were reported for 3 patients in the every 8- week and 4 patients in the every 12-week maintenance treatment group.
- The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
- Pneumonia was reported for 3 patients, (2 in the every 8-week and 1 in the every 12-week maintenance treatment groups).
- Herpes zoster was reported for 2 patients in the every 8-week maintenance treatment group.
In Study Peds Crohn's, 18% of randomized patients experienced 1 or more infusion reactions, with no notable difference between treatment groups. Of the 112 patients in Study Peds Crohn's, there were no serious infusion reactions, and 2 patients had non-serious anaphylactoid reactions.
- In Study Peds Crohn's, in which all patients received stable doses of 6-MP, AZA, or MTX, excluding inconclusive samples, 3 of 24 patients had antibodies to infliximab.
- Although 105 patients were tested for antibodies to infliximab, 81 patients were classified as inconclusive because they could not be ruled as negative due to assay interference by the presence of infliximab in the sample.
- Elevations of ALT up to 3 times the upper limit of normal (ULN) were seen in 18% of pediatric patients in Crohn's disease clinical trials; 4% had ALT elevations ≥3 × ULN, and 1% had elevations ≥5 × ULN. (Median follow-up was 53 weeks.)
Adverse reactions have been identified during post approval use of infliximab products in adult and pediatric patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions, some with fatal outcome, have been reported during postapproval use of infliximab products:
- agranulocytosis (including infants exposed in utero to infliximab),
- interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and very rare rapidly progressive disease),
- idiopathic thrombocytopenic purpura,
- thrombotic thrombocytopenic purpura,
- pericardial effusion,
- systemic and cutaneous vasculitis,
- erythema multiforme,
- Stevens-Johnson Syndrome,
- toxic epidermal necrolysis,
- peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy),
- new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar),
- transverse myelitis, and neuropathies (additional neurologic reactions have also been observed),
- acute liver failure,
- hepatitis, and cholestasis,
- serious infections and malignancies, including
- In postmarketing experience, cases of anaphylactic reactions, including laryngeal/pharyngeal edema and severe bronchospasm, and seizure have been associated with administration of infliximab products.
- Cases of transient visual loss have been reported in association with infliximab products during or within 2 hours of infusion. Cerebrovascular accidents, myocardial ischemia/infarction (some fatal), and arrhythmia occurring within 24 hours of initiation of infusion have also been reported.
Adverse Reactions In Pediatric Patients
- The following serious adverse reactions have been reported in the postmarketing experience in children: infections (some fatal) including opportunistic infections and tuberculosis, infusion reactions, and hypersensitivity reactions.
- Serious adverse reactions in the postmarketing experience with infliximab products in the pediatric population have also included malignancies, including HSTCL, transient hepatic enzyme abnormalities, lupus-like syndromes, and the development of autoantibodies.
What drugs interact with Inflectra (infliximab-dyyb)?
Use With Anakinra Or Abatacept
- An increased risk of serious infections was seen in clinical studies of other TNFa blocking agents used in combination with anakinra or abatacept, with no added clinical benefit.
- Because of the nature of the adverse reactions seen with these combinations with TNF blocker therapy, similar toxicities may also result from the combination of anakinra or abatacept with other TNFa blocking agents. Therefore, the combination of Inflectra and anakinra or abatacept is not recommended.
Use With Tocilizumab
- The use of tocilizumab in combination with biological DMARDs such as TNF antagonists, including Inflectra, should be avoided because of the possibility of increased immunosuppression and increased risk of infection.
Use With Other Biological Therapeutics
- The combination of Inflectra with other biological therapeutics used to treat the same conditions as Inflectra is not recommended.
Methotrexate (MTX) And Other Concomitant Medications
- Specific drug interaction studies, including interactions with MTX, have not been conducted.
- The majority of patients in rheumatoid arthritis or Crohn's disease clinical studies received one or more concomitant medications.
- In rheumatoid arthritis, concomitant medications besides MTX were nonsteroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids and/or narcotics. Concomitant Crohn's disease medications were antibiotics, anti-virals, corticosteroids, 6-MP/AZA and aminosalicylates.
- In psoriatic arthritis clinical trials, concomitant medications included MTX in approximately half of the patients as well as NSAIDs, folic acid and corticosteroids.
- Concomitant MTX use may decrease the incidence of anti-infliximab antibody production and increase infliximab concentrations.
- Patients with Crohn's disease who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants. Serum infliximab concentrations appeared to be unaffected by baseline use of medications for the treatment of Crohn's disease including corticosteroids, antibiotics (metronidazole or ciprofloxacin) and aminosalicylates.
Cytochrome P450 Substrates
- The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, interleukin-1 (IL-1), IL-6, IL-10, IFN) during chronic inflammation.
- Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab products, the formation of CYP450 enzymes could be normalized.
- Upon initiation or discontinuation of Inflectra in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.
Live Vaccines/Therapeutic Infectious Agents
- It is recommended that live vaccines not be given concurrently with Inflectra. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab products for at least 6 months following birth.
- It is recommended that therapeutic infectious agents not be given concurrently with Inflectra.
Inflectra (infliximab-dyyb) is an antibody administered intravenously and is used to treat several chronic inflammatory diseases such as Crohn's disease, psoriatic arthritis, or rheumatoid arthritis. Common side effects of Inflectra include upper respiratory tract infections, urinary tract infections (UTIs), cough, rash, back pain, nausea, vomiting, abdominal pain, headache, weakness, fever, low or high blood pressure, chest pain, difficulty breathing, rash, itching, fever, and chills. Use of Inflectra during pregnancy has not been adequately evaluated. It is unknown if Inflectra is secreted in breast milk.
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Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure.
How Serious Is Ulcerative Colitis?
Ulcerative colitis (UC) is a lifelong disease with constant periods of flare-ups and remissions (periods without symptoms, which may last for weeks or years). Presently, there is no permanent medical cure for it, but there are various medications that can provide symptomatic relief, reduce inflammation and manage flare-ups.
Can Ulcerative Colitis Be Cured With Surgery?
Ulcerative colitis is a chronic inflammatory condition of the colon (the large bowel) characterized by frequent bloody diarrhea (10 to 30 episodes) throughout the day. Medicines can only reduce the intensity of its symptoms and surgery is the only option to cure it.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.