Ocrevus

Ocrevus (ocrelizumab) is a prescription biologic medicine used to treat relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS).

Ocrevus infusion is a disease-modifying therapy (DMT) that was shown in clinical trials to reduce MS relapses (flare-ups), slow the worsening of disability, and reduce new areas of nerve damage (lesions) seen on brain MRI scans. Ocrevus is a type of immunotherapy, not chemotherapy.

Ocrevus is given as an intravenous (IV) infusion every 6 months to adults with relapsing MS or PPMS, and to children 10 years and older with relapsing-remitting MS who weigh at least 25 kg (55 pounds).

Ocrevus works by lowering the number of B cells, white blood cells that are thought to help cause the nerve damage in MS. Lowering B cells helps reduce inflammation and damage to the nerves. Ocrevus attaches to a protein on B cells called CD20, so it is known as a CD20 monoclonal antibody. Learn more about how Ocrevus works for MS.

Ocrevus infusion at a glance

• Drug class: CD20 monoclonal antibody (a biologic)
• How it is given: IV infusion by a healthcare professional
• How often: 2 infusions 2 weeks apart to start, then 1 infusion every 6 months
• Infusion time: about 2.5 hours or longer for the first doses; about 2 or 3.5 hours for later doses
• Subcutaneous form: Ocrevus Zunovo is a 10-minute injection under the skin every 6 months, for adults only
• FDA approved: 2017

Ocrevus is FDA-approved to be used for:

• Relapsing forms of multiple sclerosis in adults, including: Clinically isolated syndrome, or CIS Relapsing-remitting MS, or RRMS Active secondary progressive MS, or active SPMS
• Primary progressive multiple sclerosis (PPMS) in adults
• Relapsing-remitting MS in pediatric patients who are 10 years of age or older and who weigh at least 25 kg (55 pounds).

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) is FDA-approved for adults with:

• Relapsing forms of MS, including CIS, RRMS, and active SPMS
• Primary progressive MS
• Ocrevus Zunovo is not approved for use in pediatric patients.

Ocrevus infusion and Ocrevus Zunovo contain the same medicine, ocrelizumab, and both are given every 6 months. The main difference is how they are given. Ocrevus is an intravenous (IV) infusion that takes about 2 to 3.5 hours or longer, while Ocrevus Zunovo is an injection under the skin that takes about 10 minutes.

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

Ocrevus infusion

• Ocrevus infusion is given through a needle placed in your vein (intravenous (IV) infusion) in your arm.
• Before your first infusion, 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 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. See the Warnings section.
• Your first full dose of Ocrevus will be given as 2 separate infusions, 2 weeks apart.
• Each infusion must be given slowly, and the infusion can take about 2 to 3.5 hours or longer to complete.
• You will be watched closely for at least 1 hour after receiving ocrelizumab to make sure you do not have an allergic reaction to the medication.
• Infusion reactions can happen during the infusion or up to 24 hours afterward. After you go home, call your healthcare provider if you have symptoms such as itching, rash, flushing, throat irritation, headache, fever, nausea, fast heartbeat, or trouble breathing.
• Your maintenance doses of Ocrevus will be given as 1 infusion every 6 months.
• This medicine affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
• If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

Ocrevus Zunovo

• Ocrevus Zunovo is given by a healthcare provider as an injection under the skin of your abdomen over about 10 minutes, every 6 months.
• See How should I receive Ocrevus Zunovo? for details about the injection, premedication, and monitoring.

Infusion or injection reactions: Infusion or injection reactions can occur, which can be serious and may require you to be hospitalized. When you receive your Ocrevus infusion or Ocrevus Zunovo, you will be monitored for signs and symptoms of an infusion reaction or injection reaction, and it will be interrupted or stopped if any symptoms occur. Appropriate supportive treatment will be administered if necessary.

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.

Infusion or 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: This medicine has an increased risk of upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious bacterial, viral, parasitic, and fungal infections can occur, 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. Tell your healthcare provider right away if you have symptoms of 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 medicine, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a 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 Ocrevus.

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

Malignancies: Ocrevus may increase the risk of certain cancers, including breast cancer. Follow standard breast cancer screening guidelines.

Immune-mediated colitis: In rare cases, inflammation of the colon has been reported. Tell your healthcare provider if you develop new or ongoing diarrhea, stomach pain, or other gastrointestinal signs and symptoms so you can be evaluated promptly.

