Ocrevus

Generic name: Ocrelizumab
Dosage form: intravenous (infusion) injection
Drug class: CD20 monoclonal antibodies

Usage of Ocrevus

Ocrevus (Ocrelizumab) is a monoclonal antibody used for the treatment of a central nervous system (CNS) disorder called multiple sclerosis (MS).

It's not known exactly how Ocrevus works in people with MS, but it targets and binds to B-cells expressing CD20 on their surface, which results in their destruction via antibody-Dependent cellular cytolysis and complement-mediate lysis. B cells are a type of white blood cell that contributes to the development and ongoing disease process involved in MS in a number of ways. The CD20 antigen is mainly found on the surface of B cells, which are also known as B lymphocytes, making it a good target for MS and certain other conditions affecting B cells.

Ocrevus was approved by the US Food and Drug Administration (FDA) in March 2017.

Ocrevus side effects

Ocrevus may cause serious side effects, including:

see "What is the most important information I should know about Ocrevus?" above

risk of cancers (malignancies) including breast cancer. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer.

Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:

Diarrhea (loose stools) or more frequent bowel movements than usual

Stools that are black, tarry, sticky or have blood or mucus

Severe stomach-area (abdomen) pain or tenderness

These are not all the possible side effects of this medication. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Ocrevus

Tell you healthcare provider if you are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with this medication and for 6 months after your last infusion. Talk with your healthcare provider about what birth control method is right for you during this time.

There is a pregnancy registry for women who take Ocrevus during pregnancy. If you become pregnant while receiving this medication, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Ocrevus Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby's health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting www.Ocrevuspregnancyregistry.com.

If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby's healthcare provider about receiving this medication so they can decide when your baby should be vaccinated.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medication.

Relate drugs

How to use Ocrevus

The recommended dose of Ocrevus is:

Starting dose: 300 mg IV infusion, followed two weeks later by a second 300 mg IV infusion

Subsequent doses: 600 mg IV infusion every 6 months

See Full Prescribing Information for further details about Ocrevus dosing.

Warnings

Ocrevus can cause serious side effects, including:

Infusion Reactions: Infusion reactions are a common side effect of this medication, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:

itchy skin

rash

hives

tiredness

coughing or wheezing

trouble breathing

throat irritation or pain

feeling faint

fever

redness on your face (flushing)

nausea

headache

swelling of the throat

dizziness

shortness of breath

fatigue

fast heart beat These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

Infection:

Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away.

Signs of herpes infection include:

cold sores

shingles

genital sores

skin rash

pain

itching

Signs of a more serious herpes infection include:

changes in vision

eye redness or eye pain

severe or persistent headache

stiff neck

confusion Signs of infection can happen during treatment or after you have received your last dose of this medication. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with this medication, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever HAD hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving this medication.

Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with this medication. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:

thinking

eyesight

strength

balance

weakness on 1 side of your body

using your arms or legs

Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

See "What are the possible side effects of Ocrevus?" below for more information about side effects.

What other drugs will affect Ocrevus

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider about other immunosuppressive or immune-modulating drugs that you have taken or are currently taking.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. 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.