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Ocrelizumab

Class
Biologic agents
Subclass
Anti-CD20 monoclonal antibodies
Substance name
Ocrelizumab
Brand names
Ocrevus®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Multiple sclerosis • Relapsing forms
•
Start at: 300 mg IV q2 weeks, administered over ≥ 2.5 hours, for 2 doses
•
Maintenance: 600 mg IV q6 months, administered over ≥ 3.5 hours, or ≥ 2 hours if no prior serious infusion reaction occured
Multiple sclerosis • Primary progressive
•
Start at: 300 mg IV q2 weeks, administered over ≥ 2.5 hours, for 2 doses
•
Maintenance: 600 mg IV q6 months, administered over ≥ 3.5 hours, or ≥ 2 hours if no prior serious infusion reaction occured
Indications for use
Labeled indications
Adults
•
Treatment of multiple sclerosis (primary progressive)
•
Treatment of multiple sclerosis (relapsing forms)
Safety risks
Contraindications
Hypersensitivity to ocrelizumab or its components
Active HBV infection
•
Obtain HBV screening in all patients before initiating ocrelizumab.
History of life-threatening infusion reaction to ocrelizumab
Use of live or live-attenuated vaccines
•
Do not use live or live-attenuated vaccines during treatment and until B-cell repletion. Complete all vaccinations at least 4 weeks before initiating ocrelizumab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks for non-live vaccines.
Warnings and precautions
Decreased serum immunoglobulins
•
Maintain a high level of suspicion, as B-cell depleting therapy, including ocrelizumab, is associated with decreased serum IgG levels and an increased risk of serious infections. Obtain quantitative testing of serum immunoglobulins before initiating ocrelizumab. Monitor serum immunoglobulin levels during and after discontinuation of treatment until B-cell repletion, particularly in the setting of recurrent serious infections. Consider discontinuing treatment in patients developing serious opportunistic or recurrent serious infections, or prolonged hypogammaglobulinemia requiring IVIGs.
Immune-mediated colitis
•
Maintain a high level of suspicion, as ocrelizumab has been associated with an increased risk of immune-mediated colitis. Monitor for symptoms of immune-mediated colitis, such as new or persistent diarrhea or other gastrointestinal signs.
Immunosuppression
•
Use caution in patients switching from or initiating ocrelizumab after other immunosuppressive therapy.
Infections
•
Maintain a high level of suspicion, as an increased risk of serious, including life-threatening or fatal, bacterial, viral, parasitic, and fungal infections has been associated with ocrelizumab. Delay ocrelizumab administration in patients with an active infection until it has resolved.
Infusion-related reactions
•
Maintain a high level of suspicion, as infusion-related reactions can occur, including pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, fever, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. Administer premedication with methylprednisolone 100 mg (or an equivalent corticosteroid) and an antihistamine at least 30 minutes before each administration of ocrelizumab to reduce the risk of infusion reactions. Consider adding an antipyretic, such as acetaminophen. Monitor patients during infusion and for at least 1 hour afterward. Reduce the infusion rate by half and maintain for at least 30 minutes for mild-to-moderate infusion reactions. Increase the rate gradually if tolerated. Stop the infusion immediately and provide supportive treatment for severe infusion reactions. Restart only after symptoms resolve, beginning at half the previous rate. Increase the rate gradually if tolerated.
Malignancy
•
Maintain a high level of suspicion, as ocrelizumab has been associated with an increased risk of malignancy, including breast cancer.
Progressive multifocal leukoencephalopathy
•
Maintain a high level of suspicion, as ocrelizumab has been associated with an increased risk of progressive multifocal leukoencephalopathy. Monitor for signs and symptoms of progressive multifocal leukoencephalopathy, including progressive weakness, clumsiness, vision disturbances, and cognitive changes. Consider obtaining MRI monitoring for early signs of progressive multifocal leukoencephalopathy. Withhold ocrelizumab/hyaluronidase at the first sign or symptom suggestive of progressive multifocal leukoencephalopathy and obtain a clinical evaluation. Discontinue ocrelizumab/hyaluronidase if progressive multifocal leukoencephalopathy is confirmed.
Specific populations
Renal impairment
eGFR ≥ 60 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 60 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
No guidance available.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Insufficient evidence. Evidence of fetal harm in animals. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose.
•
Monoclonal antibodies cross the placenta, with transport increasing as pregnancy progresses and peaks during the third trimester. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. Do not administer live or live-attenuated vaccines in infants of mothers exposed to ocrelizumab during pregnancy before confirming the recovery of B-cell counts (CD19-positive B-cells).
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown drug levels in breastfed infants.
Unlikely to cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ blood neutrophil count, ↓ serum IgM, infusion-related reactions, skin infections, upper respiratory tract infections
Common 1-10%
•
↓ serum IgA, ↓ serum IgG, herpes zoster, lower respiratory tract infections, orolabial herpes, peripheral edema, ⊕ rapid antibody test, back pain, cough, depression, diarrhea, pain in extremity
Uncommon < 1%
•
Genital herpes
Unknown frequency
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Progressive multifocal leukoencephalopathy, immune-mediated colitis, pyoderma gangrenosum, babesiosis
Interactions
Drug(s)
Check Interactions
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