Liver injury: Serious liver injury has occurred in some people, without viral hepatitis, while using this medicine. Blood tests to check liver function should be done before Ocrevus treatment and may be repeated during treatment if needed. Tell your healthcare provider if you have any symptoms of liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. Ocrevus may be stopped if there are signs of liver injury and another cause isn’t found.

You should not be treated with this medicine if you are allergic to the active ingredient ocrelizumab or any of the inactive ingredients, or if you have:

• active infection with hepatitis B.

Your doctor may perform tests to make sure you do not have hepatitis B or other infections.

You should not receive any "live" or "live-attenuated" vaccine within the 4 weeks before you start treatment with ocrelizumab. If you need a "non-live" vaccine, you should receive it at least 2 weeks before you start treatment with ocrelizumab.

Also, tell your doctor if you have:

• ever had colitis or inflammatory bowel disease
• any type of infection in the past several weeks
• ever used medicine that can weaken your immune system
• are a carrier of hepatitis B

Using this medicine may increase your risk of developing certain types of cancer, such as breast cancer. Ask your doctor about your specific risk.

Pregnancy

It is not known whether ocrelizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for 6 months after your last dose.

If you are pregnant, you will need to tell your baby's doctor if you used ocrelizumab during pregnancy, especially before the baby receives any childhood vaccines.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

• 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 the active ingredient ocrelizumab or any of the inactive ingredients in this medicine.

Common Ocrevus side effects

The most common Ocrevus side effects are stuffy nose, sneezing, sore throat, infusion reactions, injection site reactions, and skin infections.

Serious side effects

Ocrevus may cause serious side effects, including severe allergic reactions, brain infections (progressive multifocal leukoencephalopathy (PML)), other serious infections, hepatitis B virus (HBV) reactivation, and decreased immunoglobulins.

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.

Some side effects may occur during the infusion or 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.

Progressive multifocal leukoencephalopathy (PML): Ocrevus 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.

Ocrevus may cause other serious side effects. 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 treatments may be delayed or permanently discontinued if you have certain side effects.

Also, see the Warnings and Precautions section.

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.

With the Ocrevus copay card, you may pay as little as $0, depending on your health insurance plan. Find out who qualifies for Ocrevus copay assistance and how to apply, or see the Ocrevus price guide for links to the Ocrevus Co-pay Program and start form. If you are paying without insurance, see How much does Ocrevus cost?

Adult Ocrevus intravenous infusion

Initial adult Ocrevus infusion dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusionMaintenance adult Ocrevus infusion doses: 600 mg intravenous infusion every 6 months

Pediatric Ocrevus intravenous infusion

Pediatric patients 10 years and older with relapsing-remitting MS

Your child's healthcare provider will choose the dose based on your child's weight.

General dosing information (adults and children)

• Must be diluted before administration.
• You will be monitored closely during and for at least one hour after infusion.
• Before your first treatment, you should have hepatitis B virus and quantitative serum immunoglobulin screening.
• Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) before each infusion.

Dose modifications

If you have an infusion reaction, your infusion may be slowed down or paused until your symptoms go away. This makes the infusion take longer, but you still receive the full dose. Ocrevus will be stopped permanently if you have a life-threatening or disabling infusion reaction.

Ocrevus Zunovo subcutaneous injection

The recommended Ocrevus Zunovo dose is 920 mg ocrelizumab and 23,000 units hyaluronidase, given as a single injection under the skin every 6 months. Ocrevus Zunovo has different dosage and administration instructions than Ocrevus IV. See Ocrevus Zunovo dosage information.

What happens if I miss a dose?

If you miss a dose of Ocrevus, 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.

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.

Review the Ocrevus Package Insert or Ocrevus Zunovo Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Ocrevus J code is J2350. Ocrevus is available as ocrelizumab 300 mg single-dose vial for IV infusion.

Ocrevus Zunovo J code is J2351. Ocrevus Zunovo is available as ocrelizumab 920 mg and hyaluronidase-ocsq 23,000 units/23 mL for subcutaneous injection.

Multiple sclerosis ICD-10-CM G35

Ocrevus

• 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.

Ocrevus Zunovo

• See Ocrevus Zunovo storage information.

Keep out of sight and reach of children.

Ocrevus

Active ingredient: ocrelizumab.Inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate trihydrate, trehalose dihydrate.

Ocrevus Zunovo

See Ocrevus Zunovo ingredients.

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