ocrelizumab/hyaluronidase

Contraindicated in:

Hypersensitivity to ocrelizumab or hyaluronidase;
Active hepatitis B virus (HBV) infection (may reactivate infection during and for several months after treatment);
Active infection;
History of life-threatening reaction to ocrelizumab.

Use Cautiously in:

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

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema

GI: diarrhea, HBV REACTIVATION, IMMUNE-MEDIATED COLITIS

Hemat: neutropenia

Local: injection reactions

MS: back pain

Neuro: depression, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Resp: cough

Misc: infection, MALIGNANCY (PRIMARILY BREAST CANCER)

Interactions ⬆ ⬇

Drug-drug:

Immunosuppressive therapies may ↑ risk of immunosuppression.
May ↓ antibody response to or ↑ risk of adverse reactions to nonlive vaccines and live vaccines.

Availability ⬆ ⬇

Solution for injection: ocrelizumab 40 mg and hyaluronidase 1000 units/mL

Route/Dosage ⬆ ⬇

SC (Adults ): Ocrelizumab 920 mg/hyaluronidase 23,000 units every 6 mo.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Ocrelizumab: Binds to the CD20 antigen on pre-B and mature B lymphocytes, which results in antibody-dependent and complement-mediated cell lysis. Hyaluronidase: Acts locally by depolymerizing hyaluronan, which increases permeability of the SUBQ tissue.

Therapeutic effects:

Reduction in relapse rate and decreased progression toward disability.

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: 81% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 20 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	4 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Inform patient that injection reaction can occur during or within 24 hr of dose and to notify health care provider immediately if severe reaction occurs.
Advise patient to notify health care provider for any sign of infection (fever, chills, cough, dysuria, cold sores, shingles, genital sores) or PML (progressive unilateral weakness, clumsiness, vision change, memory loss, confusion, personality changes) during therapy or after last dose.
Advise patient to notify health care provider if diarrhea, abdominal pain, or blood in the stool occurs.
Advise patient not to take live or live-attenuated vaccines during therapy and until B-cell recovery.
Inform patient of ↑ malignancy risk, including breast cancer, and to follow standard screening guidelines.
Pedi: Advise caregiver of infants exposed to ocrelizumab/hyaluronidase during pregnancy to have B-cell (CD19+) recovery confirmed prior to taking live or live-attenuated vaccines and to consider assessing for protective immune response after nonlive vaccines.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise patient to use effective contraception during and for 6 mo after last dose.

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Indications ⬇

Contraind./Precautions ⬆ ⬇