What is mechanism of action?

mechanism of action is B Lymphocyte Stimulator-directed Antibody Interactions [MoA]

Benlysta (Belimumab)

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Dosage & administration

* •See Full Prescribing Information for complete preparation and administration information. (

2.1 Important Administration Instructions

BENLYSTA may be administered intravenously or subcutaneously

[see Dosage and Administration (

2.2

2.3

)].

Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use).

Precautions Prior to Intravenous Use

BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis

[see Warnings and Precautions ].

Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions

[see Warnings and Precautions , Adverse Reactions ]

2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions

BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.

Recommended Dosage and Administration

The recommended intravenous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is 10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter.

Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. Do not concomitantly infuse BENLYSTA in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of BENLYSTA with other agents.

The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction

[see Contraindications , Warnings and Precautions ]

Preparation of the Intravenous Solution

BENLYSTA for intravenous use is provided as a lyophilized powder in a single‑dose vial and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows. Use of a 21- to 25-gauge needle is recommended when piercing the vial stopper for reconstitution and dilution.

Reconstitution Instructions for Intravenous Use:

* 1.000000000000000e+00Remove the vial of BENLYSTA from the refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
* 2.000000000000000e+00Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
* 1.000000000000000e+00Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
* 2.000000000000000e+00Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.

* 3.000000000000000e+00Direct the stream of sterile water towards the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.

Do not shake.

Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.
* 4.000000000000000e+00If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, do not exceed 500 rpm or swirl the vial for more than 30 minutes.
* 5.000000000000000e+00Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.

Dilution Instructions for Intravenous Use:

* 1.000000000000000e+00Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP (half-normal saline), or Lactated Ringer’s Injection, USP to a volume of 250 mL for intravenous infusion. To prepare the intravenous infusion solution for patients whose body weight is less than or equal to 40 kg, a 100 mL bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection may be used such that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/mL. From a 250‑mL (or 100‑mL) infusion bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient’s dose. Then add the required volume of the reconstituted solution of BENLYSTA into the intravenous infusion solution in the infusion bag or bottle. Gently invert the bag or bottle to mix the intravenous infusion solution. Any unused solution in the vials must be discarded.
* 2.000000000000000e+00Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
* 3.000000000000000e+00If the reconstituted solution of BENLYSTA is not used immediately, store, protect from direct sunlight and refrigerate at 36°F to 46°F (2°C to 8°C). Store solutions of BENLYSTA diluted in normal saline, half‑normal saline, or Lactated Ringer’s Injection at 36°F to 46°F (2°C to 8°C) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
* 4.000000000000000e+00No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.

2.3 Recommended Subcutaneous Dosage, and Preparation and Administration Instructions

The recommended subcutaneous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is provided in

Table 1

. Administer BENLYSTA subcutaneously in the abdomen or thigh. For patients less than 10 years of age, BENLYSTA must be administered by a healthcare professional or trained caregiver.

Patients greater than or equal to 40 kg: 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once

every 2 weeks

Patients greater than or equal to 40 kg: 400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once

every 2 weeks

Table 1. Recommended Subcutaneous Dosage of BENLYSTA
^aThe prefilled syringe has not been studied in pediatric patients less than 18 years of age.
^bThe 400-mg dose requires administration of two 200-mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)a
Active SLE	200 mg once weekly	*
Active Lupus Nephritis	400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly	*

Administration Instructions for Subcutaneous Injection

* 1.000000000000000e+00Administer the first subcutaneous injection of BENLYSTA under the supervision of a healthcare provider. Provide patients or caregivers with proper training on subcutaneous administration and education about signs and symptoms of hypersensitivity reactions

[see Warnings and Precautions ]

. For adults and pediatric patients 10 years of age and older, subsequent subcutaneous BENLYSTA administrations may be performed by the patient or trained caregiver, if determined to be appropriate. For pediatric patients less than 10 years of age, subsequent subcutaneous BENLYSTA administrations must be performed by a healthcare provider or trained caregiver.
* 2.000000000000000e+00Instruct the patient or caregiver to follow the directions for administration provided in the Instructions for Use.
* 3.000000000000000e+00Instruct the patient or caregiver to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the subcutaneous injection. Do not warm BENLYSTA in any other way.
* 4.000000000000000e+00Prior to administration, instruct the patient or caregiver to visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration. BENLYSTA should be clear to opalescent and colorless to pale yellow. Do not use BENLYSTA if the product exhibits discoloration or particulate matter. Instruct the patient or caregiver not to use the BENLYSTA autoinjector or prefilled syringe if dropped on a hard surface.
* 5.000000000000000e+00When injecting in the same body region, advise the patient or caregiver to use a different injection site for each injection; never give injections into areas where the skin is tender, bruised, red, or hard. When administering a 400‑mg dose, inject each 200‑mg injection at least 5 cm (approximately 2 inches) apart.
* 6.000000000000000e+00Instruct the patient or caregiver to administer BENLYSTA, preferably on the same day each week or the same day of alternate weeks, as appropriate.
* 7.000000000000000e+00If a dose is missed, instruct the patient or caregiver to administer a dose as soon as the patient remembers. Thereafter, the patient can resume dosing on their usual day of administration or start a new schedule from the day that the missed dose was administered.

