Belimumab Dosage

Medically reviewed by Drugs.com. Last updated on Oct 5, 2020.

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.

Uses:
-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.

Use: For the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS:
-Patients who have had anaphylaxis with belimumab.

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

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.

Storage requirements:
-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.
Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility:
-Not compatible with dextrose intravenous solutions.
-Do not infuse concomitantly in the same intravenous line with other agents.

Patient advice:
-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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer