Generic name: BELIMUMAB 400mg in 5mL
Dosage form: injection, powder, lyophilized, for solution
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BENLYSTA may be administered as an intravenous infusion or as a subcutaneous injection. 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).
Intravenous Preparation and Dosing Instructions
Recommended Intravenous Dosage Regimen
BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.
The recommended intravenous dosage regimen 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. 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 (4), Warnings and Precautions (5.3)].
Premedication Recommendations prior to Intravenous Use
Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions [see Warnings and Precautions (5.3, 5.4), Adverse Reactions (6.1)].
Preparation of Intravenous Solutions
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:
- Remove the vial of BENLYSTA from the refrigerator and allow to stand for 10 to 15 minutes for the vial to reach room temperature.
- Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
- Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
- Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
- The stream of sterile water should be directed toward 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.
- If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, it should not exceed 500 rpm and the vial swirled for no longer than 30 minutes.
- Once 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:
- Dextrose 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. From a 250‑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 infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
- The reconstituted solution of BENLYSTA, if not used immediately, should be stored protected from direct sunlight and refrigerated at 2° to 8°C (36° to 46°F). Solutions of BENLYSTA diluted in normal saline, half-normal saline, or Lactated Ringer’s Injection may be stored at 2° to 8°C (36° to 46°F) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
- No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.
Administration Instructions for Intravenous Use
- The diluted solution of BENLYSTA should be administered by intravenous infusion, over a period of 1 hour.
- BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis [see Warnings and Precautions (5.3)].
- BENLYSTA should not be infused concomitantly 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.
2.2 Subcutaneous Dosing Instructions
Recommended Subcutaneous Dosage Regimen
The recommended dosage is 200 mg once weekly given as a subcutaneous injection in the abdomen or thigh. Subcutaneous dosing is not based on weight.
If transitioning from intravenous therapy with BENLYSTA to subcutaneous administration, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose.
Administration Instructions for Subcutaneous Injection
- It is recommended that the first subcutaneous injection of BENLYSTA should be under the supervision of a healthcare professional. The healthcare provider should provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions [see Warning and Precautions (5.3)]. A patient may self-inject or the patient caregiver may administer BENLYSTA subcutaneously after the healthcare provider determines it is appropriate.
- Instruct the patient or patient caregiver to follow the directions for administration provided in the Instructions for Use.
- Instruct the patient 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 patient 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 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 to use a different injection site each week; never give injections into areas where the skin is tender, bruised, red, or hard.
- Instruct the patient to administer BENLYSTA 200 mg once a week, preferably on the same day each week.
- If a dose is missed, instruct the patient 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 weekly schedule from the day that the missed dose was administered. It is not recommended to administer 2 doses on the same day.
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