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Ocrevus

Generic Name: Ocrelizumab
Dosage Form: Intravenous (infusion) injection
Drug Class: CD20 monoclonal antibodies

What is Ocrevus?

Ocrevus (ocrelizumab) is an anti-monoclonal antibody that is used in treating a condition known as central nervous system (CNS) disorder known as MS.

It's unclear precisely how Ocrevus is able to work in patients with MS; however, it targets and binds to B cells, which express CD20 on their surface, which causes their degeneration through antibody-dependent cell cytolysis and complement-mediated elimination. B-cells are forms of white blood cells that contribute to the growth and ongoing process of disease in MS in many ways. It is believed that the CD20 antigen is mostly found on the surface of B cells, also referred to as B lymphocytes. This makes it a suitable option for MS as well as other diseases that affect B cells.

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

What exactly is Ocrevus hired to do?

Ocrevus is an prescription medicine used for treating:

  • Relapsing forms of MS, which include a syndrome that is clinically isolated, Relapsing-remitting diseases and active secondary progressive diseases in adults
  • Primary progressive MS for adults

It isn't known whether it is safe or efficient for children.

Important information

Ocrevus can have serious side effects, which include:

  • Infusion reactions Reactions to infusions are a frequent adverse effect of this medication. They could be severe and necessitate hospitalisation. The patient will be screened during your infusion as well as for at least one hour following each injection to look for signs that indicate a reaction to the infusion. Contact your doctor or nurse in the event that you experience any of the following symptoms:
    • itchy skin
    • Rash
    • Hives
    • tiredness
    • wheezing or coughing
    • Trouble breathing
    • Pain or irritation in the throat
    • feeling faint
    • The fever
    • the appearance of redness in your skin (flushing).
    • nausea
    • headache
    • My throat is swollen.
    • dizziness
    • breathlessness
    • fatigue
    • rapid heartbeatThese reactions to infusion can last for as long as 24 hours following your infusion. It is essential to notify your healthcare provider in the event that you notice any of the symptoms or signs listed above following every infusion.
      If you experience reactions to your infusion, Your healthcare provider might require stopping or slowing down the pace for your next infusion.
  • Infection:
    • Ocrevus increases the risk of contracting upper respiratory tract infections, low respiratory tract infections, skin conditions, and herpes-related infections. Infections are a typical adverse effect that can be very serious. Inform your doctor if you're suffering from an infection or are experiencing any of these symptoms of infection, such as chills, fever, and a cough that won't disappear.
      • The signs of herpes are:
        • Cold sores
        • Sheaths
        • genital sores
        • Skin the rash
        • Pain
        • Itching
      • The signs of a more serious herpes infection may include:
        • Vision changes
        • Eye redness or discomfort
        • chronic or severe headache
        • stiff neck
        • confusionInfection signs can occur when you are receiving treatment or after you have had your last dose of the medication. Contact your healthcare professional immediately if you suspect an infection. Your doctor should stop the treatment with Ocrevus until the infection has disappeared.
    • Hepatitis B virus (HBV) activation: Before beginning treatment with this drug, your doctor will conduct blood tests to determine if you have the hepatitis B virus. If you've had the Hepatitis B virus or a similar condition, the Hepatitis B virus could be active once again following the treatment of Ocrevus. Hepatitis B virus being active once more (called reactivation) can cause serious liver issues such as liver failure or even death. Your doctor will be able to tell your health if you're at risk of suffering from hepatitis B virus reactivation in the course of treatment and also after you cease taking the medication.
    • A weak immune system: Taking Ocrevus prior to or following other medications that weaken your immune system can increase the chances of contracting an infection.
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain disease that usually causes the death of a person or severe impairment and has been associated with this drug. The symptoms of PML worsen over a period of weeks or days. It is crucial to get in touch with your doctor immediately if you notice any new or deteriorating neurological signs or symptoms that last for more than a day and include:
    • Thinking
    • eyesight
    • Strength
    • Balance
    • an area of weakness on one part of the body
    • by using your legs or arms
  • Reduced immunoglobulins Ocrevus could cause a decrease in certain kinds of immunoglobulins. Your doctor will conduct blood tests to assess the levels of your blood immunoglobulin.

