Patients taking immunomodulatory drugs for nonmalignant conditions
Overview
This section covers assessing the need for and duration of antimicrobial prophylaxis in patients taking the following immunomodulatory drugs for a nonmalignant condition:
To assess the need for antimicrobial prophylaxis in patients taking immunomodulatory drugs for malignancy, see:
- Patients with haematological malignancies
- Patients treated with chemotherapy for solid organ malignancies.
Novel immune-modulatory monoclonal antibodies and small-molecule inhibitors (eg natalizumab, eculizumab) cause specific immune deficits—understanding the mechanism of immunomodulation is important to predict and prevent subsequent infection. Experience with novel immune-modulatory monoclonal antibodies and small-molecule inhibitors is rapidly evolving. Seek expert advice for the latest information on infection risks with these drugs.
Patients taking cyclophosphamide for a nonmalignant condition
Patients taking cyclophosphamide (orally or intravenously) for a nonmalignant condition are at increased risk of infection. For antimicrobial prophylaxis recommendations, see Antimicrobial prophylaxis for patients taking cyclophosphamide for a nonmalignant condition .
Antimicrobial prophylaxis reduces the risk of infection; however, infection can occur despite prophylaxis. Adherence to antimicrobial prophylaxis increases efficacy. Nonpharmacological preventive measures (including infection control, diet and lifestyle strategies) also reduce the risk of infection—see the guidelines listed in Further reading.
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Pneumocystis jirovecii pneumonia (PJP) |
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PJP prophylaxis is indicated for all patients. For antimicrobial regimens, see here. Duration of PJP prophylaxis: The optimal duration of PJP prophylaxis is uncertain. Assess the patient’s level of immune compromise and risk of infection before stopping PJP prophylaxis. Review the benefit of ongoing prophylaxis regularly. Continue PJP prophylaxis for the duration of treatment with cyclophosphamide. After stopping cyclophosphamide, continue PJP prophylaxis for 6 weeks. For patients with significant lymphopenia, continue prophylaxis until the lymphocyte count has recovered for 3 to 6 months. A longer duration of prophylaxis may be needed if the patient is taking other immunosuppressive drugs—seek expert advice. |
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Other |
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Hepatitis B virus and tuberculosis reactivation can occur—some patients require antimicrobial treatment. See Hepatitis B virus prophylaxis and Prevention of tuberculosis. The risk of Listeria monocytogenes meningitis is increased. Consult local protocols and consider nonpharmacological dietary and food safety measures to prevent L. monocytogenes infection [NB1]. Patients with past or present risk of melioidosis ( Burkholderia pseudomallei infection) or Strongyloides stercoralis infection may require antimicrobial prophylaxis. See Burkholderia pseudomallei prophylaxis and Strongyloides stercoralis prophylaxis. If the patient has recurrent oral mucocutaneous or genital herpes simplex virus (HSV) infection, consider suppressive therapy. See Recurrent oral mucocutaneous herpes and Suppressive therapy for genital herpes. |
Note: NB1: For dietary and food safety measures to prevent L. monocytogenes infection, see the Food Standards Australia New Zealand website.
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Patients taking tumour necrosis factor inhibitors for a nonmalignant condition
Patients taking a tumour necrosis factor inhibitor (eg adalimumab, certolizumab, etanercept, golimumab, infliximab) for a nonmalignant condition are at increased risk of infection. For antimicrobial prophylaxis recommendations, see Antimicrobial prophylaxis for patients taking tumour necrosis factor inhibitors for a nonmalignant condition.
Antimicrobial prophylaxis reduces the risk of infection; however, infection can occur despite prophylaxis. Adherence to antimicrobial prophylaxis increases efficacy. Nonpharmacological preventive measures (including infection control, diet and lifestyle strategies) also reduce the risk of infection—see the guidelines listed in Further reading.
