CONTRAINDICATIONS / PRECAUTIONS
Infusion-related reactions
Ocrelizumab is associated with a variety of infusion-related reactions, with severities ranging from mild to life-threatening. Ocrelizumab is contraindicated for use in patients with a history of a life-threatening infusion reaction to ocrelizumab. The drug must be administered under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions. While no fatal infusion reactions occurred during clinical trials, 0.3% of patients did experience serious reactions, some requiring hospitalization. The highest incidence of infusion reactions is associated with the first infusion. To reduce the risk of an infusion reaction, pre-medication with methylprednisolone (or an equivalent corticosteroid) and an antihistamine should be used. The addition of an antipyretic may also be considered. Infusion reactions did occur in patients who were pre-medicated during clinical trials. Observe patients for infusion reactions during the infusion and for 1 or more hours following infusion completion. Infusion reactions may occur up to 24 hours after the infusion. Dose adjustments are necessary for patients who experience infusion reactions, and adjustments are dependent on the severity of the reaction. For life-threatening reactions, immediately and permanently stop treatment. For less severe reactions, management may include temporarily stopping the infusion and/or reducing the infusion rate. In all cases, appropriate supportive treatment must be administered.
Hepatitis, herpes infection, infection, progressive multifocal leukoencephalopathy, respiratory infection, viral infection
Ocrelizumab increases a patient's susceptibility to infection due to suppression of the immune system. Patients are at increased risk for serious infection. Delay treatment with ocrelizumab until an active infection resolves. Serious cases of viral infection caused by herpes simplex virus and varicella-zoster virus, including central nervous system infections (encephalitis and meningitis), intraocular infections, and disseminated skin and soft tissue infections, have been reported with ocrelizumab during postmarketing experience. Some infections were life-threatening. A serious herpes infection may occur at any time during treatment. Be alert for the potential for respiratory infection, skin infection, or serious infections of other types. Cases of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain caused by the JC virus (JCV), have been reported in patients treated with ocrelizumab in the postmarketing setting. PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies, and it has been associated with some risk factors (e.g., concomitant immunosuppression, immunocompromised patients). As PML usually leads to death or severe disability, it is of vital importance to withhold ocrelizumab and perform an appropriate diagnostic evaluation at the first sign or symptom of PML. Symptoms of PML are diverse, including progressive weakness on 1 side of the body, clumsiness of limbs, vision disturbances, confusion, or personality alterations from changes in thinking, memory, or orientation. MRI findings of PML may be apparent before clinical signs or symptoms. MRI monitoring for signs that may be consistent with PML may be useful, and any suspicious findings should spark further investigation to allow for an early diagnosis of PML, if present. Discontinue ocrelizumab treatment if PML is confirmed. Hepatitis B reactivation has been reported in patients treated with ocrelizumab during postmarketing experience. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with other anti-CD20 antibodies. Ocrelizumab is contraindicated for use in patients with active hepatitis B infection. Perform HBV screening for all patients prior to treatment, and do not administer ocrelizumab to patients with active HBV confirmed by positive results for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HB) tests. If patients are negative for HBsAg and positive for HB core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult liver disease experts before initiation and during treatment.
Hypogammaglobulinemia, immunosuppression
Perform testing for quantitative serum immunoglobulins before initiating ocrelizumab treatment. Consult immunology experts before initiating treatment with ocrelizumab in patients with low serum immunoglobulins (hypogammaglobulinemia). Monitor quantitative serum immunoglobulin concentrations during treatment and after treatment discontinuation, until B-cell repletion, especially in the setting of recurrent serious infections. Consider ocrelizumab discontinuation in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins. Ocrelizuamb decreased total immunoglobulins with the greatest decline seen in IgM concentrations; however, a decrease in IgG concentrations was associated with an increased rate of serious infections. When initiating ocrelizumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab treatment, consider the potential for increased immunosuppression. Ocrelizumab has not been studied in combination with other multiple sclerosis therapies.
Vaccination
Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab, and administer non-live vaccines at least 2 weeks before initiation whenever possible. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide, and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Do not administer live or live-attenuated vaccines to a newborn or infant born to mothers exposed to ocrelizumab while pregnant before confirming B-cell count recovery as measured by CD19+ B-cells; a newborn or infant may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine.[61838] ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.[43236]
Breast cancer, new primary malignancy
Ocrelizumab may increase the risk of developing a new primary malignancy. During controlled trials, malignancies, including breast cancer, occurred more frequently in patients given ocrelizumab compared to interferon beta-1a or placebo. Follow standard breast cancer screening guidelines. Use caution when treating patients with pre-existing or ongoing malignancies.
