Inflectra

Inflectra is a prescription medication used to treat:

• moderate to severe active Crohn’s disease who have had an inadequate response to conventional therapy in adults and children (six years and older)
• moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy in adults
• moderate to severe active rheumatoid arthritis (to be given with methotrexate)
• active ankylosing spondylitis (arthritis of the spine)
• active psoriatic arthritis;
• chronic severe plaque psoriasis in adults 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Inflectra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if you will stop nursing or stop the medication. 

Call your doctor for instructions if you miss an appointment for your infliximab injection.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• abatacept (Orencia);

• anakinra (Kineret);

• tocilizumab (Actemra);

• any "biologic" medications to treat your condition--adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others;

• phototherapy for psoriasis; or

• any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

This list is not complete. Other drugs may interact with infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab injection for the treatment of Crohn disease or ulcerative colitis in children 6 years and older. However, safety and efficacy have not been established in children younger than 6 years.

Appropriate studies have not been performed on the relationship of age to the effects of infliximab injection in children with plaque psoriasis. Safety and efficacy have not been established.

Appropriate studies performed to date have demonstrated that infliximab injection is not helpful in children with juvenile rheumatoid arthritis. Efficacy has not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infliximab injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Anakinra
• Bacillus of Calmette and Guerin Vaccine, Live
• Cyclosporine
• Fosphenytoin
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Phenytoin
• Poliovirus Vaccine, Live
• Quinidine
• Rilonacept
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sirolimus
• Smallpox Vaccine
• Tacrolimus
• Tocilizumab
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aspergillosis (fungus infection), history of or
• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (eg, pancytopenia), or history of or
• Candidiasis (fungus infection), history of or
• Coccidioidomycosis (fungus infection), history of or
• Diabetes or
• Guillain-Barré syndrome (nervous system disorder), history of or
• Hepatitis B, active or history of or
• Histoplasmosis (fungus infection), history of or
• Legionellosis (bacterial infection), history of or
• Leukopenia or neutropenia (low white blood cells) or
• Listeriosis (bacterial infection), history of or
• Liver disease or
• Multiple sclerosis, history of or
• Optic neuritis (eye problem) or
• Pneumocystosis (fungus infection), history of or
• Psoriasis (skin disease) or
• Seizures (convulsions), history of or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD)—Use with caution. May increase the chance of getting new cancers.

• Tuberculosis, history of—Use with caution. Patients may need additional tuberculosis therapy.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Infliximab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, shortness of breath, trouble breathing, or swelling of the face, tongue, and throat.

Your body's ability to fight an infection may be reduced while you are using infliximab. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Serious skin reactions can occur while you are using this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth, or unusual tiredness or weakness.

This medicine may increase your chance of having a lupus-like syndrome or a liver disease called autoimmune hepatitis. Check with your doctor right away if you have dark brown-colored urine, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, light-colored stools, nausea and vomiting, a rash on the cheeks or arms that is worse in the sun, severe tiredness, upper right-sided stomach pain, or yellow eyes and skin.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. This is more common in patients who have lung diseases (eg, emphysema, COPD) or are heavy smokers, and in psoriasis patients who have had phototherapy treatment for a long time. Phototherapy treatment is ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, unexplained weight loss, or red, scaly patches, or raised bumps with pus on the skin.

Using this medicine may increase your risk of getting skin cancer (eg, melanoma, Merkel cell carcinoma). If you have any changes or growths on your skin, tell your doctor right away.

While you are being treated with infliximab, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab. Your child's vaccinations must be current before using infliximab. Talk to your child's doctor if you have any questions about this.

Women: If you have a baby while receiving infliximab, make sure the baby's doctor knows that you were using this medicine. You will need to wait a few months before giving certain vaccines to your baby. Talk to the baby's doctor if you have questions.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

It is important to have your heart checked closely if you receive infliximab. Call your doctor right away if you have shortness of breath, swelling in the ankles and feet, or a sudden weight gain.

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other medicines called biologics that are used to treat the same conditions as infliximab. Using these medicines together with infliximab may increase your chance of having serious unwanted effects.

Serious Infections

Patients treated with infliximab products are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Inflectra should not be initiated in patients with an active infection, including clinically important localized infections. Patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients:

• with chronic or recurrent infection;
• who have been exposed to tuberculosis;
• with a history of an opportunistic infection
• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or
• with underlying conditions that may predispose them to infection.

