Ocrelizumab and hyaluronidase-ocsq injection

Ocrelizumab and hyaluronidase-ocsq injection is used to treat various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control. Ocrelizumab is in a class of medications called monoclonal antibodies. It works by stopping certain cells of the immune system from causing damage. Hyaluronidase is in a class of medications called endoglycosidase. It helps to keep ocrelizumab in the body longer so that the medication will have a greater effect.

Ocrelizumab and hyaluronidase-ocsq injection comes as a solution (liquid) to be given subcutaneously (under the skin) by a doctor or nurse at a hospital or clinic. It is usually over 10 minutes every 6 months.

Ocrelizumab and hyaluronidase-ocsq injection may cause serious reactions during an infusion and up to a day after receiving the infusion. You will be given other medications to help prevent reactions to ocrelizumab and hyaluronidase-ocsq. A doctor or nurse will watch you closely while receiving the infusion and for at least 1 hour afterwards (for the first dose and 15 minutes after future doses) to provide treatment in case of certain side effects to the medication. Your doctor may temporarily or permanently stop your treatment or decrease the dose, if you experience certain side effects. Tell your doctor or nurse if you experience any of the following during or within 24 hours after your infusion: rash; itching; hives; redness at the injection site; difficulty breathing or swallowing; cough; wheezing; feeling faint; throat irritation; mouth or throat pain; shortness of breath; swelling of the face, eyes, mouth, throat, tongue, or lips; flushing; fever; fatigue; tiredness; headache; dizziness; nausea; or a racing heartbeat. Call your doctor immediately or get immediate emergency medical attention if you experience any of these symptoms after you leave your doctor's office or medical facility.

Ocrelizumab and hyaluronidase-ocsq injection controls multiple sclerosis symptoms but does not cure it. Your doctor will watch you carefully to see how well ocrelizumab works for you. It is important to tell your doctor how you are feeling during your treatment.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving ocrelizumab and hyaluronidase-ocsq,

• tell your doctor and pharmacist if you are allergic to ocrelizumab, hyaluronidase, any other medications, or any of the ingredients in ocrelizumab and hyaluronidase-ocsq injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• make sure you have discussed any medications you are currently taking or plan to take before starting ocrelizumab and hyaluronidase-ocsq with your doctor and pharmacist. Before starting, stopping, or changing any medications while receiving ocrelizumab and hyaluronidase-ocsq, please get the advice of your doctor or pharmacist.
• tell your doctor if you have an infection with hepatitis B virus (HBV; a virus that infects the liver and may cause severe liver damage or liver cancer. Your doctor will probably tell you not to receive ocrelizumab and hyaluronidase-ocsq.
• tell your doctor if you have any type of infection before you begin treatment with ocrelizumab and hyaluronidase-ocsq. Also tell your doctor if you have or have ever had inflammatory bowel disease (IBD; a group of conditions that cause swelling of the lining of the intestines) such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Use effective birth control during your treatment with ocrelizumab and for 6 months after the final dose. If you become pregnant while receiving ocrelizumab, call your doctor. If you receive ocrelizumab injection during your pregnancy, be sure to talk to your baby's doctor about this after your baby is born. Your baby may need to delay receiving certain vaccines.
• tell your doctor if you have had a recent vaccination or are scheduled to receive any vaccinations. You may need to receive certain types of vaccines at least 4 weeks before and others at least 2 weeks before you start treatment with ocrelizumab injection. Do not have any vaccinations without talking to your doctor during your treatment.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of ocrelizumab and hyaluronidase-ocsq injection, call your doctor to reschedule it as soon as possible. Then resume the every 6 months dosing schedule after that.

Ocrelizumab and hyaluronidase-ocsq may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling or pain in hands, arms, legs, or feet

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, chills, persistent cough, or other signs of infection
• mouth sores
• shingles (a rash that can occur in people who have had chickenpox in the past)
• sores around the genitals or rectum
• skin infection
• changes in vision, severe or persistent headache, confusion, eye redness or eye pain, or stiff neck
• weakness on one side of the body; clumsiness of arms and legs; vision changes; changes in thinking, memory, and orientation; confusion; or personality changes
• diarrhea or more frequent, loose stools; stools that are black, tarry or sticky or have blood in them; abdominal pain or tenderness

Ocrelizumab and hyaluronidase-ocsq may increase your risk of certain cancers, including breast cancer. Talk to your doctor about the risks of receiving this medication.

Ocrelizumab and hyaluronidase-ocsq may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ocrelizumab and hyaluronidase-ocsq.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Ocrevus Zunovo^®