Pronunciation:

ok-re-LIZ-ue-mab

Brand Names:

• Ocrevus

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Modulator

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Ocrelizumab injection is used to treat the relapsing forms (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) 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 to be given only by or under the direct supervision of your doctor.

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:

Allergies—

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.

Children—

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.

Older adults—

Appropriate studies on the relationship of age to the effects of ocrelizumab 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.

Breast-feeding—

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.

Other medicines—

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

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, active or
• Infusion reaction, history of—Should not be used in patients with this condition.

• Hepatitis B infection, history of—Use with caution. May make this condition worse.

• Infection, active—Should be treated first before receiving this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

You will receive your first dose of this medicine in 2 doses, given at least 2 weeks apart. Each infusion is given for at least 2 hours and 30 minutes. You will receive your next doses as 1 infusion every 6 months. These infusions are given for at least 2 hours or 3 hours and 30 minutes. Your doctor will decide how long you will receive the infusion.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine, steroid) before each infusion of this medicine to prevent unwanted effects. Your doctor may also want you to stay for at least 1 hour after infusion to check for unwanted effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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 requires immediate medical attention. Tell your doctor right away if you start to have a cough, difficulty with swallowing, sore throat, dizziness, headache, nausea, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, skin itching, redness, rash, or hives, lightheadedness or faintness, or unusual tiredness or weakness while you are receiving this medicine.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 6 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may increase your risk of developing infections. 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.

Check with your doctor right away if you have ear congestion, chills, cough, chest tightness, fever, sneezing, sore throat, body aches or pain, headache, loss of voice, runny or stuffy nose, unusual tiredness or weakness, or trouble breathing. These could be symptoms of a lung infection.

This medicine may increase your risk for herpes infection. Tell your doctor right away if you have a fever, blistering, burning, crusting, irritation, itching, reddening, stinging, or swelling of the skin, painful cold sores, or blisters on the lips, nose, eyes, genitals, or trunk of the body, skin rash, pain, or itching, changes in vision, confusion, eye pain or redness, headache, or stiff neck.

Check with your doctor if you have weakness on one side of the body, clumsiness, blurred vision, changes in thinking, memory problems, confusion, or personality changes. These could be symptoms of a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML).

This medicine may cause hepatitis B virus reactivation. Tell your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.

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 may receive live or live-attenuated vaccines at least 4 weeks or non-live vaccines at least 2 weeks before starting 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 (eg, breast cancer). Talk to your doctor if you have concerns about this risk.

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:

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:

More common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chest tightness

chills

confusion

cough

difficulty with breathing

dizziness

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

fever

headache

hives, itching, or skin rash

loss of voice

nausea

pain, redness, swelling, tenderness, or warmth on the skin

rapid weight gain

redness of the face, neck, arms, and occasionally, upper chest

runny or stuffy nose

sneezing

sore throat

sweating

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Burning or stinging of the skin

painful blisters on the trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or genitals

Incidence not known

Eye pain or redness

mental changes

stiff neck

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:

More common

Diarrhea

discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

trouble concentrating

trouble sleeping

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.