Infants, neonates, pregnancy
No adequate and well-controlled studies of ocrelizumab have been conducted during human pregnancy and the ability of the drug to cause fetal harm or affect reproductive capacity is unknown. Human IgG is known to cross the placental barrier; therefore, ocrelizumab may cross the placental barrier and cause fetal B-cell depletion and lymphocytopenia. During animal studies, depletion of B-lymphocytes in lymphoid tissues (spleen and lymph nodes) was observed in the fetuses of pregnant monkeys given ocrelizumab at doses of 2 times to 20 times the recommended human dose of 600 mg (on a mg/kg basis). Increased perinatal mortality was observed in the offspring of pregnant monkeys. The exact cause of death is unknown; however, the 2 neonates affected both had bacterial infections. Other adverse effects observed in the neonate monkeys include renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, severe decreases in circulating B-lymphocytes, and reduced testicular weight. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. Neonates and infants may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to ocrelizumab; information about the registry can be obtained at www.ocrevuspregnancyregistry.com or by calling 1-833-872-4370.[61838]
Contraception requirements, reproductive risk
Ocrelizumab may pose a reproductive risk. Instruct females of childbearing age to avoid becoming pregnant while receiving the drug due to the potential for fetal harm. Discuss contraception requirements with the patient. Instruct patients that if they are pregnant or plan to become pregnant while receiving this drug that they should inform their healthcare provider. Women of childbearing potential should use effective contraception while receiving ocrelizumab therapy and for 6 months after the last infusion.
Breast-feeding
There are no data regarding use of ocrelizumab during breast-feeding and its excretion in human milk is unknown. Human IgG antibodies are excreted in human milk; therefore, the potential for absorption of ocrelizumab and subsequent B-cell depletion in the infant are unknown. Weigh the benefits of breast-feeding along with the mother's clinical need for ocrelizumab and any potential adverse effects on the breastfed infant or from the underlying maternal condition prior to using ocrelizumab. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
DRUG INTERACTIONS
Alemtuzumab: (Major) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as alemtuzumab. Concomitant use of ocrelizumab with alemtuzumab may increase the risk of immunosuppression. Avoid the use of these drugs together.
Anifrolumab: (Major) Coadministration is not recommended. Anifrolumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab. Potential concerns with use of these drugs together include an increased susceptibility to immunosuppression and serious infections, some of which might be fatal.
Anthrax Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Bacillus Calmette-Guerin Vaccine, BCG: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Belimumab: (Major) Avoid use together. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ocrelizumab. Therefore, belimumab use is not recommended in combination with biologic therapies. Potential concerns with use together include an increased susceptibility to immunosuppression and serious infections, some of which might be fatal.
Betamethasone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine.
Cortisone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Daclizumab: (Major) Avoid use of these drugs together. Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as daclizumab. The elimination half-life of daclizumab is approximately 20 days.
Dexamethasone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Dimethyl Fumarate: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as dimethyl fumarate. Concomitant use of ocrelizumab with dimethyl fumarate may increase the risk of immunosuppression. Avoid the use of these drugs together.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Inactivated Poliovirus Vaccine, IPV: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV : (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria Toxoid; Tetanus Toxoid Adsorbed, DT, Td: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria/Tetanus Toxoids; Pertussis Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diphtheria/Tetanus Toxoids; Pertussis Vaccine; Haemophilus influenzae type b Conjugate Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Diroximel Fumarate: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as diroximel fumarate. Concomitant use of ocrelizumab with diroximel fumarate may increase the risk of immunosuppression. Avoid the use of these drugs together.
Glatiramer: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as glatiramer. Concomitant use of ocrelizumab with glatiramer may increase the risk of immunosuppression. Avoid the use of these drugs together.
Haemophilus influenzae type b Conjugate Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Hepatitis A Vaccine, Inactivated: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Hepatitis A Vaccine, Inactivated; Hepatitis B Vaccine, Recombinant: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Hepatitis B Vaccine, Recombinant: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Human Papillomavirus 9-Valent Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Human Papillomavirus Bivalent Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Human Papillomavirus Quadrivalent Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Hydrocortisone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Influenza Virus Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Interferon Beta-1a: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as interferon beta-1a or interferon beta-1b. Concomitant use of ocrelizumab with interferon beta may increase the risk of immunosuppression.
