Hyaluronidase / Ocrelizumab Side Effects

Applies to hyaluronidase / ocrelizumab: subcutaneous solution.

Important warnings This medicine can cause some serious health issues

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.

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:

• signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body;

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• cold sores, skin rash, pain, itching, sores on your genital or anal area;

• vision changes, eye pain or redness, severe headache, stiff neck, or confusion;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Call your doctor at once if you have:

• 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 may include:

• pain, bruising, swelling, or irritation where the medicine was injected;

• headache, nausea;

• skin infections; or

• 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.

For healthcare professionals

Applies to hyaluronidase / ocrelizumab: subcutaneous solution.

General adverse events

The most common adverse reactions were injection reactions which were reported in at least 10% of the treated patients.^[Ref]

Hypersensitivity

• Very common (10% or more): Injection reactions (49%)^[Ref]

Of a total of 118 patients, 47% and 11% experienced at least one local injection reaction and one systemic injection reaction, respectively. The most common symptoms reported included: injection site erythema, pain, swelling, and pruritus, headache, and nausea. Injection reactions occurred within 24 hours in 83% of the patients, and during the injection in 19%. All injection reactions were of mild (73%) or moderate (27%) severity.^[Ref]

Gastrointestinal

• Postmarketing reports: Immune-mediated colitis^[Ref]

Dermatologic

• Postmarketing reports: Pyoderma gangrenosum^[Ref]

Further information

Hyaluronidase/ocrelizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer