Ocrelizumab is a recombinant humanized monoclonal antibody.

Ocrelizumab intravenous infusion is a prescription medicine used to treat primary progressive multiple sclerosis in adults.

Ocrelizumab is also used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

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.

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.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 300 mg IV followed 2 weeks later by a second 300 mg IV infusion
Maintenance dose: 600 mg IV every 6 months

RECOMMENDED INFUSION RATES:
INFUSION 1: (300 mg of this drug in 250 mL 0.9% sodium chloride injection): Start at 30 mL/hr and increase by 30 mL/hr every 30 minutes to a maximum of 180 mL/hr; duration of 2.5 hours or longer
INFUSION 2 (TWO WEEKS LATER): (300 mg of this drug in 250 mL 0.9% sodium chloride injection): Start at 30 mL/hr and increase by 30 mL/hr every 30 minutes to a maximum of 180 mL/hr; duration of 2.5 hours or longer
SUBSEQUENT INFUSIONS:
-OPTION 1 (600 mg of this drug in 500 mL 0.9% sodium chloride injection): Start at 40 mL/hr and increase by 40 mL/hr every 30 minutes to a maximum of 200 mL/hr; duration of 3.5 hours or longer
OR
-OPTION 2 if no prior serious infusion reaction (600 mg of this drug in 500 mL 0.9% sodium chloride injection): Start at 100 mL/hr for the first 15 minutes and increase to 200 mL/hr for the next 15 minutes; increase to 250 mL/hr for the next 30 minutes; increase to 300 mL/hr for the remaining 60 minutes; duration of 2 hours or longer

Uses:
-For relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
-Primary progressive MS

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;

• you have any type infection;

• you are a carrier of hepatitis B; or

• you 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.

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.

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 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.

Common ocrelizumab side effects may include:

• skin infections;

• reactions to an injection; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

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.