Ocrelizumab (Ocrevus)
Immune Modulator | Immunological Agent
Black Boxed Warning: Ocrevus carries a black boxed warning for an increased risk of hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML), a rare brain infection that can result in death or severe disability.
Ocrevus (ocrelizumab) is a monoclonal antibody used primarily to treat patients with relapsing or primary progressive forms of multiple sclerosis (MS).
- Mechanism of Action: Ocrevus targets CD20-positive B lymphocytes, which are thought to contribute to myelin and axonal damage that leads to MS progression.
- Dosage and Administration: Administered via intravenous infusion, the initial dose is given as two separate infusions, two weeks apart. From then on, a single infusion is given every six months. Observe patients for at least one hour post-infusion to monitor for reactions.
- Monitoring for Infusion Reactions: Infusion reactions are common, particularly with the first dose. Pre-medicate with corticosteroids, antihistamines, and possibly antipyretics to mitigate these reactions.
- Risk of Infections: Due to its immunosuppressive action, Ocrevus increases the susceptibility to infections, including respiratory tract infections and herpes virus associated infections. Patient education on recognizing early signs of infection is crucial.
- Cancer Screening: While data is limited, there is some concern regarding a potential increase in the risk of malignancies. Regular cancer screenings, in accordance with age-appropriate guidelines, should be considered.
- Vaccination: Administer all immunizations according to current immunization guidelines at least 6 weeks prior to starting Ocrevus. Live or live-attenuated vaccines should be avoided during treatment and until B-cell repletion.
- Pregnancy and Breastfeeding: Ocrevus should only be used in pregnancy if the potential benefit justifies the potential risk to the fetus. It is unknown whether Ocrevus is present in human milk; a decision must be made whether to discontinue nursing or the drug, considering the importance of the drug to the mother.
- HBV Screening: Prior to initiation of Ocrevus, screen all patients for HBV. Carriers of HBV require close monitoring for reactivation during Ocrevus therapy and several months afterward.
- Patient Education: Educate patients on possible side effects, including symptoms of HBV reactivation and PML. Ensure they understand the necessity of reporting any unusual symptoms, particularly neurological changes.
- Handling and Storage: Proper handling is essential. Ocrevus vials should be refrigerated and protected from light, and once prepared, the infusion solution should be used immediately or stored in the refrigerator and used within 24 hours.
https://www.gene.com/download/pdf/ocrevus_prescribing.pdf -
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