Ocrelizumab (Intravenous route)
Uses of This Medicine:
Ocrelizumab injection is used to treat the relapsing forms or primary progressive forms of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ocrelizumab injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of alemtuzumab injection have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of ocrelizumab injection in the elderly are not expected.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer or
- Weak immune system—Use with caution. May increase risk for more serious side effects.
- Hepatitis B infection—Should not be used in patients with this condition.
- Infection—May decrease your body's ability to fight infection.
Proper Use of This Medicine:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Precautions While Using This Medicine:
It is very important that your doctor check you at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.
This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have cough, difficulty with swallowing, dizziness, fast heartbeat, trouble with breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving this medicine.
This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
While you are being treated with ocrelizumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should receive live vaccines for at least 6 weeks before starting treatment with this medicine. Ocrelizumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Using this medicine may increase your risk of getting cancer (including breast cancer). Talk to your doctor if you have concerns about this risk.
It is important to tell your doctor if you are pregnant or planning to become pregnant. Use effective birth control during treatment and for 6 months after your treatment ends.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Back pain
- blurred vision
- body aches or pain
- chest tightness
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- hives, itching, or skin rash
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- loss of voice
- nasal congestion
- nausea and vomiting
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sore throat
- trouble breathing
- unusual tiredness or weakness
- Less common
- Burning or stinging of the skin
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- Incidence not known
- More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- rapid weight gain
- tingling of the hands or feet
- trouble concentrating
- trouble sleeping
- unusual weight gain or loss
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017