Ocrelizumab Intravenous

Name: Ocrelizumab Intravenous

Commonly used brand name(s)

In the U.S.

  • Ocrevus

Available Dosage Forms:

  • Solution

Therapeutic Class: Immune Modulator

Pharmacologic Class: Monoclonal Antibody

Uses For ocrelizumab

Ocrelizumab injection is used to treat the relapsing forms or primary progressive forms of multiple sclerosis (MS). ocrelizumab will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.

ocrelizumab is available only with your doctor's prescription.

Before Using ocrelizumab

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 ocrelizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ocrelizumab 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.

Pediatric

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.

Geriatric

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 ocrelizumab. 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.

ocrelizumab Side Effects

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
  • 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
  • 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
  • sneezing
  • sore throat
  • sweating
  • 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
  • Convulsions
  • drowsiness

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
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • diarrhea
  • discouragement
  • feeling sad or empty
  • irritability
  • 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

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.

Side Effects

See also How to Use section.

Cold symptoms such as stuffy/runny nose or cough may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infections (such as sore throat or cough that doesn't go away, fever, chills, herpes cold sores or genital sores, shingles).

Before treatment with this medication, your doctor will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, ocrelizumab may cause it to become active again and it could cause serious liver problems. Ask your doctor for more details.

This medication may rarely increase your risk of developing cancer, including breast cancer. Tell your doctor right away if you have symptoms such as unusual growths, a lump in the breast, nipple discharge. Ask your doctor for more details.

This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these new or worsening side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Ocrelizumab Solution side effects by likelihood and severity.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as blood tests to check for hepatitis B infection, breast cancer screening) should be done before you start using this medication, as well as during and after treatment. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in an infusion center and will not be stored at home.Information last revised April 2017. Copyright(c) 2017 First Databank, Inc.

(web3)