)
* •Intravenous dosage for active SLE or lupus nephritis:
* o10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter.
* oReconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. (

2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions

BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.

Recommended Dosage and Administration

[see Contraindications , Warnings and Precautions ]

Preparation of the Intravenous Solution

Reconstitution Instructions for Intravenous Use:

Do not shake.

Dilution Instructions for Intravenous Use:

)
* oConsider prophylactic premedication for infusion reactions and hypersensitivity reactions. (

2.1 Important Administration Instructions

BENLYSTA may be administered intravenously or subcutaneously

[see Dosage and Administration (

2.2

2.3

)].

Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use).

Precautions Prior to Intravenous Use

BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis

[see Warnings and Precautions ].

Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions

[see Warnings and Precautions , Adverse Reactions ]

2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions

BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.

Recommended Dosage and Administration

[see Contraindications , Warnings and Precautions ]

Preparation of the Intravenous Solution

Reconstitution Instructions for Intravenous Use:

Do not shake.

Dilution Instructions for Intravenous Use:

)

* •Subcutaneous dosage for active SLE or lupus nephritis: (

2.3 Recommended Subcutaneous Dosage, and Preparation and Administration Instructions

The recommended subcutaneous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is provided in

Table 1

. Administer BENLYSTA subcutaneously in the abdomen or thigh. For patients less than 10 years of age, BENLYSTA must be administered by a healthcare professional or trained caregiver.

Patients greater than or equal to 40 kg: 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once

every 2 weeks

Patients greater than or equal to 40 kg: 400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once

every 2 weeks

Table 1. Recommended Subcutaneous Dosage of BENLYSTA
^aThe prefilled syringe has not been studied in pediatric patients less than 18 years of age.
^bThe 400-mg dose requires administration of two 200-mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)a
Active SLE	200 mg once weekly	*
Active Lupus Nephritis	400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly	*

Administration Instructions for Subcutaneous Injection

[see Warnings and Precautions ]

)

*

every 2 weeks

^b
*

every 2 weeks

•
^aPrefilled syringe has not been studied in children less than 18 years of age.
^bThe 400-mg dose requires administration of two 200‑mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)^a
Active SLE	200 mg once weekly	*
Active Lupus Nephritis	400 mg^b once weekly for 4 doses, followed by 200 mg once weekly	*

≥40 kg: 200 mg once weekly15 kg to less than 40 kg: 200 mg once ≥40 kg: 400 mg once weekly for 4 doses, followed by 200 mg once weekly15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200mg once

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Benlysta prescribing information

Administer the first subcutaneous injection of BENLYSTA under the supervision of a healthcare provider. Provide patients or caregivers with proper training on subcutaneous administration and education about signs and symptoms of hypersensitivity reactions

[see Warnings and Precautions ]

Instruct the patient or caregiver to follow the directions for administration provided in the Instructions for Use.

Instruct the patient or caregiver to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the subcutaneous injection. Do not warm BENLYSTA in any other way.

Prior to administration, instruct the patient or caregiver to visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration. BENLYSTA should be clear to opalescent and colorless to pale yellow. Do not use BENLYSTA if the product exhibits discoloration or particulate matter. Instruct the patient or caregiver not to use the BENLYSTA autoinjector or prefilled syringe if dropped on a hard surface.

When injecting in the same body region, advise the patient or caregiver to use a different injection site for each injection; never give injections into areas where the skin is tender, bruised, red, or hard. When administering a 400‑mg dose, inject each 200‑mg injection at least 5 cm (approximately 2 inches) apart.

Instruct the patient or caregiver to administer BENLYSTA, preferably on the same day each week or the same day of alternate weeks, as appropriate.

