Generic Name: ocrelizumab (OK re LIZ ue mab)
Brand Name: Ocrevus
What is ocrelizumab?
Ocrelizumab is used to treat multiple sclerosis (relapsing or progressive forms).
Ocrelizumab may also be used for purposes not listed in this medication guide.
Ocrelizumab may cause unpleasant side effects while the medicine is injected, or up to 24 hours later. Tell your caregivers if you have unpleasant side effects such as dizziness, nausea, skin rash, chest tightness, or trouble breathing within 24 hours after your injection.
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.
Before taking this medicine
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 any type of active 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.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
How is ocrelizumab given?
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.
This medicine must be given slowly, and the infusion can take from 2.5 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. Your doctor will need to examine you on a regular basis.
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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your 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 ocrelizumab?
Do not receive a "live" vaccine while using ocrelizumab or within 4 weeks before you start using ocrelizumab. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Ask your doctor before getting a yearly flu shot while you are being treated with ocrelizumab.
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 caregiver right away if you feel dizzy, sleepy, nauseated, light-headed, feverish, sweaty, itchy, or have a red skin rash, headache, fast heartbeats, chest tightness, trouble breathing, or swelling and irritation in your throat.
Call your doctor at once if you have:
fever, chills, cough with yellow or green mucus;
stabbing chest pain, wheezing, feeling short of breath;
skin warmth, redness, itching, or swelling;
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 side effects may include:
reactions to an injection; or
respiratory infections (affecting the nose, sinuses, throat, or lungs).
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 dosing information
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
Manufacturer recommended infusion rates (consult manufacturer product information):
-Infusions 1 and 2 (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 (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
-Prior to initiating therapy, perform Hepatitis B virus (HBV) screening. For patients who are negative for surface antigen (HBsAg) and positive for HB core antibody (HBcAb+) or are carriers of HBV (HBsAg+), consult liver disease experts before starting and during therapy.
-Premedicate patients with methylprednisolone (or equivalent) 100 mg IV approximately 30 minutes prior to each infusion and an antihistamine (e.g., diphenhydramine) 30 to 60 minutes prior to each infusion. The addition of an antipyretic (e.g., acetaminophen) may also be considered.
-Observe the patient for at least one hour after the completion of the infusion.
-If an infusion is missed, administer it as soon as possible; do not wait until the next scheduled dose. Reset the dose schedule to administer the next sequential dose 6 months after the missed dose is administered. Separate doses by at least 5 months.
Use: For relapsing or primary progressive forms of multiple sclerosis (MS)
What other drugs will affect ocrelizumab?
Tell your doctor about all other medicines you have recently used to treat multiple sclerosis.
Other drugs may affect 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 4.01.
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- Drug class: CD20 monoclonal antibodies
Other brands: Ocrevus