Read "What are the possible side effects of Ocrevus?" Below, you will find more information on the possible side below for more information about the possible side effects.

How to Take Ocrevus?

  • Do not take this medication if you are already suffering from hepatitis B virus (HBV) infection.
  • Do not take this medication if you've had an extremely dangerous allergic reaction to it. Contact your doctor if you've had reactions in the past to Ocrevus or any other of the ingredients it contains. Read "What are the ingredients in Ocrevus?" below for a full description of all the components.
  • Ocrevus is administered via an injection into the vein (intravenous (IV) infusion) inside your arm.
  • Prior to treatment, your doctor will prescribe corticosteroid medicines along with an antihistamine to lessen the severity of reactions to infusion (making these less frequent and therefore less serious). There are other medications to lessen the severity of reactions to infusions. Read "What is the most important information to know about Ocrevus?"
  • The first dose of Ocrevus will be administered in two separate infusions two weeks apart. Each infusion is expected to last approximately two hours and thirty minutes.
  • The next dose of the medication will be administered as an infusion every six months. Infusions can last from 2 to 3 hours, depending on the dose recommended by your doctor.

Before you Take this Drug

Before you receive Ocrevus, inform your doctor about your medical conditions, especially the following:

  • You may be suffering from an infection. "What is the most important information I should know about Ocrevus?" in the previous paragraph.
  • You have taken or are planning to take any medications that impact your immune system or other therapies for MS. These medications could increase your chance of getting an infection.
  • If you've ever suffered from the virus hepatitis B or are a carrier of the B virus,
  • are afflicted with colitis or inflammatory bowel diseases.
  • are currently receiving a vaccination or have been planning to undergo any vaccinations.
    • It is recommended that you receive any live or 'live-attenuated' vaccinations at least 4 weeks prior to the start of the treatment process with Ocrevus. It is also recommended not to receive live or 'live attenuated vaccines while being treated for it or until your healthcare professional confirms your immunity is not weaker.
    • If possible, take any vaccines that are non-live at least two weeks prior to the start of the treatment process with Ocrevus. If you'd prefer to receive other non-live (inactivated) shots, such as the flu season vaccine, during the time you are treated with this medication, speak with your physician.
    • If you are expecting a child and you've been diagnosed with Ocrevus during pregnancy, it's important to inform your doctor about taking this medication so they can determine the best time for your baby to be vaccinated.

What Happens If I Miss a Dose?

If you have missed the dose of Ocrevus, contact your doctor and request rescheduling your appointment so that you receive the missed dose as quickly as possible. Don't wait until your next scheduled dose. After you receive your missed dose, reschedule your next dose for 6 months after your missed dose. Ocrevus doses need to be separated by at least five months.

Details on Dosage

The recommended dosage of Ocrevus is:

  • Initial dose: 300 mg IV infusion, and two weeks later, another 300 mg IV injection.
  • Subsequent doses: 600 mg IV infusion every 6 months

Read the full prescribing information for more details on Ocrevus dosage.

Side effects of Ocrevus

Ocrevus could result in serious adverse reactions, including:

  • See "What is the most important information I should know about Ocrevus?" above.
  • Risk of developing the risk of developing cancers (malignancies), which includes the risk of breast cancer. Follow the advice of your physician regarding the standard screening guidelines for breast cancer.
  • Colon inflammation or colitis: Inform your physician if you are experiencing any signs of colitis, for example:
    • Diarrhoea (loose stool) as well as more frequent or less frequent movements of the bowel than is normal
    • Staining that is black, tarry, sticky, or contains mucus or blood
    • The stomach area is extremely tender and painful. (abdomen) tenderness or pain

These aren't all the possible side effects that could occur from this drug. Contact your doctor to seek medical advice on possible side effects. You can report any side effects to the FDA at 1-800-FDA-1088.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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