Ocrelizumab

Cytostatic · Monoclonal antibody

Indications

Treatment of relapsing or primary progressive forms of multiple sclerosis in adult patients.

Dosage

Multiple sclerosis, relapsing or progressive: Adults: IV: 300 mg on day 1, followed by 300 mg 2 wks later, subsequent doses of 600 mg are administered once every 6 mths (starting 6 mths after the first 300 mg dose). If a dose is missed, administer as soon as possible. Do not wait until the next scheduled dose, then adjust the dose schedule to administer the next sequential dose 6 mths after the missed dose was administered. Doses must be separated by at least 5 mths.

Administration

Administer through a dedicated IV line using a 0.2 or 0.22 micron in-line filter. Premedicate with methylprednisolone (100 mg IV) 30 mins prior to each infusion, and an antihistamine (e.g. Diphenhydramine) 30-60 mins prior each infusion; may also consider premedication with acetaminophen. First 2 infusions (300 mg dose): Begin infusion at 30 mL/hr; increase by 30 mL/hr every 30 mins to a max rate of 180 mL/hr. Inf duration is 2.5 hrs or longer. Subsequent infusions (600 mg dose): Begin inf at 40 mL/hr; increase by 40 mL/hr every 30 mins to a max rate of 200 mL/hr. Inf duration is 3.5 hrs or longer. Reconstitution: Dilute for infusion in NS (dilute 300 mg dose in a 250 mL bag and 600 mg dose in a 500 mL bag) to a final conc of approx. 1.2 mg/mL. Do not shake. Compatibility: Stable in NS. Do not dilute in any other solutions. Stability: Store intact vials at 2°C-8°C in the outer carton to…

Adverse Effects

Risk of cancers (malignancies) including breast cancer. Infusion reactions including itchy skin, rash, hives, tiredness, coughing/wheezing, difficulty in breathing, throat irritation/pain, flushing, nausea, headache, swelling of throat, dizziness, fatigue, fast heartbeat.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Caution advised or effect undetermined. Contraindications: Active hepatitis B virus (HBV) infection. History of life-threatening infusion reaction to ocrelizumab. Current or history of confirmed progressive multifocal leucoencephalopathy (PML). Precautions: Monitor for infusion reactions during the infusion and for at least 1 hr after the end of the infusion. Assess for infections prior to treatment initiation and delay treatment in patients with an active infection until it is resolved. Perform HBV screening in all patients prior to treatment initiation. Administer all necessary immunizations at least 6 wks prior to treatment initiation.

Interactions

BCG (Intravesical), belimumab, natalizumab, pimecrolimus, topical tacrolimus, live vaccines; avoid. Fingolimod, immunosuppressants, leflunomide, tofacitinib, roflumilast, trastuzumab, nivolumab.

Advice to Patient

Inform prescriber if you have ever taken, take or plan to take medicines that affect immune system, or other treatments for MS. Inform prescriber if you have ever had hepatitis B or are a carrier of the hepatitis B virus. Inform prescriber if you have had a recent vaccination or are scheduled to receive any vaccinations. Contact prescriber if there is any sign of infection including fever, chills, cough that does not go away, or sign of herpes (cold sores, shingles, or genital sores). Contact prescriber if there is any infusion reaction such as itchy skin, rash, hives, tiredness, coughing/wheezing, difficulty in breathing, throat irritation/pain, flushing, nausea, headache, swelling of throat, dizziness, fatigue, fast heartbeat. These infusion reactions can occur for up to 24 hrs after infusion.

Pharmacokinetics

Onset of action: Serum CD-19+ B-cell counts (used as a marker for B-cell counts) are reduced within 14 days after infusion. Duration of action: Median time for B-cell recovery (to baseline or the lower limit of normal): 72 wks (range: 27-175 wks). Metabolism: Antibodies are primarily cleared by catabolism. Half-life elimination: 26 days. Excretion: Constant clearance (estimated): 0.17 L/day; Initial time-dependent clearance: 0.05 L/day.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.