Benlysta Special Precautions

Concomitant use with B cell targeted therapy: BENLYSTA has not been studied in combination with other B cell targeted therapy. Caution should be exercised if BENLYSTA is co-administered with other B cell targeted therapy.
Infusion reactions and hypersensitivity: Administration of BENLYSTA may result in infusion and hypersensitivity reactions, which can be severe, and can be fatal. In the event of a severe reaction, BENLYSTA administration must be interrupted and appropriate medical therapy administered. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk (see Adverse Reactions).
Premedication with an oral antihistamine, with or without an antipyretic, may be administered before the infusion of BENLYSTA. There is insufficient evidence to determine whether premedication diminishes the frequency or severity of infusion reactions. In clinical trials, serious infusion and hypersensitivity reactions affected less than 1% of patients, and included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnea. Infusion reactions occurred more frequently on the first two infusion days and tended to decrease with subsequent infusions. Delay in the onset of acute hypersensitivity reactions has been observed. Therefore, patients should be monitored during and for an appropriate period of time after administration of BENLYSTA. Patients treated with BENLYSTA should be made aware of the potential risk, the signs and symptoms of such reactions, and the importance of immediately seeking medical attention. Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema.
Risk of infections: As with other immunomodulating agents, the mechanism of action of BENLYSTA may increase the risk for the development of infections. In controlled clinical studies, fatal infections were uncommon but occurred more frequently in patients receiving BENLYSTA compared with placebo. Overall, the incidence of severe infections was similar across the BENLYSTA and placebo groups (see Adverse Reactions). Patients who develop an infection while undergoing treatment with BENLYSTA should be monitored closely, and consideration should be given to stopping immunosuppressant therapy. Physicians should exercise caution when considering the use of BENLYSTA in patients with severe or chronic infections.
Depression and suicidality: In controlled clinical intravenous and subcutaneous studies, psychiatric disorders (depression, suicidal ideation and behaviour) have been reported more frequently in patients receiving BENLYSTA including one suicide in a patient receiving 10 mg/kg and one suicide in a patient receiving 1 mg/kg (see Adverse Reactions). Physicians should carefully assess the risk of depression and suicide considering the patient’s medical history and current psychiatric status before treatment with BENLYSTA and continue to monitor patients during treatment. Physicians should advise patients (and caregivers where appropriate) to contact their healthcare provider about new or worsening psychiatric symptoms. The risk and benefit of continued treatment with BENLYSTA should be carefully assessed for patients who develop such symptoms.
Progressive multifocal leukoencephalopathy (PML): Progressive multifocal leukoencephalopathy (PML) resulting in neurological deficits, including fatal cases, has been reported in SLE patients receiving immunosuppressant pharmacotherapy, including BENLYSTA. A diagnosis of PML should be considered in any patient presenting with new-onset or deteriorating neurological signs and symptoms. The patient should be referred to a neurologist or other appropriate specialist for evaluation and if PML is confirmed, consideration should be given to stopping immunosuppressant therapy, including BENLYSTA.
Risk of malignancies: As with other immunomodulating agents, the mechanism of action of BENLYSTA may increase the potential risk for the development of malignancies. In clinical trials, there was no difference in the rate of malignancies between BENLYSTA-treated and placebo-treated groups.
Immunisation: Live vaccines should not be given for 30 days before, or concurrently with BENLYSTA as clinical safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving BENLYSTA.
Because of its mechanism of action, BENLYSTA may interfere with the response to immunisations. However, in a study evaluating the response to a 23-valent pneumococcal vaccine, overall immune responses to the different serotypes were similar in SLE patients receiving belimumab compared with those not receiving treatment at the time of vaccination.
Limited data suggest that BENLYSTA does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of BENLYSTA.
Effects on Ability to Drive and Use Machines: There have been no studies to investigate the effect of BENLYSTA on driving performance or the ability to operate machinery. No detrimental effects on such activities are predicted from the pharmacology of BENLYSTA.
The clinical status of the patient and the safety profile of BENLYSTA should be borne in mind when considering the patient's ability to perform tasks that require judgment, motor or cognitive skills.