The active ingredient of Ocrevus® is ocrelizumab. It is used for the treatment of patients with relapsing remitting MS to delay the progression of physical disability and to reduce the frequency of relapse. Ocrevus is also indicated for the treatment of patients with primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability.
In MS, the immune system mistakenly attacks the protective layer (myelin) around the nerve cells. This causes inflammation and damage which stops the nervous system working properly. Ocrevus® works on the immune system to reduce the inflammation and attacks on the nervous system.
In clinical trials, Ocrevus® showed a reduction in relapses, less new lesions on magnetic resonance scan (MRI), less brain volume loss and lower levels of disability progression.
Ocrevus should not be used in people:
Intravenous: Ocrevus® is infused intravenously (IV) into a drip at a hospital infusion unit. You will be monitored by trained staff before, during and after your infusion.
When first starting Ocrevus®, the full 600mg dosage is split into 2 half doses of 300mg each, administered two weeks apart. Subsequent infusions of 600 mg of Ocrevus® will be given six months after the previous infusion.
Subcutaneous: Ocrevus® for subcutaneous injection should be prepared by a healthcare professional (920mg in 23 ml; drawn from a vial into a syringe). It is then injected under the skin of the abdomen over approximately 10 min, under the supervision of a healthcare professional. After the first dose, monitoring by a healthcare professional for at least one hour is required to manage any severe injection reactions. For subsequent doses, monitoring after injection is at the discretion of the healthcare professional.
For both intravenous and subcutaneous dosing, premedication with steroids and antihistamines is used to reduce the risk of infusion/injection reactions. Fever reducing medication such as paracetamol may also be used. Your doctor or nurse can provide more details.
Ocrevus® helps most people with MS, but may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.
Clinical trials and the continued monitoring period following the trials (“open-label extension”; where the treatment identity is revealed) have provided data on around ten years of continuous Ocrevus® treatment.
Tell your doctor or nurse immediately if you notice any of the following while receiving an infusion: swelling of the face, lips tongue or throat or other parts of the body, shortness of breath, rash, itching or hives, feeling sick (nausea), fever, cough, tiredness, headaches and dizziness, fast heartbeat.
Patients should tell their doctor immediately if they have any signs or symptoms of an infusion reaction or allergic reaction.
Very common side effects of subcutaneous Ocrevus® are injection reactions, including headache, nausea, and redness, pain, swelling and/or itchiness at the injection site.
Clinical trials indicated that there may also be a slightly higher risk of some common viral infections such as the common cold.
Your neurologist will assist you to assess the risks and expected benefit of treatment with Ocrevus® prior to starting therapy and over the course of the treatment. Your health professional can provide comprehensive information on the use of Ocrevus®, including precautions and other potential side effects.
In controlled trials, malignancies, including breast cancer, occurred more frequently in Ocrevus-treated patients although the incidence was within the background rate expected for an MS population. After approximately 10 years of continuous ocrelizumab treatment over the controlled period and Open-Label Extension phase of the pivotal clinical trials, the incidence of malignancies remained within the background rate expected for an MS population.
Avoid treatment during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment and for 4 months after the last dose.
If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.
A small clinical study of 29 women found Ocrevus® at low levels in breastmilk (relative infant dose of 0.07%-0.7%) over 90 days after the mother’s first post-birth dose of Ocrevus®. Follow-up of 21 infants breastfed for at least 2 weeks showed normal growth and development up to 1 year. However, the potential for Ocrevus® absorption leading to B-cell depletion is unknown.
Breastfeeding offers developmental and health benefits for your baby and it’s also important to consider your clinical need for Ocrevus ®. If treatment is necessary, Ocrevus ® may be used during breastfeeding, starting a few days after birth, under the guidance of your healthcare team.
If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.
Ocrevus® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of people with relapsing forms of MS and also for the treatment of people with primary progressive MS.
As Ocrevus® has specific patient management requirements, only neurologists are able to initiate treatment. Your neurologist will need to obtain a special authority to prescribe you with the medication. There are several criteria you are required to meet before your neurologist obtains authority to write this prescription.
For details of the criteria required to receive a prescription for Ocrevus® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/medicine/item/11237K-11242Q
You will need to click on the red Authority Required (STREAMLINED) link.
If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.
Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website at: www.medicare.gov.au
Ocrevus® is currently not available on the PBS for people with primary progressive MS. Ocrevus® will be available for people with primary progressive MS to purchase privately.
If you are not eligible for Ocrevus® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.
Speak to your neurologist about what treatment best suits your individual circumstances.
MS Nurses can also provide information, training and ongoing support in managing your immunotherapy.
MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects for each individual’s circumstances, should be made in careful consultation with the person’s neurologist.
