Ocrevus (ocrelizumab)

8,016.33

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with relapsing or primary progressive forms of multiple sclerosis (MS). It is the first approved treatment for the primary progressive form of MS.

DISEASE INDICATIONS

Multiple Sclerosis

MANUFACTURER

Roche Registration Limited

USAGE

Intravenous

MEDICINE APPROVED BY

  • European Medical Agency (EMA)

  • Food and Drug Administration (FDA)

  • Health Canada

  • Therapeutic Goods Administration (TGA)

  • Medsafe (NZ)

    PATIENTS HELPED

    • Over 1.2 million patients reached

    • More than 11,000 patients helped

    • 100% successful deliveries to 88 countries

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What is Ocrevus (ocrelizumab) for?

Ocrevus (ocrelizumab) is a CD20-directed cytolytic antibody indicated for the treatment of people with relapsing or primary progressive forms of multiple sclerosis (MS)[1,4]. It is the first approved treatment for the primary progressive form of MS[2].

Relapsing MS (RMS) is characterized by episodes of worsening function (relapses) which are initially followed by recovery periods (remissions). In its primary progressive form (PPMS), MS is characterized by steadily worsening function from the onset of symptoms, often without early relapses or remissions[2].

How does Ocrevus (ocrelizumab) work?

MS is a chronic, inflammatory, autoimmune disease that affects the central nervous system, and in particular the communication between the brain and other parts of the body[2].

The patient’s own immune system is supposed to be the cause of the damage to neurons[3].

The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to bind to a type of antigen, named CD20, found on the surface of some antibodies (pre-B and mature B lymphocytes) and induce their death[2]. In this way, it is supposed to prevent these antibodies from damaging neurons.

Where has Ocrevus (ocrelizumab) been approved?

Ocrevus (ocrelizumab) was approved for relapsing or primary progressive forms of multiple sclerosis (MS) by:

  • Food and Drug Administration (FDA), USA, March 28, 2017[1]
  • European Medical Agency (EMA), European Union, January 8, 2018[5]
  • Therapeutic Goods Administration (TGA), Australia, July 13, 2017[4]
  • Health Canada, September 21, 2017[6]
  • Medsafe, New Zealand, December 21, 2017[7]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team for assistance.

How is Ocrevus (ocrelizumab) taken?

The standard dosage is[1,4,5]:

  • Starting dose of 300 mg intravenous infusion (drip), followed two weeks later by a second 300 mg intravenous infusion
  • Subsequent doses of 600 mg intravenous infusion every 6 months.

Patients should be monitored closely during and for at least one hour after infusion as injection reactions may be possible.

Complete information about Ocrevus (ocrelizumab) dosage and administration can be found in the official prescribing information listed in our references section[1,4,5].

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Ocrevus (ocrelizumab)?

Common Adverse Reactions

Relapsing MS

The most common adverse reactions listed in the prescribing information include[1,4,5]:

  • upper respiratory tract infections
  • infusion reactions.

Primary progressive MS

The most common adverse reactions listed in the prescribing information include[1,4,5]:

  • upper respiratory tract infections
  • infusion reactions
  • skin infections
  • lower respiratory tract infections.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include[1,4,5]:

  • serious infusion reactions requiring hospitalisation
  • infections: administration should be delayed in patients with an active infection until the infection is resolved.
  • an increased risk of malignancy, including breast cancer, may exist.

Use in a specific population

Ocrevus (ocrelizumab) can cause fetal harm, it is advised to avoid pregnancies[1] unless the potential benefit to the mother outweighs the potential risk to the foetus[4,5]. It is unknown whether ocrelizumab/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Women should be advised to discontinue breastfeeding during Ocrevus (ocrelizumab) therapy[1,4,5].

Patients in a severely immunocompromised state must not be treated until the condition resolves[1,4,5].

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[1,4,5].

Please note that Occrevus and Ocravis are common misspellings of Ocrevus. These are not different medicines.

References

  1. Summary of Product Characteristics [FDA]: Ocrevus (ocrelizumab)[PDF]
    Genentech, March 2017
  2. FDA News Release: FDA approves new drug to treat multiple sclerosis
      September 2017
  3. Wikipedia. Multiple sclerosis
      cited on 19/05/21017
  4. Summary of Product Characteristics [TGA]: Ocrevus (ocrelizumab)[PDF]
    Roche, July 2017
  5. Summary of Product Characteristics [EMA]: Ocrevus (ocrelizumab)[PDF]
    Roche, January 2018
  6. Summary of Product Characteristics [Health Canada]: Ocrevus (ocrelizumab)[PDF]
    Roche, April 2019
  7. Medsafe Product Detail [Medsafe]: Ocrevus (ocrelizumab)[PDF]
    Roche, March 2020

This content has been reviewed by a Medical Doctor.

OCREVUS (OCRELIZUMAB) Package

1 vial of 300 mg/mL

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