Ocrevus

^{Generic name: ocrelizumab
Intravenous (infusion) injection is the form of dosage.
CD20 monoclonal antibodies are a type of drug.}

Describe Ocrevus

Multiple sclerosis is treated with Ocrevus (ocrelizumab), which is a monoclonal antibody. Multiple sclerosis is a disorder of the central nervous system (CNS) (MS).

We don’t know exactly how Ocrevus helps people with MS, but we do know that it goes after and binds to B-cells that have CD20 on their surface. This kills them through antibody-dependent cellular cytolysis and complement-mediated lysis. B cells are a type of white blood cell that contributes in a number of ways to the development and progression of MS. The CD20 antigen is mostly found on the surface of B cells, which are also called B lymphocytes. This makes it a good target for MS and other conditions that affect B cells.

In March 2017, the US Food and Drug Administration (FDA) gave Ocrevus the green light.

How does Ocrevus work?

Ocrevus is a prescription medicine used to treat:

• Relapsing forms of MS, such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
• Primary progressive MS in adults.

No one knows if it is safe and good for kids.

What you need to know

Ocrevus can cause serious side effects, such as:

• Infusion reactions are a common side effect of this drug. They can be dangerous and may require you to stay in the hospital. You will be watched for signs and symptoms of an infusion reaction during your infusion and for at least an hour after each infusion. Tell your doctor or nurse if you have any of the following signs:
  • Itchy skin
  • Rash
  • Hives
  • Feeling tired
  • Coughing or wheezing
  • Trouble breathing
  • Itchy throat or pain.
  • Feeling faint
  • Fever
  • A red face (flushing)
  • Nauseousness
  • Headache
  • Throat swelling
  • Dizziness
  • Shortness of breath
  • Fatigue, and
  • A fast heart beat.

You can have these reactions up to 24 hours after your infusion. After each infusion, it’s important to call your doctor right away if you notice any of the above signs or symptoms.

If you have reactions to an infusion, your healthcare provider may need to stop the infusion or slow it down.

• Infections
  • If you take Ocrevus, you are more likely to get infections in your upper respiratory tract, lower respiratory tract, skin, or herpes. One common side effect that can be dangerous is getting an infection. Tell your doctor if you think you have an infection or if you have fever, chills, or a cough that won’t go away.
    • Some of the signs of a herpes infection are:
      • Cold sores
      • Shingles
      • Genital sores
      • A rash
      • Pain, and
      • Itching
    • Signs of a more serious case of herpes are:
      • Changes in vision
      • Redness or pain in the eyes
      • A severe or long-lasting headache
      • A stiff neck, and
      • Confusion

All signs of a more serious herpes infection.

Signs of infection can happen while you are taking this medicine or after you have finished taking it. If you think you have an infection, tell your doctor or nurse right away. Your doctor should wait to give you Ocrevus until your infection has gone away.

• Reactivation of the Hepatitis B virus (HBV): Before you start taking this medicine, your doctor will check your blood for hepatitis B virus infection. If you have ever had an infection with the hepatitis B virus, the virus could become active again while you are taking Ocrevus or after you stop taking it. Reactivation of the Hepatitis B virus can cause serious problems with the liver, such as liver failure or death. Your doctor will keep an eye on you during treatment and after you stop taking this medicine to see if you are at risk for the hepatitis B virus to come back.
• Weaker immune system: Taking Ocrevus with other medicines that weaken the immune system could make you more likely to get sick.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually causes death or severe disability. It has been linked to this medication. Symptoms of PML get worse over days to weeks. You should call your doctor right away if you have any new or worsening neurologic signs or symptoms that have been going on for more than a few days. This includes problems with:

• Thinking
• Eyesight
• Strength
• Balance, or coordination.
• Weakness on one side of your body
• Using your arms or legs

Immunoglobulins may drop because of Ocrevus. Some types of immunoglobulins may drop. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

For more information about possible side effects, see “What are the possible side effects of Ocrevus?” below.

Who is ineligible to receive Ocrevus?

• Don’t take this medicine if you have an active infection with the hepatitis B virus (HBV).
• Don’t get this medicine if you’ve had a dangerous allergic reaction to it in the past. Tell your doctor if you have ever had an allergic reaction to Ocrevus or one of its ingredients. See the question “What are the ingredients in Ocrevus?” for a full list.

What do I need to tell my doctor before I get Ocrevus?

Before you get Ocrevus, you should tell your doctor about all of your health problems. This is especially important if you:

• Have or think you have an infection. See the question “What is the most important thing I need to know about Ocrevus?” above.
• You have ever taken, are taking, or plan to take medicines that affect your immune system or other MS treatments. Taking these medicines could make you more likely to get sick.
• Have had hepatitis B or are a carrier of the hepatitis B virus.
• You have had inflammatory bowel disease or colitis in the past.
• Have been vaccinated recently or are scheduled to be vaccinated.
  • If you need a “live” or “live-attenuated” vaccine, you should get it at least 4 weeks before you start taking Ocrevus. You also shouldn’t get “live” or “live-attenuated” vaccines while you’re on this medicine and until your doctor says your immune system is no longer weak.
  • If you can, you should get any “non-live” vaccines at least 2 weeks before starting Ocrevus treatment. Talk to your healthcare provider if you want to get any non-live (inactivated) vaccines, such as the flu shot, while you are taking this medication.
  • If you had Ocrevus while you were pregnant and you now have a baby, you should tell your baby’s doctor about it so they can decide when your baby should get vaccinated.

