Usual Adult Dose for Systemic Lupus Erythematosus

300 mg IV over 30 minutes every 4 weeks

Comment:

• The efficacy of this drug has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, therefore, the use in these situations is not recommended.

• For the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Patients with a history of anaphylaxis

Dialysis

Data not available

Other Comments

Administration advice:

• Visually inspect the vial for the presence of particulate matter and discoloration, discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial.
• Administer intravenously over a 30-minute period through an infusion line containing a sterile, low-protein binding 0.2 to 15 micron in-line or add-on filter.
• Administer the infusion immediately after preparation.
• If a planned infusion is missed, administer it as soon as possible.
• Maintain a minimum interval of 14 days between infusions.

• Refrigerate vials at 36F to 46F (2C to 8C) in the original container until ready to use to protect from light.
• The diluted solution might be stored at room temperature 15C to 25C (59F to 77F) for up to 4 hours or refrigerated 2C to 8C (36F to 46F) for up to 24 hours.
• Do not freeze.
• Do not shake.

• The manufacturer product information should be consulted.

• Do not co-administer other medicines through the same infusion line.

• This drug may decrease the ability to fight infections, including fatal ones.
• There is an increased risk of respiratory infections and herpes zoster during treatment with this drug.
• Advise patients to contact their healthcare provider if they develop any symptoms of an infection, including fever or flu-like symptoms; muscle aches; cough; shortness of breath; burning when they urinate or urinating more often than usual; diarrhea or stomach pain; and shingles (a red skin rash that can cause pain and burning).
• Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of this drug.
• Instruct patients to immediately tell their healthcare provider or go to the emergency department if they experience symptoms of an allergic reaction (e.g., anaphylaxis) during or after the administration of this drug.
• Inform patients that they should not receive live or live-attenuated vaccines during treatment with this drug.
• Advise patients to discuss with their healthcare provider before seeking immunizations on their own.
• Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant, or become pregnant while receiving this drug.
• Inform women that they can find information about a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug by calling 1-877-693-9268.

Frequently asked questions

• What is the difference between Benlysta and Saphnelo?