Interferon Beta-1b: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as interferon beta-1a or interferon beta-1b. Concomitant use of ocrelizumab with interferon beta may increase the risk of immunosuppression.
Intranasal Influenza Vaccine: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Japanese Encephalitis Virus Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Live Vaccines: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Meningococcal Conjugate Vaccine (MCV4): (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Meningococcal Group B Vaccine (3 strain): (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Meningococcal Group B Vaccine (4 strain): (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Meningococcal Haemophilus influenzae type b Conjugate Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Methylprednisolone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Mitoxantrone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as mitoxantrone. The median elimination half-life of mitoxantrone is 75 hours (range 23 to 215 hours).
Monomethyl Fumarate: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as dimethyl fumarate. Concomitant use of ocrelizumab with dimethyl fumarate may increase the risk of immunosuppression. Avoid the use of these drugs together.
Natalizumab: (Major) Natalizumab should not be used in combination with ocrelizumab because of the potential for increased risk of progressive multifocal leukoencephalopathy and other serious infections. Ordinarily, multiple sclerosis patients receiving chronic immunomodulatory therapy should not be treated with natalizumab.
Non-Live Vaccines: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Moderate) Concomitant use of ofatumumab with ocrelizumab may increase the risk of immunosuppression. Ofatumumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as ocrelizumab. Consider the duration and mechanism of action of drugs with immunosuppressive effects when switching therapies for multiple sclerosis patients.
Ozanimod: (Moderate) Concomitant use of ozanimod with ocrelizumab may increase the risk of immunosuppression. Ozanimod has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis.
Peginterferon beta-1a: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, such as peginterferon beta-1a. Concomitant use of ocrelizumab with peginterferon beta-1a may increase the risk of immunosuppression.
Pneumococcal Vaccine, Polyvalent: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Poliovirus Vaccine, Inactivated, IPV: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Prednisolone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Prednisone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Rabies Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Rituximab: (Major) Avoid the use of ocrelizumab and rituximab together. Both drugs are monoclonal antibodies directed against CD20-expressing B-cells. There are no data on the safety and efficacy of using these drugs at the same time. The concomitant use of rituximab and ocrelizumab may result in additive immunosuppression and an increased risk of infection. Additionally, additive immunosuppression may occur if ocrelizumab is administered before or after rituximab therapy. When switching from drugs with prolonged immune effects, such as rituximab, consider the duration and mode of action of rituximab when initiating ocrelizumab. Monitor patients closely for signs or symptoms of infection.
Rituximab; Hyaluronidase: (Major) Avoid the use of ocrelizumab and rituximab together. Both drugs are monoclonal antibodies directed against CD20-expressing B-cells. There are no data on the safety and efficacy of using these drugs at the same time. The concomitant use of rituximab and ocrelizumab may result in additive immunosuppression and an increased risk of infection. Additionally, additive immunosuppression may occur if ocrelizumab is administered before or after rituximab therapy. When switching from drugs with prolonged immune effects, such as rituximab, consider the duration and mode of action of rituximab when initiating ocrelizumab. Monitor patients closely for signs or symptoms of infection.
Rotavirus Vaccine: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Rubella Virus Vaccine Live: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.
Smallpox and Monkeypox Vaccine, Live, Nonreplicating: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Smallpox Vaccine, Vaccinia Vaccine: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Teriflunomide: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects such as teriflunomide. The median half-life of teriflunomide is 18 to 19 days, and teriflunomide may remain in plasma for up to 2 years after discontinuation.
Tetanus Toxoid: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Tick-Borne Encephalitis Vaccine: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Triamcinolone: (Moderate) Ocrelizumab has not been studied in combination with other immunosuppressive or immune modulating therapies used for the treatment of multiple sclerosis, including immunosuppressant doses of corticosteroids. Concomitant use of ocrelizumab with any of these therapies may increase the risk of immunosuppression. Monitor patients carefully for signs and symptoms of infection.
Typhoid Vaccine: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Varicella-Zoster Virus Vaccine, Live: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Yellow Fever Vaccine, Live: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.