If a dose is missed, instruct the patient or caregiver to administer a dose as soon as the patient remembers. Thereafter, the patient can resume dosing on their usual day of administration or start a new schedule from the day that the missed dose was administered.

2.4 Switching from Intravenous to Subcutaneous BENLYSTA Use

Active SLE

Administer the first subcutaneous BENLYSTA dose 1 to 4 weeks after the last intravenous dose. To switch:

Adults and pediatric patients greater than or equal to 40 kg, administer the first 200 mg subcutaneous dose 1 to 4 weeks after the last intravenous dose, then continue 200 mg subcutaneous dosing once weekly.

Pediatric patients 15 kg to less than 40 kg, administer the first 200 mg subcutaneous dose 1 to 4 weeks after the last intravenous dose, then continue 200 mg subcutaneous dosing every 2 weeks.

Active Lupus Nephritis

Patients may be switched from intravenous BENLYSTA treatment to subcutaneous BENLYSTA treatment after completing at least 2 intravenous doses. To switch:

Adults and pediatric patients greater than or equal to 40 kg, administer the first 200 mg subcutaneous dose 1 to 2 weeks after the last intravenous dose, then continue 200 mg subcutaneous dosing once weekly.

Pediatric patients 15 kg to less than 40 kg, administer the first 200 mg subcutaneous dose 1 to 2 weeks after the last intravenous dose, then continue 200 mg subcutaneous dosing every 2 weeks.

)

Dosage and Administration (

2.3 Recommended Subcutaneous Dosage, and Preparation and Administration Instructions

The recommended subcutaneous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is provided in

Table 1

. Administer BENLYSTA subcutaneously in the abdomen or thigh. For patients less than 10 years of age, BENLYSTA must be administered by a healthcare professional or trained caregiver.

Patients greater than or equal to 40 kg: 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once

every 2 weeks

Patients greater than or equal to 40 kg: 400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once

every 2 weeks

Table 1. Recommended Subcutaneous Dosage of BENLYSTA
^aThe prefilled syringe has not been studied in pediatric patients less than 18 years of age.
^bThe 400-mg dose requires administration of two 200-mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)a
Active SLE	200 mg once weekly
Active Lupus Nephritis	400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Administration Instructions for Subcutaneous Injection

6/2025

BENLYSTA is indicated for the treatment of patients 5 years of age and older with:

•Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and
•Active lupus nephritis who are receiving standard therapy.

Limitations of Use

The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.

•See Full Prescribing Information for complete preparation and administration information. (

2.1 Important Administration Instructions

BENLYSTA may be administered intravenously or subcutaneously

[see Dosage and Administration (

2.2

2.3

)].

Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use).

Precautions Prior to Intravenous Use

BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis

[see Warnings and Precautions ].

Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions

[see Warnings and Precautions , Adverse Reactions ]

2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions

BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.

Recommended Dosage and Administration

[see Contraindications , Warnings and Precautions ]

Preparation of the Intravenous Solution

Reconstitution Instructions for Intravenous Use:

1.000000000000000e+00Remove the vial of BENLYSTA from the refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
2.000000000000000e+00Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
- 1.000000000000000e+00Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
- 2.000000000000000e+00Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
3.000000000000000e+00Direct the stream of sterile water towards the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.
Do not shake.
Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.
4.000000000000000e+00If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, do not exceed 500 rpm or swirl the vial for more than 30 minutes.
5.000000000000000e+00Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.

Dilution Instructions for Intravenous Use:

1.000000000000000e+00Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP (half-normal saline), or Lactated Ringer’s Injection, USP to a volume of 250 mL for intravenous infusion. To prepare the intravenous infusion solution for patients whose body weight is less than or equal to 40 kg, a 100 mL bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection may be used such that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/mL. From a 250‑mL (or 100‑mL) infusion bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient’s dose. Then add the required volume of the reconstituted solution of BENLYSTA into the intravenous infusion solution in the infusion bag or bottle. Gently invert the bag or bottle to mix the intravenous infusion solution. Any unused solution in the vials must be discarded.
2.000000000000000e+00Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
3.000000000000000e+00If the reconstituted solution of BENLYSTA is not used immediately, store, protect from direct sunlight and refrigerate at 36°F to 46°F (2°C to 8°C). Store solutions of BENLYSTA diluted in normal saline, half‑normal saline, or Lactated Ringer’s Injection at 36°F to 46°F (2°C to 8°C) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
4.000000000000000e+00No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.

