Overview
Benlysta is an injectable drug indicated for treatment of systemic lupus. It can be administered in subcutaneous or intravenous forms.
Warnings/precautions
(from Uptodate)
Concerns related to adverse effects:
- Hypersensitivity/infusion reactions: Acute hypersensitivity reactions including anaphylaxis (with fatalities) have been reported, including in patients who had previously tolerated infusions of belimumab; onset may occur within hours of the infusion or may be delayed. Non-acute hypersensitivity reactions, including facial edema, fatigue, headache, myalgia, nausea, and rash have been reported and may occur up to a week following infusion. Risk for hypersensitivity reactions may be increased in patients with history of multiple drug allergies or significant hypersensitivity. Infusion-related reactions (which may be difficult to distinguish from hypersensitivity) may also occur; symptoms may include angioedema, bradycardia, dyspnea, headache, hypotension, myalgia, pruritus, rash, and urticaria. Consider premedication prior to infusion; however, it is unknown if premedication prevents or reduces the severity of hypersensitivity reactions.
- Infections: Serious and potentially fatal infections may occur during treatment. Use with caution and consider the risk and benefit before initiating treatment in patients with severe or chronic infections.
- Malignancy: Immunosuppressant therapy may increase the risk of malignancy. Consider the risk and benefit before initiating treatment in patients with risk factors for developing new or recurrent malignancy or continuing therapy in patients who develop malignancy while receiving belimumab.
- Progressive multifocal leukoencephalopathy: Cases of progressive multifocal leukoencephalopathy (PML) associated with JC virus (some fatal) have been reported in patients with systemic lupus erythematosus (SLE) receiving immunosuppressants, including belimumab. Risk factors for PML include immunosuppressant therapies and impaired immune function. Consider diagnosis of PML in any patient presenting with new-onset or deteriorating neurologic signs/symptoms; consult a neurologist (or other appropriate specialist).
- Psychiatric events: Psychiatric disorders (including depression and suicidal ideation and behavior) have been reported. Prior to and during treatment, the risk of depression and suicide should be assessed based on medical history and current psychiatric status. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new-onset or worsening depression, anxiety, or other mood changes; risk and benefit of continued treatment should be assessed for patients who develop such symptoms.
Dose
- 200 mg. SC weekly
- Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks.
