OCREVUS 30 MG — DIN 02467224

What is OCREVUS?

OCREVUS 30 MG contains OCRELIZUMAB : 30 MG. It is listed in the Health Canada Drug Product Database under DIN 02467224, held by HOFFMANN-LA ROCHE LIMITED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 21-Sep-2017. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is OCREVUS used for?

OCREVUS® is indicated for: - the management of adult patients with early primary progressive multiple sclerosis (PPMS) as defined by disease duration and level of disability, in conjunction with imaging features characteristic of inflammatory activity has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for OCREVUS®, please refer to Health Canada's Notice of Compliance with conditions - drug products web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html - the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features has been issued market authorization without conditions. Treatment with OCREVUS (ocrelizumab) should be initiated and supervised by neurologists experienced in the treatment of patients with MS and who have fully familiarized themselves with the efficacy and safety profile of OCREVUS.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

OCREVUS® (ocrelizumab) for injection is administered as a concentrate for intravenous infusion. Recommended Premedication: Pre-medicate with 100 mg of methylprednisolone (or an equivalent corticosteroid) administered intravenously approximately 30 minutes prior to each Ocrevus infusion to reduce the frequency and severity of infusion reactions. Pre-medicate with an antihistamine drug (e.g. diphenhydramine) approximately 30-60 minutes prior to each infusion of Ocrevus to further reduce the frequency and severity of infusion reactions. The addition of an antipyretic (e.g. acetaminophen) may also be considered. Recommended Dose and Dosage Adjustment: - Initial dose: 300 mg intravenous infusion, followed 2 weeks later by a second 300 mg intravenous infusion. - Subsequent doses: single 600 mg intravenous infusion every 6 months. - Observe the patient for at least one hour after the completion of the infusion. - If patients did not experience a serious infusion-related reaction (IRR) with any previous Ocrevus infusion, a shorter (2-hour) infusion can be administered for subsequent doses (see Table 1, Option 2). - A minimum interval of 5 months should be maintained between each dose of Ocrevus. Preparation of the Dilute Solution for Infusion and Administration: Ocrevus must be prepared by a healthcare professional using aseptic technique. A sterile needle and syringe should be used to prepare the diluted infusion solution. Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature. Visually inspect for particulate matter and discolouration prior to administration. Do not use the solution if discoloured or if the solution contains discrete foreign particulate matter. Do not shake. Withdraw intended dose and further dilute into an infusion bag containing 0.9% Sodium Chloride Injection, to a final drug concentration of approximately 1.2 mg/mL. - Withdraw 10 mL (300 mg) of Ocrevus and inject into 250 mL. - Withdraw 20 mL (600 mg) of Ocrevus and inject into 500 mL. Do not use other diluents to dilute Ocrevus since their use has not been tested. The product contains no preservative and is intended for single use only. Administration: Administer Ocrevus under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions. The diluted infusion solution must be administered through a dedicated line using an infusion set with a 0.2 or 0.22 micron in-line filter. Missed Dose: If a planned infusion of Ocrevus is missed, administer Ocrevus as soon as possible; do not wait until the next scheduled dose. Reset the dose schedule to administer the next sequential dose 6 months after the missed dose is administered.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Ocrevus is contraindicated in patients: - Who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. - With a history of life-threatening infusion reaction to Ocrevus. - With active HBV infection. - With severe, active infections. - Who have or have had confirmed progressive multifocal leukoencephalopathy (PML). - Who are in a severely immunocompromised state. - With known active malignancies.

Warnings and precautions

Infusion Reactions: Fatal infusion reactions have been observed with other anti-CD20 antibodies. Ocrevus can cause infusion reactions, including pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. The incidence of infusion reactions in Ocrevus-treated patients was 34% to 40%, with the highest incidence with the first infusion. No fatal infusion reactions were observed, but 0.3% of Ocrevus-treated MS patients experienced serious infusion reactions, some requiring hospitalization. Patients should be observed for infusion reactions during and for at least one hour after infusion completion. Infusion reactions can occur up to 24 hours after the infusion. Infections: Delay Ocrevus administration in patients with an active infection until resolved. Ocrevus increased the risk for upper respiratory tract infections, lower respiratory tract infections, and herpes-related infections. Serious herpes infections, including central nervous system infections, intraocular infections, and disseminated skin and soft tissue infections, have been reported post-marketing. Some cases were life-threatening. If serious herpes infections occur, Ocrevus should be discontinued or withheld until the infection has resolved. Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in immunocompromised patients and can lead to death or severe disability. JC virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including Ocrevus. At the first sign or symptom suggestive of PML, withhold Ocrevus and perform diagnostic evaluation. If PML is confirmed, discontinue treatment permanently. Hepatitis B Reactivation: HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been reported in patients treated with anti-CD20 antibodies. HBV screening should be performed before initiation of treatment. Patients with active HBV should not be treated. Patients with positive serology should consult liver disease experts and be monitored. Malignancies: An increased risk of malignancy with Ocrevus may exist. In controlled trials, malignancies, including breast cancer, occurred more frequently in Ocrevus-treated patients. Patients with a known active malignancy should not be treated. Patients should follow standard breast cancer screening guidelines. Serious Adverse Events Reported in Other Anti-CD20 Antibodies: Serious cardiovascular events and severe mucocutaneous reactions have occurred rarely with other anti-CD20 antibodies. Patients experiencing a severe mucocutaneous reaction should discontinue treatment and seek prompt medical evaluation.