Belimumab Dosage

Medically reviewed by Drugs.com. Last updated on Apr 5, 2024.

Usual Adult Dose for Systemic Lupus Erythematosus

IV: 10 mg/kg IV every 2 weeks for the first 3 doses and every 4 weeks thereafter
Subcutaneous: 200 mg subcutaneously once a week

Comments:

• Subcutaneous dosing is not based on weight.
• If transitioning from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered 1 to 4 weeks after the last IV dose.

Use: For the treatment of patients with active systemic lupus erythematosus (SLE) who are receiving standard therapy

Usual Adult Dose for Lupus Nephritis

IV: 10 mg/kg IV every 2 weeks for the first 3 doses and every 4 weeks thereafter
Subcutaneous:

• As initial therapy: 400 mg subcutaneously once a week for 4 doses, then 200 mg subcutaneously once a week thereafter

Comments:

• Patients may transition from IV therapy to subcutaneous therapy any time after completion of the first 2 IV doses; if transitioning, the first subcutaneous dose of 200 mg should be administered 1 to 2 weeks after the last IV dose.

Use: For the treatment of 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 every 2 weeks for the first 3 doses and every 4 weeks thereafter

Uses:

• For the treatment of patients with active SLE who are receiving standard therapy
• For the treatment of patients with active lupus nephritis who are receiving standard therapy

Usual Pediatric Dose for Lupus Nephritis

5 years and older: 10 mg/kg IV every 2 weeks for the first 3 doses and every 4 weeks thereafter

Uses:

• For the treatment of patients with active SLE who are receiving standard therapy
• For the treatment of patients with active lupus nephritis who are receiving standard therapy

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended

Precautions

CONTRAINDICATIONS:

• Previous anaphylaxis to the active component

Safety and efficacy of IV administration have not been established in patients younger than 5 years. Safety and efficacy of subcutaneous administration have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
IV Administration:

• May administer as an IV infusion in patients aged 5 years and older or as a subcutaneous injection in patients aged 18 years and older
• Vials are intended for IV use only (not for subcutaneous use); autoinjectors and prefilled syringes are intended for subcutaneous use only (not for IV use).
• This drug should be administered by health care providers prepared to manage anaphylaxis.
• Reconstitute, dilute, and administer as an IV infusion over 1 hour; do not administer as an IV push or bolus.
• The infusion rate may be slowed or interrupted if the patient develops an infusion reaction.
• Discontinue the infusion immediately if the patient has a serious hypersensitivity reaction.
• Do not infuse concomitantly in the same IV line with other agents.
• Monitor patients during infusion and for an appropriate period of time after IV administration of this drug.
• Before IV dosing, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions.

Subcutaneous Administration:

• The first subcutaneous injection should be under the supervision of a health care professional.
• The health care provider should provide proper training in subcutaneous technique and education about signs/symptoms of hypersensitivity reactions.
• A patient may self-inject or the patient caregiver may administer this drug subcutaneously after the health care provider determines it is appropriate.
• Instruct the patient or caregiver to follow the directions for administration in the Instructions for Use.
• Administer as a subcutaneous injection in the abdomen or thigh; administer weekly, preferably on the same day each week.
• Remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes before subcutaneous injection; do not warm in any other way.
• Do not use the autoinjector or prefilled syringe if dropped on a hard surface.
• When injecting in the same body region, use a different injection site for each injection; do not inject into areas where skin is tender, bruised, red, or hard.
• When a 400 mg dose is administered at the same site, administer the 2 individual 200 mg injections at least 5 cm (about 2 inches) apart.
• If a dose is missed, administer a dose as soon as remembered; thereafter, resume dosing on the usual day of administration or start a new weekly schedule from the day that the missed dose was administered.

Storage requirements:
IV Infusion:

• Unopened vials: Refrigerate at 2C to 8C (36 F to 46F); store in original carton until use to protect from light. Do not freeze; avoid exposure to heat.
• Before reconstitution, remove vial from refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
• Allow vial to sit at room temperature during reconstitution (usually complete within 10 to 15 minutes after adding sterile water but may take up to 30 minutes).
• Reconstituted solution: If not used immediately, protect from sunlight, and refrigerate at 2C to 8C (36 F to 46F).
• Diluted solution: Store at 2C to 8C (36 F to 46F) or room temperature.
• The total time from reconstitution to completion of infusion should not exceed 8 hours.

Subcutaneous Injection:

• Before dispensing: Refrigerate prefilled autoinjectors and prefilled syringes at 2C to 8C (36 F to 46F); keep in original carton until time of use to protect from light. Do not freeze or shake; avoid exposure to heat.
• After dispensing: Refrigerate prefilled autoinjectors and prefilled syringes at 2C to 8C (36 F to 46F); keep in original carton until time of use to protect from light. Do not freeze or shake; avoid exposure to heat.
• May store outside of refrigerator up to 30C (86F) for up to 12 hours if protected from sunlight; do not use and do not return to refrigerator if left out for more than 12 hours.

Reconstitution/preparation techniques:

• For IV use: This drug must be reconstituted and diluted before administration.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile Water for Injection, USP; 0.9% Sodium Chloride Injection, USP (normal saline); 0.45% Sodium Chloride Injection, USP (half-normal saline); Lactated Ringer's Injection, USP
• No incompatibilities between this drug and polyvinylchloride or polyolefin bags have been observed.
• Incompatible: Dextrose IV solutions
• No physical or biochemical compatibility studies have been conducted to evaluate coadministration of this drug with other agents.

General:

• Limitations of Use: Efficacy has not been evaluated in patients with severe active CNS lupus; this drug should not be used in this situation.
• This drug should be used with caution in older adult patients (65 years and older).

Monitoring:

• General: For infusion-related reactions (during and after IV infusion)
• Hypersensitivity: For hypersensitivity reactions (during and after IV infusion)
• Psychiatric: Psychiatric status (before and during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Notify health care provider if signs/symptoms of an infection develop.
• Contact health care professional if new/worsening neurological symptoms (e.g., memory loss, confusion, dizziness/loss of balance, difficulty talking/walking, vision problems) occur.
• Hypersensitivity and infusion-related reactions (including wheezing, difficulty breathing, angioedema, rash, hypotension, bradycardia, headache) have been reported; notify health care provider immediately if symptoms of an allergic reaction occur during or after administration of this drug. Seek immediate medical care if a hypersensitivity reaction occurs.
• Delayed reactions that may include a combination of symptoms (e.g., rash, nausea, fatigue, muscle aches, headache, facial swelling) are possible and may occur after administration of this drug; contact health care provider.
• Contact health care provider if new/worsening depression, suicidal thoughts/behavior, or other mood changes occur.
• Do not receive live vaccines while taking this drug; response to vaccinations could be impaired by this drug.
• A pregnancy registry has been established to evaluate fetal outcomes of pregnant women with lupus exposed to this drug.
• Patients of childbearing potential: This drug may affect the immune system in infants of treated mothers; notify prescriber of a known/suspected pregnancy.

Frequently asked questions

• What is the difference between Benlysta and Saphnelo?

Further information

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

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