How am I supposed to take Ocrevus?

• Intravenous (IV) infusion is how Ocrevus is given. The needle is put into a vein in your arm.
• Before treatment, your doctor will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also get other medicines to help lessen the side effects of the infusion. See “What is the most important information about Ocrevus?”
• Your first full dose of Ocrevus will be given to you in two separate infusions, two weeks apart. About 2 hours and 30 minutes will pass between each infusion.
• You will get your next doses of this medicine as an infusion once every six months. Depending on how fast your doctor tells you to give the infusion, it will take anywhere from 2 hours to 3 hours and 30 minutes.

What will happen if I don’t take a dose?

If you miss a dose of Ocrevus, call your doctor and reschedule your appointment so you can get the dose as soon as possible. Do not wait until your next planned dose. After you get the dose you missed, move your next dose to 6 months after the dose you missed. At least 5 months must pass between Ocrevus doses.

Dosage information:

The recommended dose of Ocrevus is

• A 300 mg IV infusion to start, followed by another 300 mg IV infusion two weeks later.
• After that, a 600 mg IV infusion is given every six months.

See the Full Prescribing Information for more information about how to take Ocrevus.

What side effects does Ocrevus have?

Ocrevus may have serious side effects, such as:

• See the question “What’s the most important thing I should know about Ocrevus?” above.
• Risk of cancers and other diseases like breast cancer. Follow your doctor’s advice about how often you should get screened for breast cancer.
• Colitis, also known as inflammation of the colon: Tell your doctor if you have any of the following signs of colitis:
  • Diarrhea (loose stools) or having to go to the toilet more often than normal
  • Stools that are black, smell like tar, are sticky, or contain blood or mucus
  • Abdominal pain or tenderness that is very bad

Not all of the possible side effects of this medicine are listed here. You should talk to your doctor about any side effects. You can call 1-800-FDA-1088 to tell the FDA about side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, vitamins, herbal supplements, and over-the-counter medicines. Tell your doctor about any other immunosuppressants or drugs that change the way your immune system works that you have taken or are taking.

Getting pregnant and nursing

Tell your doctor if you think you might be pregnant, are pregnant, or plan to become pregnant. It is not known if Ocrevus will hurt your baby while you are pregnant. You should use a method to prevent pregnancy (contraception) while taking this medicine and for 6 months after your last infusion. Talk to your doctor about what method of birth control is best for you at this time.

For women who take Ocrevus while they are pregnant, there is a pregnancy registry. Tell your healthcare provider right away if you get pregnant while taking this medicine. Talk with your doctor or nurse about signing up for the Ocrevus Pregnancy Registry. The goal of this registry is to find out about your health and the health of your baby. By calling 1-833-872-4370 or going to www.Ocrevuspregnancyregistry.com, your doctor can sign you up for this registry.

If you had Ocrevus while you were pregnant and you now have a baby, you should tell your baby’s doctor about it so they can decide when your baby should get vaccinated.

Tell your doctor if you are breastfeeding or if you plan to start. No one knows if Ocrevus gets into your breast milk or not. Talk to your doctor about how to feed your baby best if you are taking this medicine.

Storage

• Keep Ocrevus vials in the outer carton at 2°C to 8°C (36°F to 46°F) to keep out light.
• Don’t freeze or shake the vials.
• Use the Ocrevus infusion solution right away after it has been made. If you don’t use it right away, you can keep it in the fridge for up to 24 hours at 2°C to 8°C (36°F to 46°F) and at room temperature for up to 8 hours at up to 25°C (77°F). This includes the time it takes to infuse. If an intravenous infusion can’t be finished on the same day, throw away the rest of the solution.

Keep out of children’s sight and reach.

What kinds of things are in Ocrevus?

Active ingredient: ocrelizumab.

Glacial acetic acid, polysorbate 20, sodium acetate trihydrate, and trehalose dihydrate are some of the inactive ingredients.

Genentech, Inc., a member of the Roche Group, makes Ocrevus. Their address is 1 DNA Way, South San Francisco, CA 94080-4990.

References

1. ^{The Food and Drug Administration (FDA). Product Label for Ocrevus}
2. ^{Hausser-Kinzel S, Weber MS. The Role of B Cells and Antibodies in Multiple Sclerosis, Neuromyelitis Optica, and Other Disorders. Front Immunol. 2019;10:201. Dated February 8, 2019, doi:10.3389/fimmu.2019.00201}

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