Bonspri Injection

Ofatumumab 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. Ofatumumab 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.

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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.

Infections: Serious, including life-threatening and fatal infections, have occurred in patients treated with anti-CD20 therapies. Delay Ofatumumab 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 Ofatumumab and after discontinuation, until B-cell repletion. Injection-Related Reactions and Hypersensitivity Reactions: Management for injection-related reactions and hypersensitivity reactions depends on the type and severity of the reaction. Reduction in Immunoglobulins: Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with Ofatumumab until B-cell repletion. Consider discontinuing Ofatumumab if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise. Liver Injury: Clinically significant liver injury has occurred. Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating Ofatumumab, and during treatment as clinically indicated. Discontinue Ofatumumab in patients with evidence of liver injury in the absence of an alternative etiology. Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping Ofatumumab. Infections Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. In Ofatumumab Study 1 and Study 2, the overall rate of infections and serious infections in patients treated with Ofatumumab was similar to patients who were treated with teriflunomide (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by Ofatumumab-treated patients in the randomized clinical relapsing MS (RMS) trials included upper respiratory tract infection (39%) and urinary tract infection (10%). Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants When initiating Ofatumumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after Ofatumumab, consider the potential for increased immunosuppressive effects. Ofatumumab has not been studied in combination with other MS therapies. Hepatitis B Virus Reactivation There were no reports of HBV reactivation in patients with MS treated with Ofatumumab. 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 clinically significant adverse reactions are discussed in greater detail elsewhere in the labeling: Infections Injection-Related Reactions and Hypersensitivity Reactions Reduction in Immunoglobulins Liver Injury Most common adverse reactions (incidence greater than 10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction 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. Approximately 1500 patients with RMS received Ofatumumab in clinical studies. In Study 1 and Study 2, 1882 patients with RMS were randomized, 946 of whom were treated with Ofatumumab for a median duration of 85 weeks; 33% of patients receiving Ofatumumab were treated for up to 120 weeks. The most common adverse reactions occurring in greater than 10% of patients treated with Ofatumumab and more frequently than in patients treated with teriflunomide were upper respiratory tract infections, injection-related reactions (systemic), headache, and injection-site reactions (local). The most common cause of discontinuation in patients treated with Ofatumumab was low immunoglobulin M (3.3%), defined in trial protocols as IgM at 10% below the lower limit of normal (LLN). Table 1 summarizes the adverse drug reactions that occurred in Study 1 and Study 2. Table 1: Adverse Reactions in Patients With RMS With an Incidence of at Least 5% With Ofatumumab and a Greater Incidence Than Teriflunomide (Pooled Study 1 and Study 2) a Includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis. 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.