Benlysta injection for active lupus and lupus nephritis treatment

Benlysta is a medicine containing belimumab, designed for intravenous or subcutaneous injection. It is used to treat patients aged 5 years and older who have active systemic lupus erythematosus (SLE) or active lupus nephritis, both alongside standard therapy.

Benlysta is approved for the treatment of:

• Active systemic lupus erythematosus (SLE) in patients 5 years and older receiving standard lupus therapy.
• Active lupus nephritis in patients 5 years and older receiving standard therapy.

Limitations: Benlysta has not been evaluated for patients with severe active central nervous system lupus and is not recommended in those cases.

belimumab

Benlysta works by specifically inhibiting a protein called B-lymphocyte stimulator (BLyS), which is involved in the survival and activity of B cells. By blocking BLyS, Benlysta reduces the abnormal B cell activity responsible for inflammation and tissue damage in lupus.

Intravenous administration (for patients 5 years and older with active SLE or lupus nephritis):

• 10 mg per kg body weight given as an infusion every 2 weeks for the first 3 doses, then every 4 weeks thereafter.
• Reconstitute and dilute as a lyophilized powder into normal saline, half-normal saline, or Lactated Ringer's solution to a final volume of 250 mL (or 100 mL for patients ≤40 kg) before infusion over 1 hour.
• Infusion rate may be slowed or interrupted if infusion reactions occur; discontinue immediately if serious hypersensitivity occurs.
• Premedication may be considered to prevent infusion and hypersensitivity reactions.

Subcutaneous administration (for patients 5 years and older with active SLE or lupus nephritis):

• Administer by injection into the abdomen or thigh.
• For active SLE: 200 mg once weekly for adults and patients ≥40 kg; 200 mg every 2 weeks for patients 15 to less than 40 kg.
• For active lupus nephritis: 400 mg once weekly for 4 doses followed by 200 mg once weekly for adults and patients ≥40 kg; 200 mg once weekly for 4 doses followed by 200 mg every 2 weeks for patients 15 to less than 40 kg.
• First injection should be given under healthcare provider supervision with proper patient or caregiver training.
• For patients under 10 years old, injections must be administered by healthcare professionals or trained caregivers.
• Allow autoinjectors or prefilled syringes to reach room temperature (30 minutes) before use; inspect for discoloration or particles before injection.
• Use different injection sites for subsequent doses and do not inject into bruised, red, tender or hard skin.
• If a dose is missed, administer as soon as remembered and resume original schedule.

• History of anaphylaxis to belimumab.
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis associated with belimumab.

Serious infections:

Serious and sometimes fatal infections have occurred with Benlysta, as it suppresses the immune system. Use cautiously in patients with severe or chronic infections. Interrupt treatment if new infections develop and monitor closely.

Progressive multifocal leukoencephalopathy (PML):

Evaluate patients who develop new or worsening neurological symptoms for PML. Suspend Benlysta until PML is excluded. If confirmed, permanently discontinue Benlysta.

Hypersensitivity and anaphylaxis:

Serious and fatal hypersensitivity reactions including anaphylaxis have been reported. Benlysta should be administered by healthcare providers prepared to manage these reactions. Premedication may be considered.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN):

Discontinue Benlysta immediately if signs or symptoms of SJS/TEN occur.

Depression and suicidality:

Monitor patients for depression and suicidal thoughts before and during treatment. Patients should report new or worsening mood symptoms promptly.

Immunization:

Live vaccines should not be given during Benlysta treatment.

Common side effects:

• Infections such as upper respiratory tract infections.
• Infusion or injection site reactions.

Serious side effects:

• Severe hypersensitivity reactions including anaphylaxis.
• Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Serious and fatal infections.
• Progressive multifocal leukoencephalopathy (PML).
• Depression and suicidal ideation.

Live vaccines should be avoided during Benlysta treatment due to immunosuppression. No physical or biochemical compatibility studies support mixing Benlysta with other intravenous agents in the same infusion line.

• Vials for intravenous use: Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Protect reconstituted solution from direct sunlight and refrigerate if not used immediately.
• Solutions diluted for infusion can be stored refrigerated or at room temperature but must be used within 8 hours from reconstitution to completion of infusion.
• Subcutaneous autoinjectors and prefilled syringes: Store refrigerated at 2°C to 8°C and allow to sit at room temperature for 30 minutes before injection; do not warm by other means.