Ocrevus Zunovo

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) is the injection form of Ocrevus, used to treat relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS) in adults. It is given as a 10-minute subcutaneous (under-the-skin) injection every 6 months.

Ocrevus Zunovo is a disease-modifying therapy (DMT) that lowers the number of B cells, white blood cells that are thought to help cause the nerve damage in MS. It contains the same medicine as Ocrevus, ocrelizumab, plus hyaluronidase, an enzyme that helps the medicine spread and be absorbed under the skin. Ocrevus Zunovo is a type of immunotherapy, not chemotherapy.

Ocrevus Zunovo at a glance

• Drug class: CD20 monoclonal antibody (a biologic)
• How it is given: injection under the skin of the abdomen, by a healthcare professional
• How often: 1 injection every 6 months, including the first dose
• Injection time: about 10 minutes
• Who can use it: adults only
• FDA approved: September 2024

Ocrevus Zunovo is FDA-approved to treat adults with:

• Relapsing forms of multiple sclerosis, including: Clinically isolated syndrome (CIS) Relapsing-remitting MS (RRMS) Active secondary progressive MS (active SPMS)
• Primary progressive MS (PPMS)

Ocrevus Zunovo is not approved for use in children. Ocrevus, given as an IV infusion, is approved for some children 10 years and older with relapsing-remitting MS.

Ocrevus Zunovo is injected under the skin in about 10 minutes, while Ocrevus is given as an IV infusion into a vein that takes about 2 to 3.5 hours or longer. Both contain ocrelizumab, both are given every 6 months, and both are given by a healthcare professional.

• First dose: Ocrevus Zunovo starts with a single injection. Ocrevus IV starts with 2 infusions given 2 weeks apart.
• Medicines before each dose: for Ocrevus Zunovo, these are taken by mouth. For Ocrevus IV, the corticosteroid is given into a vein.
• Who can use it: Ocrevus Zunovo is for adults only. Ocrevus IV is also approved for some children.

Learn more about Ocrevus infusion, or compare Ocrevus vs. Ocrevus Zunovo side by side.

• Ocrevus Zunovo is given by a healthcare professional as an injection under the skin (subcutaneous injection) of your abdomen, over about 10 minutes. It is not injected at home.
• It is not injected within 2 inches (5 cm) of your navel, or into skin that is red, bruised, tender, or hard, or that has moles or scars.
• Before your first injection, your healthcare provider will do blood tests to check for hepatitis B, measure the antibodies (immunoglobulins) in your blood, and check your liver function. Any vaccines you need should be given before you start treatment.
• Before every injection, you will be checked for an active infection. If you have one, your injection will be delayed until the infection goes away.
• At least 30 minutes before each injection, you will take a corticosteroid (such as dexamethasone) and an antihistamine (such as desloratadine) by mouth to help reduce injection reactions. You may also be given a fever reducer, such as acetaminophen.
• You will be watched closely for at least 1 hour after your first injection and for at least 15 minutes after later injections.
• Injection reactions can happen during the injection or up to 24 hours afterward. After you go home, call your healthcare provider if you have symptoms such as redness, pain, swelling, or itching where the shot was given, headache, nausea, rash, or trouble breathing.
• You will receive 1 injection every 6 months.

Injection reactions: 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 the injection. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after an injection.

Infection: Infections are a common side effect. Ocrevus Zunovo increases 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.

Risk of cancers: There is a risk of cancers (malignancies), including breast cancer, with this medication. Follow your healthcare provider's instructions about standard screening guidelines for breast cancer.

Immune-mediated colitis: Inflammation of the colon (colitis), which can be severe and start suddenly, has been reported with ocrelizumab. Some people needed treatment in the hospital, and a few needed surgery. This can happen weeks to years after starting treatment. Tell your healthcare provider right away if you develop new or ongoing diarrhea, stomach pain, or other stomach or bowel symptoms so you can be checked promptly.

Liver damage: Ocrevus Zunovo may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus Zunovo and while you take it if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as yellowing of the skin and eyes (jaundice), nausea, vomiting, unusual darkening of the urine, or feeling tired or weak.

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 administration reaction to ocrelizumab, or a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of Ocrevus Zunovo. 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 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 a history of liver problems.
• 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 Zunovo, talk to your healthcare provider.

Pregnancy

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

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

Breastfeeding

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

Common Ocrevus Zunovo side effects

Common Ocrevus Zunovo side effects are injection reactions, respiratory tract infection and skin infections.

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.

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.

Recommended Ocrevus Zunovo dose

The recommended dose is 920 mg ocrelizumab and 23,000 units hyaluronidase, given as a single 23 mL injection under the skin of the abdomen over about 10 minutes, every 6 months. There is no split first dose.

Ocrevus Zunovo has different dosage and administration instructions than Ocrevus IV, and the two are not interchangeable.

If you miss a dose of Ocrevus Zunovo, 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, your next dose will be scheduled 6 months later. Ocrevus Zunovo doses must be at least 5 months apart.

Since Ocrevus Zunovo is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

In case of overdose, call the poison control helpline at 1-800-222-1222. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store Ocrevus Zunovo vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze or shake.
• If necessary, vials can be removed from the refrigerator and put back.
• Unopened vials may be kept in the original carton without refrigeration at up to 25°C (77°F) for a total of up to 12 hours.

Keep out of sight and reach of children.

Active ingredient: ocrelizumab and hyaluronidase-ocsq.

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

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