Tuberculosis

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving infliximab products, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with infliximab products during treatment for latent tuberculosis.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Inflectra and periodically during therapy. Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Inflectra, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

Anti-tuberculosis therapy should also be considered prior to initiation of Inflectra in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.

Tuberculosis should be strongly considered in patients who develop a new infection during Inflectra treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

Monitoring

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Inflectra, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with Inflectra.

Inflectra should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Inflectra should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

Invasive Fungal Infections

For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy.

Malignancies

Malignancies, some fatal, have been reported among children, adolescents and young adults who received treatment with TNF blocking agents (initiation of therapy ≤ 18 years of age), 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 (range 1 to 84 months) after the first dose of TNF blocker therapy. Most of the patients were receiving concomitant immunosuppressants. These cases were reported postmarketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.

Lymphomas

In the controlled portions of clinical trials of all the TNF blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared with control patients. In the controlled and open-label portions of infliximab clinical trials, 5 patients developed lymphomas among 5707 patients treated with infliximab (median duration of follow-up 1.0 years) vs. 0 lymphomas in 1600 control patients (median duration of follow-up 0.4 years). In rheumatoid arthritis patients, 2 lymphomas were observed for a rate of 0.08 cases per 100 patient-years of follow-up, which is approximately three-fold higher than expected in the general population. In the combined clinical trial population for rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis, 5 lymphomas were observed for a rate of 0.10 cases per 100 patient-years of follow-up, which is approximately four-fold higher than expected in the general population. Patients with Crohn's disease, rheumatoid arthritis or plaque psoriasis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF blocking therapy. Cases of acute and chronic leukemia have been reported with postmarketing TNF blocker use in rheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.

Hepatosplenic T-cell lymphoma (HSTCL)

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), 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. Almost all patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. 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. It is uncertain whether the occurrence of HSTCL is related to TNF blockers or TNF blockers in combination with these other immunosuppressants. When treating patients, consideration of whether to use Inflectra alone or in combination with other immunosuppressants such as azathioprine or 6-mercaptopurine should take into account a possibility that there is a higher risk of HSTCL with combination therapy versus an observed increased risk of immunogenicity and hypersensitivity reactions with infliximab product monotherapy from the clinical trial data from studies with infliximab [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Skin cancer

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products [see Adverse Reactions (6.2)]. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

Other Malignancies

In the controlled portions of clinical trials of some TNF blocking agents, including infliximab products, more malignancies (excluding lymphoma and nonmelanoma skin cancer [NMSC]) have been observed in patients receiving those TNF blockers compared with control patients. During the controlled portions of trials with infliximab, in patients with moderately to severely active rheumatoid arthritis, Crohn's disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis, 14 patients were diagnosed with malignancies (excluding lymphoma and NMSC) among 4019 infliximab-treated patients vs. 1 among 1597 control patients (at a rate of 0.52/100 patient-years among infliximab-treated patients vs. a rate of 0.11/100 patient-years among control patients), with median duration of follow-up 0.5 years for infliximab-treated patients and 0.4 years for control patients. Of these, the most common malignancies were breast, colorectal, and melanoma. The rate of malignancies among infliximab-treated patients was similar to that expected in the general population whereas the rate in control patients was lower than expected.

In a clinical trial exploring the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, the majority of lung or head and neck origin, were reported in infliximab-treated patients compared with control patients. All patients had a history of heavy smoking [see Adverse Reactions (6.1)]. Prescribers should exercise caution when considering the use of Inflectra in patients with moderate to severe COPD.

Psoriasis patients should be monitored for NMSCs, particularly those patients who have had prior prolonged phototherapy treatment. In the maintenance portion of clinical trials for infliximab, NMSCs were more common in patients with previous phototherapy [see Adverse Reactions (6.1) ].

The potential role of TNF blocking therapy in the development of malignancies is not known [see Adverse Reactions (6.1) ]. Rates in clinical trials for infliximab cannot be compared to rates in clinical trials of other TNF blockers and may not predict rates observed in a broader patient population. Caution should be exercised in considering Inflectra treatment in patients with a history of malignancy or in continuing treatment in patients who develop malignancy while receiving Inflectra.

Hepatitis B Virus Reactivation

Use of TNF blockers, including infliximab products, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. The majority of these reports have occurred in patients concomitantly receiving other medications that suppress the immune system, which may also contribute to HBV reactivation. Patients should be tested for HBV infection before initiating TNF blocker therapy, including Inflectra. For patients who test positive for hepatitis B surface antigen, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require treatment with TNF blockers should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, TNF blockers should be stopped and anti-viral therapy with appropriate supportive treatment should be initiated. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, prescribers should exercise caution when considering resumption of TNF blocker therapy in this situation and monitor patients closely.

