Ocrelizumab

Ocrelizumab is used for adults with relapsing or primary progressive forms of multiple sclerosis.

Ocrelizumab is available under the following different brand names: Ocrevus.

Dosages of Ocrelizumab:

Dosage Forms and Strengths

Solution for Injection

• 30mg/mL (10mL single-dose vial)

Dosage Considerations – Should be Given as Follows:

Multiple Sclerosis

Ocrelizumab only

• Indicated for adults with relapsing or primary progressive forms of multiple sclerosis
• Initial 2 doses: 300 mg intravenously (IV) once; repeat dose 2 weeks later
• Subsequent doses: 600 mg IV every 6 months

Dosing considerations

Infusion reactions

• Dose modifications in response to infusion reactions depend on the severity
• Mild-to-moderate
  • Reduce infusion rate to half the rate at the onset of the infusion reaction and maintain the reduced rate for at least 30 minutes; if tolerated, may increase the rate
• Severe
  • Immediately interrupt the infusion and administer appropriate supportive treatment, as necessary
  • Restart infusion once symptoms have resolved
  • When restarting, begin at half of the infusion rate at the time of onset of the infusion reaction; if tolerated, may increase the rate
• Life-threatening
  • Immediately stop and permanently discontinue ocrelizumab if there are signs of a life-threatening or disabling infusion reaction

Dosage Considerations

HBV screening

• Perform Hepatitis B virus (HBV) screening before initiating ocrelizumab
• Contraindicated with active HBV infection confirmed by positive results for HBsAg and anti-HBV tests
• For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment

Vaccinations

• Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion
• Administer all immunizations according to immunization guidelines at least 4 weeks before initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiation for non-live vaccines

Safety and efficacy not established in pediatric patients

Common side effects of ocrelizumab include:

• Ocrelizumab
• Upper and lower respiratory tract infections
• Infusion-related reactions
• Skin infections
• Decreased white blood cell counts
• Depression
• Cough
• Back pain
• Herpes virus-associated infections
• Diarrhea
• Swelling of extremities
• Pain in extremities

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Ocrelizumab has no listed severe interactions with other drugs.
• Ocrelizumab has serious interactions with at least 36 different drugs.
• Ocrelizumab has moderate interactions with at least 39 different drugs.
• Ocrelizumab has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains Ocrelizumab. Do not take Ocrevus if you are allergic to ocrelizumab or any ingredients contained in this drug.

Contraindications

• Active hepatitis B (HBV) infection
• History of life-threatening infusion reaction to ocrelizumab

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Ocrelizumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ocrelizumab?"

Cautions

• Infusion reactions (e.g., itching, rash, hives, redness, bronchospasm, throat irritation, mouth and throat pain, dyspnea, pharyngeal or laryngeal swelling, flushing, low blood pressure, fever, fatigue, headache, dizziness, nausea, fast heart rate) may occur; monitor during treatment and at least 1 hour after treatment
• May increase risk for malignancy
• In infants of mothers exposed to ocrelizumab during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts as measured by CD19+ B-cells
• Administer all immunizations according to immunization guidelines; administer live or live-attenuated vaccines at least 4 weeks before initiation of therapy, whenever possible, and non-live vaccines at least 2 weeks before initiation of therapy; may administer non-live vaccines, as indicated, before recovery from B-cell depletion, but should consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether the protective immune response was mounted; vaccination with live-attenuated or live vaccines not recommended during treatment and until B-cell repletion

Infections

• In clinical trials, a higher proportion of ocrelizumab-treated patients experienced infections (e.g., respiratory tract, herpes) compared with interferon-beta1a or placebo
• HBV reactivation: Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with other anti-CD20 antibodies
• Progressive multifocal leukoencephalopathy (PML)
  • PML is an opportunistic viral infection of the brain caused by the John Cunningham (JC) virus
  • PML observed in patients treated with other anti-CD20 antibodies and other multiple sclerosis therapies and has also been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants)
  • At the first sign or symptom suggestive of PML, withhold drug and perform an appropriate diagnostic evaluation

Drug interaction overview

• Coadministration with immunosuppressants may increase the risk for immunosuppressive effects
• Vaccinations
  • May interfere with the efficacy of non-live vaccines (live or live-attenuated vaccines not studied)
  • Administer all immunizations according to immunization guidelines at least 4 weeks before initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiation for non-live vaccines
• Vaccination of infants of mothers exposed to ocrelizumab during pregnancy
  • Do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts (measured by CD19+ B-cells)
  • Depletion of B-cells in these infants may increase risks from live or live-attenuated vaccines
  • Non-live vaccines may be administered as indicated, before recovery from B-cell depletion; consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether a protective immune response was mounted

Pregnancy and Lactation

• No data are available to assess the risk of the use of ocrelizumab in pregnant women. Ocrelizumab is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to drugs have not been studied in clinical trials; the potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown.
• See "Cautions" for information regarding vaccinating infants born to mothers taking ocrelizumab.
• Women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion.
• It is unknown if ocrelizumab is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ocrelizumab, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.