Ocrelizumab
OCREVUS
What it isAnti-CD20 monoclonal antibody that depletes B cells; relapsing and primary progressive multiple sclerosis.
Why this oneIt was the first therapy of any kind approved for primary progressive MS, which had no disease-modifying option before it, and it is highly effective in relapsing disease.
What limits itInfusion reactions and infections are major hazards; screen for hepatitis B and monitor immunoglobulins before repeat treatment.
FDA-approved for
- relapsing forms of multiple sclerosis
- primary progressive multiple sclerosis
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Relapsing forms of MS (CIS, relapsing-remitting, active secondary progressive) | Adults | 300 mg IV, then 300 mg IV 2 weeks later | 600 mg IV every 6 months | |
| Primary progressive MS | Adults | 300 mg IV, then 300 mg IV 2 weeks later | 600 mg IV every 6 months | |
| Relapsing-remitting MS | Peds ≥10 yr weighing ≥25 kg | ≥35 kg: 300 mg ×2 (2 wk apart); 25–<35 kg: 150 mg ×2 (2 wk apart) | ≥35 kg: 600 mg q6 months; 25–<35 kg: 300 mg q6 months |
Renal Undefined
Hepatic Undefined
Doses must be separated by at least 5 months
Instructions
- Screen for HBV and obtain serum immunoglobulins, aminotransferases, alkaline phosphatase, bilirubin before first dose
- Premedicate with methylprednisolone (or equivalent) + an antihistamine (± antipyretic) before each infusion
- Administer by IV infusion; observe patient during and ≥1 h after infusion
- Separate doses by at least 5 months
Contraindications
- Active hepatitis B virus (HBV) infection
- History of life-threatening infusion reaction to OCREVUS
Cautions
- Infusion reactions (premedicate; may occur up to 24 h after)
- Serious/fatal infections; delay dosing during active infection
- Progressive multifocal leukoencephalopathy (PML)
- Reduction in immunoglobulins / hypogammaglobulinemia
- Malignancies, including breast cancer
- Immune-mediated colitis
- Liver injury
Adverse reactions
- Upper respiratory tract infections
- Infusion reactions
- Skin infections
- Lower respiratory tract infections
Pregnancy May cause fetal B-cell depletion (animal data); IgG crosses placenta; delay live/live-attenuated vaccines in exposed infants
Lactation No human data; ocrelizumab excreted in animal milk; weigh benefits against maternal need
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Ocrelizumab ballicule
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