Ocrelizumab

Name: Ocrelizumab

Ocrelizumab Interactions

Do not receive a "live" vaccine while using ocrelizumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Tell your doctor about all other medicines you have recently used to treat multiple sclerosis.

Other drugs may interact with ocrelizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is the most important information I should know about ocrelizumab?

Ocrelizumab may cause unpleasant side effects while the medicine is injected, or up to 24 hours later. Tell your caregivers right away if you have any unusual discomfort during the injection.

Call your doctor if you have unpleasant side effects such as dizziness, nausea, skin rash, chest tightness, or trouble breathing within 24 hours after your injection.

How is ocrelizumab given?

Before you start treatment with ocrelizumab, your doctor may perform tests to make sure you do not have hepatitis B or other infections.

Ocrelizumab is injected into a vein through an IV. A healthcare provider will give you this injection.

You may be given other medications to prevent certain side effects of ocrelizumab.

Your first dose of ocrelizumab will be split into 2 separate infusions. You will receive these infusions 2 weeks apart. The following doses will be given once every 6 months.

Ocrelizumab must be given slowly and each infusion can take up to 3 hours and 30 minutes to complete.

You will be watched closely for at least 1 hour after receiving ocrelizumab, to make sure you do not have an allergic reaction to the medication.

If you have ever had hepatitis B, ocrelizumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What should I avoid while receiving ocrelizumab?

Do not receive a "live" vaccine while using ocrelizumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

How is this medicine (Ocrelizumab) best taken?

Use ocrelizumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of skin infection like oozing, heat, swelling, redness, or pain.
  • Burning, itching, numbness, or tingling feeling in the genitals.
  • Shingles.
  • Shortness of breath.
  • Flushing.
  • Dizziness or passing out.
  • Fever.
  • Feeling tired or weak.
  • Headache.
  • Upset stomach.
  • A fast heartbeat.
  • A lump in the breast or breast soreness.
  • Swelling in the arms or legs.
  • Low mood (depression).
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Index Terms

  • Ocrevus

Liver Dose Adjustments

Data not available

Dialysis

Data not available

Ocrelizumab Pregnancy Warnings

In animal studies, this drug caused depletion of B-lymphocytes in lymphoid tissue (spleen and lymph nodes) and perinatal deaths (some associated with bacterial infections), renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe decreases in circulating B-lymphocytes in neonates. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk. US FDA pregnancy category: Not assigned. Risk Summary: There are no adequate data on the developmental risk associated with use of this drug in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure; however, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. This drug is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. In animal studies at doses similar to or greater than equivalent human doses, increased perinatal mortality, depletion of B-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity. Comments: -Women of childbearing potential should use adequate contraception while receiving this drug and for 6 months after the last dose.

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