Hepatotoxicity

Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported rarely in postmarketing data in patients receiving infliximab products. Autoimmune hepatitis has been diagnosed in some of these cases. Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of infliximab; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases. Some of these cases were fatal or necessitated liver transplantation. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (e.g., ≥5 times the upper limit of normal) develop, Inflectra should be discontinued, and a thorough investigation of the abnormality should be undertaken. In clinical trials, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab products without progression to severe hepatic injury [see Adverse Reactions (6.1)].

Patients with Heart Failure

Infliximab products have been associated with adverse outcomes in patients with heart failure, and Inflectra should be used in patients with heart failure only after consideration of other treatment options. The results of a randomized study evaluating the use of infliximab in patients with heart failure (NYHA Functional Class III/IV) suggested higher mortality in patients who received 10 mg/kg infliximab, and higher rates of cardiovascular adverse events at doses of 5 mg/kg and 10 mg/kg. There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab. There have also been rare postmarketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease. Some of these patients have been under 50 years of age. If a decision is made to administer Inflectra to patients with heart failure, they should be closely monitored during therapy, and Inflectra should be discontinued if new or worsening symptoms of heart failure appear [see Contraindications (4)and Adverse Reactions (6.1)].

Hematologic Reactions

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients receiving infliximab products, The causal relationship to infliximab therapy remains unclear. Although no high-risk group(s) has been identified, caution should be exercised in patients being treated with Inflectra who have ongoing or a history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on Inflectra. Discontinuation of Inflectra therapy should be considered in patients who develop significant hematologic abnormalities.

Hypersensitivity

Infliximab products have been associated with hypersensitivity reactions that vary in their time of onset and required hospitalization in some cases. Most hypersensitivity reactions, which include urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hours of infusion. However, in some cases, serum sickness-like reactions have been observed in patients after initial therapy with infliximab products (i.e., as early as after the second dose), and when therapy with infliximab products was reinstituted following an extended period without treatment. Symptoms associated with these reactions include fever, rash, headache, sore throat, myalgias, polyarthralgias, hand and facial edema and/or dysphagia. These reactions were associated with a marked increase in antibodies to infliximab product, loss of detectable serum concentrations of infliximab products, and possible loss of drug efficacy.

Inflectra should be discontinued for severe hypersensitivity reactions. Medications for the treatment of hypersensitivity reactions (e.g., acetaminophen, antihistamines, corticosteroids and/or epinephrine) should be available for immediate use in the event of a reaction [see Adverse Reactions (6.1)].

In rheumatoid arthritis, Crohn's disease and psoriasis clinical trials, readministration of infliximab after a period of no treatment resulted in a higher incidence of infusion reactions relative to regular maintenance treatment [see Adverse Reactions (6.1)]. In general, the benefit-risk of readministration of Inflectra after a period of no-treatment, especially as a reinduction regimen given at weeks 0, 2 and 6, should be carefully considered. In the case where Inflectra maintenance therapy for psoriasis is interrupted, Inflectra should be reinitiated as a single dose followed by maintenance therapy.

Neurologic Reactions

Agents that inhibit TNF have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of Inflectra in patients with these neurologic disorders and should consider discontinuation of Inflectra if these disorders develop.

Use with Anakinra

Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone. Because of the nature of the adverse reactions seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα blocking agents. Therefore, the combination of Inflectra and anakinra is not recommended.

Use with Abatacept

In clinical studies, concurrent administration of TNF blocking agents and abatacept have been associated with an increased risk of infections including serious infections compared with TNF blocking agents alone, without increased clinical benefit. Therefore, the combination of Inflectra and abatacept is not recommended [see Drug Interactions (7.1)].

Concurrent Administration with other Biological Therapeutics

There is insufficient information regarding the concomitant use of infliximab products with other biological therapeutics used to treat the same conditions as Inflectra. The concomitant use of Inflectra with these biologics is not recommended because of the possibility of an increased risk of infection [see Drug Interactions (7.3)].

Switching between Biological Disease-Modifying Antirheumatic Drugs (DMARDs)

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, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Inflectra, treatment should be discontinued [see Adverse Reactions (6.1)].

Live Vaccines/Therapeutic Infectious Agents

In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. The concurrent administration of live vaccines with Inflectra is not recommended.

