Ocrelizumab

OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more. OCREVUS is a CD20-directed cytolytic antibody indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 ) Primary progressive MS, in adults ( 1 ) Relapsing-remitting MS, in pediatric patients 10 years of age and olde …

• Before initiating OCREVUS, screen for Hepatitis B virus and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion Administer OCREVUS by intravenous infusion
• Adults and pediatric patients (10 years of age and older), who weigh 35 kg or more: Start dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion Subsequent doses: 600 mg intravenous infusion every 6 months
• Pediatric patients (10 years of age and older) who weigh 25 kg to less than 35 kg: Start dose: 150 mg intravenous infusion, followed two weeks later by a second 150 mg intravenous infusion Subsequent doses: 300 mg intravenous infusion every 6 months Must be diluted prior to administration Monitor patients closely during and for at least one hour after infusion Assessments Prior to First Dose of OCREVUS Hepatitis B Virus Screening Prior to initiating OCREVUS, perform Hepatitis B virus (HBV) screening
• OCREVUS is contraindicated in patients with active HBV confirmed by positive results for HBsAg and anti-HBV tests
• For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment [see Warnings and Precautions ] . …

Injection: 300 mg/10 mL (30 mg/mL) clear or slightly opalescent, and colorless to pale brown solution in a single-dose vial. Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial ( 3 )

• The safety and effectiveness of OCREVUS
• For the treatment of relapsing-remitting MS have been established
• In pediatric patients 10 years of age and older who weigh 25 kg or more
• Use of OCREVUS for this indication is supported by evidence from one randomized, double-blind clinical study in 187
• Pediatric patients (93 of whom received OCREVUS) and additional pharmacokinetic data
• In pediatric patients [see Clinical Pharmacology and Clinical Studies ] . …

Clinical studies of OCREVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• Advise the patient and caregiver to read the FDA-approved patient labeling (Medication Guide)
• Infusion Reactions Inform patients and caregivers about the signs and symptoms of infusion reactions, and that infusion reactions can occur up to 24 hours after infusion
• Advise patients and caregivers to contact the patient's healthcare provider immediately for signs or symptoms of infusion reactions [see Warnings and Precautions ]
• Infection Advise patients and caregivers to contact the patient's healthcare provider for any signs of infection during treatment or after the last dose [see Clinical Pharmacology ]. …

OCREVUS is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] A history of life-threatening infusion reaction to OCREVUS [see Warnings and Precautions (5.1) ] Active hepatitis B virus infection ( 4 ) History of life-threatening infusion reaction to OCREVUS ( 4 )

7.1 Immunosuppressive or Immune-Modulating Therapies The concomitant use of OCREVUS and other immune-modulating or immunosuppressive therapies, including immunosuppressant doses of corticosteroids, is expected to increase the risk of immunosuppression. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with OCREVUS. When switching from drugs with prolonged immune effects, such as daclizumab, fingolimod, natalizumab, teriflunomide, or mitoxantrone, consider the duration and mode of action of these drugs because of additive immunosuppressive effects when initiating OCREVUS [see Warnings and Precautions (5.2) ]. …

Infusion Reactions: Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs ( 2.3 , 5.1 ) Infections: Serious, including life-threatening and fatal infections, have occurred. Delay OCREVUS administration in patients with an active infection until the infection is resolved. …

The following serious adverse reactions are discussed elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Malignancies [see Warnings and Precautions (5.5) ] Immune-Mediated Colitis [see Warnings and Precautions (5.6) ] Liver Injury [see Warnings and Precautions (5.7) ] The most common adverse reactions were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions ( 6.1 ) PPMS (incidence ≥10% and > placebo): upper respiratory tra …

8.1 Pregnancy Risk Summary OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS 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. …

Store OCREVUS vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze or shake.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.