Belimumab Dosage
Medically reviewed by Drugs.com. Last updated on Oct 5, 2020.
Applies to the following strengths: 200 mg/mL; 120 mg; 400 mg
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
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.
More about belimumab
- Side Effects
- During Pregnancy or Breastfeeding
- Drug Interactions
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- Drug class: selective immunosuppressants
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