2.3 Recommended Subcutaneous Dosage, and Preparation and Administration Instructions

The recommended subcutaneous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is provided in

Table 1

. Administer BENLYSTA subcutaneously in the abdomen or thigh. For patients less than 10 years of age, BENLYSTA must be administered by a healthcare professional or trained caregiver.

Patients greater than or equal to 40 kg: 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once

every 2 weeks

Patients greater than or equal to 40 kg: 400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once

every 2 weeks

Table 1. Recommended Subcutaneous Dosage of BENLYSTA
^aThe prefilled syringe has not been studied in pediatric patients less than 18 years of age.
^bThe 400-mg dose requires administration of two 200-mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)a
Active SLE	200 mg once weekly
Active Lupus Nephritis	400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Administration Instructions for Subcutaneous Injection

1.000000000000000e+00Administer the first subcutaneous injection of BENLYSTA under the supervision of a healthcare provider. Provide patients or caregivers with proper training on subcutaneous administration and education about signs and symptoms of hypersensitivity reactions
[see Warnings and Precautions ]
. For adults and pediatric patients 10 years of age and older, subsequent subcutaneous BENLYSTA administrations may be performed by the patient or trained caregiver, if determined to be appropriate. For pediatric patients less than 10 years of age, subsequent subcutaneous BENLYSTA administrations must be performed by a healthcare provider or trained caregiver.
2.000000000000000e+00Instruct the patient or caregiver to follow the directions for administration provided in the Instructions for Use.
3.000000000000000e+00Instruct the patient or caregiver to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the subcutaneous injection. Do not warm BENLYSTA in any other way.
4.000000000000000e+00Prior to administration, instruct the patient or caregiver to visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration. BENLYSTA should be clear to opalescent and colorless to pale yellow. Do not use BENLYSTA if the product exhibits discoloration or particulate matter. Instruct the patient or caregiver not to use the BENLYSTA autoinjector or prefilled syringe if dropped on a hard surface.
5.000000000000000e+00When injecting in the same body region, advise the patient or caregiver to use a different injection site for each injection; never give injections into areas where the skin is tender, bruised, red, or hard. When administering a 400‑mg dose, inject each 200‑mg injection at least 5 cm (approximately 2 inches) apart.
6.000000000000000e+00Instruct the patient or caregiver to administer BENLYSTA, preferably on the same day each week or the same day of alternate weeks, as appropriate.
7.000000000000000e+00If a dose is missed, instruct the patient or caregiver to administer a dose as soon as the patient remembers. Thereafter, the patient can resume dosing on their usual day of administration or start a new schedule from the day that the missed dose was administered.

)

