Multiple sclerosis (RMS)

Active Ingredient: Ocrelizumab

Indication for Ocrelizumab

Population group: only adults (18 years old or older)

Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

For this indication, competent medicine agencies globally authorize below treatments:

300-600 mg

Route of admnistration

Intravenous

Defined daily dose

300 - 600 mg

Dosage regimen

From 300 To 600 mg once every 14 day(s)

Loading dose

300 mg

Maintenance dose

600 mg

Detailed description

Premedication for infusion-related reactions

The following two premedications must be administered prior to each ocrelizumab infusion to reduce the frequency and severity of IRRs:

  • 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each ocrelizumab infusion;
  • antihistamine approximately 30-60 minutes prior to each ocrelizumab infusion.

In addition, premedication with an antipyretic (e.g paracetamol) may also be considered approximately 30-60 minutes prior to each ocrelizumab infusion.

Posology

Initial Dose: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.

Subsequent Doses: Subsequent doses of ocrelizumab thereafter are administered as a single 600 mg intravenous infusion every 6 months. The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose. A minimum interval of 5 months should be maintained between each dose of ocrelizumab.

Dosage considerations

After dilution, ocrelizumab is administered as an intravenous infusion through a dedicated line. Ocrelizumab infusions should not be administered as an intravenous push or bolus.

Dose and Schedule of ocrelizumab:

 Amount of ocrelizumab to be administeredInfusion instructions
Initial Dose (600 mg) divided into 2 infusionsInfusion 1 300 mg in 250 mLInitiate the infusion at a rate of 30 mL/hour for 30 minutes
 Infusion 2 (2 weeks later) 300 mg in 250 mLThe rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
   Each infusion should be given over approximately 2.5 hours.
Subsequent Doses (600 mg) once every 6 monthsSingle infusion600 mg in 500 mLInitiate the infusion at a rate of 40 mL/hour for 30 minutes
   The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour
   Each infusion should be given over approximately 3.5 hours

Active ingredient

Ocrelizumab

Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells. The precise mechanisms through which ocrelizumab exerts its therapeutic clinical effects in MS is presumed to involve immunomodulation through the reduction in the number and function of CD20-expressing B cells. Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis. The capacity of B-cell reconstitution and preexisting humoral immunity are preserved.

Read more about Ocrelizumab

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