Interactions between Humira and Temsirolimus

Temsirolimus has a major potential interaction with Anaphylaxis.

Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity and anaphylaxis, have been associated with the administration of temsirolimus. Caution should be exercised during the infusion and appropriate supportive care should be available. For patients who develop hypersensitivity reaction during the infusion, it is recommended to stop the infusion and close observation with the possibility of resuming therapy at a slower rate should be contemplated at the discretion of the physician. Temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered. A benefit-risk assessment should be done prior to the continuation of therapy in patients with severe or life-threatening reactions.

The adalimumab in Humira has a moderate potential interaction with Bone Marrow Depression/Low Blood Counts.

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients treated with TNF blocking agents. Caution should be exercised when treating patients who have ongoing or a history of significant hematologic abnormalities. Discontinuation of therapy should be considered in patients with confirmed significant hematologic abnormalities.

Temsirolimus has a moderate potential interaction with Brain Tumor.

Inhibition of mTOR activity results in delays of wound healing and increases the occurrence of wound-related complications, which might require surgical intervention. Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes). Caution is recommended when using these agents, particularly in the perioperative period.

The adalimumab in Humira has a major potential interaction with Central Nervous System Disorders.

The use of TNF blocking agents has been associated with rare cases of CNS manifestations 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. Care should be exercised when considering the use of these agents in patients with neurologic disorders and discontinuing the agent is recommended if these disorders develop during therapy.

Temsirolimus has a moderate potential interaction with Coagulation Defects and Disorders.

Inhibition of mTOR activity results in delays of wound healing and increases the occurrence of wound-related complications, which might require surgical intervention. Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes). Caution is recommended when using these agents, particularly in the perioperative period.

The adalimumab in Humira has a moderate potential interaction with COPD.

In controlled trials of other TNF blockers, other than adalimumab, in adult patients at higher risk for malignancies (i.e., patients with COPD with a significant smoking history and cyclophosphamide-treated patients with Wegener's granulomatosis), a greater portion of malignancies occurred in the TNF blocker group compared to the control group.

Temsirolimus has a major potential interaction with Dermatitis, Drug-Induced.

Hypersensitivity/infusion reactions, including but not limited to flushing, chest pain, dyspnea, hypotension, apnea, loss of consciousness, hypersensitivity and anaphylaxis, have been associated with the administration of temsirolimus. Caution should be exercised during the infusion and appropriate supportive care should be available. For patients who develop hypersensitivity reaction during the infusion, it is recommended to stop the infusion and close observation with the possibility of resuming therapy at a slower rate should be contemplated at the discretion of the physician. Temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered. A benefit-risk assessment should be done prior to the continuation of therapy in patients with severe or life-threatening reactions.

Temsirolimus has a moderate potential interaction with Diabetes Mellitus.

Elevations in serum blood glucose levels have been reported in patients taking inhibitors of mTOR (mammalian target of rapamycin). Monitoring of fasting serum glucose levels is recommended prior to the start of therapy and periodically thereafter. Clinicians should achieve control of glucose levels before initiating therapy with these agents.

Temsirolimus has a major potential interaction with Gastrointestinal Perforation.

Cases of fatal bowel perforation occurred in patients who received temsirolimus. Therapy with temsirolimus should be administered with caution in patients who may be at increased risk for gastrointestinal perforation, such as those with a history of diverticulitis. Patients presenting with new onset or worsening of abdominal symptoms or blood in the stools should be evaluated promptly for early identification of gastrointestinal perforation.

The adalimumab in Humira has a moderate potential interaction with Heart Failure.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab. Adalimumab has not been formally studied in patients with CHF; however, in clinical trials of another TNF blocker, a higher rate of serious CHF-related adverse reactions was observed. Exercise caution when using adalimumab in patients who have heart failure and monitor them carefully.

Temsirolimus has a moderate potential interaction with High Cholesterol.

Elevations in cholesterol and triglyceride levels have been reported in patients taking inhibitors of mTOR (mammalian target of rapamycin). Monitoring of fasting lipid profile is recommended prior to the start of therapy and periodically thereafter. Clinicians should achieve control of lipid levels before initiating therapy with these agents.

The adalimumab in Humira has a major potential interaction with History, Skin Cancer.

In clinical trials malignancies have been observed in patients receiving TNF-blockers agents. Patients with psoriasis should be monitored for non-melanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers. Caution should be exercised when considering these agents in the treatment of patients with a history of malignancies or in continuing treatment in patients who develop malignancies while receiving these agents.

The adalimumab in Humira has a major potential interaction with Infection.

There have been reports of serious infections, including sepsis and opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis with TNF blockers. Treatment with these agents should not be initiated in patients with an active infection, including clinically important localized infections. Caution and close monitoring is recommended when considering their use in patients with a history of recurrent infections, underlying conditions which may predispose them to infections, or chronic, latent, or localized infections. Administration of these agents should be discontinued if a patient develops a serious infection or sepsis.

Temsirolimus has a moderate potential interaction with Infection.

