Ocrelizumab

Ocrelizumab is a prescription medicine used to treat relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in certain adults and children.

Ocrelizumab is administered 2 times a year (every 6 months), after initial dosing. Ocrelizumab IV infusion (brand name: Ocrevus) is administered over 2 to 3.5 hours, and ocrelizumab and hyaluronidase subcutaneous injection (brand name: Ocrevus Zunovo) is administered under the skin over approximately 10 minutes.

Ocrelizumab works by targeting and removing CD20-positive B cells, which are involved in MS-related inflammation. This helps to decrease immune activity against nerves in the central nervous system, which may help reduce MS relapses and disease activity.

Ocrelizumab class of medicines called CD20-directed cytolytic monoclonal antibodies.

Ocrelizumab infusion FDA-approved uses

Ocrelizumab infusion is FDA-approved to be used for:

• Relapsing forms of multiple sclerosis in adults, including:
• Primary progressive MS, or PPMS, in adults
• Relapsing-remitting MS in pediatric patients who are 10 years of age or older and weigh 55 pounds, or 25 kg, or more

Ocrelizumab with hyaluronidase injection FDA-approved uses

Ocrelizumab with hyaluronidase is FDA-approved for adults with:

• Relapsing forms of MS, including CIS, RRMS, and active SPMS
• Primary progressive MS

Ocrelizumab with hyaluronidase is not approved for use in children.

Both ocrelizumab and ocrelizumab plus hyaluronidase are medicines used to treat certain forms of multiple sclerosis. The main difference is how they are given.

Ocrelizumab is given as an intravenous (IV) infusion. Infusion time can vary depending on the dose and a person’s treatment history, but is usually given over about 2 to 3.5 hours.

Ocrelizumab plus hyaluronidase is given as a subcutaneous injection, meaning it is injected under the skin. It contains ocrelizumab plus hyaluronidase, an added ingredient that helps the medicine spread and absorb under the skin. It is given by a healthcare professional in the abdomen over about 10 minutes.

Ocrelizumab Infusion

• Ocrelizumab is given as an infusion into a vein. A healthcare provider will give you this injection.
• Your first dose of ocrelizumab will be split into 2 separate infusions given 2 weeks apart. The following doses will be given once every 6 months.
• Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ocrelizumab.
• This medicine must be given slowly, and the infusion can take from 2 to 3.5 hours to complete.
• You may be given other medications to help prevent serious side effects of ocrelizumab.
• 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.
• Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
• If you've ever had hepatitis B, this virus may become active or get worse during treatment with ocrelizumab or in the months after you stop using this medicine. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Ocrelizumab with hyaluronidase injection

• Ocrelizumab with hyaluronidase injection is given every 6 months by subcutaneous injection.
• This medicine is given over 10 minutes and will be given to you by a healthcare provider.
• Ocrelizumab with hyaluronidase is injected under the skin of your abdomen, except for 2 inches (5 cm) around your navel.
• This medicine should not be injected into areas of the skin that are red, bruised, hard or where there are moles or scars.
• You will be watched closely during and after receiving an injection to make sure you do not have serious side effects.
• You may get infections more easily, even serious or fatal infections. Your doctor will need to check your progress on a regular basis, and you will need frequent medical tests.
• You will be given other medications to help prevent serious side effects of Ocrelizumab with hyaluronidase injection at least 30 minutes before your injection. Take these medicines as your doctor has prescribed.
• 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.

Ocrelizumab 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 ocrelizumab infusion or up to 24 hours later. Tell your caregiver if you feel dizzy, nauseated, itchy, or have chest tightness, throat irritation, or trouble breathing.

Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, skin sores or blisters, itching, tingling, burning pain, or problems with speech, thought, vision, or muscle movement.

If you've ever had hepatitis B, it may become active or get worse while you are using or after you stop using ocrelizumab. You may need frequent liver function tests for several months.

This medicine may increase the risk of certain cancers, including breast cancer.

Serious liver injury has occurred in some people, without viral hepatitis, while using this medicine.

In rare cases, inflammation of the colon has been reported.

You should not be treated with ocrelizumab if you are allergic to it, 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
• have any type of infection
• are a carrier of hepatitis B, or
• have ever used medicine that can weaken your immune system.

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

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 at least 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ocrelizumab on the baby.

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

Common ocrelizumab side effects may include:

• skin infections;
• reactions to an injection; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ocrelizumab may cause a brain infection called Progressive multifocal leukoencephalopathy (PML), 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 heart beats, 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 ocrelizumab treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ocrelizumab Intravenous Infusion

Initial Adult Ocrelizumab Dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusionMaintenance Adult Ocrelizumab doses: 600 mg intravenous infusion every 6 monthsGeneral dosing information:

• 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.

The pediatric ocrelizumab infusion dose is based on the child's weight. See prescribing information for more details.

Ocrelizumab with hyaluronidase Subcutaneous Injection

• Inject 23 mL Ocrelizumab with hyaluronidase (920 mg ocrelizumab and 23,000 units hyaluronidase) subcutaneously over approximately 10 minutes every 6 months.
• DO NOT administer the remaining priming volume in the subcutaneous infusion set to the patient.

Comments:

• Ocrelizumab with hyaluronidase subcutaneous injection has different dosage and administration instructions than ocrelizumab IV infusion.

Call your doctor for instructions if you miss an appointment for your ocrelizumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using ocrelizumab or within 4 weeks before you start using ocrelizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Do not receive a "non-live" vaccine while using ocrelizumab or within 2 weeks before you start using this medicine. Non-live vaccines include hepatitis A, polio, rabies, and a yearly flu shot.

Tell your doctor about all other medicines you have recently used to treat multiple sclerosis.

Other drugs may interact with ocrelizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.