Ocrevus Zunovo

Pronunciation: OH-creh-vus zoo-NOH-voh
Generic name: ocrelizumab and hyaluronidase
Dosage form: subcutaneous injection (920 mg ocrelizumab and 23,000 units hyaluronidase per 23 mL)
Drug class: CD20 monoclonal antibodies

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 27, 2024.

What is Ocrevus Zunovo?

Ocrevus Zunovo (ocrelizumab and hyaluronidase) is a treatment for multiple sclerosis (MS) to help reduce relapses and brain lesions and to slow disability. Ocrevus Zunovo is used for relapsing forms of MS (clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease in adults) and primary progressive MS (PPMS) in adults.

Ocrevus Zunovo is given by an injection under the skin (subcutaneous injection) which takes approximately 10 minutes and is given twice a year as a maintenance dose.

Multiple sclerosis is a disabling condition caused by your immune system mistakenly attacking and damaging the protective cover (myelin sheath) of nerves in your brain, spinal cord, and optic nerves. B cells and T cells are part of the immune system that are involved in causing damage to the myelin sheath.

How does Ocrevus Zunovo work?

Ocrevus Zunovo mechanism of action is believed to be targeting B cells, a type of white blood cell. It is thought that Ocrevus Zunovo works by binding to proteins called CD20 on the outside of B cells to destroy them. Less B cells in the body means less damage to the nerves and this helps to reduce the number of relapses and brain lesions and to slow progression of disability.

What is Ocrevus Zunovo used for?

Ocrevus Zunovo is a prescription medicine approved by the FDA to treat adults with:

• relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease.
• primary progressive MS (PPMS).

Ocrevus Zunovo became FDA-approved on September 13, 2024.

Ocrevus Zunovo Side Effects

Common Ocrevus Zunovo side effects

Common Ocrevus Zunovo side effects are injection reactions and cold symptoms such as stuffy nose, sneezing, sore throat which are symptoms of an upper respiratory tract infection.  These occurred in 10% or more patients and greater than Rebif, when used for RMS.

Common Ocrevus Zunovo side effects are lower respiratory tract infections, cold symptoms such as stuffy nose, sneezing, and sore throat, which are symptoms of an upper respiratory tract infection, skin infections, and also injection reactions.  These occurred ≥10% and > placebo), when used for PPMS.

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 the FDA at 1-800-FDA-1088.

Serious Ocrevus Zunovo side effects

Ocrevus Zunovo may cause serious allergic reactions. Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Ocrevus Zunovo may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, itchy, warm and tingly, or if you have a skin rash, headache, fast heartbeats, chest tightness, pain or irritation in your throat, or trouble breathing.

Call your doctor at once if you have:

• diarrhea or more frequent bowel movements than usual, or black, tarry, sticky or bloody stools, or stomach pain or tenderness;
• fast heartbeats, tiredness;
• headache, nausea, dizziness;
• itchy skin, rash, hives;
• fever, chills, cough;
• throat pain or irritation;
• wheezing, breathing problem, feeling short of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• skin sores, blisters, pus, or oozing;
• cold sores or fever blisters on or around your lips;
• nerve pain (tingling, burning pain, "pins and needles" feeling);
• mood or behavior changes, confusion, memory problems;
• weakness on one side of your body; or
• problems with speech, vision, or muscle movement.

Your Ocrevus Zunovo treatments may be delayed or permanently discontinued if you have certain side effects.

Warnings

Injection reactions (Ocrevus Zunovo): Injection reactions are a common side effect of Ocrevus Zunovo, which can be serious and may require you to be hospitalized. When you receive your Ocrevus Zunovo injection, you will be monitored for signs and symptoms of an injection reaction for at least 1 hour after your first injection and for at least 15 minutes after all injections following the first injection.

