Ocrevus 300mg Injection

Ocrelizumab 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. Ocrelizumab 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 Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Infusion Reactions: Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue Ocrelizumab if a life-threatening or disabling infusion reaction occurs Infections: Serious, including life-threatening and fatal infections, have occurred. Delay Ocrelizumab administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with Ocrelizumab and after discontinuation, until B-cell repletion Progressive Multifocal Leukoencephalopathy (PML): Withhold Ocrelizumab at the first sign or symptom suggestive of PML Reduction in Immunoglobulins: Monitor the level of immunoglobulins at the beginning of treatment. Monitor during and after discontinuation of treatment with Ocrelizumab, until B-cell repletion, and especially when recurrent serious infections are suspected. Consider discontinuing Ocrelizumab in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins Malignancies: An increased risk of malignancy, including breast cancer, may exist with Ocrelizumab Immune-Mediated Colitis: Immune-mediated colitis has been reported in the postmarketing setting. Monitor patients for new or persistent diarrhea or other gastrointestinal symptoms, and evaluate promptly if colitis is suspected Liver Injury: Clinically significant liver injury has occurred. Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating Ocrelizumab, and during treatment as clinically indicated. Discontinue Ocrelizumab in patients with evidence of liver injury in the absence of an alternative etiology. Infusion Reactions Ocrelizumab can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. These reactions are more commonly reported with the first infusion. In multiple sclerosis (MS) clinical trials, all adult and pediatric patients who were treated with Ocrelizumab received premedication with methylprednisolone (or an equivalent steroid), and may have also received an antihistamine (all pediatric patients) and/or an analgesic/antipyretic to reduce the risk of infusion reactions prior to each infusion. In adults, the incidence of infusion reactions in patients treated with Ocrelizumab was 34 to 40%. There were no fatal infusion reactions, but 0.3% of patients with MS who were treated with Ocrelizumab experienced infusion reactions that were serious, some requiring hospitalization. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following serious adverse reactions are discussed elsewhere in the labeling: Infusion Reactions Infections Progressive Multifocal Leukoencephalopathy Reduction in Immunoglobulins Malignancies Immune-Mediated Colitis Liver Injury The most common adverse reactions were: RMS (incidence ≥10% and > REBIF ® ): upper respiratory tract infections and infusion reactions PPMS (incidence ≥10% and > placebo): upper respiratory tract infections, infusion reactions, skin infections, and lower respiratory tract infections RRMS in pediatric patients 10 years of age and older: Adverse reactions were consistent with those observed in adults with RMS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults The safety of Ocrelizumab has been evaluated in 1311 adult patients across MS clinical studies, which included 825 patients in active-controlled clinical trials in patients with relapsing forms of MS (RMS) and 486 patients in a placebo-controlled study in patients with primary progressive MS (PPMS). Adverse Reactions in Adult Patients with Relapsing Forms of MS In active-controlled clinical trials (Study 1 and Study 2), 825 patients with RMS received Ocrelizumab 600 mg intravenously every 24 weeks (initial treatment was given as two separate 300 mg infusions at Weeks 0 and 2). The overall exposure in the 96-week controlled treatment periods was 1448 patient-years. The most common adverse reactions in RMS trials (incidence ≥ 10%) were upper respiratory tract infections and infusion reactions. Table 4 summarizes the adverse reactions that occurred in RMS trials (Study 1 and Study 2). Table 4 Adverse Reactions in Adult Patients with RMS with an Incidence of at least 5% for Ocrelizumab and Higher than REBIF Adverse Reactions Studies 1 and 2 Ocrelizumab 600 mg IV Every 24 Weeks The first dose was given as two separate 300 mg infusions at Weeks 0 and 2. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.