The immunosuppressant effect of inhibitors of mTOR (mammalian target of rapamycin) may decrease host resistance to infectious agents and may predispose patients to bacterial, fungal, viral, or protozoal infections, infections with opportunistic pathogens, and reactivation of viral infections. Therapy with these agents should be administered with caution in patients with an infection, particularly active infections or any untreated systemic fungal, bacterial, parasitic, or viral infection. It is recommended to complete the treatment of preexisting invasive fungal infections prior to starting treatment and if a diagnosis of invasive systemic fungal infection is made during treatment, discontinue and treat with appropriate antifungal therapy.

The adalimumab in Humira has a moderate potential interaction with Infectious Hepatitis.

The use of TNF blockers has been associated with reactivation of hepatitis B, in some cases fatal, in patients who were previously infected with the hepatitis B virus (HBV). Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with these agents. Monitor patients at risk or with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV. It is recommended to monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following therapy. In patients who develop HBV reactivation, therapy should be stopped and antiviral therapy with appropriate supportive treatment should be initiated. The safety of resuming these agents after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy.

Temsirolimus has a moderate potential interaction with Interstitial Lung Disease.

Cases of interstitial lung disease, some resulting in death, occurred in patients who received temsirolimus. It is recommended that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to the initiation of therapy. Close monitoring for the occurrence of any new or worsening respiratory symptoms is advisable and if clinically significant respiratory symptoms develop, consider withholding administration until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.

Temsirolimus has a major potential interaction with Liver Disease.

Temsirolimus is contraindicated in patients with bilirubin >1.5×ULN. Caution is recommended when treating patients with mild hepatic impairment and a dose reduction may be needed depending on AST and bilirubin levels. Dosage adjustment is needed based on hepatic function; therefore, assessment of AST and bilirubin levels is recommended before initiation of therapy and periodically thereafter.

The adalimumab in Humira has a major potential interaction with Lymphoma.

In clinical trials malignancies have been observed in patients receiving TNF-blockers agents. Patients with psoriasis should be monitored for non-melanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers. Caution should be exercised when considering these agents in the treatment of patients with a history of malignancies or in continuing treatment in patients who develop malignancies while receiving these agents.

The adalimumab in Humira has a moderate potential interaction with Pancytopenia.

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia, some with a fatal outcome, have been reported in patients treated with TNF blocking agents. Caution should be exercised when treating patients who have ongoing or a history of significant hematologic abnormalities. Discontinuation of therapy should be considered in patients with confirmed significant hematologic abnormalities.

Temsirolimus has a moderate potential interaction with Pulmonary Impairment.

Cases of interstitial lung disease, some resulting in death, occurred in patients who received temsirolimus. It is recommended that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to the initiation of therapy. Close monitoring for the occurrence of any new or worsening respiratory symptoms is advisable and if clinically significant respiratory symptoms develop, consider withholding administration until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.

Temsirolimus has a major potential interaction with Renal Dysfunction.

Cases of renal failure, including acute renal failure and elevations of serum creatinine and proteinuria, some with a fatal outcome, have been observed in patients treated with inhibitors of mTOR (mammalian target of rapamycin). Therapy with these agents should be administered cautiously in patients with renal dysfunction, in particularly where patients have additional risk factors that may further impair renal function. Renal impairment is not expected to influence drug exposure, and no dosage adjustment is recommended in patients with renal impairment. Monitoring of renal function, including measurement of blood urea nitrogen (BUN), urinary protein, or serum creatinine, is recommended prior to the start of therapy and periodically thereafter.

The adalimumab in Humira has a major potential interaction with Skin Cancer.

In clinical trials malignancies have been observed in patients receiving TNF-blockers agents. Patients with psoriasis should be monitored for non-melanoma skin cancers (NMSCs), particularly those patients who have had prior prolonged phototherapy treatment. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers. Caution should be exercised when considering these agents in the treatment of patients with a history of malignancies or in continuing treatment in patients who develop malignancies while receiving these agents.

The adalimumab in Humira has a major potential interaction with Tuberculosis, Active.

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF blocking agents, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with these agents during treatment for latent tuberculosis. Prior to initiating TNF blocking agents, patients should be screened for latent tuberculosis infection with a tuberculin skin test and periodically during therapy. Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with TNF blocking agents. Anti-tuberculosis therapy should also be considered prior to initiation of therapy 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. Tuberculosis should be strongly considered in patients who develop a new infection during 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.

The adalimumab in Humira has a major potential interaction with Tuberculosis, Latent.

Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF blocking agents, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred in patients being treated with these agents during treatment for latent tuberculosis. Prior to initiating TNF blocking agents, patients should be screened for latent tuberculosis infection with a tuberculin skin test and periodically during therapy. Patients testing positive in tuberculosis screening should be treated by standard medical practice prior to therapy with TNF blocking agents. Anti-tuberculosis therapy should also be considered prior to initiation of therapy 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. Tuberculosis should be strongly considered in patients who develop a new infection during 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.

Temsirolimus has a major potential interaction with Vaccination.

The administration of live vaccines should be avoided during therapy with inhibitor of mTOR (mammalian target of rapamycin). It is recommended that close contact with individuals who have received live vaccines should be avoided because of the potential risk for shedding from the household contact and transmission to patient. It is recommended to be up-to-date with all required immunizations, as recommended by current immunization guidelines, before initiating therapy with these agents.