Hyaluronidase and ocrelizumab

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

Hyaluronidase and ocrelizumab may also be used for reasons not mentioned in this medication guide.

Your doctor will perform tests to ensure hyaluronidase and ocrelizumab is the right treatment for you.

Hyaluronidase and ocrelizumab is given once every 6 months.

Hyaluronidase and ocrelizumab is injected under the skin. This medicine is given over 10 minutes, and a healthcare provider will administer this injection.

You will be closely monitored during and after receiving an injection to ensure you do not have serious side effects.

You may become more susceptible to infections, including serious or fatal infections. Your doctor will need to check your progress regularly, and you will require frequent medical tests.

You may be prescribed other medications to help prevent serious side effects of hyaluronidase and ocrelizumab. Take these medications as your doctor has instructed.

If you have had hepatitis B, it may return or worsen. You may need liver function tests while using this medicine and for several months after you stop.

You may be more likely to get infections, including serious or life-threatening infections. Contact your doctor if you experience flu symptoms, a cough, night sweats, neck stiffness, confusion, or vision problems.

If you have a history of hepatitis B, it may return or worsen. Inform your doctor if you feel unwell and have pain in the upper right side of your stomach, vomiting, loss of appetite, or yellowing of your skin or eyes.

Hyaluronidase and ocrelizumab can weaken your immune system, making it easier for you to get an infection or make an existing infection worse. Inform your doctor about any illness or infection you had in the past several weeks.

You should not be treated with hyaluronidase and ocrelizumab if you are allergic to it or any of its ingredients, or if you have:

• a severe reaction to ocrelizumab; or
• an active infection with hepatitis B.

Tell your doctor if you have or have ever had:

• an active or chronic infection;
• a weak immune system (due to disease or certain medicines);
• hepatitis B or if you are a carrier of hepatitis B;
• received a vaccine in the past 4 weeks or are scheduled to receive a vaccine; or
• inflammatory bowel disease or colitis.

Ensure you are up to date on all vaccines before you start using hyaluronidase and ocrelizumab.

Using hyaluronidase and ocrelizumab may increase your risk of developing certain types of cancer, such as breast cancer. Discuss your specific risk with your doctor.

It is not known if hyaluronidase and ocrelizumab will harm an unborn baby. Inform your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while receiving hyaluronidase and ocrelizumab and for at least 6 months after your last dose.

Inform your baby's doctor if you used hyaluronidase and ocrelizumab during pregnancy, as it could affect your baby's vaccination schedule.

Ask a doctor if it is safe to breastfeed while receiving hyaluronidase and ocrelizumab.

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

Some side effects may happen during the injection or within 24 hours after. Tell your medical caregivers if you feel dizzy, tired, nauseous, have a fever, itchiness, redness on your face, or if you have a skin rash, headache, fast heartbeats, tightness in your chest, pain or irritation in your throat, or trouble breathing.

Hyaluronidase and ocrelizumab may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thinking, vision, or muscle movement. These symptoms can worsen quickly.

You may get infections more easily, including serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• signs of shingles--flu-like symptoms, a tingling or painful blistering rash on one side of your body;
• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• cold sores, skin rash, pain, itching, sores on your genital or anal area;
• vision changes, eye pain or redness, severe headache, stiff neck, or confusion;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough, or rapid weight loss.

Hyaluronidase and ocrelizumab may cause serious side effects. Call your doctor immediately if you have:

• diarrhea, more frequent bowel movements than usual, black, tarry, sticky or bloody stools, or severe stomach pain or tenderness.

Your treatments may be delayed or stopped permanently if you have certain side effects.

Common side effects of hyaluronidase and ocrelizumab may include:

• pain, bruising, swelling, or irritation where the medicine was injected;
• headache, nausea;
• skin infections; or
• cold symptoms such as a 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.

Usual Adult Dose for Multiple Sclerosis:

23 mL (920 mg ocrelizumab and 23,000 units hyaluronidase) subcutaneously over approximately 10 minutes every 6 months Comments:-This drug has different dosage and administration instructions than IV ocrelizumab.Uses:-Relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease -Primary progressive MS

Call your doctor for instructions if you miss an appointment for your Hyaluronidase and 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 hyaluronidase and ocrelizumab or within 4 weeks before you start using hyaluronidase and ocrelizumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Ask your doctor before receiving a "live" vaccine after your treatment ends.

Do not receive a "non-live" vaccine while using hyaluronidase and 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 your other medicines, especially:

• medicines that weaken the immune system; or
• medicines used to treat multiple sclerosis.

Other drugs may affect hyaluronidase and ocrelizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.