Cyltezo Side Effects

Subcutaneous route (Solution)

Patients treated with adalimumab are at increased risk of infection, some of which may become serious and lead to hospitalization or death.

These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria.

The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection.

Evaluate for latent TB and treat if necessary prior to initiating therapy.

Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment.

Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness.

Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis.

Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.

Subcutaneous route (Solution)

Serious Infections Patients treated with adalimumab products including adalimumab-aacf are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aacf if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB.

Patients with TB have frequently presented with disseminated or extrapulmonary disease.

Test patients for latent TB before adalimumab-aacf use and during therapy.

Initiate treatment for latent TB prior to adalimumab-aacf use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with adalimumab-aacf prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aacf, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.

Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products.

These cases have had a very aggressive disease course and have been fatal.

The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males.

Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis.

It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Subcutaneous route (Solution)

Serious Infections Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-fkjp if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-fkjp.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.

Subcutaneous route (Solution)

Serious Infections Patients treated with adalimumab products including adalimumab-aqvh are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aqvh if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB.

Patients with TB have frequently presented with disseminated or extrapulmonary disease.

Test patients for latent TB before adalimumab-aqvh use and during therapy.

Initiate treatment for latent TB prior to adalimumab-aqvh use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with adalimumab-aqvh prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aqvh, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.

Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products.

These cases have had a very aggressive disease course and have been fatal.

The majority of reported TNF blocker cases have occurred in patients with Crohn disease or ulcerative colitis and the majority were in adolescent and young adult males.

Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis.

It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Subcutaneous route (Solution)

Serious Infections Patients treated with adalimumab products including adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB.

Patients with TB have frequently presented with disseminated or extrapulmonary disease.

Test patients for latent TB before adalimumab-aaty use and during therapy.

Initiate treatment for latent TB prior to adalimumab-aaty use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection.Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.

Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products.

These cases have had a very aggressive disease course and have been fatal.

The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males.

Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis.

It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Subcutaneous route (Solution)

Serious Infections Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-bwwd if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-bwwd.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.

Subcutaneous route (Solution)

Patients treated with adalimumab-atto are at increased risk of infection, some of which may become serious and lead to hospitalization or death.

These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria.

The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection.

Evaluate for latent TB and treat if necessary prior to initiating therapy.

Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment.

Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness.

Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including adalimumab products.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab products, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis.

Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.

Subcutaneous route (Solution)

Serious Infections Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-adaz if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-adaz.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.

Subcutaneous route (Solution)

Serious Infections Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.Discontinue adalimumab-afzb if a patient develops a serious infection or sepsis during treatment.Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab-afzb.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.

Subcutaneous route (Solution)

Patients treated with adalimumab-adbm are at increased risk of infection, some of which may become serious and lead to hospitalization or death.

These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria.

The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection.

Evaluate for latent TB and treat if necessary prior to initiating therapy.

Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment.

Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness.

Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab-adbm.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab-adbm, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis.

Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.