•Intravenous dosage for active SLE or lupus nephritis:
- o10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter.
- oReconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. (
  2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions
  BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.
  Recommended Dosage and Administration
  The recommended intravenous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is 10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter.
  Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. Do not concomitantly infuse BENLYSTA in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of BENLYSTA with other agents.
  The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction
  [see Contraindications , Warnings and Precautions ]
  .
  Preparation of the Intravenous Solution
  BENLYSTA for intravenous use is provided as a lyophilized powder in a single‑dose vial and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows. Use of a 21- to 25-gauge needle is recommended when piercing the vial stopper for reconstitution and dilution.
  Reconstitution Instructions for Intravenous Use:
  1.000000000000000e+00Remove the vial of BENLYSTA from the refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
  2.000000000000000e+00Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
  1.000000000000000e+00Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
  2.000000000000000e+00Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
  3.000000000000000e+00Direct the stream of sterile water towards the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.
  Do not shake.
  Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.
  4.000000000000000e+00If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, do not exceed 500 rpm or swirl the vial for more than 30 minutes.
  5.000000000000000e+00Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.
  Dilution Instructions for Intravenous Use:
  1.000000000000000e+00Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP (half-normal saline), or Lactated Ringer’s Injection, USP to a volume of 250 mL for intravenous infusion. To prepare the intravenous infusion solution for patients whose body weight is less than or equal to 40 kg, a 100 mL bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection may be used such that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/mL. From a 250‑mL (or 100‑mL) infusion bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient’s dose. Then add the required volume of the reconstituted solution of BENLYSTA into the intravenous infusion solution in the infusion bag or bottle. Gently invert the bag or bottle to mix the intravenous infusion solution. Any unused solution in the vials must be discarded.
  2.000000000000000e+00Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
  3.000000000000000e+00If the reconstituted solution of BENLYSTA is not used immediately, store, protect from direct sunlight and refrigerate at 36°F to 46°F (2°C to 8°C). Store solutions of BENLYSTA diluted in normal saline, half‑normal saline, or Lactated Ringer’s Injection at 36°F to 46°F (2°C to 8°C) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
  4.000000000000000e+00No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.
  )
- oConsider prophylactic premedication for infusion reactions and hypersensitivity reactions. (
  2.1 Important Administration Instructions
  BENLYSTA may be administered intravenously or subcutaneously
  [see Dosage and Administration (
  2.2
  ,
  2.3
  )].
  Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use).
  Precautions Prior to Intravenous Use
  BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis
  [see Warnings and Precautions ].
  Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions
  [see Warnings and Precautions , Adverse Reactions ]
  .
  ,
  2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions
  BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.
  Recommended Dosage and Administration
  The recommended intravenous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is 10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter.
  Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. Do not concomitantly infuse BENLYSTA in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of BENLYSTA with other agents.
  The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction
  [see Contraindications , Warnings and Precautions ]
  .
  Preparation of the Intravenous Solution
  BENLYSTA for intravenous use is provided as a lyophilized powder in a single‑dose vial and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows. Use of a 21- to 25-gauge needle is recommended when piercing the vial stopper for reconstitution and dilution.
  Reconstitution Instructions for Intravenous Use:
  1.000000000000000e+00Remove the vial of BENLYSTA from the refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
  2.000000000000000e+00Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
  1.000000000000000e+00Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
  2.000000000000000e+00Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
  3.000000000000000e+00Direct the stream of sterile water towards the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.
  Do not shake.
  Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.
  4.000000000000000e+00If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, do not exceed 500 rpm or swirl the vial for more than 30 minutes.
  5.000000000000000e+00Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.
  Dilution Instructions for Intravenous Use:
  1.000000000000000e+00Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP (half-normal saline), or Lactated Ringer’s Injection, USP to a volume of 250 mL for intravenous infusion. To prepare the intravenous infusion solution for patients whose body weight is less than or equal to 40 kg, a 100 mL bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection may be used such that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/mL. From a 250‑mL (or 100‑mL) infusion bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient’s dose. Then add the required volume of the reconstituted solution of BENLYSTA into the intravenous infusion solution in the infusion bag or bottle. Gently invert the bag or bottle to mix the intravenous infusion solution. Any unused solution in the vials must be discarded.
  2.000000000000000e+00Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
  3.000000000000000e+00If the reconstituted solution of BENLYSTA is not used immediately, store, protect from direct sunlight and refrigerate at 36°F to 46°F (2°C to 8°C). Store solutions of BENLYSTA diluted in normal saline, half‑normal saline, or Lactated Ringer’s Injection at 36°F to 46°F (2°C to 8°C) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
  4.000000000000000e+00No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.
  )

•Subcutaneous dosage for active SLE or lupus nephritis: (

2.3 Recommended Subcutaneous Dosage, and Preparation and Administration Instructions

The recommended subcutaneous BENLYSTA dosage in patients 5 years of age and older with active SLE or lupus nephritis is provided in

Table 1

. Administer BENLYSTA subcutaneously in the abdomen or thigh. For patients less than 10 years of age, BENLYSTA must be administered by a healthcare professional or trained caregiver.

Patients greater than or equal to 40 kg: 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once

every 2 weeks

Patients greater than or equal to 40 kg: 400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Patients 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once

every 2 weeks

Table 1. Recommended Subcutaneous Dosage of BENLYSTA
^aThe prefilled syringe has not been studied in pediatric patients less than 18 years of age.
^bThe 400-mg dose requires administration of two 200-mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)a
Active SLE	200 mg once weekly
Active Lupus Nephritis	400 mg^bonce weekly for 4 doses, followed by 200 mg once weekly