Tell your healthcare provider or nurse if you get any of these symptoms: itchy skin, trouble breathing, nausea, shortness of breath, rash, throat irritation or pain, headache, fatigue, hives, feeling faint, swelling of the throat, fast heartbeat, tiredness, fever, dizziness, coughing or wheezing or redness on your face (flushing), injection site pain, swelling and redness.

Injection reactions can happen during or up to 24 hours after administration. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection.

Infection: Infections are a common side effect. Ocrevus Zunovo increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus Zunovo, which can be life-threatening or cause death. 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 or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus Zunovo. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus Zunovo until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, 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 Zunovo. 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 Ocrevus Zunovo.

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

Who should not receive Ocrevus Zunovo?

Do not receive this medication if you have an active hepatitis B virus (HBV) infection.

Do not receive this medication if you have had a life-threatening allergic reaction to it. Tell your healthcare provider if you have had an allergic reaction to Ocrevus, Ocrevus Zunovo or any of its ingredients in the past.

Before receiving this medicine

Before receiving Ocrevus Zunovo, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See “Warnings”

• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.

• have ever had hepatitis B or are a carrier of the hepatitis B virus.

• have a history of inflammatory bowel disease or colitis.

• have had a recent vaccination or are scheduled to receive any vaccinations.

You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus Zunovo. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus Zunovo and until your healthcare provider tells you that your immune system is no longer weakened.

When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus Zunovo. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus or Ocrevus Zunovo, talk to your healthcare provider.

Pregnancy and breastfeeding

Tell your healthcare provider if you are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if this medicine 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.

How should I receive Ocrevus Zunovo?

Ocrevus Zunovo is given as a subcutaneous injection (under the skin) in the abdominal area, except for 2 inches (5 cm) around the navel. Do not administer injections into areas where the skin is red, bruised, tender, or hard or areas where there are moles or scars. 

Before every injection, you will be checked to see if you have an active infection. If you do, your injection will be delayed until the infection resolves.

Premedication

• Before treatment, your healthcare provider will give you a corticosteroid medicine and an antihistamine to help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help reduce infusion reactions. 
• Your first full dose of Ocrevus will be given as a subcutaneous injection in the abdomen over approximately 10 minutes.
• You will be monitored closely during injections, there should be access to appropriate medical support to manage severe injection reactions. For the initial dose, you will be monitored for at least one hour post-injection. For subsequent doses, you will be monitored for at least 15 minutes post-injection 

What happens if I miss a dose?

If you miss a dose of your injection, call your healthcare provider and reschedule your appointment to receive your missed dose as soon as possible. Do not wait until your next planned dose. After you receive your missed dose, reschedule your next dose for 6 months after your missed dose. Ocrevus doses must be separated by a minimum of 5 months.

Dosing information

Recommended Ocrevus Zunovo Dose

• is 920 mg/23,000 units (920 mg ocrelizumab and 23,000 units of hyaluronidase) administered as a single 23 mL subcutaneous injection in the abdomen over approximately 10 minutes every 6 months.

See Full Prescribing Information for further details about Ocrevus and Ocrevus Zunovo dosing.

Related/similar drugs

Ocrevus, Tecfidera, Betaseron, Briumvi, Rebif, Extavia, Copaxone, Aubagio, Gilenya, Avonex

Interactions

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.

Storage

• Store Ocrevus vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light.
• Do not freeze or shake
• Use prepared Ocrevus infusion solution immediately. If not used immediately, store up to 24 hours in the refrigerator at 2°C to 8°C (36°F to 46°F) and 8 hours at room temperature up to 25°C (77°F), which includes infusion time. In the event an intravenous infusion cannot be completed the same day, discard the remaining solution.

Keep out of sight and reach of children.

Ocrevus Zunovo Ingredients

Active ingredient: ocrelizumab and hyaluronidase-ocsq.

Inactive ingredients: glacial acetic acid, methionine, polysorbate 20, sodium acetate, trehalose, and water for injection.

Ocrevus Zunovo by Genentech

Ocrevus Zunovo are manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.

Ocrevus zunovo Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ocrevus Zunovo.

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Further information

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