Hyaluronidase and ocrelizumab
Generic name: hyaluronidase and ocrelizumab [ HYE-al-ure-ON-i-dase-- OK-re-LIZ-ue-mab ]
Brand name: Ocrevus Zunovo
Dosage form: subcutaneous solution (ocsq 23,000 units-920 mg /23 mL)
Drug class: CD20 monoclonal antibodies
What is 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 purposes not listed in this medication guide.
Hyaluronidase and ocrelizumab 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.
Some side effects may occur during the injection or up to 24 hours later. Tell your medical caregivers if you feel dizzy, tired, nauseated, have a fever, itchy, redness on your face, or if you have a skin rash, headache, fast heartbeats, chest tightness, 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, thought, vision, or muscle movement. These symptoms can get worse quickly.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
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signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body;
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fever, chills, sore throat;
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mouth sores, red or swollen gums;
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cold sores, skin rash, pain, itching, sores on your genital or anal area;
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vision changes, eye pain or redness, severe headache, stiff neck, or confusion;
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pale skin, easy bruising, unusual bleeding; or
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chest discomfort, wheezing, dry cough or hack, rapid weight loss.
Hyaluronidase and ocrelizumab may cause serious side effects. Call your doctor at once if you have:
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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 permanently discontinued if you have certain side effects.
Common side effects of hyaluronidase and ocrelizumab may include:
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pain, bruising, swelling, or irritation where the medicine was injected;
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headache, nausea;
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skin infections; or
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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.
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Warnings
You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.
If you've had hepatitis B, it may come back or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.
Before taking this medicine
Hyaluronidase and ocrelizumab can weaken your immune system, making it easier for you to get an infection or worsen an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.
You should not be treated hyaluronidase and ocrelizumab if you are allergic to it or any of its ingredients, or if you have:
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a severe reaction to ocrelizumab; or
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active infection with hepatitis B.
Tell your doctor if you have or have ever had:
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an active or chronic infection;
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a weak immune system (caused by disease or by using certain medicine);
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hepatitis B or if you are a carrier of hepatitis B;
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recently received a vaccine in the past 4 weeks or are scheduled to receive a vaccine; or
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inflammatory bowel disease or colitis.
Make sure you are current 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. Ask your doctor about your specific risk.
It is not known if hyaluronidase and 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 receiving hyaluronidase and ocrelizumab and for at least 6 months after your last dose.
Tell your baby's doctor if you used hyaluronidase and ocrelizumab during pregnancy. It could affect your baby's vaccination schedule.
Ask a doctor if it is safe to breastfeed while receiving hyaluronidase and ocrelizumab.
How is hyaluronidase and ocrelizumab given?
Your doctor will perform tests to make sure 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 give you this injection.
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 may be given other medications to help prevent serious side effects of hyaluronidase and ocrelizumab. 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.
Hyaluronidase and ocrelizumab dosing information
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
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your hyaluronidase and ocrelizumab injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving hyaluronidase and ocrelizumab?
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.
What other drugs will affect hyaluronidase and ocrelizumab?
Tell your doctor about all your other medicines, especially:
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medicines that weaken the immune system; or
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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.
Hyaluronidase/ocrelizumab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for hyaluronidase/ocrelizumab.
Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) - Genentech, Inc.
Formulation type | Strength |
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Single-Dose Vial | 920 mg/23 mL; 23,000 units/23 mL (40 mg/1,000 units/mL) |
View Ocrevus Zunovo information in detail.
More about hyaluronidase / ocrelizumab
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- Drug class: CD20 monoclonal antibodies
- En español
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