Usual Adult Dose for Systemic Lupus Erythematosus

IV:
10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

SUBCUTANEOUS:
For Systemic lupus erythematosus (SLE): 200 mg subcutaneously once a week
For Lupus Nephritis: 400-mg subcutaneously (two 200-mg injections) once weekly for 4 doses, then 200 mg subcutaneously once a week thereafter

Comments:

• If SLE patient transitions from IV to subcutaneous administration, administer the first subcutaneous dose 1 to 4 weeks after the last IV dose.
• A patient with lupus nephritis may transition from IV therapy to subcutaneous administration any time after completing the first 2 intravenous doses.
• If a lupus nephritis patient transitions from IV therapy to subcutaneous administration, administer the first subcutaneous dose of 200 mg 1 to 2 weeks after the last intravenous dose.
• Subcutaneous dosing is not based on weight.
• Do not administer as an intravenous push or bolus.
• Consider premedication, including an antihistamine, with or without an antipyretic, before the infusion.
• Consider discontinuing therapy if there is no improvement in disease control after 6 months.
• Beyond 52 weeks, regularly monitor to ensure the benefit and durability of therapy are maintained.
• The efficacy of this drug has not been evaluated in patients with severe active central nervous system lupus; therefore, its use is not recommended for these patients.
• This drug has not been studied in combination with other biologics, including B-cell-targeted therapies, and its use is not recommended with these treatments.

• For the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy
• For the treatment of adult patients with active lupus nephritis who are receiving standard therapy

Usual Pediatric Dose for Systemic Lupus Erythematosus

5 years and older:
10 mg/kg IV over 1 hour at 2-week intervals for the first 3 doses and at 4-week intervals thereafter

Comments:

• Subcutaneous dosing has not been evaluated and is not approved for patients younger than 18 years.
• Consider premedication, including an antihistamine, with or without an antipyretic, before the infusion.
• The efficacy of this drug has not been evaluated in patients with severe active central nervous system lupus; therefore, its use is not recommended for these patients.
• This drug has not been studied in combination with other biologics, including B-cell-targeted therapies, and its use is not recommended with these treatments.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS:

• Patients who have had anaphylaxis with belimumab.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not administer intravenous push or bolus.
• Administer the subcutaneous dose in the abdomen or thigh, preferably on the same day each week.
• The total time from reconstitution to completion of infusion should not exceed 8 hours.

• Refrigerate vials at 36F to 46F (2C to 8C) in the original container until ready to use to protect from light.
• After final dilution in normal saline, half-normal saline, or Lactated Ringer's Injection, the product may be stored at 36F to 46F (2C to 8C) or at room temperature.
• The subcutaneous injection may be stored outside of the refrigerator at room temperature for up to 12 hours if protected from sunlight.
• Do not use and do not place back the subcutaneous injection in the refrigerator if left out for more than 12 hours.
• Avoid exposure to heat.
• Do not freeze.

• Not compatible with dextrose intravenous solutions.
• Do not infuse concomitantly in the same intravenous line with other agents.

• Inform patients of the symptoms of hypersensitivity reactions and instruct them to seek immediate medical care should a reaction occur.
• When injecting in the same body region, advise the patient to use a different injection site for each injection.
• Advise patients to administer the subcutaneous injection in the abdomen or thigh, preferably on the same day each week.
• Advise patients to never give injections into areas where the skin is tender, bruised, red, or hard.
• Recommend patients using a 400-mg dose at the same site, that the 2 individual 200-mg injections be administered at least 5 cm (approximately 2 inches) apart.
• Advise patients that the subcutaneous injection may be stored outside of the refrigerator at room temperature for up to 12 hours if protected from sunlight.
• Advise patients not to use and not place back the subcutaneous injection in the refrigerator if left out for more than 12 hours.

Frequently asked questions

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