Fatal outcome due to disseminated BCG infection has been reported in an infant who received a BCG vaccine after in utero exposure to infliximab products. Infliximab products are known to cross the placenta and have been detected up to 6 months following birth. At least a six month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.

Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections. It is recommended that therapeutic infectious agents not be given concurrently with Inflectra.

It is recommended that all pediatric patients be brought up to date with all vaccinations prior to initiating Inflectra therapy. The interval between vaccination and initiation of Inflectra therapy should be in accordance with current vaccination guidelines.

Use with Anakinra or Abatacept

An increased risk of serious infections was seen in clinical studies of other TNFα 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 TNFα blocking agents. Therefore, the combination of Inflectra and anakinra or abatacept is not recommended [see Warnings and Precautions (5.9 and 5.10)].

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 [see Warnings and Precautions (5.11)].

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.

Immunosuppressants

Patients with Crohn's disease who received immunosuppressants tended to experience fewer infusion reactions compared to patients on no immunosuppressants [see Adverse Reactions (6.1)]. 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 [see Warnings and Precautions (5.14)].

It is recommended that therapeutic infectious agents not be given concurrently with Inflectra [see Warnings and Precautions (5.14)].

Each Inflectra 20 mL vial is individually packaged in a carton.

NDC 0069-0809-01     100 mg vial

Each single use vial contains 100 mg of infliximab-dyyb for final reconstitution volume of 10 mL.

Storage and Stability

Inflectra must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Do not use Inflectra beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.

NDC 0069-0809-01

Pfizer

Inflectra™
(infliximab-dyyb)
For Injection

100 mg per vial

For Intravenous
Infusion Only

Single-use vial -
Discard unused portion

Applies to infliximab: intravenous powder for injection

General

One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache, and rash)[Ref]

Immunologic

Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)
Common (1% to 10%): Bacterial infections (e.g., sepsis, cellulitis, abscess), moniliasis
Uncommon (0.1% to 1%): Tuberculosis, fungal infections (e.g., candidiasis), vaginitis
Rare (less than 0.1%): Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation[Ref]

Most cases of tuberculosis occurred within the first two months after the start of infliximab therapy and may reflect recrudescence of latent disease.

Cutaneous and miliary tuberculosis, as a result of tuberculosis reactivation, has been reported in a 56-year-old white male with a history of Crohn's disease treated with infliximab.

Infections have been observed in all organ systems and have been reported in patients receiving infliximab alone or in combination with immunosuppressive agents.

Patients with antibodies to infliximab were more likely to have higher rates of clearance, reduced efficacy, and to experience an infusion reaction.

Crohn's patients with (+) ANA prior to infliximab were approximately 2 times as likely to develop anti-dsDNA antibodies.

Various case reports of non-Crohn's and Crohn's patient, developed clinical symptoms of a lupus-like syndrome. Symptoms resolved and antibodies disappeared when infliximab was discontinued.

Disseminated Salmonella typhimurium infection has been reported in a Fijian Indian man while undergoing his twenty-eighth week of infliximab therapy for the treatment of psoriasis and psoriatic arthritis. Patient's symptoms resolved after treatment with intravenous ciprofloxacin.

Disseminated cryptococcal infection has been reported in a 72-year-old male after his second infusion of infliximab for rheumatoid arthritis.

A 56-year-old male developed protothecosis after a stem cell transplantation coincident with infliximab therapy. He was administered infliximab for graft-versus-host disease. Two weeks later, he became lethargic and developed bilateral olecranon bursitis and bullous skin lesions. Blood cultures grew Klebsiella pneumoniae and Prototheca wickerhamii. The patient subsequently developed multiorgan failure and died after 5 weeks of hospitalization. The use of infliximab likely played a role in this case.[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 32%), sinusitis (up to 14%), pharyngitis (up to 12%), cough (up to 12%), bronchitis (up to 10%)
Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis
Uncommon (0.1% to 1%): Pulmonary edema, bronchospasm, pleurisy, pleural effusion
Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome
Frequency not reported: Respiratory insufficiency, pulmonary embolism, shortness of breath[Ref]

Other

Common (1% to 10%): Hot flush, flushing, fatigue, fever, chills
Uncommon (0.1% to 1%): Impaired healing, autoantibody positive
Rare (less than 0.1%): Granulomatous lesion, complement factor abnormal[Ref]

Hypersensitivity

In order to avoid the development of delayed severe systemic reactions, some researchers recommend multiple early infusions of infliximab (the active ingredient contained in Inflectra) if retreatment is anticipated.

