Pronunciation:

ok-re-LIZ-ue-mab, hye-al-ure-ON-i-dase - ocsq

Brand Names:

• Ocrevus Zunovo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immune Modulator

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Ocrelizumab and hyaluronidase-ocsq combination 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 and hyaluronidase-ocsq combination 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 and hyaluronidase-ocsq combination injection have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of ocrelizumab and hyaluronidase-ocsq combination 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
• Anthrax Vaccine Adsorbed
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Diphtheria Toxoid, Adsorbed
• Ebola Zaire Vaccine, Live
• Haemophilus B Vaccine
• Hepatitis A Vaccine, Inactivated
• Hepatitis B Vaccine
• Human Papillomavirus Vaccine
• Influenza Virus Vaccine
• Influenza Virus Vaccine, Live
• Japanese Encephalitis Virus Vaccine
• Measles Virus Vaccine, Live
• Meningococcal Vaccine
• Mumps Virus Vaccine, Live
• Pertussis Vaccine
• Pneumococcal Vaccine
• Pneumococcal Vaccine, Diphtheria Conjugate
• Pneumococcal Vaccine Polyvalent
• Poliovirus Vaccine, Inactivated
• Poliovirus Vaccine, Live
• Rabies Vaccine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Novavax)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Sanofi)
• Smallpox Monkeypox Vaccine
• Tetanus Toxoid
• Tick-Borne Encephalitis Vaccine
• Typhoid Vaccine
• Typhoid Vaccine, Live
• Typhoid Vi Polysaccharide Vaccine
• Varicella Virus Vaccine
• 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
• Injection 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 (eg, bacterial, fungal, parasitic, viral), 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. This medicine is given as a shot under your skin, usually in the stomach for at least 10 minutes every 6 months.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine, steroid) 30 minutes before each injection of this medicine to prevent unwanted effects. Your doctor may also want you to stay for at least 1 hour after the injection 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.

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 cause serious injection reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

This medicine may increase your risk of developing serious infections (eg, bacterial, fungal, parasitic, viral). 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.

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 hyaluronidase-ocsq combination injection, 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 and hyaluronidase-ocsq combination injection 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.

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).

Using this medicine may increase your risk of getting cancer (eg, breast cancer). Talk to your doctor if you have concerns about this risk.

Colitis (inflammation of the bowels) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

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

Body aches or pain

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

cough

discouragement

dizziness

ear congestion

facial swelling

feeling sad or empty

fever or chills

headache

lack of appetite

loss of interest or pleasure

loss of voice

nausea or vomiting

rapid weight gain

skin rash

sneezing

sore throat

stuffy or runny nose

tingling of the hands or feet

trouble breathing

trouble concentrating

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Back pain

blurred vision

burning or stinging of the skin

clay-colored stools

clear or bloody discharge from nipple

confusion

dark urine

dimpling of the breast skin

drowsiness

inverted nipple

irritability

lump in the breast or under the arm

painful cold sores or blisters on the lips, nose, eyes, or sex organs

persistent crusting or scaling of the nipple

redness or swelling of the breast

seizures

sore on the skin of the breast that does not heal

stiff neck or back

stomach cramps, pain, or tenderness

unpleasant breath odor

vomiting of blood

watery or bloody diarrhea

yellow eyes or skin

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

Arm or leg pain

warmth on the skin

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.