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Pneumocystis jirovecii pneumonia (PJP) |
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PJP prophylaxis is indicated for patients with risk factors for PJP; these include:
For antimicrobial regimens, see here. Duration of PJP prophylaxis: The optimal duration of PJP prophylaxis is uncertain. Assess the patient’s level of immune compromise and risk of infection before stopping PJP prophylaxis. Review the benefit of ongoing prophylaxis regularly. Continue PJP prophylaxis for the duration of treatment with the tumour necrosis factor inhibitor. After stopping the tumour necrosis factor inhibitor, continue PJP prophylaxis for 6 weeks. For patients with significant lymphopenia, continue prophylaxis until the lymphocyte count has recovered for 3 to 6 months. |
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Other |
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Risk of tuberculosis reactivation is high, so treatment of latent tuberculosis infection is almost always indicated. See Prevention of tuberculosis. Hepatitis B virus reactivation can occur—some patients require antiviral treatment. See Hepatitis B virus prophylaxis. The risk of Listeria monocytogenes meningitis is increased. Consult local protocols and consider dietary and food safety measures to prevent L. monocytogenes infection [NB1]. Patients with past or present risk of melioidosis ( Burkholderia pseudomallei infection) or Strongyloides stercoralis infection may require antimicrobial prophylaxis. See Burkholderia pseudomallei prophylaxis and Strongyloides stercoralis prophylaxis. If the patient has recurrent oral mucocutaneous or genital herpes simplex virus (HSV) infection, consider suppressive therapy. See Recurrent oral mucocutaneous herpes and Suppressive therapy for genital herpes. |
Note: NB1: For dietary and food safety measures to prevent L. monocytogenes infection, see the Food Standards Australia New Zealand website.
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Patients taking rituximab for a nonmalignant condition
Patients taking rituximab for a nonmalignant condition are at increased risk of infection. For antimicrobial prophylaxis recommendations, see Antimicrobial prophylaxis for patients taking rituximab for a nonmalignant condition.
Antimicrobial prophylaxis reduces the risk of infection; however, infection can occur despite prophylaxis. Adherence to antimicrobial prophylaxis increases efficacy. Nonpharmacological preventive measures (including infection control, diet and lifestyle strategies) also reduce the risk of infection—see the guidelines listed in Further reading.
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Pneumocystis jirovecii pneumonia (PJP) |
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PJP prophylaxis is indicated for patients with risk factors for PJP; these include:
Patients treated with rituximab monotherapy (ie without other immunosuppressive drugs) are at low risk of PJP; there is limited evidence to support giving PJP prophylaxis to these patients. For antimicrobial regimens, see here. Duration of PJP prophylaxis: The optimal duration of PJP prophylaxis is uncertain. Assess the patient’s level of immune compromise and risk of infection before stopping PJP prophylaxis. Review the benefit of ongoing prophylaxis regularly. Continue PJP prophylaxis for the duration of treatment with rituximab, and for at least 12 months after stopping rituximab or until the lymphocyte count has recovered for 3 to 6 months, whichever is later. |
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Other |
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Hepatitis B virus reactivation can occur, including in patients who are hepatitis B surface antigen (HBsAg) negative but who have antibodies to hepatitis B core antigen (anti-HBc). See Hepatitis B virus prophylaxis. Tuberculosis reactivation can occur—some patients require antimicrobial treatment. See Prevention of tuberculosis. The risk of Listeria monocytogenes meningitis is increased. Consult local protocols and consider dietary and food safety measures to prevent L. monocytogenes infection [NB1]. Patients with past or present risk of melioidosis ( Burkholderia pseudomallei infection) or Strongyloides stercoralis infection may require antimicrobial prophylaxis. See Burkholderia pseudomallei prophylaxis and Strongyloides stercoralis prophylaxis. If the patient has recurrent oral mucocutaneous or genital herpes simplex virus (HSV) infection, consider suppressive therapy. See Recurrent oral mucocutaneous herpes and Suppressive therapy for genital herpes. |
Note: NB1: For dietary and food safety measures to prevent L. monocytogenes infection, see the Food Standards Australia New Zealand website.
