Dosing & Uses
Dosage Forms & Strengths
solution for injection
- 30mg/mL (10mL single-dose vial)
Multiple Sclerosis
Indicated for adults with relapsing or primary progressive forms of multiple sclerosis
Initial 2 doses: 300 mg IV once; repeat dose 2 wk later
Subsequent doses: 600 mg IV every 6 months
Also see Administration
Dosage Modifications
Infusion reactions
- Dose modifications in response to infusion reactions depends on the severity
-
Mild-to-moderate
- Reduce infusion rate to half the rate at the onset of the infusion reaction and maintain the reduced rate for at least 30 min; if tolerated, may increase the rate (see Administration)
-
Severe
- Immediately interrupt infusion and administer appropriate supportive treatment, as necessary
- Restart infusion once symptoms have resolved
- When restarting, begin at half of the infusion rate at the time of onset of the infusion reaction; if tolerated, may increase the rate
-
Life-threatening
- Immediately stop and permanently discontinue ocrelizumab if there are signs of a life-threatening or disabling infusion reaction
Dosing Considerations
HBV screening
- Perform Hepatitis B virus (HBV) screening before initiating ocrelizumab
- Contraindicated with active HBV infection confirmed by positive results for HBsAg and anti-HBV tests
- For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment
Vaccinations
- Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion
- Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation for non-live vaccines
Serum immunoglobulins
- Before initiating treatment, test for quantitative serum immunoglobulins
- For patients with low serum immunoglobulins, consult immunology experts before initiating treatment
Safety and efficacy not established
See Cautions for information regarding vaccinating infants born to mothers taking ocrelizumab
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (43)
- adenovirus types 4 and 7 live, oral
ocrelizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- axicabtagene ciloleucel
ocrelizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib and ocrelizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- BCG intravesical live
ocrelizumab decreases effects of BCG intravesical live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of ocrelizumab with BCG intravesical because immunosuppressive effects may decrease the efficacy of BCG intravesical.
- brexucabtagene autoleucel
ocrelizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
ocrelizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
ocrelizumab decreases effects of hepatitis A vaccine inactivated by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- hepatitis a/b vaccine
ocrelizumab decreases effects of hepatitis a/b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- hepatitis b vaccine
ocrelizumab decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- HIV vaccine
ocrelizumab decreases effects of HIV vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- human papillomavirus vaccine, nonavalent
ocrelizumab decreases effects of human papillomavirus vaccine, nonavalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- human papillomavirus vaccine, quadrivalent
ocrelizumab decreases effects of human papillomavirus vaccine, quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- idecabtagene vicleucel
ocrelizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ifosfamide
ifosfamide, ocrelizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.
- influenza A (H5N1) vaccine
ocrelizumab decreases effects of influenza A (H5N1) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine (H5N1), adjuvanted
ocrelizumab decreases effects of influenza virus vaccine (H5N1), adjuvanted by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine quadrivalent
ocrelizumab decreases effects of influenza virus vaccine quadrivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine quadrivalent, adjuvanted
ocrelizumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine quadrivalent, cell-cultured
ocrelizumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine quadrivalent, intranasal
ocrelizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine trivalent
ocrelizumab decreases effects of influenza virus vaccine trivalent by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- influenza virus vaccine trivalent, adjuvanted
ocrelizumab decreases effects of influenza virus vaccine trivalent, adjuvanted by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- Japanese encephalitis virus vaccine
ocrelizumab decreases effects of Japanese encephalitis virus vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- lisocabtagene maraleucel
ocrelizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lomustine
lomustine and ocrelizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.
- measles (rubeola) vaccine
ocrelizumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- measles mumps and rubella vaccine, live
ocrelizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- measles, mumps, rubella and varicella vaccine, live
ocrelizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- mechlorethamine
mechlorethamine, ocrelizumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- melphalan
melphalan, ocrelizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.
- natalizumab
ocrelizumab increases toxicity of natalizumab by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- oxaliplatin
oxaliplatin and ocrelizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.
- procarbazine
procarbazine, ocrelizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.
- rabies vaccine
ocrelizumab decreases effects of rabies vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- rabies vaccine chick embryo cell derived
ocrelizumab decreases effects of rabies vaccine chick embryo cell derived by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- rotavirus oral vaccine, live
ocrelizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- rubella vaccine
ocrelizumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- smallpox (vaccinia) vaccine, live
ocrelizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- tisagenlecleucel
ocrelizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- upadacitinib
ocrelizumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- varicella virus vaccine live
ocrelizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- yellow fever vaccine
ocrelizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
- zoster vaccine live
ocrelizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.
Monitor Closely (44)
- abatacept
abatacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppessants is expected to increase the risk of immunosuppression.
- anakinra
anakinra and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- antithymocyte globulin equine
antithymocyte globulin equine and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- auranofin
auranofin and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- azathioprine
azathioprine and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppessants is expected to increase the risk of immunosuppression.