Delayed hypersensitivity reactions during psoriasis studies generally occurred within 2 weeks following repeat infusion.

During one clinical trial, Crohn's disease patients were retreated following 2 to 4 years without infliximab. Patients experiencing side effects following readministration did not have infusion-related side effects associated with their initial infliximab treatment.[Ref]

Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction
Rare (less than 0.1%): Anaphylactic shock, vasculitis, sarcoid-like reaction
Frequency not reported: Facial, hand, or lip edema, sore throat[Ref]

Nervous system

Very common (10% or more): Headache (up to 18%)
Common (1% to 10%): Vertigo, dizziness, hypoesthesia, paresthesia
Uncommon (0.1% to 1%): Seizure, neuropathy
Rare (less than 0.1%): Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), rheumatoid vasculitis, systemic vasculitis
Frequency not reported: Dysesthesia, meningitis, brain infarction, neuritis, peripheral neuropathy, Miller Fisher syndrome[Ref]

One patient reported hypoesthesia in the left leg eight hours after her first infliximab infusion.

Another patient reported dysesthesia in the distribution of the left peroneal nerve, after her 6th intravenous infliximab infusion.

Although demyelination observed in postmarketing experience did not show causal relationship between adverse events and infliximab, the neurologic side effects resolved, partially or completely, on discontinuation of therapy.

A 51-year-old female with Crohn's disease experienced meningitis coincident with infliximab therapy. The patient developed a headache, fever, arthralgia, myalgia, and meningismus after receiving an infliximab infusion. Cerebrospinal fluid analysis was remarkable for a neutrophilic pleocytosis and elevated protein. Other potential causes of meningitis were ruled out. The patient's symptoms completely resolved within 24 hours of presentation.

A 28-year-old female with a 7-year history of Crohn disease experienced acute neuropathy with multiple conduction blocks coincident with infliximab therapy. Infliximab (5 mg/kg, 4 infusions in 2 years) therapy was added to azathioprine (150 mg per day) 5 years into her disease. Three weeks after the overall fourth dose of infliximab treatment, she developed left radial nerve palsy and slight weakness of left foot flexion and extension. Neurologic examination and motor nerve conduction studies were positive for acute neuropathy with multiple conduction blocks.

A 66-year-old male with rheumatoid arthritis experienced West Nile virus (WNV) coincident with infliximab therapy. The patient presented with a 2-day history of fever, headache, confusion, agitation, nausea, malaise, myalgias, gait instability, and rapidly worsening lower extremity weakness. He had received infliximab 3 weeks prior to symptom onset. His only other medications were amlodipine (5 mg per day) and methotrexate (15 mg per week). WNF was confirmed by with cerebral spinal fluid positive for WNV IgM antibodies by ELISA capture technique. The patient eventually died due to WNF infection.

A 41-year-old female with erosive rheumatoid arthritis experienced neurosarcoidosis coincident with infliximab therapy. She had been successfully treated with infliximab 3 mg/kg every 6 to 8 weeks together with methotrexate, without side effects. Approximately five years later, after receiving an infliximab infusion, she experienced feeling tired, a low grade fever, and headache. Two weeks later, she presented without any neurological symptoms besides headache. She was hospitalized one week later. The headache remained unchanged and 4 weeks after admission, she developed diplopia. At neuron-ophthalmological examination, nerve palsy of the left eye and a severe papilledema in both eyes were observed. Further, bilateral granulomatous iridocyclitis and retinal periphlebitis, typical for sarcoidosis, were noted. The sarcoidosis diagnosis was supported by the increased activity in the mediastinal lymph nodes bilaterally and in the parotid glands observed with In-DTPA-octreotide scintigraphy. She received a ventriculoperitoneal shunt 5 weeks after being admitted. Following surgery, the patient became free of headache and the pathological ophthalmologic changes slowly subsided.

