Ocrelizumab

OCREVUS

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Pronunciation: ok-re-LIZ-yoo-mab

Ocrelizumab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ocrelizumab ballicule

Ocrelizumab OCREVUS mascot mnemonic cartoon — Visual mnemonic: Ocrelizumab mascot
**“Oak realizes, maybe (Oak Crevice)”**

What it isAnti-CD20 monoclonal antibody that depletes B cells; relapsing and primary progressive multiple sclerosis.

Why this oneIt was the first therapy of any kind approved for primary progressive MS, which had no disease-modifying option before it, and it is highly effective in relapsing disease.

What limits itInfusion reactions and infections are major hazards; screen for hepatitis B and monitor immunoglobulins before repeat treatment.

Ocrelizumab molecular structure (skeletal formula) — Molecular structure: Ocrelizumab

FDA-approved for

relapsing forms of multiple sclerosis
primary progressive multiple sclerosis

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target
Relapsing forms of MS (CIS, relapsing-remitting, active secondary progressive)	Adults	300 mg IV, then 300 mg IV 2 weeks later	600 mg IV every 6 months
Primary progressive MS	Adults	300 mg IV, then 300 mg IV 2 weeks later	600 mg IV every 6 months
Relapsing-remitting MS	Peds ≥10 yr weighing ≥25 kg	≥35 kg: 300 mg ×2 (2 wk apart); 25–<35 kg: 150 mg ×2 (2 wk apart)	≥35 kg: 600 mg q6 months; 25–<35 kg: 300 mg q6 months

Renal Undefined

Hepatic Undefined

Doses must be separated by at least 5 months

Instructions

Screen for HBV and obtain serum immunoglobulins, aminotransferases, alkaline phosphatase, bilirubin before first dose
Premedicate with methylprednisolone (or equivalent) + an antihistamine (± antipyretic) before each infusion
Administer by IV infusion; observe patient during and ≥1 h after infusion
Separate doses by at least 5 months

Available strengths

inj 300 mg/10 mL

Contraindications

Active hepatitis B virus (HBV) infection
History of life-threatening infusion reaction to OCREVUS

Cautions

Infusion reactions (premedicate; may occur up to 24 h after)
Serious/fatal infections; delay dosing during active infection
Progressive multifocal leukoencephalopathy (PML)
Reduction in immunoglobulins / hypogammaglobulinemia
Malignancies, including breast cancer
Immune-mediated colitis
Liver injury

Adverse reactions

Upper respiratory tract infections
Infusion reactions
Skin infections
Lower respiratory tract infections

Pregnancy May cause fetal B-cell depletion (animal data); IgG crosses placenta; delay live/live-attenuated vaccines in exposed infants

Lactation No human data; ocrelizumab excreted in animal milk; weigh benefits against maternal need

Cost

Ocrelizumab (OCREVUS)

Strength		#/mo	generic $/unit	CostPlus
300 mg/10 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ocrelizumab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskInfusion or injection reactions; infections, including PML

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityInfusion reactions and prolonged immune suppression

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