Classes
DEA Class; Rx
Common Brand Names; Ocrevus
- Monoclonal Antibodies;
- Multiple Sclerosis Treatments
Description
CD20-directed cytolytic monoclonal antibody which targets B-cells
Used in adults for primary progressive MS and relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Infusion reactions are common; pre-medication is needed prior to infusion
Indications
Indicated for the treatment of primary progressive or relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
Active HBV infection
History of life-threatening infusion reaction to ocrelizumab
Adverse Effects
- Upper respiratory tract infections (40-49%)
- Infusion-related reactions (34-40%)
- Skin infections (14%)
- Decreased neutrophil counts (13%)
- 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%)
- Gastrointestinal disorders: Immune-mediated colitis
- Infections and infestations: Serious herpes infections and progressive multifocal leukoencephalopathy
Warnings
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
Pregnancy and Lactation
No data available to assess risk in pregnant women
Unknown if distributed in human breast milk
Maximum Dosage
600 mg/dose IV.
600 mg/dose IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
How supplied
Ocrelizumab
solution for injection
- 30mg/mL (10mL single-dose vial)