A 62-year-old female reported she was hospitalized for five days due to a reaction characterized by shaking uncontrollably due to taking infliximab. The patient did not know the date of admission stating it was a long time ago when she was in her twenties. The patient reported being diagnosed with Crohn's disease at age 21.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 21%), abdominal pain (up to 12%), diarrhea (up to 12%), dyspepsia (up to 10%)
Common (1% to 10%): Gastrointestinal hemorrhage, gastroesophageal reflux, constipation, vomiting
Uncommon (0.1% to 1%): Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
Frequency not reported: Abdominal hernia, abscess, intestinal obstruction, proctalgia, ileus, abdominal hernia, abscess, intestinal obstruction, peritonitis, proctalgia[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, palpitation, chest pain
Uncommon (0.1% to 1%): Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia
Rare (0.01% to 0.1%): Cyanosis, pericardial effusion, circulatory failure, vasospasm
Very rare (less than 0.01%): Heart block
Frequency not reported: Myocardial ischemia/myocardial infarction occurring during or within 2 hours of infusion[Ref]

A higher incidence of mortality and hospitalization for worsening heart failure have been reported among patients with moderate to severe (NYHA class III-IV) heart failure treated with the higher dose of infliximab (10 mg/kg). At 1 year, eight patients in the infliximab 10 mg/kg group had died compared with four deaths each in the infliximab 5 mg/kg and the placebo group.

Heart failure (n=18) reported in postmarketing experience developed on average 6 months after initiation of infliximab therapy.

Bradycardia with second degree atrioventricular (AV) block has been reported to occur, as soon as 30 minutes into the infliximab infusion, in a 52-year-old woman with fistulizing Crohn's disease who had no previous history of cardiac disease. The bradycardia, and second degree AV block, persisted for 36 hours after infliximab was discontinued. After a cardiology consult, and placement of a pacemaker, patient resumed her infliximab therapy without adverse events reported.

A 70-year-old man with fistulizing Crohn's disease, and a prior history of coronary artery disease and taking atenolol, developed dyspnea, chest heaviness, and dizziness while receiving his third infusion of infliximab. He had reported chills and pruritus during previous infusions of infliximab. He presented with a drop in heart rate with ECG showing type 2 Sinoatrial block. Patient received a permanent pacemaker. Infliximab therapy was stopped and patient had surgery for fistulizing Crohn's disease.[Ref]

Dermatologic

Very common (10% or more): Rash (up to 10%)
Common (1% to 10%): Ecchymosis, new onset or worsening psoriasis including pustular psoriasis (primarily palms and soles), urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia
Uncommon (0.1% to 1%): Bullous eruption, onychomycosis, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, cellulitis, eczema/seborrhea, furunculosis, verruca
Rare (0.01% to 0.1%): Petechia, granulomatous lesion
Very rare (less than 0.01%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, necrotising fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas
Postmarketing reports: Worsening of symptoms of dermatomyositis[Ref]

Necrotizing fasciitis resulting in death has been reported in a 54-year-old man with rheumatoid arthritis receiving infliximab every 8 weeks along with intramuscular methotrexate weekly dosage. Blood cultures and skin swabs grew hemolytic group A streptococcus.

Bullous skin lesions have been reported in a 72-year-old white man one day after his fourth dose of infliximab for the treatment of severe rheumatoid arthritis. Although proximity of symptoms point to infliximab, causality was not definitive.

Two cases of aggressive cutaneous T-cell lymphomas that progressed rapidly have been reported during therapy with infliximab. Sezary syndrome developed in one patient after 18 months of treatment and systemic anaplastic large cell lymphoma with cutaneous involvement developed in the other patient four weeks following the third dose of infliximab.

A 40-year-old female with Crohn disease experienced acne coincident with infliximab therapy. The patient had been administered infliximab 5 mg/kg with rapid and effective symptomatic control. Several weeks after initiating infliximab therapy, the patient developed a papulopustular eruption on the face and back with some comedones. The eruption persisted, albeit with fluctuating severity, and dermatological opinion was obtained. Histology was consistent with the clinical diagnosis of acne and other Crohn disease-associated dermatoses were excluded. Infliximab was not discontinued because of the excellent control of the bowel disease. Instead, the patient was treated with minocycline 100 mg daily.

A 70-year-old male with rheumatoid arthritis (RA) experienced a primary cutaneous Nocardia otitidiscaviarum infection after a skin injury coincident with infliximab therapy. He was treated for RA with infliximab (3 mg/kg) for 3 years, as well as methotrexate (20 mg/week), and corticosteroids. Two weeks before the 18th infusion of infliximab, he was injured, and had a deep wound in his right palm. The hand lesion was not inflamed, but an erythematous pustular lesion appeared on the anterior side of his right forearm. Two weeks later the lesion spontaneously drained and formed a cutaneous nonpainful ulcer covered by white pus, with erythematous periphery. Nocardia otitidiscaviarum was subsequently isolated from the ulcer and biological samples showed inflammation. Infliximab therapy was discontinued. He was treated with combination clindamycin and ofloxacin antibiotic therapy for 3 months. Twenty days later, the skin ulcer had completely healed.

