ocrelizumab

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Contraindicated in:

Active hepatitis B virus (HBV) infection (may reactivate infection during and for several mo after treatment);
Active infection;
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.

Adv. Reactions/Side Effects ⬆ ⬇

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)

Interactions ⬆ ⬇

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.

Route/Dosage ⬆ ⬇

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

Availability ⬆ ⬇

Solution for injection: 30 mg/mL

Assessment ⬆ ⬇

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 ≥1 hr after completion of infusion. If mild to moderate infusion reaction occurs,↓ infusion rate by 50% at onset of reaction and for ≥30 min. If reduced infusion rate tolerated, ↑ rate (see Rate below). Will ↑ 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 by ↓ infusion rate by 50% at time of onset of reaction. If tolerated, ↑ rate (see Rate below). Will ↑ duration of infusion, but not total dose. If life-threatening infusion reaction occurs, immediately stop infusion and permanently discontinue therapy. Provide supportive treatment.
Assess for signs and symptoms of PML (progressive weakness on one side of body or clumsiness of limbs; disturbance of vision; 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.

Lab Test Considerations:

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.

Implementation ⬆ ⬇

Administer in a health care setting by an experienced health care professional with access to appropriate medical support and equipment in case of a infusion or severe reaction. Monitor during and for ≥1 hr after infusion.
Administer all necessary immunizations ≥4 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 the 300-mg dose (10 mL) in 250 mL of 0.9% NaCl and the 600-mg dose (20 mL) in 500 mL of 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. ↑ 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. ↑ 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. ↑ to 200 mL/hr for next 15 min. ↑ to 250 mL/hr for next 30 min. ↑ to 300 mL/hr for last 60 min. Duration 2 hr or longer.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Explain the importance of maintaining a 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 ≥5 mo.
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.
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, strength, or using arms or legs; weakness on one side of body) occur.
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.

Evaluation/Desired Outcomes ⬆ ⬇

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

US Brand Names ⬆ ⬇

Code ⬆

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

67643- Lonza Biologics, Inc.
- 67643-7000-
  - 67643-7000-1- 120000 mL in 1 TANK (67643-7000-1)

67643- Lonza Biologics, Inc.
- 67643-7000-
  - 67643-7000-2- 300000 mL in 1 TANK (67643-7000-2)

67643- Lonza Biologics, Inc.
- 67643-7001-
  - 67643-7001-1- 300 L in 1 TANK (67643-7001-1)

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Pronunciation ⬇

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Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