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Neurology Multiple Sclerosis
Marketing Authorisation Holder Roche Registration Limited
Mode of Action Monoclonal antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 30 milligram / millilitre
Package 1 vial of 10 ml – Vials

Ocrevus infusion
Cost of ocrevus
Ocrelizumab
Ocrelizumab

Category:
Description

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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 MS2.

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 remissions2.

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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 body2. The patient’s own immune system is supposed to be the cause of the damage to neurons3.

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 death2. In this way, it is supposed to prevent these antibodies from damaging neurons.

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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, 20171
  • European Medical Agency (EMA), European Union, January 11, 20175
  • Therapeutic Goods Administration (TGA), Australia, July 13, 20174

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HOW IS OCREVUS (OCRELIZUMAB) TAKEN?

The standard dosage is1,4,5:

  • Starting dose of 300 mg intravenous infusion, 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 infusion reactions may be possible.

Complete information about Ocrevus (ocrelizumab) dosage and administration can be found in the official prescribing information listed in our resources section1,4,5.

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

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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 include1,4,5:

  • upper respiratory tract infections
  • infusion reactions.

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Primary progressive MS

The most common adverse reactions listed in the prescribing information include1,4,5:

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

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SERIOUS ADVERSE REACTIONS

The serious adverse reactions listed in the prescribing information include1,4,5:

  • 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.
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USE IN A SPECIFIC POPULATION

Ocrevus (ocrelizumab) can cause fetal harm, it is advised to avoid pregnancies1 unless the potential benefit to the mother outweighs the potential risk to the foetus4,5. 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) therapy1,4,5.

Patients in a severely immunocompromised state must not be treated until the condition resolves1,4,5.

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For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,4,5.

 

Follow the following prescription medicine precautions :

    Ocrelizumab may be harmful in pregnancy and there is a potential risk of miscarriage or carrying a child with birth defects if you or your partner becomes pregnant during this time. Take proper medical help in case you are pregnant, may be pregnant or planning to become pregnant in the near future.

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  This medicine is not indicated for use in women. It is not known if  Ocrelizumab is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Ocrelizumab, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

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  Your health care professional may recommend blood tests to see how your body is working. Blood tests help doctors check for certain diseases and conditions. They also help check the function of your organs and show how well treatments are working.

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  Before taking Ocrelizumab, tell your doctor and pharmacist if you are allergic to Ocrelizumab, any other medications, or any of the ingredients in Ocrelizumab injection. This medicine is not recommended for use in patients with a known allergy to Ocrelizumab.

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  If you take Ocrelizumab, you must stop drinking alcohol. This is one of the ways to prevent this disease from getting worse. If you are dependent on alcohol and want to stop drinking, your doctor can recommend a therapy that’s tailored for your needs.
  If you use other prescription drugs or over the counter products at the same time, the effects of Ocrelizumab may change. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that your pharmacist can help you prevent or manage drug interactions.
  Missing a dose of Ocrelizumab can upset your treatment plan. If you do miss one of your doses, take it as soon as you remember, unless it’s almost time to take your next dose. In this case, you should just skip the missed dose. Don’t take a double dose to “make up” for the one you missed. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
  Do not take Ocrelizumab the use by (expiry) date printed on the pack. Do not take it if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
  During your treatment with Ocrelizumab, it is very important for your doctor to know about your medical history if you have Kidney problems, liver problems, HIV, triglycerides, diabetes or other health problems.

 

What are the storage instructions for Ocrelizumab 30mg/L mg ?

Patients must properly store the drug to retain its quality and efficacy. Following storage instructions will be helpful in storing the drug in the best of manner.

  • Store Ocrelizumab 30mg/L at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).
  • Store it in a cool, dry place, protected from light and refrigerated when necessary. Improper storage can affect the effectiveness and shelf life of your medicine.
  • Consider storing your medications separately from your other family members. You can put them on a different shelf, or in a different cabinet or drawer.
  • If you’re driving, you may want to have certain medicines at hand, but don’t store them in the glove compartment, where they could be damaged from the heat, cold, or rain outside or from the car’s heater or air conditioner.
  • Always remember to store your medication out of sight and reach of children and pets, to prevent accidental ingestion.

Prescription Required:

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Note:

The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
Remember, keep this and all other medicines out of the reach of children and away from pets, never share your medicines with others, and use this medication only for the indication prescribed.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

How to use Ocrelizumab Solution

Read the Medication Guide provided by your pharmacist before you start using ocrelizumab and each time you get an infusion. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor on a treatment schedule. The first 2 infusions are usually given 2 weeks apart. After that, an infusion is usually given once every 6 months. Follow your doctor’s treatment schedule.

Ocrelizumab may cause very serious (rarely fatal) side effects called infusion reactions during or up to 24 hours after treatment. Your doctor or nurse will monitor you closely during your infusion and for at least 1 hour afterward. Your infusion may be slowed down or stopped depending on your symptoms. Tell your doctor or nurse right away if any of these side effects occur: rashitchingtrouble breathing, throat swelling/pain, tiredness, fever, fainting, flushing of the face, nauseaheadachedizziness, fast heartbeat.

You may also be given additional medications before each treatment, including a corticosteroid (such as methylprednisolone), an antihistamine (such as diphenhydramine), and acetaminophen to help reduce the severity of an infusion reaction.

Side Effects

See also How to Use section.

Cold symptoms such as stuffy/runny nose or cough may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat or cough that doesn’t go away, fever, chills, herpes cold sores or genital sores, shingles).

Before treatment with this medication, your doctor will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, ocrelizumab may cause it to become active again and it could cause serious liver problems. Ask your doctor for more details.

This medication may rarely increase your risk of developing cancer, including breast cancer. Tell your doctor right away if you have symptoms such as unusual growths, a lump in the breastnipple discharge. Ask your doctor for more details.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these new or worsening side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizurevision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rashitching/swelling (especially of the face/tongue/throat), severe dizzinesstrouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using ocrelizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/past/returning infections (including hepatitis Bherpestuberculosis), life-threatening infusion reaction to ocrelizumab.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Ocrelizumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpoxmeaslesflu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ocrelizumab due to the risk of harm to an unborn baby. Discuss the use of reliable forms of birth control while using this medication and for 6 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. Infants born to mothers who receive ocrelizumab during pregnancy should be tested for the ability to respond to vaccines before receiving any vaccinations.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as natalizumabrituximab).

Does Ocrelizumab Solution interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as blood tests to check for hepatitis B infection, breast cancer screening, immunoglobulin levels) should be done before you start using this medication, as well as during and after treatment. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in an infusion center and will not be stored at home.

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