febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .zoster vaccine recombinantbelimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.Minor (0)adenovirus types 4 and 7 live, oralSerious - Use Alternative (1)belimumab decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.anthrax vaccine adsorbedContraindicated (1)belimumab decreases effects of anthrax vaccine adsorbed by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.BCG vaccine liveContraindicated (1)belimumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.belataceptMonitor Closely (1)belatacept and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.denosumabMonitor Closely (1)belimumab, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.diphtheria & tetanus toxoidsContraindicated (1)belimumab decreases effects of diphtheria & tetanus toxoids by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.diphtheria & tetanus toxoids/ acellular pertussis vaccineContraindicated (1)belimumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccineContraindicated (1)belimumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.fingolimodMonitor Closely (1)belimumab increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .hepatitis A vaccine inactivatedContraindicated (1)belimumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.hepatitis a/b vaccineContraindicated (1)belimumab decreases effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.hepatitis b vaccineContraindicated (1)belimumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.human papillomavirus vaccine, nonavalentSerious - Use Alternative (1)belimumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.human papillomavirus vaccine, quadrivalentSerious - Use Alternative (1)belimumab decreases effects of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.hydroxyureaMonitor Closely (1)hydroxyurea, belimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of infection.ifosfamideMonitor Closely (1)ifosfamide, belimumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.influenza A (H5N1) vaccineContraindicated (1)belimumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.influenza virus vaccine (H5N1), adjuvantedContraindicated (1)belimumab decreases effects of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.influenza virus vaccine quadrivalent, adjuvantedSerious - Use Alternative (1)belimumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.influenza virus vaccine quadrivalent, cell-culturedContraindicated (1)belimumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.influenza virus vaccine quadrivalent, intranasalContraindicated (1)belimumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.influenza virus vaccine quadrivalent, recombinantMonitor Closely (1)belimumab decreases effects of influenza virus vaccine quadrivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.influenza virus vaccine trivalent, adjuvantedSerious - Use Alternative (1)belimumab decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.influenza virus vaccine trivalent, recombinantMonitor Closely (1)belimumab decreases effects of influenza virus vaccine trivalent, recombinant by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.Japanese encephalitis virus vaccineContraindicated (1)belimumab decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.lomustineMonitor Closely (1)lomustine and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.measles (rubeola) vaccineContraindicated (1)belimumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.measles mumps and rubella vaccine, liveContraindicated (1)belimumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.measles, mumps, rubella and varicella vaccine, liveContraindicated (1)belimumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.meningococcal A C Y and W-135 polysaccharide vaccine combinedContraindicated (1)belimumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.meningococcal group B vaccineMonitor Closely (1)belimumab decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.ofatumumab SCMonitor Closely (1)ofatumumab SC, belimumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.olaparibMonitor Closely (1)belimumab and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity. oxaliplatinMonitor Closely (1)oxaliplatin and belimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.pneumococcal vaccine 13-valentContraindicated (1)belimumab decreases effects of pneumococcal vaccine 13-valent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.pneumococcal vaccine heptavalentContraindicated (1)belimumab decreases effects of pneumococcal vaccine heptavalent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.pneumococcal vaccine polyvalentContraindicated (1)belimumab decreases effects of pneumococcal vaccine polyvalent by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.poliovirus vaccine inactivatedMonitor Closely (1)belimumab decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .rabies vaccineContraindicated (1)belimumab decreases effects of rabies vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.rabies vaccine chick embryo cell derivedContraindicated (1)belimumab decreases effects of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.rotavirus oral vaccine, liveContraindicated (1)belimumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.rubella vaccineContraindicated (1)belimumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.sipuleucel-TMonitor Closely (1)belimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.smallpox (vaccinia) vaccine, liveContraindicated (1)belimumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.tetanus toxoid adsorbed or fluidContraindicated (1)belimumab decreases effects of tetanus toxoid adsorbed or fluid by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.trastuzumabMonitor Closely (1)trastuzumab, belimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .trastuzumab deruxtecanMonitor Closely (1)trastuzumab deruxtecan, belimumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .travelers diarrhea and cholera vaccine inactivatedContraindicated (1)belimumab decreases effects of travelers diarrhea and cholera vaccine inactivated by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.tuberculin purified protein derivativeContraindicated (1)belimumab decreases effects of tuberculin purified protein derivative by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.typhoid polysaccharide vaccineContraindicated (1)belimumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.typhoid vaccine liveContraindicated (1)belimumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.upadacitinibContraindicated (1)belimumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.varicella virus vaccine liveContraindicated (1)belimumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.yellow fever vaccineContraindicated (1)belimumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.zoster vaccine liveContraindicated (1)belimumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.zoster vaccine recombinantMonitor Closely (1)belimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant. Listed adverse reactions of belimumab PLUS standard therapy >10% SC Nausea (15%) Diarrhea (12%) 1-10% IV Pyrexia (10%) Nasopharyngitis (9%) Bronchitis (9%) Insomnia (7%) Pain in extremity (6%) Depression (5%) Migraine (5%) Pharyngitis (5%) Cystitis (4%) Leukopenia (4%) Gastroenteritis viral (3%) SC Serious infections (4.1%) Depression-related events (2.7%) Suicidal ideation (1.3%) <1% SC Fatal infections (0.5%) Serious psychiatric events (0.2%) Postmarketing Reports Fatal anaphylaxis Contraindications Anaphylaxis to belimumab Cautions Serious and sometimes fatal infections reported in patients receiving immunosuppressive agents; consider risk and benefit before initiating treatment in patients with severe or chronic infections; consider interrupting therapy in patients who develop a new infection during therapy and monitor patients closely Impact on development of malignancies is unknown; as with other immunomodulating agents, mechanism of action of belimumab could increase the risk for developing malignancies; consider individual benefit-risk in patients with known risk factors for development or reoccurrence of malignancy prior to prescribing this medication; in patients who develop malignancies, consider risk and benefit of continued treatment Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, reported in patients with SLE receiving immunosuppressants; risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function; consider diagnosis of PML in any patient presenting with new-onset or deteriorating neurological signs and symptoms and consult with a neurologist or other appropriate specialist as clinically indicated; in patients with confirmed PML, consider stopping therapy Hypersensitivity reactions Acute hypersensitivity reactions, including anaphylaxis and death, reported; events