A 63-year-old female with a history of rheumatoid arthritis (RA) experienced atypical varicella exanthema coincident with infliximab therapy. The patient presented with a 10-day history of pruritic generalized papulovesicles which quickly progressed to flaccid vesicles, pustules, or erosions accompanied by fever and sore throat. Her RA had been treated with methotrexate (10 mg per week) and bucillamine (200 mg per day) for 6 years. Despite this medication, her RA was poorly controlled, so infliximab (3 mg/kg) was additionally administered twice, separated by 2-weekly intervals. Two days after the second course of infliximab therapy, a cutaneous eruption developed abruptly. Polymerase chain reaction showed varicella zoster virus. Based on these findings, the patient was diagnosed with varicella and was promptly started on a course of intravenous acyclovir and prophylactic antibiotics for 7 days. Three weeks later, her recovery was complete with minimal scars.

A 60-year-old male with a 5-year history of diffuse polyarthritis experienced leprosy and type 1 leprosy reaction coincident with infliximab therapy. The patient had been given 3 courses of infliximab; the last had been given 3 months prior to admission. One month after he received the first dose of infliximab, the patient developed a rash on 1 extremity that progressed to all extremities. Results of a skin biopsy suggested leprosy or Hansen disease. He was treated with multidrug therapy (MDT) of dapsone (100 mg daily), clofazimine (50 mg daily), and rifampin (300 mg monthly). One month after starting this treatment, the patient developed "reversal," or type 1, reactions. After 4 years, the cutaneous lesions had resolved, and MDT was withdrawn. Results of a skin biopsy performed 5 years after diagnosis showed advanced regression of the lesion with no residual bacilli.

A 37-year-old female with Crohn disease developed palmoplantar pustulosis (PPP) coincident with infliximab therapy. The patient was given a regimen of infliximab of 5 mg/kg resulting in complete remission of her bowel symptoms. One month later, she experienced classic PPP together with a mild psoriasiform eruption on the lower legs. In particular, the patient's feet were painful, which adversely affected her mobility. As treatment, she was prescribed betamethasone dipropionate twice daily, polythene occlusion at night, and soap-free wash and moisturizer. Over the following 3 to 4 weeks, the patient improved clinically and symptomatically and did not need additional psoriasis therapy.

Alopecia areata has been reported in a 51-year-old white woman with rheumatoid arthritis and Sjogren syndrome after 11 months of infliximab therapy. The hair loss eventually involved 100% of the scalp as well as her eyebrows and eyelashes.[Ref]

Oncologic

Rare (less than 0.1%): Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukemia, melanoma
Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer
Frequency not reported: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn's disease and ulcerative colitis), Merkel cell carcinoma
Frequency not reported: Nonmelanoma skin cancer, neoplasms (basal cell and breast)[Ref]

Clinical trials of infliximab have reported a 3-fold higher incidence than expected in the general population of developing lymphomas among rheumatoid arthritis patients. Among patients diagnosed with Crohn's disease and rheumatoid arthritis, there is 6-fold higher incidence than expected in the general population. Patients with highly active disease and/or chronic exposure to immunosuppressants may be at a higher risk (up to several fold) than the population at large for the development of lymphoma.

During a controlled clinical trial studying the use of infliximab in 157 patients with moderate to severe COPD who were either current smokers or ex-smokers, 9 patients developed a malignancy, including 1 lymphoma.

Acute lymphoblastic leukemia has been diagnosed in a patient eight days after receiving a third infusion of infliximab 5 mg/kg for the treatment of Crohn's disease. A causal relationship was not clearly established.

Postmarketing adverse events reports have included lymphoproliferative disorders (n=8) that developed, on average, 8 weeks after initiation of therapy with infliximab. The majority of cases (81%) were non-Hodgkin's lymphomas.

A meta-analysis has reported that there is dose-dependent increased risk of malignancies in patients with rheumatoid arthritis treated with anti-TNF antibody therapy.

A 75-year-old male with ankylosing spondylitis experienced Sezary syndrome coincident with infliximab therapy. He had been initially treated with nonsteroidal antiinflammatory drugs, then with prednisone 10 mg daily for 6 months, and thereafter treatment was switched to infliximab 3 mg/kg at 2 monthly intervals. After 17 months of this therapy, he was diagnosed with Sezary syndrome. Cutaneous lesions partially remitted following infliximab discontinuation and methotrexate treatment.[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal, transaminases increased
Uncommon (0.1% to 1%): Hepatitis, hepatocellular damage, cholecystitis, cholelithiasis
Rare (less than 0.1%): Autoimmune hepatitis, jaundice
Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus[Ref]

Severe hepatic reactions have occurred between weeks two to more than a year after initiation of infliximab.

