• Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• Primary progressive MS.

Contraindicated in:

• Active hepatitis B virus (HBV) infection (may reactivate infection during and for several mo after treatment)
• History of life-threatening infusion reaction to ocrelizumab.

Use Cautiously in:

• Patients who are immunocompromised or receiving other immunosuppressants
• OB: Safety not established in pregnancy (may cause fetal B-cell depletion)
• Lactation: Safety not established in breastfeeding
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: peripheral edema.

GI: diarrhea, HEPATITIS B VIRUS REACTIVATION, IMMUNE-MEDIATED COLITIS.

Hemat: neutropenia.

MS: back pain.

Neuro: depression, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).

Resp: cough.

Misc: infection, infusion reactions (including anaphylaxis), MALIGNANCY (PRIMARILY BREAST CANCER).

Drug-Drug:

• Concurrent use with immunosuppressive therapies may ↑ risk of immunosuppression.
• May ↓ antibody response to or ↑ risk of adverse reactions to non-live vaccines and live vaccines.

• Solution for injection: 30 mg/mL;

• IV (Adults): 300 mg initially, then 300 mg in 2 wk, then 600 mg every 6 mo.

Ocrevus

• Binds to the CD20 antigen on pre-B and mature B lymphocytes, which results in antibody-dependent and complement-mediated cell lysis.

• Reduction in relapse rate and decreased progression toward disability.

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Binds specifically to CD20 binding sites on B lymphocytes.

Metabolism/Excretion: Unknown.

Half-life: 26 days.

• Explain purpose of infusions and importance of maintaining schedule to patient. If infusion is missed, administer as soon as possible; do not wait for next scheduled dose. Reset schedule for 6 mo after missed dose is given. Separate doses by at least 5 mo. Advise patient to read Medication Guide before starting therapy and with each dose in case of changes.
• Inform patient that infusion reactions may occur up to 24 hr after infusion. Advise patient to notify health care professional immediately if infusion reaction symptoms occur.
• Advise patient to notify health care professional if signs and symptoms of infection (fever, chills, constant cough, cold sore, shingles, genital sores), immune-mediated colitis (new or persistent diarrhea, abdominal pain, blood in stool) or PML (problems with thinking, balance, eyesight, weakness on 1 side of body, strength, using arms or legs) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Instruct patient to avoid live vaccines during therapy. Administer any live or live-attenuated vaccines ≥4 wk prior to start of therapy and administer any non-live vaccines ≥2 wk prior to start of therapy.
• Inform patient of increased risk of malignancy. Advise patient to receive regular breast cancer screening.
• Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for 6 mo after last infusion and to notify health care professional if breastfeeding. Do not administer live or live-attenuated vaccines to infants born to mothers taking ocrelizumab until recovery of B-cell counts is confirmed; may administer non-live vaccines to these infants, but should consider assessing vaccine immune responses to determine whether protective immune response developed. Inform patient of pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to ocrelizumab during pregnancy. Encourage patient to register themselves by calling 1-833-872-4370 or visiting .

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NDC Code^*

• 50242- Genentech, Inc.
  • 50242-150- OCREVUS
    • 50242-150-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) > 10 mL in 1 VIAL, SINGLE-USE