- basiliximab
basiliximab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- belatacept
belatacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- betamethasone
betamethasone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- certolizumab pegol
certolizumab pegol and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- corticotropin
corticotropin and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- cortisone
cortisone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- cyclophosphamide
cyclophosphamide and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- cyclosporine
cyclosporine and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppessants is expected to increase the risk of immunosuppression.
- deflazacort
deflazacort and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- dexamethasone
dexamethasone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of ocrelizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- fingolimod
fingolimod and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- fludrocortisone
fludrocortisone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- glatiramer
glatiramer and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- hydrocortisone
hydrocortisone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- infliximab
infliximab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- isavuconazonium sulfate
ocrelizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- leflunomide
ocrelizumab increases toxicity of leflunomide by unknown mechanism. Modify Therapy/Monitor Closely. Coadminstration of leflunomide and ocrelizumab may cause increased risk of infections, pancytopenia, agranulocytosis and thrombocytopenia.
- mercaptopurine
mercaptopurine and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- methotrexate
methotrexate and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppessants is expected to increase the risk of immunosuppression.
- methylprednisolone
methylprednisolone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- muromonab CD3
muromonab CD3 and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- mycophenolate
mycophenolate and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- ofatumumab SC
ofatumumab SC, ocrelizumab. 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.
- poliovirus vaccine inactivated
ocrelizumab decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. 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. .
- prednisolone
prednisolone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- prednisone
prednisone and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- rilonacept
rilonacept and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- siltuximab
siltuximab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- sirolimus
sirolimus and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- tacrolimus
tacrolimus and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- tocilizumab
tocilizumab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- tofacitinib
tofacitinib and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.
- trastuzumab
trastuzumab, ocrelizumab. 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 deruxtecan
trastuzumab deruxtecan, ocrelizumab. 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. .
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.
- ublituximab
ublituximab and ocrelizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- zoster vaccine recombinant
ocrelizumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
>10%
Upper respiratory tract infections (40-49%)
Infusion-related reactions (34-40%)
Skin infections (14%)
Decreased neutrophil counts (13%)
1-10%
Lower respiratory tract infections (8-10%)
Depression (8%)
Cough (7%)
Back pain (6%)
Herpes virus-associated infections (5-6%)
Diarrhea (6%)
Peripheral edema (6%)
Pain in extremity (5%)
Postmarketing Reports
Gastrointestinal disorders: Immune-mediated colitis
Infections and infestations: Serious herpes infections and progressive multifocal leukoencephalopathy
Warnings
Contraindications
Active HBV infection
History of life-threatening infusion reaction to ocrelizumab
Cautions
Infusion reactions (eg, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia) may occur; monitor during treatment and at least 1 hr after treatment; inform patients that infusion reactions can occur up to 24 hours after infusion
B-cell depleting therapy decreases immunoglobulin levels, which is associated with increased rates of serious infections; monitor levels of quantitative serum immunoglobulins during treatment and after discontinuing until B-cell repletion; consider discontinuing in patients with serious opportunistic or recurrent serious infection, and if prolonged hypogammaglobulinemia requires treatment with IVIG
Increased risk of malignancy, including breast cancer exists; patients should follow standard breast cancer screening guidelines
Infections
- In clinical trials, a higher proportion of ocrelizumab-treated patients experienced infections (eg, respiratory tract) compared with interferon-beta1a or placebo
- HBV reactivation: Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with other anti-CD20 antibodies
- Perform HBV screening in all patients before initiation of treatment; do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests; for patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment
-
Herpes simplex virus
- Serious cases of infections 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, reported in the postmarketing setting
- Serious herpes virus infections may occur at any time during treatment; some cases life-threatening
- If serious herpes infections occur, discontinue therapy or withhold until infection has resolved; appropriate treatment should be administered
-
Progressive multifocal leukoencephalopathy (PML)
- PML is an opportunistic viral infection of the brain caused by the John Cunningham (JC) virus
- PML observed in patients treated with other anti-CD20 antibodies and other multiple sclerosis therapies and has also been associated with some risk factors (eg, immunocompromised patients, polytherapy with immunosuppressants)
- PML has occurred in ocrelizumab-treated patients who had not been treated previously with natalizumab (which has a known association with PML), were not taking any immunosuppressive or immunomodulatory medications associated with the risk of PML prior to or concomitantly with this drug, and did not have any known ongoing systemic medical conditions resulting in compromised immune system function
- Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes
- MRI findings may be apparent before clinical signs or symptoms; cases of PML, diagnosed based on MRI findings and detection of JCV DNA in the cerebrospinal fluid in absence of clinical signs or symptoms specific to PML, reported in patients treated with other MS medications associated with PML
- Monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present; following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis
- Not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients
- At the first sign or symptom suggestive of PML, withhold drug and perform an appropriate diagnostic evaluation; if PML confirmed, treatment should be discontinued
Immune-mediated colitis
- Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, reported in patients receiving this medication in postmarketing setting; some cases of colitis were serious, requiring hospitalization, with a few patients requiring surgical intervention; systemic corticosteroids were required in many of these patients
- The time from treatment initiation to onset of symptoms in these cases ranged from a few weeks to years; monitor patients for immune-mediated colitis during treatment, and evaluate promptly if signs and symptoms that may indicate immune-mediated colitis, such as new or persistent diarrhea or other gastrointestinal signs and symptoms, occur
Drug interaction overview
- Coadministration with immunosuppressants may increase risk for immunosuppressive effects
-
Vaccinations
- May interfere with efficacy of nonlive vaccines (live or live-attenuated vaccines not studied)
- Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation for nonlive vaccines
-
Vaccination of infants of mothers exposed to ocrelizumab during pregnancy
- Do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts (measured by CD19+ B-cells)
- Depletion of B-cells in these infants may increase risks from live or live-attenuated vaccines
- Nonlive vaccines may be administered as indicated, prior to recovery from B-cell depletion; consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether a protective immune response was mounted
Pregnancy
Pregnancy
No data available to assess risk in pregnant women
Drug is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier
However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy
B-cell levels in infants following maternal exposure to drug have not been studied in clinical trials; the potential duration of B-cell depletion in such infants, and impact of B-cell depletion on vaccine safety and effectiveness, is unknown
See Cautions for information regarding vaccinating infants born to mothers taking ocrelizumab
A pregnancy exposure registry monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to OCREVUS during pregnancy; physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com
Contraception
- Women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized monoclonal antibody designed to selectively target CD20, a cell surface antigen present on pre-B and mature B lymphocytes
Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis
Absorption
Peak plasma concentration: 212 mcg/mL (600 mg); 141 mcg/mL (300 mg)
AUC: 3510 mcg·mL/day
Distribution
Vd
- Central volume distribution: 2.78 L
- Peripheral volume compartment: 2.68 L/day
- Intercompartment: 0.29 L/day
Elimination
Terminal half-life: 26 days
Clearance: 0.17 L/day
Initial time-dependent clearance: 0.05 L/day (declines with a half-life of 33 wk)
Administration
IV Compatibilities
0.9% NaCl
Polyvinyl chloride (PVC) bags and IV sets
Polyolefin (PO) bags and IV sets
IV Preparation
Visually inspect vial for particulate matter and discoloration; do not use if solution is discolored or contains discrete foreign particulate matter
Do not shake vial
Withdraw dose and further dilute into 0.9% NaCl infusion bag to final concentration of ~1.2 mg/mL (ie, 300 mg in 250-mL bag, 600 mg in 500-mL bag)
Product contains no preservative and is intended for single use only
Assure IV solution is at room temperature before initiating infusion
Use the prepared infusion solution immediately or refrigerate
IV Administration
Administer diluted IV solution through a dedicated line using an infusion set with a 0.2 or 0.22 micron inline filter
Observe for infusion reactions during infusion and for at least 1 hr after completion; inform patients that infusion reactions can occur up to 24 hr afterwards
Infection assessment
- Determine whether there is an active infection before each infusion
- In case of active infection, delay infusion until infection resolves
Premedication
- Premedicate to reduce frequency and severity of infusion reactions
- Methylprednisolone 100 mg IV (or an equivalent corticosteroid): Premedicate ~30 min before each infusion
- Antihistamine (eg, diphenhydramine): Premedicate ~30-60 min before each infusion
- Antipyretic (eg, acetaminophen): Consider adding to the above medications
Infusion rate (initial 300-mg dose)
-
First 2 IV infusions
- Start IV at 30 mL/hr
- Increase by 30 mL/hr q30min
- Maximum rate: 180 mL/hr
- Infusion duration: ≥2.5 hr
Infusion rate (subsequent 600-mg doses)
-
Option 1
- Start IV at 40 mL/hr
- Increase by 40 mL/hr q30min
- Maximum rate: 200 mL/hr
- Infusion duration: ≥3.5 hr
-
Option 2
- May use this option if no prior serious infusion reaction with any previous ocrelizumab infusion
- Start IV at 100 mL/hr for first 15 minutes
- Increase to 200 mL/hr for next 15 minutes
- Increase to 250 mL/hr for next 30 minutes
- Increase to 300 mL/hr for remaining 60 minutes
- Infusion duration: ≥2 hr
Delayed or missed dose
- Administer as soon as possible; do not wait until next scheduled dose
- Reset dose schedule to administer next sequential dose 6 months after missed dose is administered
- Doses must be separated by at least 5 months
Storage
Unopened vials
- Refrigerate at 2-8°C (36-46°F) in the outer carton to protect from light
- Do not freeze
- Do not shake
Diluted solution
- Refrigerated at 2-8°C (36-46°F): Up to 24 hr
- Room temperature up to 25°C (77°F): 8 hr (including infusion time)
- In the event an IV infusion cannot be completed the same day, discard the remaining solution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ocrevus intravenous - | 30 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
