Ocrevus Ocrelizumab Application Scope

Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Primary progressive multiple sclerosis (PPMS) in adults.

ocrevus ocrelizumab

Ocrevus Ocrelizumab Characteristics

Ingredients: Ocrelizumab
Properties: A clear or slightly opalescent, colorless to pale brown solution for intravenous infusion
Packaging Specification: Supplied as a single-dose vial containing 300 mg/10 mL (30 mg/mL) solution
Storage: Store refrigerated (2 °C to 8 °C); do not freeze; protect from light; use immediately once diluted (or per local label)
Expiry Date: As per vial label / packaging (e.g. shelf life from manufacture) — check the specific package for expiry date
Executive Standard: As defined by regulatory authorities (e.g. U.S. FDA, EMA) and Roche / Genentech product monograph documents
Approval Number: Varies by country (in the U.S., the FDA label; in Europe, EMA’s marketing authorization)
Date of Revision: As per the latest prescribing document
Manufacturer: F. Hoffmann-La Roche Ltd (Roche) / Genentech

Guidelines for the Use of Ocrevus Ocrelizumab

Dosage and Administration:
- Recommended Dose:
  - Initial dose: 600 mg total, split into two infusions of 300 mg each, given 14 days apart.
  - Subsequent doses: 600 mg as a single IV infusion every 6 months.
- Administration:
  - Dilute in 0.9% sodium chloride; infuse with a 0.2 or 0.22 μm in-line filter.
  - The first infusions are often slower to reduce risk of infusion reactions; later infusions may proceed over ~3.5 hours or per label.
  - Patients should be observed during infusion and for at least 1 hour post-infusion for reactions.
  - Pre-medication (e.g. corticosteroid, antihistamine, optional antipyretic) is recommended ~30 minutes before infusion to reduce infusion reactions
- Missed Dose: If a dose is missed or delayed, consult the prescribing physician. Re-initiation or rescheduling should consider B cell repletion and infusion reaction risk.
Adverse Reactions:
- Common Adverse Reactions: From clinical trials (incidence ≥ 10% in RMS trials) include:
  - Infusion reactions (e.g., pruritus, rash, flushing, hypotension, headache, fever).
  - Upper respiratory tract infections, nasopharyngitis
- Serious Adverse Reactions:
  - Severe infusion reactions (including anaphylaxis and bronchospasm).
  - Infections: risk of serious infections (bacterial, viral, opportunistic). Herpes virus infections, respiratory infections, etc.
  - Reactivation of hepatitis B virus (HBV) in those with prior infection.
  - Malignancies (including possible increased risk of breast cancer) observed in clinical trials—causal relationship uncertain.
  - Immune-mediated colitis (rare, postmarketing reports).
  - Decreased immunoglobulin levels (e.g., IgM, IgG) over time, possibly contributing to infection risk.
  - Progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, reported in some patients receiving ocrelizumab.
Contraindications:
- Known history of life-threatening infusion reactions to ocrelizumab or any component of the formulation.
- Active hepatitis B virus infection (since risk of HBV reactivation).
Precautions:
- Screen for HBV before initiation; monitor patients at risk for reactivation.
- Delay initiation in presence of active infection until resolved.
- Live or live-attenuated vaccines should be given at least 4 weeks before starting therapy; avoid use of live vaccines during treatment.
- Monitor immunoglobulin levels periodically during treatment.
- Pregnancy/lactation: Safety not well established; effective contraception recommended during treatment and for some time after last dose.
- Caution in patients switching from other immunosuppressive/immunomodulatory MS therapies to avoid overlapping immunosuppression.
- Monitor for malignancies, especially breast cancer in women, per local screening guidelines.

Ocrevus Interactions

Concomitant use of other immunosuppressants may increase risk of infection and immunosuppression; caution when combining therapies.
Vaccines: Live vaccines are contraindicated during ocrelizumab treatment; response to inactivated vaccines may be diminished.
There are limited data on other specific drug–drug interactions; always review concomitant medications before initiation.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.