Administration Instructions for Subcutaneous Injection

1.000000000000000e+00Administer the first subcutaneous injection of BENLYSTA under the supervision of a healthcare provider. Provide patients or caregivers with proper training on subcutaneous administration and education about signs and symptoms of hypersensitivity reactions
[see Warnings and Precautions ]
. For adults and pediatric patients 10 years of age and older, subsequent subcutaneous BENLYSTA administrations may be performed by the patient or trained caregiver, if determined to be appropriate. For pediatric patients less than 10 years of age, subsequent subcutaneous BENLYSTA administrations must be performed by a healthcare provider or trained caregiver.
2.000000000000000e+00Instruct the patient or caregiver to follow the directions for administration provided in the Instructions for Use.
3.000000000000000e+00Instruct the patient or caregiver to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the subcutaneous injection. Do not warm BENLYSTA in any other way.
4.000000000000000e+00Prior to administration, instruct the patient or caregiver to visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration. BENLYSTA should be clear to opalescent and colorless to pale yellow. Do not use BENLYSTA if the product exhibits discoloration or particulate matter. Instruct the patient or caregiver not to use the BENLYSTA autoinjector or prefilled syringe if dropped on a hard surface.
5.000000000000000e+00When injecting in the same body region, advise the patient or caregiver to use a different injection site for each injection; never give injections into areas where the skin is tender, bruised, red, or hard. When administering a 400‑mg dose, inject each 200‑mg injection at least 5 cm (approximately 2 inches) apart.
6.000000000000000e+00Instruct the patient or caregiver to administer BENLYSTA, preferably on the same day each week or the same day of alternate weeks, as appropriate.
7.000000000000000e+00If a dose is missed, instruct the patient or caregiver to administer a dose as soon as the patient remembers. Thereafter, the patient can resume dosing on their usual day of administration or start a new schedule from the day that the missed dose was administered.

)

≥40 kg: 200 mg once weekly

15 kg to less than 40 kg: 200 mg once

every 2 weeks

≥40 kg: 400 mg^b once weekly for 4 doses, followed by 200 mg once weekly

15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200

mg once

every 2 weeks

•
^aPrefilled syringe has not been studied in children less than 18 years of age.
^bThe 400-mg dose requires administration of two 200‑mg injections.
Indication	Adults (Autoinjector or Prefilled Syringe)	Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only)^a
Active SLE	200 mg once weekly
Active Lupus Nephritis	400 mg^b once weekly for 4 doses, followed by 200 mg once weekly

Pregnancy Exposure Registry

There is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to BENLYSTA during pregnancy. Healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

Risk Summary

Available data on use of BENLYSTA in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with SLE

(see

Clinical Considerations

)

. Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant

(see

Clinical Considerations

)

. In an animal combined embryo-fetal and pre- and post-natal development study with monkeys that received belimumab by intravenous administration, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose (MRHD). Belimumab-related findings in monkey fetuses and/or infants included reductions of B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, and altered IgG and IgM titers. The no-adverse-effect-level (NOAEL) was not identified for these findings; however, they were reversible within 3 to 12 months after the drug was discontinued

(see

Data

)

. Based on animal data and the mechanism of action of belimumab, the immune system in infants of treated mothers may be adversely affected. It is unknown, based on available data, whether immune effects, if identified, are reversible

[see Clinical Pharmacology (

12.1 Mechanism of Action

BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

)]

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk:

Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block.

Fetal/Neonatal Adverse Reactions:

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to BENLYSTA in utero. Monitor an infant of a treated mother for B-cell reduction and other immune dysfunction

[see Warnings and Precautions (

5.5 Immunization

Because of its mechanism of action, BENLYSTA may interfere with the response to immunizations. Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving BENLYSTA or the effect of BENLYSTA on new immunizations.

)]

Data

Animal Data:

In a combined embryo-fetal and pre- and post-natal development study, pregnant cynomolgus monkeys received belimumab at intravenous doses of 0, 5, or 150 mg/kg every 2 weeks from confirmation of pregnancy at Gestation Days (GD) 20 to 22, throughout the period of organogenesis (up to approximately GD 50), and continuing to either the day of scheduled cesarean section (GD 150 [late third trimester]) or the day of parturition. There was no evidence of maternal toxicity, effects on embryofetal and infant survival, or structural abnormalities at exposure approximately 9 times the MRHD of 10 mg/kg intravenously or 20 times the MRHD of 200 mg subcutaneously (on an area under the curve [AUC] basis with maternal animal intravenous doses up to 150 mg/kg). Belimumab-related findings in mothers included reductions of immature and mature B-cell counts and in fetuses and/or infants included reductions of immature and mature B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, reduced spleen weights, increased IgG titers, and reduced IgM titers. B-cell counts in infant monkeys exposed to belimumab in utero recovered by 3 months of age and in mothers after 1 year. Immunoglobulin G (IgG) and IgM levels in infant monkeys recovered by 6 months of age and the reductions in B-lymphocytes in the lymph nodes and spleen were reversed by 1 year of age. Belimumab crossed the placenta, as it was detected in fetal cord blood and amniotic fluid on GD 150.

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