In general, patients who developed elevated ALT and AST were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant medications.

Cholestatic liver disease has been reported in a 44-year-old woman 19 days after a single dose of infliximab.

A 45-year-old female with a history of Crohn disease experienced cytomegalovirus hepatitis coincident with infliximab therapy. She had been administered mercaptopurine 50 mg per day for the past 8 years until intravenous infliximab 5 mg/kg at 4 to 8 week intervals was added for better control of the disease. Approximately one year later, the patient was admitted to the hospital with a 4-week history of daily fever and chills unresponsive to several courses of empirical antimicrobial therapy. Histological examination of a liver biopsy specimen showed intranuclear inclusion bodies, confirmed by cytomegalovirus by paraffin immunoperoxidase staining with antibody against this virus. After intravenous ganciclovir 5 mg/kg twice daily therapy, the patient's symptoms and laboratory values improved within a few days.[Ref]

Hematologic

Common (1% to 10%): Neutropenia, leucopenia, lymphadenopathy
Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis
Rare (less than 0.1%): Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura,
Frequency not reported: Aplastic anemia, splenic infarction, splenomegaly[Ref]

Some cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia had a fatal outcome.[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia, back pain
Uncommon (0.1% to 1%): Tendon injury
Frequency not reported: Intervertebral disk herniation, infective arthritis, swelling of fingers, paresthesia in the forearm region[Ref]

Renal

Common (1% to 10%): Kidney infarction (less than 2%)
Uncommon (0.1% to 1%): Renal calculus, renal failure
Very rare (less than 0.01%): IgA nephropathy, pyelonephritis[Ref]

Metabolic

Uncommon (0.1% to 1%): Dehydration
Frequency not reported: Extra-high levels of VLDL-triglycerides[Ref]

Local

Very common (10% or more): Injection site reaction (up to 27%)(mainly erythema, pruritus, rash, and pain of mild to moderate severity)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, moniliasis
Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction[Ref]

Ocular

Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Keratitis, periorbital edema, hordeolum
Rare (0.01% to 0.1%): Endophthalmitis
Very rare (less than 0.01%): Retrobulbar optic neuritis of the left eye, orbital cellulitis, third nerve palsy, transient visual loss associated with infliximab (the active ingredient contained in Inflectra) administration (during or within 2 hours of infusion)
Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion[Ref]

A 55-year-old woman diagnosed with rheumatoid arthritis developed decreased vision in the left eye accompanied by pain with eye movement 3 days after her 9th infusion (at 1 year of treatment) with infliximab. Patient's vision slowly improved and her visual field deficit resolved after treatment with 1 g methylprednisolone injection per day for 3 days followed by a tapering dose of oral prednisone over 10 days.

A week after the seventh infusion of infliximab 5 mg/kg, a 45-year-old woman with type 2 diabetes mellitus and Crohn's disease developed pain and blurred vision in the left eye. Visual acuity was 20/70. Patient recovered after treatment with intravenous methylprednisolone, followed by a tapering dose of oral prednisone. On examination 3 months later she had 20/20 visual acuity, normal color vision, mild residual left-sided headache, and a normal-appearing optic nerve in the left eye.

A 42-year-old male developed severe unilateral orbital cellulitis while receiving infliximab therapy for ankylosing spondylitis during a clinical trial. Cultures showed Staphylococcus aureus. Infliximab therapy was stopped and the patient made a full recovery after receiving appropriate antibiotic therapy. Infliximab treatment was resumed after three weeks.

A 47-year-old male with rheumatoid arthritis experienced third nerve palsy coincident with infliximab therapy. He received monthly infusions of 300 mg of infliximab for the disease. He initially presented with painless ptosis of his right upper eyelid along with double vision in left and up gaze. Brain magnetic resonance imaging (MRI) showed gadolinium enhancement of the cisternal segment of the right oculomotor nerve. After stopping infliximab therapy, the diplopia and ptosis gradually resolved during 3 months. Repeat MRI imaging showed resolution of the oculomotor nerve enhancement.[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness
Rare (less than 0.1%): Apathy
Frequency not reported: Suicide attempt[Ref]

Some side effects of Inflectra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.