Ocrevus 300mg/10ml Infusion

Ocrelizumab

300mg

F. Hoffmann-La Roche Ltd.

Pack size	1 Glass Vial (10ml)
Dispensing mode	POM
Source	SWITZERLAND
Agent	CITY MEDICAL STORE
Retail Price	33195.00 AED

Indications

Ocrevus 300mg/10ml Infusion is used for: Multiple Sclerosis

Adult Dose

Multiple Sclerosis Indicated for treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease or primary progressive MS Initial 2 doses: 300 mg IV once; repeat dose 2 wk later Subsequent doses: 600 mg IV every 6 months

Child Dose

Renal Dose

Administration

IV Preparation Visually inspect vial for particulate matter and discoloration; do not use if solution is discolored or contains discrete foreign particulate matter Do not shake vial Using aseptic technique, withdraw dose and further dilute into 0.9% NaCl infusion bag to final concentration of ~1.2 mg/mL (ie, 300 mg in 250-mL bag, 600 mg in 500-mL bag) Product contains no preservative and is intended for single use only Before starting the IV infusion, the content of the infusion bag should be at room temperature Use the prepared infusion solution immediately or refrigerate (see Storage) IV Administration Administer infusion solution through a dedicated line using an infusion set with a 0.2 or 0.22 micron inline filter Observe for infusion reactions during the infusion and for at least 1 hr after completion of the infusion; inform patients that infusion reactions can occur up to 24 hr after the infusion

Contra Indications

Active HBV infection History of life-threatening infusion reaction to ocrelizumab

Precautions

May increase risk for malignancy In infants of mothers exposed to ocrelizumab during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts as measured by CD19+ B-cells Administer all immunizations according to immunization guidelines; administer live or live attenuated vaccines at least 4 weeks prior to initiation of therapy, whenever possible, and non-live vaccines at least 2 weeks prior to initiation of therapy; may administer non-live vaccines, as indicated, prior to recovery from B-cell depletion, but should consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether protective immune response was mounted; vaccination with live-attenuated or live vaccines not recommended during treatment and until B-cell repletion

Pregnancy-Lactation

Pregnancy No data available to assess risk in pregnant women However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy See Cautions for information regarding vaccinating infants born to mothers taking ocrelizumab Contraception Women of childbearing potential should use contraception while receiving ocrelizumab and for 6 months after the last infusion Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Coadministration with immunosuppressants may increase risk for immunosuppressive effects Vaccinations May interfere with efficacy of nonlive vaccines (live or live-attenuated vaccines not studied) Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation for nonlive vaccines Vaccination of infants of mothers exposed to ocrelizumab during pregnancy Do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts (measured by CD19+ B-cells) Depletion of B-cells in these infants may increase risks from live or live-attenuated vaccines Nonlive vaccines may be administered as indicated, prior to recovery from B-cell depletion; consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether a protective immune response was mounted

Adverse Effects

Side effects of Ocrelizumab : >10% Upper respiratory tract infections (40-49%) Infusion-related reactions (34-40%) Skin infections (14%) Decreased neutrophil counts (13%) 1-10% Lower respiratory tract infections (8-10%) Depression (8%) Cough (7%) Back pain (6%) Herpes virus-associated infections (5-6%) Diarrhea (6%) Peripheral edema (6%) Pain in extremity (5%)

Mechanism of Action

Humanized monoclonal antibody designed to selectively target CD20, a cell surface antigen present on pre-B and mature B lymphocytes Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis

Note

Ocrevus 300mg/10ml 300mg Infusion manufactured by F. Hoffmann-La Roche Ltd.. Its generic name is Ocrelizumab. Ocrevus 300mg/10ml is availble in United Arab Emirates. Farmaco UAE drug index information on Ocrevus 300mg/10ml Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.