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Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

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

• 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.

Absorption: IV administration results in complete bioavailability.

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

Metabolism/Excretion: Unknown.

Half-life: 26 days.

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.

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

• Solution for injection: 30 mg/mL;

• Assess for active infection prior to each infusion. Delay infusion until infection resolves.
• Monitor for signs and symptoms of infusion reaction (pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia) during and for at least 1 hr after completion of infusion. If mild to moderate infusion reaction occurs, reduce infusion rate by half at onset of reaction and for at least 30 min. If rate tolerated, increase rate (see Rate below). Will increase duration of infusion, but not total dose. If severe reaction occurs, immediately stop infusion and administer supportive treatment. Restart infusion only after all symptoms resolved. Restart at half rate at time of onset of reaction. If tolerated, increase (see Rate below). Will increase duration of infusion, but not total dose. If life-threatening infusion reaction occurs, immediately stop infusion and permanently discontinue ocrelizumab. Provide supportive treatment.
• Assess for signs and symptoms of PML (progressive weakness on one side of body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes) periodically during therapy. Symptoms are diverse and progress over days to wks. At first sign of PML, suspend ocrelizumab and perform diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. If PML is confirmed, discontinue ocrelizumab.
• Monitor for signs and symptoms of immune-mediated colitis (diarrhea, abdominal pain, blood in stool) during therapy. May require systemic corticosteroids and hospitalization.

• Determine current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before starting therapy. Do not administer to patients with active HBV infection.
  • Perform testing for quantitative serum immunoglobulins before starting therapy. May require immunology consult if serum immunoglobulins are low.

• Administer all necessary immunizations at least 6 wk before starting therapy. Avoid immunizations during therapy and after discontinuation until B-cell repletion.
• Premedicate to reduce frequency and severity of infusion reactions with methylprednisolone 100 mg IV or equivalent 30 min and an antihistamine, diphenhydramine, 30–60 min before each infusion. May add an antipyretic, acetaminophen.
• Intermittent Infusion:
  Diluent: Dilute each dose with 250 mL or 500 mL 0.9% NaCl. Do not use other diluents. Do not shake. Allow infusion bag to come to room temperature before infusion.Concentration: 1.2 mg/mL. Solution is clear or slightly opalescent, and colorless to pale brown; do not administer solutions that are discolored or contain particulate matter. Solution is stable for 24 hr if refrigerated or up to 8 hr (including infusion time) at room temperature.
• Rate: Administer using a dedicated line with a 0.2 or 0.22 micron in-line filter. For first 2 infusions (300 mg in 250 mL), begin at 30 mL/hr. Increase by 30 mL/hr every 30 min to 180 mL/hr over 2.5 hr or longer. For subsequent infusions (600 mg in 500 mL), begin at 40 mL/hr. Increase by 40 mL/hr every 30 min to 200 mL/hr over 3.5 hr or longer OR start at 100 mL/hr for first 15 min. Increase to 200 mL/hr for next 15 min. Increase to 250 mL/hr for next 30 min. Increase to 300 mL/hr for last 60 min. Duration 2 hr or longer.

• 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 .

• Reduction in relapse rate and decreased progression toward disability in patients with MS.

Ocrevus

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