Exemptia Special Precautions



Zydus Cadila




Mega Lifesciences
Full Prescribing Info
Special Precautions
Infections: Patients taking TNF-antagonists or with impaired lung function are susceptible to serious infections and therefore should be monitored throughout Adalimumab treatment including before, during and after treatment.
Patients should only be treated with Adalimumab after active infections including chronic or localized infections are controlled. Risks and benefits of Adalimumab therapy should be reviewed prior to initiating the treatment in patients who have been exposed to tuberculosis (including travelled through high risk tuberculosis areas) or endemic mycoses such as histoplasmosis, blastomycosis and coccidioidomycosis.
When patients develop a new infection while being treated with Adalimumab, a complete diagnostic evaluation should be performed and the patient should be closely monitored. Adalimumab should be discontinued in cases where a new serious infection or sepsis develops and appropriate antifungal or antimicrobial therapy should be initiated to control the infection. Physicians should prescribe Adalimumab with caution after examining patient's history to infections including the use of concomitant immunosuppressive medications.
Serious infections: Patients receiving Adalimumab have encountered hospitalization, fatal outcomes, serious infections such as pneumonia, pyelonephritis, septic arthritis and septicemia, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis.
Tuberculosis: All patients must be examined in detail (including medical history) for both, active or inactive (latent) tuberculosis infection and current immunosuppressive therapy prior to administering Adalimumab as tuberculosis has been reported in patients receiving Adalimumab. The patient's file should have records of tuberculin skin test and chest X-ray. Adalimumab therapy should not be initiated in those patients who have been diagnosed with active tuberculosis.
An expert in tuberculosis should be consulted if latent tuberculosis is suspected when Adalimumab treatment is being considered.
If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Adalimumab, and in accordance with local recommendations. Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Adalimumab in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Patients should be instructed to seek medical advice for symptoms such as persistent cough, wasting/weight loss, low grade fever etc. that occur during or after Adalimumab treatment.
Other opportunistic infections: Adalimumab treatment can result in opportunistic infections including invasive fungal infections in patients which if left untreated may prove fatal.
Adalimumab treatment should be discontinued in patients who show symptoms of fever, malaise, weight loss, sweats, cough, dyspnea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock, and an invasive fungal infection should be suspected. Antifungal therapy should be initiated under extreme care and expertise in patients who show invasive fungal infections.
Hepatitis B reactivation: Patients who are chronic carriers of Hepatitis B virus (i.e., surface antigen positive) can show reactivation of hepatitis B while being treated with TNF-antagonists such as Adalimumab, which in the past have sometimes resulted in fatal outcomes. Therefore, HBV infection test should be performed prior to administration of Adalimumab and an expert in treatment of hepatitis B should be consulted for patients who test positive for hepatitis B virus infection.
Signs and symptoms for active HBV infection should be monitored in carriers of HBV throughout Adalimumab treatment and for several months after termination of therapy. Adalimumab treatment should be discontinued and anti-viral therapy should be initiated if HBV reactivation occurs in a patient.
Neurological events: Rarely, Adalimumab and other TNF-antagonists have been shown to be associated with exacerbation or new onset of central or peripheral nervous system demyelinating disorders such as multiple sclerosis and Guillain-Barré syndrome. Thus, Adalimumab should be prescribed with caution in such cases.
Allergic reactions: Only rare incidents of serious/non-serious allergic reactions such as anaphylaxis have been reported with Adalimumab treatment. Adalimumab treatment should be discontinued if serious allergic reactions such as anaphylaxis, allergic rash, fixed drug reaction, non-specified drug reaction or urticaria are observed in patients.
Immunosuppression: Adalimumab treatment is not reported to be associated with depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils in clinical studies.
Malignancies: Rare instances of malignancies such as lymphoma and leukemia have been seen in patients treated with TNF-antagonists. RA patients with long-standing highly active, inflammatory disease are at a higher risk of experiencing these malignancies.
Malignancies in Adults: Cases of malignancies other than lymphoma that have been observed in patients with RA, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and plaque psoriasis are breast cancer, colon cancer, prostate cancer, lung cancer and melanoma. Malignancies in the lung or head and neck were reported in patients treated with infliximab who had moderate to severe chronic obstructive pulmonary disease (COPD) and were heavy smokers. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Non-melanoma skin cancer: Prior to and during treatment with Adalimumab, patients should be examined for non-melanoma skin cancer especially if they have a history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment.
Lymphoma and Leukemia: The risk of lymphoma development is higher in patients with RA, other chronic inflammatory diseases particularly with highly active disease or chronic exposure to immunosuppressant therapies than general population even when a TNF blocker is not used. Acute and chronic leukemia were also reported with TNF-antagonist in RA and other indications.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤18 years of age), including Adalimumab. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Rare cases of hepatosplenic T-cell lymphoma (HSTCL) have occurred in patients treated with Adalimumab. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Some of these HSTCL with Adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine.
Haematologic reactions: The following haematologic reactions have been reported with TNF-antagonists: pancytopaenia, aplastic anaemia, cytopaenia (e.g. thrombocytopaenia, leucopaenia) and blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor). Medical attention should be sought upon observation of these symptoms and Adalimumab should be discontinued.
Vaccinations: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in adult subjects with RA who were treated with Adalimumab or placebo. Therefore, patients can receive vaccination (except live vaccines) while on Adalimumab treatment.
Congestive heart failure: Increased mortality and worsening congestive heart failure have been reported in patients treated with TNF-antagonists including Adalimumab. Treatment must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Autoimmune processes: Autoantibodies may develop in patients taking Adalimumab with rare instances of symptoms of lupus-like syndrome. Adalimumab treatment should be discontinued in such cases.
Concurrent administration of TNF-antagonists or other biological DMARDs: Serious infections have been seen with concurrent use of Anakinra with Etanercept. Therefore Adalimumab is not recommended to be used with Anakinra. Adalimumab should also not be used with Infliximab, Etanercept, Abatacept, Certolizumab pegol, or Golimumab.
Small bowel obstruction: Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment. Available data suggest that Adalimumab does not worsen or cause strictures.
Surgery: There is little or no safety experience in patients undergoing surgical procedures or arthroplasty during Adalimumab treatment. The long half-life of Adalimumab should be considered prior to planning a surgery and the patient should be monitored for infections.
Effects on Ability to Drive and Use Machines: Administration of Adalimumab may result in vertigo and visual impairment which can influence the ability to drive and use machines.
Use in Elderly: Risk of infection in elderly patients over 65 years of age is higher than those below this age with some having fatal outcomes. Thus, particular attention should be given.
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