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Patients taking alemtuzumab for multiple sclerosis
Patients taking alemtuzumab for relapsing-remitting multiple sclerosis are at increased risk of infection. For antimicrobial prophylaxis recommendations, see Antimicrobial prophylaxis for patients taking alemtuzumab for multiple sclerosis.
Antimicrobial prophylaxis reduces the risk of infection; however, infection can occur despite prophylaxis. Adherence to antimicrobial prophylaxis increases efficacy. Nonpharmacological preventive measures (including infection control, diet and lifestyle strategies) also reduce the risk of infection—see the guidelines listed in Further reading.
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Pneumocystis jirovecii pneumonia (PJP) |
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The risk of PJP is increased. Some centres recommend routine antimicrobial prophylaxis—seek expert advice or consult local protocols. For antimicrobial regimens, see here. Duration of PJP prophylaxis: The optimal duration of PJP prophylaxis is uncertain. Assess the patient’s level of immune compromise and risk of infection before stopping PJP prophylaxis. Review the benefit of ongoing prophylaxis regularly. Continue PJP prophylaxis for the duration of treatment with alemtuzumab, and for at least 2 months after stopping alemtuzumab or until the lymphocyte count has recovered for 3 to 6 months, whichever is later. |
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Herpes simplex virus (HSV) and varicella-zoster virus (VZV) |
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Antiviral prophylaxis for HSV and VZV is indicated for all patients. For antiviral regimens, see here. Duration of antiviral prophylaxis: Continue antiviral prophylaxis for the duration of treatment with alemtuzumab, and for 1 month after stopping alemtuzumab. If the patient has significant lymphopenia when stopping alemtuzumab, continue antiviral prophylaxis for a further 3 to 6 months. |
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Other |
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The risk of Listeria monocytogenes meningitis is increased. Consult local protocols and consider dietary and food safety measures to prevent L. monocytogenes infection [NB1]. Tuberculosis reactivation can occur—some patients require antimicrobial treatment. See Prevention of tuberculosis. The risk of hepatitis B virus reactivation is significant when alemtuzumab is used to treat haematological malignancy, but data to guide risk assessment when alemtuzumab is used for multiple sclerosis are lacking—seek expert advice and see Hepatitis B virus prophylaxis. The risk of cytomegalovirus infection may be increased—consult local protocols or seek expert advice. Patients with past or present risk of melioidosis (Burkholderia pseudomallei infection) or Strongyloides stercoralis infection may require antimicrobial prophylaxis. See Burkholderia pseudomallei prophylaxis and Strongyloides stercoralis prophylaxis. |
Note: NB1: For dietary and food safety measures to prevent L. monocytogenes infection, see the Food Standards Australia New Zealand website.
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Patients taking natalizumab for multiple sclerosis
Natalizumab inhibits vascular endothelial adhesion of lymphocytes and monocytes. Patients taking natalizumab for relapsing-remitting multiple sclerosis are at increased risk of progressive multifocal leukoencephalopathy (PML) caused by reactivation of the John Cunningham virus (JCV); see Progressive multifocal leukoencephalopathy (John Cunningham virus).
Other opportunistic infections (eg herpes simplex virus infection, reactivation of tuberculosis) are rarely associated with natalizumab therapy; however, evidence to recommend antimicrobial prophylaxis is lacking.
Patients taking eculizumab for a nonmalignant condition
Eculizumab blocks the formation of the membrane attack complex. Patients treated with eculizumab for a nonmalignant condition (eg paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome) are at an increased risk of invasive meningococcal disease, even if immunised; see Neisseria meningitidis prophylaxis in adults treated with eculizumab.
Antimicrobial prophylaxis reduces the risk of infection; however, infection can occur despite prophylaxis. Adherence to antimicrobial prophylaxis increases efficacy.
Rarely, cases of other opportunistic infections, including Streptococcus pneumoniae, Haemophilus influenzae type B and invasive mould infections have occurred in patients taking eculizumab. However, evidence to recommend additional antimicrobial prophylaxis for these pathogens is lacking.